(d) LightLight, like heat, provides the activation energy necessary to produce a chemical reaction. To activate a molecule, an original ray of radiation of appropriate frequency and sufficient energy must be absorbed. The unit of radiant energy is called a photon, and the energy of a photon is equivalent to a quantum. The energy of the photon is directly proportional to the frequency of the absorbed radiation energy and inversely proportional to the wavelength, so the shorter the wavelength of the light, the greater the energy absorbed per gram of molecular drug. Photochemical decomposition of pharmaceutical preparations is usually caused by absorption of violet and ultraviolet light from sunlight. Certain drugs oxidation a reduction, ring rearrangement or ring change, joint, hydrolysis and other reactions, in the special wavelength of the Shen line effect may occur or accelerate, for example, the hydrolysis of amyl nitrite. Morphine, codeine, quinine oxidation, volatile oil polymerization. The photochemical reaction has nothing to do with the humidity, but when a molecule absorbs a quantum of radiant energy, it collides with other molecules, and the humidity in the system rises. This was originally a photochemical reaction followed by a thermal reaction Table 44-2.
Whether a drug is sensitive to light is mainly related to the chemical structure of the drug, phenolic drugs (e.g., phenol, epinephrine, morpheus, etc.) and molecules with double bonds in the drug (e.g., vitamins A and D, vitamin B12, mesocarboxylic acid, lisinopril, etc.) are very sensitive to light. Halogen-containing drugs such as iodide, iodoform, chloroform, trichloroethylene, etc., are also susceptible to partitioning under the influence of light. Light reaction than decomposition should be much more complex, the country for the intensity of light, wavelength, the type of container and its shape, size and thickness, sample Lv and the distance from the light and other conditions, can significantly affect the speed of the photochemical reaction celebration. Photochemical reactions are often accompanied by reactions. Once the thermal reaction is underway, the reaction can continue even if the light stops. Photochemical reactions may be zero-, one-, or two-stage reactions. Due to the complexity of the photochemical reactions, drug claims characterization in this area are generally only qualitative. Vitamin B in a solution of P3.5-6.5 under light produces hydroxyB12 and cyanide, which is reversibly counter celebrated. Hydroxy B12 activity is lower than B12 and easy to further decomposition of physiologically inactive substances:
Neutral solution of B12, in the diffuse sunlight irradiation (intensity of about 100 lumens / square meter or 3,000 lumens / square meter) decomposition of the anti-too insignificant. Direct exposure to 8000 lumens/square meter of sunlight, B12 loses about 10% of its potency every half hour. Vitamin B12 does not decompose when the wavelength of light is 600-700 nm. In order to minimize the effect of light on the stability of the drug, it should be packaged in brown glass bottles with walls of a certain thickness. Brown bottles with thin walls are less effective. Light-sensitive note, in time to the production and storage process should be protected from light.
(E) ionic strength ionic strength on drug decomposition . (A) hydrolysis reaction caused by the stability of the drug hydrolysis reaction can be divided into ionic hydrolysis and molecular hydrolysis two categories, away from the type of hydrolysis is a strong acid and a weak base-type salt or a strong base and a weak acid salt, etc. with ionic bonding of the drug and the instantaneous reaction speed of the water is generally relatively slow, catalyzed by the H + or OH -, the counter-celebration of accelerated and tends to be complete. Molecular water causes breakage of the molecular structure, which can make the drug ineffective or less effective. For example (expressed as a general formula)
1, the decomposition of ester drugs; many drugs containing esters, in solution is easily hydrolyzed to generate organic carboxylic acids and alcohols in the mixtures. This hydrolysis is mainly between the carbon atom and oxygen atom that is between the acetyl an oxygen bond *** valence bond. Although individual esters (mainly low molecular weight primary alcohol esters of drugs) can also produce significant hydrolysis in simple water, most ester? s are catalyzed by (lysozymes) in order to accelerate their antipodes so that the antipodes proceed completely. The kinetic equation for the acid- or base-catalyzed hydrolysis of an ester has the general formula:
d ester/dt=-k ester H+
d ester/dt=-k ester OH-
