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Metformin hydrochloride enteric-coated tablets quality control method

A technology of metformin hydrochloride enteric and metformin hydrochloride, which is applied in the field of quality control of metformin hydrochloride enteric-coated tablets, and can solve the problems of no quantitative index for release in acid, fuzzy visual inspection, and no set substance inspection items, etc.

Active Publication Date: 2013-05-01
贵州天安药业股份有限公司
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Problems solved by technology

[0015] At present, the quality control of Metformin Hydrochloride Enteric-Coated Tablets adopts the standard of "Metformin Hydrochloride Tablets" in the 2005 edition of "Chinese Pharmacopoeia". There is no quantitative indicator for the amount of acid released in each tablet in the existing standard, only visual fuzzy indicators are used, and there is no set of related substance inspection items

Method used

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  • Metformin hydrochloride enteric-coated tablets quality control method
  • Metformin hydrochloride enteric-coated tablets quality control method
  • Metformin hydrochloride enteric-coated tablets quality control method

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Embodiment Construction

[0092] Prescription: metformin hydrochloride 250.0g, dextrin 30.0g, hypromellose 15g, 4% hypromellose solution 20g, 14% starch slurry 20g, silicon dioxide 1.0g, magnesium stearate 1.0g, enteric-coated bag Coating agent (4% ethanol solution) 250ml, make 1000 tablets.

[0093] Preparation:

[0094] 1. Pulverize the raw material of metformin hydrochloride, the main drug, and pass through a 100-mesh sieve, and pass through a 80-mesh sieve for other auxiliary materials, and set aside;

[0095] 2. Preparation of adhesive: add 4% hydroxypropyl methylcellulose solution to 14% starch slurry, mix well, and get ready;

[0096] 3. Making soft material: Weigh metformin hydrochloride, dextrin and hydroxypropyl cellulose according to the prescription ratio, mix them evenly, add an appropriate amount of binder, and mix well;

[0097] 4. Granulation: Granulate with 12 mesh sieve;

[0098] 5. Drying: Dry at 65-75°C for 1.5-2 hours, and control the moisture at 1.8%-2.8%;

[0099] 6. Grain si...

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Abstract

The invention discloses a quality control method of metformin hydrochloride enteric coated tablet, comprising the aspects of character, identification, examination and content measurement; wherein, release examination comprises the release quantity examination of acid in hydrochloric acid solution of 0.1 mol / l and the release quantity examination in phosphate buffer with the pH value of 6.8; the examination of relevant substances comprises the following steps: dicyandiamide is taken as reference, sulfonic group cation exchange bonded silica is taken as filler, ammonium dihydrogen phosphate solution of 1.7 percent with the pH value of 3 is mobile phase and the high performance liquid chromatography is used for examining the relevant substances. The invention controls the release quantity of the metformin hydrochloride enteric coated tablet in gastric juice strictly, reduces the adverse reaction of patients effectively, improves the release quantity of the metformin hydrochloride enteric coated tablet in the buffer solution (simulated intestinal juice) and ensures the dissolution of the enteric coated tablet in the intestinal juice effectively; the invention also adds the examination of dicyandiamide impurity under the examination item and enhances the safety of the medicine.

Description

technical field [0001] The invention relates to metformin hydrochloride enteric-coated tablets, in particular to a quality control method for metformin hydrochloride enteric-coated tablets. Background technique [0002] Metformin hydrochloride enteric-coated tablets are hypoglycemic drugs, which can reduce fasting and postprandial hyperglycemia in patients with type II diabetes, and HbAlc can be reduced by 1% to 2%. For patients with hyperinsulinemia, this drug not only has the effect of lowering blood sugar, but also has the effect of reducing body weight and hyperinsulinemia. It can be effective for some patients with poor curative effect of sulfonylureas, such as combined with sulfonylurea hypoglycemic agents, small intestinal glycosidase inhibitors or thiazolidinedione hypoglycemic agents, the effect is better than that of each alone. It can also be used in patients on insulin therapy to reduce the dosage of insulin. The preparation method of metformin hydrochloride is...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/15G01N30/02G01N21/31
Inventor 张凡方洪海金联荪尚丽江
Owner 贵州天安药业股份有限公司
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