Echem has unique products in the fields of fine chemicals and biochemistry, and at the same time, according to the needs of customers at home and abroad, give full play to its own professional advantages, and conduct targeted R&D and production for customers. We provide the following high-quality services to customers in Europe, America, Asia and China:
1. Outsourced R&D Organization (CRO) and Outsourced Production Organization (CMO)
2. R&D and production of electronic chemicals and pharmaceutical intermediates
3. Lead compound generation and structure optimization
4. Customized synthesis of fine chemicals
5. Medical technology transfer and commissioned research and development
Project 1: Technology transfer or cooperative production of 12 multivitamins and key raw materials for injection
[Drug name] 12 multivitamins for injection
[Dosage Form] Freeze-dried powder injection
[Properties] This product is orange-yellow lumps.
[Prescription] Each bottle of this product contains 9 water-soluble vitamins and 3 fat-soluble vitamins:
1. 9 water-soluble vitamins
⑴ Vitamin C ⑵ Cocarboxylase tetrahydrate ⑶ Riboflavin sodium phosphate ⑷ Vitamin B6
⑸ Vitamin B12 ⑹ Folic acid ⑺ Dexpanthenol ⑻ Biotin ⑼ Niacinamide
Two, 3 kinds of fat-soluble vitamins
⑽ Vitamin A palmitate ⑾ Vitamin D3 ⑿ Racemic-α-tocopherol
Three, pharmaceutical excipients
⒀ Glycine ⒁ Glycocholic acid ⒂ Soy lecithin
【Indications】
This product is an intravenous vitamin supplement medication, suitable for inadequate nutritional intake through the gastrointestinal tract (such as malnutrition or gastrointestinal malabsorption, etc.), or contraindications for gastrointestinal nutrition.
This product is suitable for children and adults over 11 years old to receive parenteral nutrition, the daily required dosage of multivitamins and the routine intravenous requirements in other situations, including surgery, extensive burns, fractures and other traumas, serious infectious diseases and coma. It can be used for the emergency response of the body's metabolism and the lack of tissue nutrition under continuous severe nutritional status changes. This product can provide the intake of essential vitamins to maintain the body's normal response and repair. This product should not be used for treatment when the human body lacks vitamins.
【Dosage】
For adults and children over 11 years old, one bottle is administered daily. Use a syringe to take 5ml of water for injection into the bottle, shake slowly until the lyophilized powder is dissolved. The resulting drug solution should be injected slowly through the vein (with a duration of at least 10 minutes), or dissolved in isotonic saline or glucose injection by intravenous drip.
Patients with multiple vitamin deficiencies or patients with significantly increased requirements can be continuously given the daily dose of this product for 2 or more days according to the clinical situation.
This product can be mixed with parenteral nutrients such as carbohydrates, lipids, amino acids, electrolytes and trace elements whose compatibility and stability have been determined.
Remarks: This product is registered and classified as 6+6 varieties, and it is directly reported for production according to generic drugs at the time of declaration, without the need for clinical research. The production approval and approval number of preparations and APIs, as well as the registration certificate and production approval of new pharmaceutical excipients can be obtained in about 18 months. Among them, tetrahydrate cocarboxylase, dl-a- tocopherol, right pantothenol and glycocholic acid have no legal source in China and must be declared together with the preparation.
【Intellectual property】
No Chinese patents, no administrative protection.
【Features】
This product is the only multivitamin freeze-dried powder for injection that contains both water-soluble multivitamins and fat-soluble multivitamins (without vitamin K), and added glycocholic acid and soybean phospholipid micro-capsules. Its biggest feature is that the fat-soluble vitamins and water-soluble vitamins can be dissolved in the same container, and can maintain its injectable properties in the final preparation while being stored. This product is an orange-yellow, tasteless sterile freeze-dried powder injection, which can be dissolved with 5ml water for injection, intravenous solution (such as 0.9% sodium chloride, 5% glucose) or other intravenous nutrient solutions before use. When dissolved with water for intravenous injection, its pH value is about 5.9. It can meet the needs of children over the age of 11 and adults for multiple vitamins, and can be mixed with parenteral nutrients such as carbohydrates, lipids, amino acids and trace elements with established compatibility and stability.
