Chinese medicine tablets refer to the fine powder or extract of the drug mixed with suitable excipients, processed and pressed into round or other forms of tablets in dosage forms for internal and external use. Medical Education.
Tablets are developed on the basis of the use of pills, which was created in the 1840s, to the end of the 19th century with the emergence of the tablet press machinery and continuous improvement, the production and application of tablets has been rapid development. In the last decade or so, there have been major developments in tablet production technology and mechanical equipment, such as boiling granulation, full powder direct compression tableting, semi-film coating, new excipients, new processes, and production linkage. The research and production of Chinese medicine tablets only started in the 1950s. With the comprehensive research on the chemistry, pharmacology, preparation and clinical aspects of Chinese medicine, the varieties and quantities of Chinese medicine tablets have been increasing, the process technology has been improving, and the quality of tablets has been gradually improved. In addition to general pressed tablets and sugar-coated tablets, there are also microencapsulated tablets, oral tablets, topical tablets and effervescent tablets, etc. In the production process of Chinese medicine tablets, there is a gradual increase in the number of varieties. In the production process of tablets, a set of process conditions applicable to the production of Chinese medicine tablets has been gradually worked out, such as the preparation of tablets containing fatty oils and volatile oils, how to improve the hardness of Chinese medicine tablets, improve disintegration, tablet coating, etc. Gradually, experience has been accumulated, so that the quality of the tablets has been improved continuously. In addition, research on the dissolution rate and bioavailability of drugs in Chinese medicine tablets has been gradually carried out. In short, tablets have become a variety of large production, wide range of uses, convenient use and storage and transportation, quality and stability of one of the dosage forms, tablets in China as well as many other countries Pharmacopoeia contained in the preparation, are accounted for more than 1/3 of the visible application of a wide range.
The advantages of tablets:
①In general, the dissolution rate and bioavailability of tablets better than pills;
②accurate dosage, tablets within the drug content of the smaller differences;
3 quality stability, tablets for dry solid, and some easy oxidative deterioration and deliquescence of the drug can be protected by the coatings, seemingly the light, air, moisture, etc., on the impact of the smaller; medical teaching. The quality of the tablets is stable.
4 carry, transport, take more convenient;
5 mechanized production, production, low cost, "health standards" is also easy to meet.
But tablets also have a number of shortcomings:
①Tablets in the dissolution rate of the drug is slower than the bulk and capsules, its bioavailability is a little worse;
②Children and coma patients are not easy to swallow;
③Tablets containing volatile components of the content of the tablets stored for a long time to decline.
Tablet classification:
Tablets are classified according to the route of administration, combined with the preparation and function as follows.
(1)Internal tablet It is the most widely used one, which is disintegrated and absorbed in the gastrointestinal tract to exert therapeutic effect.
Pressed tablets (vegetarian tablets): refers to the drug and excipient mixing, the processing of pressed tablets, generally uncoated tablets belong to this category, the most widely used. For example, the tablets of stomach and ginseng and antler are widely used. The most widely used tablets are those that are not coated.
Coated tablets: refers to the pressed tablets (often called the heart of the tablet) outside the bread with a film of tablets, according to the different coating materials or role, can be divided into sugar-coated tablets, film-coated tablets, enteric-coated tablets and so on. Such as niu huang detoxification tablets, silver yellow tablets, Huanglianxin hydrochloride tablets, furotoxin tablets and so on.
Long-acting tablets: refers to the tablets containing delayed disintegration materials, which can make the drug slowly release and prolong the effect. Such as long-acting aminophylline tablets.
Chewing tablets: the pressed tablets that are chewed in the mouth and then swallowed, mostly used in the treatment of gastric disorders. Such as aluminum hydroxide gel tablets, yeast tablets and so on.
(2)Oral tablet: It refers to the pressed tablet which is contained in the mouth and dissolved slowly, which can produce long-lasting medicinal effect on the local area of mouth and throat, and is used for local anti-inflammation and disinfection. Such as four seasons green throat tablets, laryngitis tablets, to protect the throat tablets, musk ketone tablets. Oral tablets are larger and harder than the usual internal tablets and have a pleasant taste.
(3) sublingual tablets are pressed tablets placed under the tongue, which can be dissolved in the saliva under the tongue and absorbed by the mucous membrane, and have a quick effect. Such as nitroglycerin tablets, wheezing tablets and so on. In addition, there is a kind of lip and cheek tablets, the tablets will be placed on the upper lip and incisor gums between the side of the high, through the buccal mucosa is absorbed, both rapid-acting and long-acting effect. Such as nitroglycerin lip and cheek tablets.
(4) external tablets refers to vaginal tablets and pressed tablets designed for the preparation of external solutions. The former is used directly in the vagina, such as fisetin external tablets for the treatment of chronic cervicitis, midexin just tablets for the treatment of trichomoniasis and trichomoniasis leukorrhea in women. Topical solution tablets will tablets with a certain amount of buffer solution or water dissolved, so that a certain concentration of solution, such as for eye drops with the white stop tablets, for gargling with the compound borax gargle tablets and furacilin gargle tablets, for disinfection of mercuric chloride tablets and so on. The components of the topical solution tablets must all be soluble.
