Clindamycin Phosphate Vaginal Expansion Suppository and Its Preparation Method and Detection Method

A technology of clindamycin phosphate and vaginal expansion suppository, applied in the directions of suppository delivery, measuring device, pharmaceutical formulation, etc., can solve problems such as difficult to clean, easy to contaminate clothes, not exerting the best curative effect, etc., to prevent outflow, avoid The effect of secondary infection

Active Publication Date: 2016-01-13
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, Yao Rongcheng et al. (Yao Rongcheng, Yuan Jianping, Zhou Hui. Development of Clindamycin Phosphate Suppository [J], Chinese Journal of Biochemical Medicine, 2002, 23 (2): 87-88) disclosed a drug produced by Clindamycin A suppository made of mycin phosphate and semi-synthetic fatty acid ester; the preparation process of the suppository is simple, and the stability has been further investigated, but the stability of the suppository is still not ideal, and the drug release is slow; and Clindamyces vulgaris Phosphate suppositories also have technical problems such as not being easy to clean and easily contaminating clothes; the contact surface between the active ingredient and the human body is small, resulting in insufficient absorption and failure to exert the best curative effect of the prescription.

Method used

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  • Clindamycin Phosphate Vaginal Expansion Suppository and Its Preparation Method and Detection Method
  • Clindamycin Phosphate Vaginal Expansion Suppository and Its Preparation Method and Detection Method
  • Clindamycin Phosphate Vaginal Expansion Suppository and Its Preparation Method and Detection Method

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Experimental program
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Effect test

Embodiment 1

[0103]

[0104] Preparation:

[0105] 1) Preparation of drug-containing matrix:

[0106] a. heating and melting the semi-synthetic fatty acid glyceride in a water bath to obtain a melt;

[0107] b. adding clindamycin phosphate to the melt obtained in step a, and mixing uniformly to obtain a drug-containing matrix;

[0108] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 bullet-shaped suppositories, each weighing about 3.5g.

Embodiment 2

[0110]

[0111] Preparation:

[0112] 1) Preparation of drug-containing matrix:

[0113] a. heating and melting witepsol and cocoa butter in a water bath to obtain a melt;

[0114] b. mixing clindamycin phosphate with xylitol and lauryl gallate uniformly to obtain the first mixture;

[0115] c. adding the first mixture to the melt obtained in step a, and mixing evenly to obtain a drug-containing matrix;

[0116] 2) Preparation of expansive suppositories: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 egg-shaped suppositories, each weighing about 1.8g.

Embodiment 3

[0118]

[0119] Preparation method: make 100 conical suppositories according to the method in Example 2, each weighing about 5.0g.

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Abstract

The invention relates to a clindamycin phosphate vaginal expansion suppository and a preparation method and a detection method thereof. The expansion suppository comprises a drug-containing matrix and an expansion carrier formed by clindamycin phosphate and a matrix; wood is added into the drug-containing matrix Sugar alcohol, lauryl gallate and triglyceryl caprylic caprate, the expansion suppository made has high stability and uniform dispersion; at the same time, the outer layer of the expansion suppository is coated with film coating, which overcomes the problem of clindamycin phosphate Clindamycin Phosphate Vaginal Expansion Suppository adopts six original leading technologies, which can prevent the outflow of medicine liquid and prevent secondary infection, etc. Beneficial effect.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a clindamycin phosphate vaginal expansive suppository, a preparation method and a detection method thereof. Background technique [0002] Clindamycin phosphate, chemical name (2S-trans)-6-(1-methyl-4-propyl-2-pyrrolidinecarbonamido)-1-thio-methyl-7-chloro -6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate; it is a white or off-white crystalline powder, odorless or almost odorless, with a taste Bitter, hygroscopic; easily soluble in water, slightly soluble in methanol, almost insoluble in ethanol; clindamycin phosphate is a semi-synthetic derivative of lincomycin, which is an anti-anaerobic and aerobic bacteria It is a broad-spectrum antibiotic that has no antibacterial activity in vitro, and is rapidly hydrolyzed into clindamycin to exert pharmacological activity after entering the body; it mainly has strong antibacterial activity against Gram-positive cocc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K31/7056A61K47/26A61K47/14A61P31/04A61P31/02A61P15/02G01N33/15G01N5/04G01N30/02
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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