Shandong Province Institute of Biological Drugs
Contact: Mr. Zhu 0531-81213086 0531-81213080
Other projects to be transferred from our institute are:
1. Donipenem raw materials and powder injection: chemical 3.1 class, broad-spectrum antibiotics, antibacterial infections, broad spectrum of antibacterial, stable against the majority of β-lactamases. Stabilization, transfer of clinical approvals.
2. Clofarabine and injection, lyophilized powder injection: chemical 3.1, used in the treatment of acute lymphoblastic leukemia and acute myeloid leukemia, is currently the only chemotherapy drugs can be specifically used for childhood leukemia, transfer of clinical approvals.
3. Irinotecan Powder Injection and Raw Materials: chemotherapy class 6, recommended for the treatment of patients with advanced colorectal cancer, can be used alone or in combination; also has a certain degree of efficacy for patients who have failed to be treated with other commonly used clinical medicines, to be reported for production, transfer of new drug technology.
4. Tigecycline lyophilized powder injection and raw materials: chemical drugs 3.1 class, broad-spectrum antibiotics, the treatment of adult intra-abdominal infections and complex skin and its soft tissue infections, with the advantages of anti-drug-resistant bacteria, broad antibacterial spectrum, and small side effects, the transfer of clinical approvals.
5. Metiprolol Ophthalmic Ready-to-Use Gel: Class 5 chemical, exclusive development in China, patented technology, treatment of glaucoma, has been reported to the SFDA, the transfer of clinical approvals.
6. Nasal gel for naphthylinamide: exclusive domestic development, treatment of various rhinitis, has been approved by the clinical approval, the transfer of clinical approvals.
7. Levofloxacin hydrochloride ear drops: chemical 2, domestic exclusive development, treatment of otitis media efficacy. Preclinical research has been completed, the transfer of clinical approval.
8. Flutemazole cream and raw materials: chemical drugs 3.1 category, the exclusive development of domestic, the treatment of superficial fungal infections, has been clinically approved, the transfer of clinical approvals.
9. Buconazole nitrate vaginal cream, effervescent tablets and raw materials: chemical 3.1, the treatment of vaginal Candida infections, therapeutic effect, novel dosage form, preclinical research has been completed, the transfer of clinical approval.
10. Compound Sodium Cromoglycate Nasal Spray: chemical medicine 3.2 category, the treatment of rhinitis, has completed clinical trials, the transfer of production approvals.
11. Guanidine Aminotomidine Tablets and raw materials: chemical drug category 3.1, non-steroidal anti-inflammatory drugs, used for the treatment of rheumatoid arthritis, osteoarthritis, extra-articular rheumatism and post-surgical pain, clinical approval has been obtained, transfer of clinical approvals.
12. Ophthalmic ready-to-use gel (in-situ gel): the latest dosage form, exclusive patents, technology platform, the development of products including brimonidine tartrate ophthalmic ready-to-use gel, levofloxacin hydrochloride ophthalmic ready-to-use gel, metiprolol ophthalmic ready-to-use gel and so on.
13. Compound Gentamicin Eye Drops, Eye Ointment: the original chemical four categories, exclusive development in China, the treatment of bacterial infections of the eye, has completed clinical trials, the transfer of production approvals.
14. Zatoprofen tablets, capsules, raw materials: chemical drugs 3.1 category, the treatment of chronic rheumatoid arthritis, deformational arthritis, lumbago, periarthritis of the shoulder joints, neck-shoulder-wrist syndrome, and anti-inflammatory and analgesic after surgery, post-traumatic injuries, and after tooth extraction. Its action is stronger than that of indomethacin, diclofenac, ibuprofen, aminopyrine and other similar drugs. Transfer of clinical approvals.
15. Cardioplegia Tablets: Chinese medicine category 6, the treatment of coronary heart disease angina pectoris gas deficiency and blood stasis, patented products, Ш phase Ш clinical trials, the end of the transfer of production approvals.
16. Pediatric pharyngeal flat capsule: 8 types of traditional Chinese medicine, the treatment of lung solid heat caused by sore throat, mouth and tongue erosion, etc., has been granted clinical approval, the transfer of clinical approvals.
17. Pediatric pharyngeal bian oral solution: Chinese medicine class 8, the treatment of lung solid heat caused by sore throat, mouth and tongue erosion, etc., has been approved by the clinical approval, the transfer of clinical approvals.
18. Cerebral Pulse Xin Granules: Traditional Chinese medicine category 6, treatment of cerebral ischemia, cerebral embolism, cerebral thrombosis, etc., patented products, Ⅲ clinical trials are over, the transfer of production approvals.
