Clindamycin Hydrochloride capsule formulation and production method thereof

Abstract

The invention discloses a formula of a clindamycin hydrochloride capsule and a production method thereof. The formula consists of a main drug clindamycin hydrochloride and adjuvants such as a filling agent and a lubricant according to a certain mixture ratio; the filling agent is dry starch and / or dextrine; and the lubricant is one of or a plurality of micropowder silicon gel, magnesium stearate and insect wax. The production method comprises the following steps: the main drug and the adjuvants are directly mixed and encapsulated; the production method reduces production steps, lowers the production cost, and avoids the loss and damage of the drug, thus improving the bioavailability of the drug; the stability tests of retained samples of the clindamycin hydrochloride capsule prepared by the formula and the production method prove that the drug has stable quality.

Description

technical field [0001] The invention relates to an antibacterial drug, in particular to a formula of clindamycin hydrochloride capsule and a production method thereof. Background technique [0002] Clindamycin hydrochloride, whose chemical name is 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-7(S)-chloro-6, 7,8-trideoxy-L-threo-α-D-galactopyranoside hydrochloride. The antibacterial spectrum of clindamycin hydrochloride is the same as that of lincomycin hydrochloride, and its antibacterial activity is 4 to 8 times stronger than that of lincomycin hydrochloride. [0003] Clindamycin hydrochloride has high antibacterial activity against aerobic Gram-positive cocci, such as Staphylococcus (including penicillin-resistant and methicillin-sensitive strains), hemolytic streptococcus, viridans streptococcus, and Streptococcus pneumoniae. It also has good antibacterial effect on anaerobic bacteria. Most of Bacteroides, Fusobacterium, Actinomyces, Peptococcus, and Pep...

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Problems solved by technology

[0005] Due to the above-mentioned effects of clindamycin hydrochloride, there are oral dosage forms such as clindamycin hydrochloride disintegrating tablets and dispersible tablets at present, but there are complex production processes, high production costs, low bioavailability, and poor drug quality. unstable problem

[0006] In China, there are existing data reports on the production technology related to clindamycin hydrochloride medicines, such as the publication of the literature titled "clindamycin hydrochloride palmitate capsules and its preparation method" (patent application number: CN200610095153.4) developed an antibacterial drug, but the technique of dry granulation, packaging moisture-proof agricultural film and then filling capsules solves the problem that the product is easy to absorb moisture and agglomerate and the capsule shell becomes broken due to moisture absorption; The literature titled "Clindamycin Hydrochloride Palmitate Soft Capsules and Its Preparation" (Patent Application No. CN200710078533.1) also discloses an antibacterial drug. , the process is simple, but its formula uses clindamycin hydrochloride palmitate as the main active drug, and there are also problems such as complicated production process requirements and high production costs

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