【Market analysis】
This product is an imported drug product of Baxter Company of the United States. It has been sold in China since October 1999, and its product name is "Schneivita, Cernevit". The market retail price before 2005 was 38 yuan/piece, and the wholesale price was 26 yuan/piece. Due to the low price and the high production and logistics costs of imported products, Baxter has gradually abandoned the sales of this product in 2004 and changed to the general agent of a domestic pharmaceutical company. The current market retail price of this product has increased. It is 140 yuan/piece, which is 5 times that of water-soluble vitamin for injection (Jiuweita) and 7 times that of compound vitamin injection (4) (Zivita). The cost of the raw materials of this product is only close to 0.8 yuan/piece. Therefore, the clinical application of this product is significantly better than the water-soluble vitamin for injection, fat-soluble vitamin for injection (II) and compound vitamin injection (4) on the domestic market. This product has a very large market potential. The domestic development of this product has broad market prospects and will become a strong profit growth point for enterprises.
Market analysis of other multi-vitamin injections:
On September 18, 2005, the National Development and Reform Commission announced the "Notice on Reducing the Retail Prices of 22 Drugs Including Cefuroxime". The new round of drug price reductions began on October 10 this year. The price reduction is still dominated by antibiotics. There are 22 kinds of varieties involved in the price reduction, of which 16 antibiotics and 6 new medicines in the medical insurance catalogue are all clinically used varieties, mainly ceftriaxone, levofloxacin, ofloxacin, azithromycin, gram Linmycin and other antibiotics are the mainstay, as well as thymosin, interferon, water-soluble multivitamins (water-soluble vitamins for injection) and other newly entered medical insurance catalogs.
The maximum retail price of water-soluble vitamins for injection has dropped to 15 yuan per bottle. This variety will basically lose its market competitiveness. Most hospitals will soon abandon the clinical use of water-soluble vitamins for injections and look for new multi-vitamin injections. Variety. Once water-soluble vitamins for injection are withdrawn from the market, 12 multivitamins for injection will quickly occupy most of the market share of multivitamin injections.
At present, there is only one domestic product approved last year (Shanxi Pude Pharmaceutical Co., Ltd.). The API has not passed GMP certification, and the preparation is currently not produced or sold.
【Transfer method】
1 Provide 12 kinds of multivitamin production technologies for injection, including freeze-drying process and quality control methods;
2 Provide the industrialized production process of raw material drug tetrahydrate cocarboxylase, dl-a-tocopherol, dexpanthenol and adjuvant glycocholic acid;
3 Assist the transferee to prepare relevant application materials.
4 The cooperation method can be complete technology transfer, or technology share dividends.
【Technical Features】
1 The freeze-drying process adopts a special processing method to ensure that the product meets the quality standards of imported varieties and has a better appearance and quality than foreign products. The process has been continuously produced in 3 batches, each batch of 1,000.
2 Thiamine pyrophosphate tetrahydrate, dl-a-tocopherol, glycocholic acid and 12 kinds of compound vitamins for injection have mature technology and have been industrialized. Our process is simple, high yield, low cost, and can fully meet the quality requirements of raw and auxiliary materials for injection. The main features are as follows:
(1) The purity of thiamine pyrophosphate tetrahydrate is above 99.5%, and the content of all unknown impurities is less than 0.1%. According to the requirements of API declaration, there is no need to do qualitative and pharmacological and toxicological tests of impurities, which greatly saves the preparation time of declaration materials And capital investment. The quality greatly exceeds the current standard for this variety approved by the State Drug Administration.
(2) The purity of glycocholic acid is above 98.5%, the maximum impurity content is less than 0.5%, and the impurity content is greater than 0.1%. It saves time and capital investment for declaration. The National Food and Drug Administration of this species has not yet approved standards.
(3) The purity of dl-a-tocopherol reaches over 98.0%, and the quality completely reaches and exceeds the most stringent European Pharmacopoeia standard for this product. It saves time and capital investment for declaration. The quality greatly exceeds the current standard for this variety approved by the State Drug Administration.
(4) The quality of dexpanthenol meets the standards approved by the National Food and Drug Administration.
(5) The above technologies are all industrialized technologies, and they have been stably produced in more than 5 batches, glycocholic acid 5kg per batch, dl-a-tocopherol 5-10kg per batch, and thiamine pyrophosphate tetrahydrate 200- per batch. 1000g. Dexpanthenol: 500g-2kg, stable process. easy to use.