19. Prostatic Shuoqing Granules: Traditional Chinese medicine class 6, the treatment of chronic prostatitis and prostate hyperplasia, patented products, has been approved by the clinical approval, the transfer of clinical approval.
20. Xinmeng Granules: Traditional Chinese medicine class 6, the treatment of insomnia, patented products, has received clinical approval, the transfer of clinical approvals.
21. Side near marigold total flavonoids oral patch: Chinese medicine category 5, the treatment of oral ulcers, patented products, has been reported to the SFDA, the transfer of clinical approvals.
22. Boswellia serrata: Traditional Chinese medicine category 5, for the treatment of rheumatoid arthritis, patented product, clinical approval has been obtained, transfer of clinical approval.
23. Xanthan Gum: Xanthan Gum is the world's largest production scale, the most widely used microbial polysaccharides, can be applied to the food industry, petroleum industry, materials industry, textile industry, paint industry and other industries. The xanthan gum production technology developed by our institute, 48h fermentation level of 29g/L, the technical indicators have reached the domestic indicators of similar products, is now transferring the production process.
24. Gellan gum: Gellan gum is one of the most promising microbial polysaccharides in recent years, as emulsifiers, suspending agents, thickening agents, stabilizers, gelling agents, tissue culture media, film-forming agents and lubricants, etc., are widely used in food, beverages, cosmetics, detergents, ceramics, petroleum extraction, chemical coatings and other industries. Its characteristics: 1, low dosage; 2, thermal stability and acid resistance; 3, superior flavor; 4, very high gel transparency; 5, adjustability of elasticity and hardness; 6, good compatibility. The production technology of Gellan gum developed by our institute, 48-72h fermentation level is 10-12g/L for crude gel, 5-6g/L for clarified gel, the technical indexes have reached the indexes of similar products in China, and now we are transferring the production process.
25.Natamycin: Natamycin (Natamycin) is an important polyene antimicrobial, can effectively inhibit the growth of yeasts and molds, to prevent the formation of aflatoxin in the filamentous fungi, but also to treat diseases caused by fungi. Due to the low solubility of natamycin, treatment of food surfaces with it to increase the shelf life of food will not affect the flavor and texture of the food. Currently, natamycin as a natural food preservative has been approved for use in certain dairy products, meat, fruits, beverages and many other food industries. The natamycin fermentation production technology developed by our institute is at the leading level in China, with a 5d fermentation level of 6g/L, which can be produced industrially, and the production process is now transferred.
26. Pullulan sugar: water-soluble mucopolysaccharide, widely used in food industry, pharmaceutical industry and petroleum, building materials industry, our yield and substrate conversion rate and the Japanese Hayashibara company is equivalent to the 48h fermentation level of 60g/L, with advanced purification process, has achieved industrial production. Transfer of production process.
27. Low molecular weight Pullulanose: further developed and researched Pullulanose production process, specializing in the production of molecular weight below 50,000 Pullulanose, suitable for special purposes. The production process is now transferred.
28. Chitooligosaccharides: chitooligosaccharides are oligosaccharides with polymerization degree of 2-20 composed of 2-glucosamine connected by β-1,4-glycosidic bond, among which, chitooligosaccharides with polymerization degree of 6-8 have good antibacterial, immune-enhancing, anti-tumor activity and other functions. The production process developed by our institute can prepare white powdery chitosan containing 6-8 degrees of polymerization of sugar, with good water solubility, and the color and inner quality reaching or exceeding the Korean products, and now we are transferring the production process.
29. Oligo-Xylose: Oligo-Xylose is a functional oligosaccharide made of 2-8 xylose connected by β-1,4-glycosidic bond, it is a kind of bifidogenic factor with superior performance, it has unique acid stability and difficult fermentation, it is difficult to be decomposed by human digestive enzyme system, and it has a high selective proliferative effect on bifidobacteria in the organism. It can be widely used as food additives in medicine, health food, beverage, confectionery, pastry, ice cream, milk powder, dairy products, flavorings and feed, etc. Now we have used high temperature enzyme to industrially produce many different series such as 70 syrup, 70 sugar powder, 95 sugar powder, 95 syrup and so on. Product quality can reach the highest level in China, transfer of production process.
30. Epidermal growth factor: human epidermal growth factor is a peptide that promotes epidermal growth, which can be used for corneal transplantation, burns, trauma and other treatments. Human epidermal growth factor is generally produced by genetically engineered bacteria. We have obtained a strain of genetically engineered E. coli for the production of human epidermal growth factor. The product has high expression and is secreted into extracellular, and it is easy to be separated and purified. The product has a natural conformation, high biological activity, small side reaction, specific activity unit ≥5×105IU/mg, and purity ≥95%. Now we are transferring the production process.