Therefore, it is a secondary reaction. But if H- or OH+>> ester, or with buffer salts to keep H- or OH+ in almost unchanged, then: d ester/dt=-k ester ester so it is a pseudo-primary reaction. Hydrolysis of esters is often a primary or pseudo-primary kinetic reaction but sometimes a secondary reaction. Succinyl chloride choline is more stable than acetyl chloride choline, injection solution (PH3-5) can be 98-1000, 30 minutes to sterilize the powder ampoule is appropriate. Succinyl chloride choline solution is most stable at about PH3.7, at P0.9-8.5 insolubility reaction is a first-order reaction, the reaction rate constant can be calculated by tom K = 1.36 × 10 "exp (-17230/RT). The hydrolysis of this product acid a base catalyzed, for example, acetate buffer (600, ionic strength = 0.2, PH = 4.69,3.98) decomposition is a secondary reaction with a reaction rate number of 5 x 10 (liters/g molecule hour). Therefore, the injection should not contain a buffer;. The degree of hydrolysis of carboxylic acid ester (R-C-OR) and the structure of the R has a great deal to do with the R. The larger the R group or the carbon on the alkyl or other groups occupy the greater the inter, the greater the role of hindering H or OH on the ester of the cold attack, the ester of the tip of the drug the more difficult to hydrolyze so the bromobenzyl, plumbecin will be more stable, but to be made into an aqueous solution that can be used for a long time is still difficult to make the tablets when the water should be noted that the plumbecin Tablets of water if more than 3%, after one year of storage, the content of cooton acid will exceed the pharmacopoeia (>2%).
2, the hydrolysis of amide drugs this class of drugs than the corresponding ester drugs can be stabilized, for example, the salt procainamide is more stable than procaine hydrochloride. However, some amide drugs, due to special reasons on the structure. Also easier to be hydrolyzed. Now cite a few common drugs as an example to illustrate:
① Penicillin drugs: penicillin drugs tun structure of the B lactam ring is a four-segmented ring, there is tension within the H, OH under the influence of easy to crack the ring and failure. For example, penicillin G potassium, aqueous solution stored at room temperature for 7 days, the effect from the decline of about 80%, and therefore can only be made into a perishable powder ampoule. According to the experiment penicillin G potassium in PH6.5 when the most stable. With the solution made of rafrate buffer (PH6.5) can only be used for up to three days. PH2, 24 ℃ half-life of only 18.5 minutes, so it can not be taken orally.
② Sodium barbiturate: barbiturates are six sections of amide drugs that are not easy to water. In the solubility is small, usually with sodium salt for injection can be CO2 in the air for barbiturates in the molecular structure of the acyl acid is weaker than carbonic acid, so its sodium plaster solution can be CO2 in the air to generate barbiturates precipitation, so the sterilized powdered needles are suitable for use in CO2-free water for injection solubility. Sodium salt aqueous solution (filled in the ampoule, no CO2) in the heating (humidity at the time of sterilization) or room temperature storage of a pon, about 22% decomposition. Injectable hyaluron with 60% propylene glycol as solvent is very stable and can be used for at least one year.
③ Chloramphenicol: chloramphenicol's chemical properties are comparable, dry powder stored in closed storage for two years, its antimicrobial efficacy is almost unchanged. Solution (solubility in water: 1:400) boiled for five hours, the potency of the first few no significant change. In significant alkaline (PH>8) or acidic hydrolysis more. Chloroform is most stable at pH=6. Salt, citric acid and its buffers can induce chloramphenicol hydrolysis (generally acid a base catalyzed). The eye drops are usually buffered with boric acid and sodium borate (pH about 7) for three ponies at room temperature and 17 months when stored in 2-8. The decomposition of chloramphenicol in the upper buffer of PH17 obeys the primary reaction. Domestic pharmaceutical factory production of chloramphenicol eye drops by increasing the amount of setting material, but the use is still less than a year. Borax can increase the solubility of chloramphenicol (may be boron and chloramphenicol molecules in the two hydroxyl groups form a complex salt), in the past often think that borax can increase the stability of chloramphenicol, in fact, not.
3, slow down the rate of hydrolysis of drugs:
① Regulation of PH: the above many examples show that the rate of hydrolysis of drugs is directly related to the PH of the solution. In the lower PH range, H-catalyzed predominantly, in the higher PH range when the OH + theory predominantly, in the middle of the PH range, hydrolysis of anti-Qingneng independent of PH or catalyzed by the H- or OH **** the same catalyst. In order to be sure that P specific drug hydrolysis can be determined for several P drug hydrolysis, using the logarithm of the reaction rate constant K on the PH graph, from the lowest point of the tribute line (turning point) can be derived from the drug's most stable when the PH value. The experiment can be carried out at a material high humidity (constant temperature) in order to but the results in a shorter period of time. So as to get the turning point to the temperature obtained at a somewhat different but usually not very large, can be catalyzed by the buffer salt used in acid or base buffer solution (generally acid and base catalyzed), then the grade salt should be kept at the lowest concentration.
