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Clindamycin phosphate vaginal tablets and preparation process thereof

A technology of clindamycin phosphate and preparation process, which can be applied in directions such as medical preparations without active ingredients, medical preparations containing active ingredients, and pill delivery, etc., and can solve the problems of affecting the use effect of vaginal tablets, falling off the tablets, and the like, To achieve the effect of shortening the medication time, increasing the adhesion, and improving the comfort of use

Active Publication Date: 2021-03-30
HAINAN HAISHEN TONGZHOU PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The tablets fall off when some patients use them, especially when the weather is dry, which affects the effect of vaginal tablets

Method used

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  • Clindamycin phosphate vaginal tablets and preparation process thereof
  • Clindamycin phosphate vaginal tablets and preparation process thereof
  • Clindamycin phosphate vaginal tablets and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1-clindamycin phosphate vaginal tablet preparation

[0026] (1) Prescription (calculated per 1000 tablets)

[0027]

[0028] (2) Process

[0029] S1. First heat and melt the microcrystalline cellulose, add clindamycin phosphate, mix and stir for the first time for 5 minutes, then add it into the melted lactose after cooling, and mix and stir for the second time for 10 minutes to obtain the primary mixture ;

[0030] S2. Take the initial mixture, add 2wt% low-substituted hypromellose aqueous solution; make soft materials, pass through a 16-mesh sieve and granulate to obtain soft granules;

[0031] S3. Dry at 50-55°C for 4 hours, pass through a 14-mesh sieve, and granulate;

[0032] S4. Add magnesium stearate and sodium carboxymethyl starch, mix for 10 minutes, and compress into tablets.

Embodiment 2

[0033] Embodiment 2-clindamycin phosphate vaginal tablet preparation

[0034] (1) Prescription (calculated per 1000 tablets)

[0035]

[0036]

[0037] (2) technology is consistent with embodiment 1.

Embodiment 3

[0038] Embodiment 3-clindamycin phosphate vaginal tablet preparation

[0039] (1) Prescription (calculated per 1000 tablets)

[0040]

[0041] (2) technology is consistent with embodiment 1.

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Abstract

The invention provides a clindamycin phosphate vaginal tablet and a preparation process thereof. The clindamycin phosphate vaginal tablet is prepared from the following raw materials in parts by weight: 125 parts of clindamycin phosphate, 140-160 parts of lactose, 90-95 parts of microcrystalline cellulose, 7-8 parts of carboxymethyl starch sodium, 1.5-2.0 parts of magnesium stearate and 10-20 parts of a 1.8-2.2 wt% hydroxypropyl methylcellulose aqueous solution. The clindamycin phosphate vaginal tablet prepared by the preparation method disclosed by the invention is good in swelling rate and relatively large in adhesive force, better exerts the drug effect of clindamycin, shortens the drug use time and improves the use compliance of a patient.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a clindamycin phosphate vaginal tablet and a preparation process thereof. Background technique [0002] Clindamycin is a lincosamide antibiotic with strong antibacterial activity and broad antibacterial spectrum. It is suitable for the treatment of many infectious diseases in various clinical departments. It has been listed as one of the highly effective antibacterial drugs for the treatment of various infections that threaten human health and life. one. Clindamycin has been included in the pharmacopoeia of China, the United States, the United Kingdom, Japan and other countries. [0003] Clindamycin phosphate (clindamycin phosphate) can be hydrolyzed into clindamycin after absorption to play an antibacterial effect. It is widely used as a semisynthetic antibacterial drug for serious infections caused by Gram-positive cocci and anaerobic bacteria. Biclindamyc...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K47/38A61K47/36A61K47/12A61K31/7056A61P31/04A61P15/02
CPCA61K9/2018A61K9/2054A61K9/2059A61K9/2013A61K9/0034A61K31/7056A61P31/04A61P15/02Y02A50/30
Inventor 韦家华刘玉
Owner HAINAN HAISHEN TONGZHOU PHARM CO LTD
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