Project 2: Technology transfer or cooperative production of raw materials and capsules of tauroursodeoxycholic acid
1. Project name
Technology transfer or cooperative production of raw materials and capsules of tauroursodeoxycholic acid
English name: Tauroursodeoxycholic Acid
Molecular formula: C26H45NO6S.2H2O
Basic information: The chemical name of tauroursodeoxycholic acid (TUDCA) is 3α, 7β dihydroxycholanoyl-N-taurine, which is composed of the shuttle group of ursodeoxycholic acid (UDCA) and the amino group of taurine Combined bile acid formed by shrinking between. TUDCA was discovered in bear bile in 1902. It is the main bile acid in bear bile and has antispasmodic, anticonvulsant, anti-inflammatory and gallstone-dissolving effects. Tauroursodeoxycholic acid (tauroursodeoxycholic acid, 1) is the active ingredient of bear bile, and its chemical name is 2-[[(3α, 5β, 7β)-3,7-dihydroxy-24-oxocholestane-24 -Yl]amino]ethanesulfonic acid dihydrate, developed by the Italian Besdi Pharmaceutical Factory, was first marketed in Italy in 1991, and was approved for sale in China under the trade name taurolite in 2007. It is mainly used in clinical practice Treatment of cholesterol gallstones, primary sclerosing cholangitis, primary biliary cirrhosis and chronic hepatitis C. Clinical studies have shown that compared with ursodeoxycholic acid, the dissolution rate is faster, the total dissolution rate is increased, and there are no obvious adverse reactions. No domestic company has been approved for listing!
2. Registration category
API: 3 categories; Capsules: 6 categories
3. Preparation
Capsule 250mg
4. Indications
Dissolve cholesterol stones.
* There are one or more cholesterol stones with a diameter less than 2 cm visible on X-ray in the gallbladder or bile duct.
* Refused to surgical treatment or not suitable for surgical treatment.
* Duodenal intubation bile examination confirmed cholesterol oversaturation.
5. Pharmacology and Toxicology:
Tauroursodeoxycholic acid can increase the secretion of bile acids, leading to changes in the composition of bile acids and increasing the content of bile. Tauroursodeoxycholic acid can also inhibit the synthesis of cholesterol in the liver, reduce the amount of cholesterol and cholesterol esters in the bile, and the saturation index of cholesterol, thereby facilitating the gradual dissolution of cholesterol in the bile.
In chronic toxicology experiments, the oral doses for dogs and rats were 400mg/kg (dogs) and 1200mg/kg (rats) respectively, and no toxicity was reported.
In view of the fact that bile acids can pass through the placental barrier, the drug should not be used in pregnant women for safety reasons. Although rabbits and rats received high-dose oral administration, there was no embryo toxicity or teratogenic effects.
In the five required studies, the results obtained failed to suggest any mutagenic effects of Taurot.
A 2-year study on the carcinogenicity of this product has been carried out on rats taking large doses of drugs (up to 300mg/kg/day), and it has proved that this product has no carcinogenic effects.
6. Research progress: The pre-production research is reported, and the pilot test and industrial optimization of APIs and preparations have been completed. Quality research has been carried out.
Project 3: Technology transfer or cooperative production of vitamin A palmitate ophthalmic gel
1. Project name
Vitamin A Palmitate Eye Gel
2. Basic introduction
[Properties] This product is a milky white gel with no visible particles.
[Indications/Functions and Indications] As an adjuvant treatment for corneal protection: dry eye caused by various reasons (for example: Sjogren's syndrome, neuroparalytic keratitis, exposure keratitis); conjunctiva and conjunctiva due to lack of tear film protection Symptoms of corneal irritation.
【Specification Model】5g:5000IU
[Pharmacology and Toxicology] Due to the long retention time, this product is suitable as a substitute for tear fluid to be used in the treatment of insufficient tear secretion and "dry eye syndrome". The latter is due to the instability of the tear film caused by the low quality of tear fluid and then high secretion. The higher viscosity enhances the protective effect of the gel through physical lubrication. The added vitamin A eliminates the symptoms of corneal epithelial dehydration and enhances the therapeutic effect. Vitamin A (retinol) is necessary for the normal differentiation of epithelial cells. Deficiency of retinol leads to a decrease in goblet cells, atrophy of epithelial cells and proliferation of conjunctival basal cells.
[Pharmacokinetics] The good local permeability of topical retinol has been confirmed in healthy rabbit eyes, and it is impossible to conduct research on the degree of penetration or distribution and persistence of human eyes.
3. Registration classification
API: 6 categories; preparation: 6 categories
Remarks: This product is a registered category 6+6 variety. It is directly reported for production as a generic drug when applying. No clinical research is required. The production approval and approval number of the preparation and API can be obtained in about 18 months. Among them, the domestic legal source of vitamin A palmitate is difficult, and it is recommended to declare together with the preparation.
4. Intellectual Property
No Chinese patents, no administrative protection.
5. Research progress
Pre-production research, pilot trials and industrial optimization of APIs and preparations have been completed. Quality research has been carried out.