② Selection of appropriate solvents: the lower dielectric constant of solvents such as ethanol, glycerol, propylene glycol, polyethylene glycol, N, N a methyl acetyl part or full ampoule instead of water as a solvent, the hydrolysis rate of the drug can be reduced. However, for individual drugs is an exception, such as cyclamic acid (C-cyclamicacid) hydrolyzed slowly in aqueous solution, but significantly faster in ethanol solution. Chloramphenicol also shows a slight increase in the rate of hydrolysis in 50% diol solution. Therefore, the specific drugs should be experimented in order to reach a consistent conclusion.
③ Formation of dimensionally soluble salts or esters: in general, the part of the drug dissolved in solution before the hydrolysis reaction. Will be easy to hydrolyze the drug into insoluble ester derivatives, its stability will increase significantly. The lower the water solubility the more stable it tends to be. For example, the potassium salt of penicillin G, which is soluble in water, is destroyed as described above, except that procaine penicillin G (solubility in water is 1:250) is 7 more stable, and its suspension, when placed under the light and stored at less than 20 degrees, retains its potency for at least 18 months. Triacetylsalicylic acid penicillin (Friacetyloleandomycinum). Erythromycin stearate and other dimensionally soluble drugs are not only chemically more stable than the parent drug, but also odorless and resistant to gastric acid; they are better than the parent drug after oral administration.
④ Formation of complexes: add a compound, so that it and the drug to form a water-soluble and have a protective effect on the drug complex, the complex so that the protective effect on the drug may have a spatial barrier and the polar effect of the celebration of two reasons.
⑤ Add surfactant: in the lipid or acyl drug solution to add appropriate surfactant, sometimes can increase the stability of some drugs, such as benzocaine containing 5% sodium lauryl sulfate (anionic surfactant) solution, can make benzocaine's half-life of half 18 times, which may be sodium lauryl sulfate and benzocaine to form the gel, benzocaine hidden in the gel inside, reducing the OH- to benzocaine. This may be due to the formation of a colloid with sodium lauryl alcoholate and benzocaine, benzocaine is hidden inside the colloid, which reduces the attack of OH- on the ester bond of benzocaine.
6 Change the molecular structure of the drug in the lipid drugs (R-COOR) and acyl drugs (R-COOR) a one-carbon original on the introduction of other groups or side chains or increase the length of the R or R'carbon logic to increase the spatial effect can be polar effect, can effectively reduce the rate of hydrolysis of these drugs. The rate of hydrolysis of these drugs can be effectively reduced.
⑦ made into solid preparations: the drug is made into solid preparations can greatly improve the stability.
⑧ control of humidity: humidity increases, the rate of hydrolysis reaction increases. (B) due to oxidation caused by drug instability oxidation reaction is one of the important reasons for drug decomposition and failure. Vitamin C, morphine, adrenaline, thiamine hydrochloride, etc., are familiar examples.
1, easy to oxidize the drug oxidative decomposition of the results of drug failure, darkening, darkening, the formation of precipitation or toxic substances (such as the new ars vanadine exposure to air, easy to oxidize and deteriorate, toxicity increased significantly and can not be used for medicinal purposes). Some injections of which the drug is only a very small part of the oxidation, but the color darkened, so that it may become waste products. The oxidation process of drugs than hydrolysis do not complex, often not easy to complete the expression of the reaction formula. This section lists the oxidation of some drugs, may be the main reaction in the hydrolysis process.