(5) other tablets (special tablets)
Microencapsulated tablets: refers to tablets made of solid or liquid drugs using microencapsulation process to make dry powder particles, pressed and made of tablets, such as oyster oil microencapsulated tablets.
Effervescent tablets: refers to tablets containing effervescent disintegrating materials. It can be used orally or externally. Such as antidiarrhea 1 tablets, drip net boiling tablets, etc..
Multi-layer tablets: refers to tablets containing different excipients in each layer of the composition of the particles or different drugs, can be avoided by compounding drug compounding changes, so that the tablets in vivo to present different therapeutic effects or both fast-acting and long-lasting effect. For example, double-layer compounded aminophylline tablets pressed with two types of granules, fast-acting and long-acting.
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Tablets
tablets
Overview: refers to the drug, pesticide and suitable excipients through the preparation of tablets made by the technology of preparation.
Consisting of the original drug, filler, adsorbent, binder, lubricant, dispersant, wetting agent, disintegrating agent, spice, color and so on.
The material is first crushed, granulated, dried, and then made into tablets with a tablet press. There are also some without granulation and drying, directly pressed into tablets.
The quality of tablets requires accurate content, small weight difference, disintegration time or dissolution in accordance with the provisions of the hardness is appropriate, the appearance of beauty, color and lustre, in line with the health inspection standards, in the provisions of the storage period of the nature of the stability and so on. Accurate dosage, stable physical and chemical properties, long storage period, easy to use, transport and carry, low price, high yield.
(1) The concept and characteristics of tablets
Tablets are tablet preparations made by pressing the drug and excipients after mixing them evenly.
Features: ① solid preparations ② production of institutionalization, high degree of automation ③ accurate dosage ④ can also meet the different needs of clinical medical or preventive
(2) the types of tablets and quality requirements
Types: ordinary pressed tablets, coated tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, vesicant tablets, chewing tablets, multi-layer tablets, dispersible tablets, sublingual tablets, oral tablets, implantable tablets, solution tablets, tablets, tablets, tablets, tablets, tablets, tablets, tablets, tablets, tablets, tablets, tablets, tablets, tablets Implantable tablets, solution tablets, slow-release tablets
Chinese medicine tablets refer to tablets or shaped tablets made of fine powder of medicinal herbs or extracts of medicinal herbs plus fine powder of medicinal herbs or excipients pressed together. It is divided into tablets of raw powder of herbs and tablets of extract (semi-impregnated paste).
The tablets shall comply with the following regulations during production and storage:
I. The raw materials and auxiliary materials shall be mixed evenly. Small doses or tablets containing toxic drugs, according to the nature of the drug with appropriate methods to make the drug dispersed uniformly.
Two, all volatile or heat decomposition of the drug, in the process of making tablets should be avoided heat loss. Preparation of granules should be controlled moisture, in order to adapt to the needs of the preparation process, and to prevent mold, deterioration and failure of tablets during storage.
Third, where there is uncomfortable odor and taste, irritation, easy moisture or light easily deteriorated drugs, made of tablets can be sugar-coated or film-coated. For some of the gastric liquid easily destroyed, irritation of the gastric mucosa or the need for intestinal release of drugs, made of tablets should be packaged enteric coating. In order to adapt to the needs of local vaginal use, can be made into vaginal tablets. Some drugs can also be made into effervescent tablets as needed.
Four, the appearance of tablets should be complete and clean, uniform color; should be appropriate hardness, so as to avoid packaging, storage and transportation in the process of fragmentation.
V. Unless otherwise specified, tablets should be sealed and stored.
Weight difference
The weight difference limit of tablets shall be in accordance with the following table:
━━━━━━━━━━━━━━━━ undertakes to ━━━━━━━━━━━━━━━━━
Average weight │ Weight difference limit
- ---------- ----┼----- ---------- --
Below 0.30g │ ±7.5%
0.30g or above │ ±5%
━━━━━━━━━━━━━━━━┷━━━━━━━━━━━━━━━━━
Checking method
Take 20 tablets of the test material. Test product 20 tablets, precision weighing of the total weight, to find the average weight of the tablets, and then precision weighing of the weight of each tablet, the weight of each tablet and the average weight of the tablets compared (where there is a tablets weight labeling, the weight of each tablet and the labeling of the weight of the tablets compared), exceeding the limits of not more than 2 tablets, and there shall not be 1 tablet exceeding the limit of double.
Sugar-coated tablets, film-coated tablets and enteric-coated tablets should be coated before checking the weight difference of the core, in line with the above table, before coating. The weight difference shall not be checked after coating.
Disintegration time
Checked according to the disintegration time check method (Appendix D.A). Unless otherwise specified, it shall comply with the regulations.
Tablet quality requirements:
① moderate hardness; ② uniform color, clean appearance; ③ meet the requirements of the weight difference, the content is accurate; ④ meet the requirements of the degree of disintegration or dissolution; ⑤ small doses of drugs or more intense effect of the drug should meet the requirements of the content of the uniformity; ⑥ comply with the requirements of the relevant hygiene.
