Stable carbocisteine ​​pharmaceutical composition

Abstract

The invention belongs to the technical field of medical science, and particularly relates to a stable carbocisteine drug composition and preparation thereof. The stable carbocisteine drug compositionis prepared from, in percentage by weight: 3-10% of carbocisteine, 3-10% of sodium hydroxide and 0.05-0.2% of stabilizer, wherein the stabilizer is composed of hydroxy propyl cellulose and D-sodium gluconate at the weight ratio of 1 to (0.1-1). The stable carbocisteine drug composition has the excellent long-term stability, and can still be clear after being stored for 36 months at the temperatureof 20 DEG C in dark, the content of the effective component just decreases within 0.3-0.4%, and outstanding advancement is made compared with the prior art.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a stable carbocisteine ​​pharmaceutical composition. Background technique [0002] Carbocisteine ​​is a multi-element compound containing two carboxyl groups and one amino group. It is often used as a sputum thinner in clinical practice. After oral administration, the secretion of organs and endobronchial glands increases, and the sputum becomes olefinic, making it easier to cough up the sputum. , rapid onset of oral administration, obvious curative effect can be seen 4 hours after taking it, usually made into solid preparations, such as tablets, etc. [0003] Compared with solid preparations, liquid preparations can limit the taste, enhance absorption, and increase bioavailability. But because carbocisteine ​​has low solubility in water (only about 0.16%), although the solubility of carbocisteine ​​after forming salt has improved, because its aqueous solution is acidic, find i...

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Problems solved by technology

But because carbocisteine ​​has low solubility in water (only about 0.16%), although the solubility of carbocisteine ​​after forming salt has improved, because its aqueous solution is acidic, find in practical application, after long-term preservation The solution will change from a clear state to a flocculent state

[0004] D-sodium gluconate, alias sodium gluconate, CAS No. 527-07-1, molecular formula C 20 h 25 NaO 10 , is a white crystalline granule or powder, easily soluble in water, slightly soluble in alcohol, insoluble in ether, used in food additives, electroplating complexing agents, printing and dyeing industry color leveling agents, steel surface treatment agents, etc., but none of them are involved Role in stabilizing carbocisteine

[0005] Hydroxypropyl cellulose is generally used as a pharmaceutical excipient and a disintegrant, which can shorten the disintegration time of solid preparations such as tablets, granules, and capsules, but does not involve its role in stabilizing carbocisteine. effect

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