① Phenolic drugs: molecular structure with phenolic hydroxyl drugs such as epinephrine, dopamine, morphine, hydromorphone, sodium salicylate, etc., in the chlorometallic ions, light, humidity, etc., are easy to oxidize and deteriorate. Phenolic drugs are oxidized, mostly because the phenolic hydroxyl group becomes quinone structure cis and yellow-brown and other colors. Vitamin C's molecular structure does not exist phenolic hydroxyl, but there is an alcohol structure, it is easy to oxidize to produce a series of colored invalid substances. The oxidative decomposition of vitamin C has been widely and y studied, and the information accumulated is very large, but its self-oxidizing anti too mechanism is still very unclear. In the absence of air, vitamin C degradation produces furfural and carbon dioxide. Furfural is easily oxidized and polymerizes to form a colored substance, which may be a reason for the yellow color on the crystal surface of this product. Oxygen in the air chlorine can oxidize vitamin C to dehydrovitamin C, in the presence of reducing agent, the latter can still be converted to vitamin C. Dehydrovitamin C is very unstable, and quickly generate 2,3 a diketo guluronic acid (sodium) and other decomposition products, the solution due to the yellow color to orange-red, vitamin C solution, if there is no metal ions, only in the PH9 or more when the more obvious oxidation reaction occurs, but if there is a copper ion However, if copper ions are present, the oxidation reaction is extremely rapid even at pH=6.5. Copper is an extremely strong oxidation catalyst for vitamin C. As long as the concentration of 2×10-4M/L, it can increase the oxidation rate of vitamin C monovalent anion by 10,000 times. Iron and aluminum ions can also decompose vitamin C. The most stable pH for vitamin C solutions is 5.4. Sodium metabisulfite is required as an antioxidant. It is better to pass the solution through carbon dioxide than through nitrogen. Sodium chloride, propylene glycol, glycerol, sucrose, chelating agents on vitamin C have a stabilizing effect.
② Aromatic amines: such as sulfonamides sodium salt, procainamide hydrochloride, sodium p-aminosalicylate and other aromatic drugs, are also relatively easy to oxidize. As with phenolic drugs, the oxidation reaction process of most aromatic amines is unusually heterogeneous, and many are not well understood.
③ Other types of drugs: pyrazolones such as aminopyralid, anhydrous solution, is also relatively easy to oxidize, resulting in a yellow color. It is generally believed that the unsaturated bond on the pyrazolone ring is oxidized. Thiazides such as promethazine hydrochloride. Chlorpromazine hydrochloride, etc., under the action of light, metal ions, oxygen, etc., it is very easy to oxidize and change color, injection injection 0 commonly used sodium metabisulfite, vitamin C, EDTA-Na2, etc. as a stabilizer to slow down the oxidation. Containing unsaturated Bin drugs, can often also easily oxidized, such as vitamin A, vitamin D, oil, in the light, oxygen, water, metal defense and microbial influence, can produce oxidation topography and decomposition. Volatile oil contains components terpene, pinene, oxidized aldehydes, ketones are formed, so there is a special flavor. Terpene and pinene can be polymerized to form resin after oxidation. Thiamine hydrochloride can be oxidized by oxygen in the air to generate ineffective color-filled pigments, but do not use sulfite as an antioxidant. Because the latter can make the salt amine safety fracture, failure.
2. Factors affecting the rate of oxidation of substances:
① Organic drugs unsaturated degree: double bond more Chin drugs are usually easy to oxidize.
② Free fatty acids: organic carboxylic acids or alcohols than their corresponding esters are easy to produce autoxidation reaction.
③ and metal ions: metal, especially metal ions above divalent Cu + + +, Fe + + +, Pb + + +, Ni + +, etc.), can promote the anti, is a catalyst for drug decomposition.
④ Physical state of drugs that are easily oxidized: usually solid fats are less prone to autoxidation reactions than liquid fats. This may be due to the fact that oxygen does not diffuse easily in solidified fats.
⑤ The amount of oxygen? Should. Sometimes only a trace amount of oxygen is needed to cause this reaction. Once the reaction is underway, the amount of oxygen is not important.
6 Humidity: In general, an increase in humidity accelerates the rate of oxidation. However, the solubility of oxygen in water decreases when humidity increases.