(3) The common excipients of tablets are divided into four categories as follows:
Filler, binder, disintegrant, lubricant.
(1) Filling agents
The main function of filling agents is to fill the weight or volume of tablets so as to facilitate tablet pressing. The commonly used fillers are starch, sugar, cellulose and inorganic salts.
① Starch The more commonly used is corn starch as the most commonly used excipient for tablets. Starch has poor compressibility, and if it acts alone, it will make the pressed tablets too loose.
② Powdered sugar Advantages of strong adhesion, can be used to increase the hardness of tablets, the disadvantage is that the hygroscopicity is strong, generally not used alone.
③ Dextrin
④ Lactose is an excellent tablet filler. It has good flowability and compressibility and can be used for direct tabletting of powders.
⑤ Compressible starch Also known as pregelatinized starch, it has good flowability, compressibility, self-lubrication and dry adhesion, and has good disintegration.
6 microcrystalline cellulose (MCC) has good compressibility, strong binding force, can be used as a powder directly pressed tablets "dry adhesive".
⑦ Inorganic salts such as calcium sulfate, calcium phosphate, calcium sulfate dihydrate is often used in tablet excipients. However, it should be noted that calcium sulfate on some of the main drug (tetracycline drugs) have interference with the absorption, should not be used at this time.
⑧ Mannitol is more suitable for the preparation of chewable tablets.
(2) wetting agent and adhesive
Some drugs have viscous powder itself, only need to add the appropriate liquid can be induced by its own inherent viscosity, the liquid added at this time is known as the wetting agent; some drugs do not have viscous powder or viscous small, need to join the starch syrup and other viscous substances, in order to make the adhesion, the viscous material added at this time is called adhesive. The viscous material added is called adhesive.
① Distilled water Distilled water is a wetting agent. As materials tend to absorb water faster. Uneven wetting occurs, it is best to use a low concentration of starch or ethanol instead.
② Ethanol Ethanol is also a wetting agent. It can be used for drugs that are easy to decompose in water, and can also be used for drugs that are too viscous in water. Generally 30% ~70%.
③ Starch slurry Starch slurry is the most commonly used adhesive in tablets, starch slurry is mainly made by two methods: boiling slurry and flushing slurry.
④ Carboxymethyl cellulose sodium (CMC-Na) is used as a binder, often used in drugs with poor compressibility.
⑤ Hydroxypropyl cellulose (HpC) to do the wet granulation of the binder, but also as a powder directly pressed tablets of the binder.
6 Methyl cellulose and ethyl cellulose (MC; EC) Methyl cellulose has good water solubility, used as a binder, ethyl cellulose is insoluble in water, often using this feature of ethyl cellulose, it is used in sustained and controlled release preparations (backbone or membrane controlled release).
7 Hydroxypropyl methyl cellulose (HpMC) This is one of the most commonly used film coating materials.
⑧ Other binders Gelatin solution, sucrose solution, aqueous or alcoholic solution of polyvinylpyrrolidone (pVp).
(3) Disintegrating agent
Except for slow (controlled) release tablets and some special effect tablets, disintegrating agent should be added to the general tablets.
① Dry starch is the most classical disintegrating agent, which is more suitable for tablets of water-insoluble or slightly soluble drugs, but the disintegration effect of soluble drugs is poorer, which is due to the concentration difference of soluble drugs dissolved in water, so that the water outside the tablet is not easy to penetrate into the inside of the tablet through the solution level, which impedes the water-absorbing and swelling of starch inside the tablet. In production, the general use of addition, addition method or "inside and outside the addition method" to achieve the desired disintegration effect.
② Carboxymethyl Starch Sodium (CMS-Na) Water absorption and swelling effect is very significant, is an excellent disintegration agent.
③ Low-substituted hydroxypropyl cellulose (L-HpC) It has very good water-absorbing speed and water absorption.
④ Crosslinked polyvinylpyrrolidone (also known as crosslinked pVp)
⑤ Crosslinked carboxymethylcellulose sodium (CCNa) Swells with water.
⑥ Effervescent disintegrants
(4) Lubricants
Lubricant is a general term for flow aids, anti-viscosity agents and (narrowly defined) lubricants.
① Magnesium stearate Magnesium stearate is a hydrophobic lubricant, and when used in excess, its hydrophobicity will cause delayed disintegration of tablets.
② Micronized silica gel is a flow aid for tablets, and can be used as a flow aid for powder direct compression tablets.
③ Talcum powder is mainly used as a light flow aid.
④ Hydrogenated vegetable oil is a lubricant with good lubricating properties.
⑤ Polyethylene glycol and magnesium lauryl sulfate are typical representatives of water-soluble lubricants. The former mainly use polyethylene glycol 4000 and 6000, the latter is water-soluble lubricity.
(5) other
such as surfactants, some of the requirements for the determination of the solubility of the tablets of its drug dissolved in the prescribed medium is slow, so add an appropriate amount of surfactant to improve its solubility. Such as sodium dodecyl sulfate.
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Tablets
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Tablets - Wikipedia, the free encyclopedia
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