3. Methods to slow down the oxidative decomposition of drugs:
① Remove oxygen;
② Add antioxidants;
③ Adjust the PH value. 1, isomerization isomerization is divided into optical isomerization and geometric isomerization, the former is divided into racemization and differential isomerization. ① Optical isomerization: A, racemization: optically active drug in solution by H +, OH - or other catalysts and temperature and so on under the influence of its enantiomeric process, this reaction process has been carried out until the generation of equal amounts of the two enantiomers, and therefore finally get 1/2 amount of levorotatory and 1/2 amount of dextrorotatory mixtures, as a result, the drug solution is equal to zero. The physiological activity of the levamers of most drugs is greater than that of the dextamers (the exceptions being calcium pantothenate and ethaminoethanol), but the dextamers are often physiologically active as well, so that the physiological activity of a racemic drug is generally more than half that of the pure levamer. Racemic reactions are morally determined by the genes attached to the asymmetric carbon atoms, which are easier to carry out if the asymmetric carbon atoms are attached to dulcimer or have the structure of benzyl alcohol. Therefore, both levosamine and levoscopoletin are easy to be racemicized. The racemic reaction is related to catalysts such as OH-, H+, etc., temperature and light. The chemical study of racemic antiknocking is similar to hydrolysis antiknocking in terms of methodology. Generally the racemic reaction is carried out according to one-stage inversion. B. Differential isomerization; the stereoisomerization of genes on one of the off-aligned carbon atoms of certain drugs with multiple off-aligned carbon atoms is called differential isomerization. Differential isomerization reaction to reach equilibrium, the two differential isomers are not staring, so its optical activity is not equal to zero, this point is different from the racemic.
② Geometric isomerization: organic drugs containing double health, the cis geometric isomer and the trans to the amount of isomer activity is often not the same. Vitamin A molecule has five *** conjugated double bonds, theoretically there are 16 geometric isomers, the physiological activity of the isomers are different from each other, which is the highest to the all-trans isomer. In the lower PH water, can generate Retro vitamin A and branched water vitamin A, the former physiological activity of only 12% of the trans-vitamin A the latter is not physiologically active. Vitamin A palmitate and other vitamins made of multivitamin suspension (suspending agent for Tween - 80, PH = 5.3), after about a year of storage, in addition to decomposition due to oxidation, there are 10 - cis and 10, 15 two cis two isomers are generated, the physiological activity of the two isomers is very weak.
2, due to polymerization and the deterioration of drugs, two or more of the same drug points polymerization and deterioration of drugs are not many instances, more familiar is the addition of formaldehyde solution can be 10%-15% methanol can slow down its polymerization. The drug itself due to polymerization and precipitation, discoloration and other phenomena are more common. For example, dextrose injection hot pressure after extinguishing not a small amount of 5-hydroxymethylfuran formaldehyde formation, the latter polymerization to generate a colored polymer, thus making the injection slightly wet yellow.
3, due to the decomposition caused by the de-reaction, due to the drug molecular structure of the carboxyl group de-cleavage caused by the decomposition of the drug, sometimes may be encountered. Sodium para-amino salicylate injection because of the decomposition of nitrogen salicylic acid, decarboxylation to generate m-aminophenol and easy to make the color darker. The decarboxylation reaction of sodium p-aminosalicylate is very much related to the PH of the solution, which is more stable than alkaline, and decarboxylation starts to be obvious from PH6.3 and reaches the highest peak at PH2.7. This product 20% solution for three months, about 2.5 due to decarboxylation and decomposition. 1150, 30 minutes, there are 15% decomposition, so this product to be made to the bacterial powder ampoule is appropriate.
4, absorption of carbon dioxide-induced decomposition of some alkaline drugs, due to the absorption of CO2 in the air to lose the role of the corresponding carbonate and change the original nature of the drug. Such as propylene ring ethyl (PropyLHexedrinum) is a volatile liquid according to the class of drugs, made of inhalants inhaled into the nasal cavity to contract the local blood vessels, propylene ring ethyl amine can absorb CO2 in the air to generate carbonate and weaken the volatility, thus affecting the efficacy of its. Barbiturate sodium salt solution may generate barbiturate precipitate when encountering CO2.
5, the interaction between the drugs will be two or more than two kinds of drugs used in conjunction, if you do not understand the physical and chemical nature of the drugs, pharmacology and other aspects of the nature of the drugs, do not understand the use of drugs in the clinic requirements and blindly mixed, often not only can not achieve the intended purpose of medical care, but also sometimes may produce adverse effects and even endanger the patient's life.
Production of pharmaceutical preparations
Liquid preparations
① Liquid preparations for internal or external use of solid or liquid drugs in certain conditions, dissolved or dispersed in water, alcohol, fatty oils or glycerol, and sometimes additives to increase the solubility of the drug, the dispersion of the product to increase the stability of the product or to improve the bad smell. The general requirements for such liquid preparations are: the solution should be clear; emulsions or suspensions should ensure that the dispersion phase is small and uniform; the concentration of the active ingredient should be accurate and stable; the preparation should be palatable, non-irritating; packaging containers should be clean or sterilized.
② injection, also known as injection, is designed for injection into the body of a dosage form, including sterilized or sterile solutions, suspensions, emulsions, or sterile powders prepared into solutions or suspensions before use. Production method is usually the raw material drug dissolved in water for injection (or oil for injection, or other appropriate solvents) to the required concentration, filtered with a filter rod or microporous membrane, filling and sealing machine into ampoules (or infusion vials), sealing, through autoclaving, leakage, capacity check, and then check the clarity of the lamp inspection machine, and finally aseptic inspection, printing (or sticking the check mark) and packaging. For drugs that are easily oxidized, inert gases (nitrogen, carbon dioxide) should be introduced to replace the air in the ampoule space when filling and sealing. Some injections need to add additives such as solubilizers, antioxidants, stabilizers, buffers or bacteriostatic agents when preparing. For drugs that are unstable in solution, sterilized powdered drugs and excipients can be packed in ampoules or other containers (called powdered needles) using a dispenser, and dissolved in water for injection or other solvents before use. Some drugs such as enzyme preparations using freeze-drying method, will be injected into the ampoule of the drug solution to remove the solvent, made of lyophilized powder injection. The production of aqueous injections has been linked to the various processes, and protected by sterile laminar flow air to prevent contamination. Aseptic powder injection production has also been realized in all the processes of linkage.
3 eye drops for direct use in the eye for external sterile liquid preparations, mainly aqueous solution.
Solid preparations are mainly tablets, capsules, suppositories, waxes and semi-solid ointments.
① Tablets The powder of raw material drug after grinding and sieving and excipients (excipient, disintegrating agent, etc.), mixed in the mixer, add appropriate amount of wetting agent and binder, made into particles on the granulating machine, drying and lubricant, stamping and molding on the tablet press.
② Coated tablets Tablets with coating machine can be made into sugar-coated tablets, enteric-coated tablets and film-coated tablets. Sugar-coated tablets have to go through five processes: sequentially wrapping the isolation layer, powder coating layer, sugar coating layer and colored sugar coating layer, and finally lightening. Enteric-coated tablets are coated with polymers insoluble in acid and soluble in pH 5-7 medium. Film-coated tablets are coated with polymers meeting the requirements dissolved in organic solvents (water emulsion can also be made), and coated by spraying method in hot air on the pressed tablet center. Tablet production equipment and packaging equipment have been energy-saving, multi-effective, high-speed, linkage and automation development. For example, there is a boiling type or mechanical one-step granulator, the feeding, mixing, granulation and drying processes are completed once, the hourly output can reach more than 100kg. Rotary tablet press has 27, 33, 45, 55, 61 and 75 rushes and other specifications, the hourly output of 30 to 600,000 tablets. The emergence of mother and child punch to expand the production potential of the tablet press, up to 330 punch, the hourly output of up to 3 million tablets, some tablet presses can be pressed shaped tablets, multi-layer tablets, core tablets, and automatic control of the weight of the tablets, rejecting unqualified tablets, in case of failure, automatic shutdown and other devices. Tablet coating equipment has a high-efficiency coating machine, equipped with quick-drying device, can be programmed to control the operation, each batch can be wrapped 150-500kg of coated tablets. In addition, by using the existing coating pot equipment and installing an airless spray system, it can make sugar coating and film coating, which can save 30%~50% of coating materials and shorten the coating time by 1/3~1/2. Due to the rapid growth of the demand for small packages, the tablet packaging is mostly done by blister packaging machine, which starts from the composite molding of the plastic films and aluminum foils, and then goes through the process of loading the tablets, thermo-combining, cutting (number of grains is customized), automatic checking, boxing, and all the way to the ex-factory packaging by linkage. All of them are linked to the factory packaging.
③ Capsules There are two kinds of hard capsules and soft capsules. Hard capsule is the raw material powder and auxiliary materials mixed evenly filled in hard hollow capsules and made. The hollow capsule is cylindrical, by the capsule cap and the capsule body of the two sections of the tightly fitted into a variety of sizes and specifications, according to the size of the drug dosage selection. Soft capsule is the oil or gelatin insoluble liquid drugs or suspension closed in a round or oval soft capsule made of internal soft-type preparations. Hollow capsules have linked production equipment - hollow capsule manufacturing machine, hourly output of 100,000 ~ 120,000 particles. Filling powder or particles of hard capsule filling machine, hourly output of 110,000, and can always adjust the amount of drugs and reject unqualified products. Soft capsule manufacturing machine from the preparation of gum liquid, preparation of rubber skin, quantitative addition of medicinal materials, pressure pill molding, stripping, drying to the output of all automatic operation, can be pressed spherical, oval, ampoule-shaped, suppositories and other forms and specifications, the hourly output of about 50,000 pills.
Aerosol will be the drug and ejection agent **** with the pressure-resistant container with a valve, the use of quantitatively or indeterminately in the form of mist sprayed preparations. Aerosol has solution type, suspension type and emulsion type, that is, by the two-phase (gas-liquid phase) or three-phase (gas-liquid-solid phase or gas-liquid-liquid phase) composition. It is usually prepared by cold or pressure loading process, and packaged after passing the leakage test and spray test. (See color chart)
Pharmaceutical preparation as a discipline, more and more for people to pay attention to, because people are sick when they can not do without it.
Objective of business training: this specialty cultivates senior scientific and technological talents with basic theoretical knowledge and basic experimental skills in pharmacy, pharmacology and pharmaceutical preparation engineering, who are able to engage in research, development, process design, production technology improvement and quality control in the field of pharmaceutical preparations and related to the preparation technology.
Business Training Requirements: Students of this program mainly study the basic theories and basic knowledge of pharmacy, biopharmacy, industrial pharmacy, pharmaceutical engineering, etc., and receive the basic training of pharmaceutical preparation research and production technology, and have the basic ability of pharmaceutical preparation research, development, production technology improvement and quality control.
Graduates should acquire the following knowledge and ability:
1. master the basic theory and knowledge of physical chemistry, medicinal chemistry, pharmaceutical polymer materials, industrial pharmacy, preparation equipment and workshop process design;
2. master the research of preparation, dosage form design and improvement, and process design of pharmaceutical preparation production and other technologies;
3. Have the research and development of pharmaceutical preparations, the design and improvement of the dosage form and the preliminary ability to design the production process of pharmaceutical preparations;
4. Familiarize with the regulations and policies of the Pharmaceutical Administration;
5. Understand the development of modern pharmaceutical preparations;
6. Master the basic methods of literature search, data query and have a preliminary scientific research and practical work Ability.
Main subjects: pharmacy, chemical engineering
Major courses: physical chemistry, chemical principles, pharmaceutical chemistry, pharmaceutical analysis, pharmacology, physical pharmacology, pharmaceutical polymer materials, biological pharmacy, industrial pharmacy, preparation equipment and workshop process design
Major practical teaching links: including production internships, thesis design, comprehensive experimental design, generally arranged for 22 weeks. experimental design, etc., generally arranged about 22 weeks.
Year of study: four years
Degree awarded: Bachelor of Science or Bachelor of Engineering
Similar majors: pharmacy
Institutions: Liaoning University of Traditional Chinese Medicine, Qingdao University of Science and Technology, Guiyang College of Traditional Chinese Medicine, Hebei Medical University, Yanbian University, Wuhan Institute of Chemical Technology, Guangzhou University of Traditional Chinese Medicine, Guangdong Pharmaceutical University, Guangdong is the Food and Drug Institute of Vocational and Technical Sciences, Shenyang Pharmaceutical University, China University of Pharmacy University East China University of Science and Technology Zhejiang University Zunyi Medical College Heilongjiang University of Traditional Chinese Medicine Hebei University of Science and Technology Inner Mongolia University for Nationalities Inner Mongolia Medical College College of Pharmacy Tongliao Vocational College Nanjing University of Traditional Chinese Medicine Zhejiang University of Technology Anhui University of Traditional Chinese Medicine Jiangxi University of Traditional Chinese Medicine Fujian Medical University Zhengzhou University Henan University of Traditional Chinese Medicine Henan University Hunan University of Traditional Chinese Medicine Chengdu University of Traditional Chinese Medicine Dali College Shaanxi University of Science and Technology Gansu University of Traditional Chinese Medicine Jiangsu Jining Medical College Lanzhou Medical College Shandong Light Industry College Qilu University of Technology, etc.