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Medicine composition with colesevelam hydrochloride and preparation medicine of medicine composition

A technology of colesevelam hydrochloride and colesevelam, applied in the direction of drug combinations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as poor stability and low content uniformity, and overcome poor fluidity, Good reproducibility and good drug content uniformity

Inactive Publication Date: 2020-05-08
ZHEJIANG JINGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem solved by the present invention is to overcome the defects of low content uniformity and poor stability of existing colesevelam hydrochloride tablets, and provide a pharmaceutical composition containing colesevelam hydrochloride and its preparation method

Method used

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  • Medicine composition with colesevelam hydrochloride and preparation medicine of medicine composition
  • Medicine composition with colesevelam hydrochloride and preparation medicine of medicine composition
  • Medicine composition with colesevelam hydrochloride and preparation medicine of medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Prepare the pharmaceutical composition according to the prescription in Table 1.

[0039] Table 1

[0040]

[0041] Preparation Process:

[0042] (1) Part of colesevelam hydrochloride (accounting for 15% of the total mass) and micropowdered silica gel were mixed and stirred at a rotation speed of 280r for 10 minutes, and then passed through a 40-mesh sieve to obtain a sieved mixture;

[0043] (2) The remaining colesevelam hydrochloride and the sieved mixture were mixed and stirred for 30 minutes at a rotation speed of 280r to obtain premix 1;

[0044] (3) Perform dry granulation on premix 1, and mix the obtained granules with microcrystalline cellulose for 30 minutes to obtain premix 2;

[0045] (4) Add the magnesium stearate that crosses 40 mesh sieves in the premix 2, after mixing 10min, obtain total mixture;

[0046] (5) Tablets were pressed with a rotary tablet press with different process parameters, and finally prepared by coating and printing at 30°C.

[0...

Embodiment 2

[0051] Prepare pharmaceutical composition according to table 3 prescription.

[0052] table 3

[0053]

[0054]

[0055] The preparation method is the same as in Example 1, wherein part of colesevelam hydrochloride accounts for 25% of the total mass, the stirring speed in steps (1) and (2) is 330r, and the tabletting pressure is 41 ± 1KN, and the tabletting speed is 41 ± 1KN. Tablet compression is carried out under the condition of 10 rpm, and the coating temperature is 38°C. After testing, the average hardness is 213N, the friability is -0.18%, the content uniformity is 0.70%, and the disintegration time is 9m13s.

Embodiment 3

[0057] Prepare pharmaceutical composition according to table 4 prescription.

[0058] Table 4

[0059]

[0060] The preparation method is the same as in Example 1, wherein part of colesevelam hydrochloride accounts for 35% of the total mass, the stirring speed in steps (1) and (2) is 300r, and the tabletting pressure is 41 ± 1KN, and the tabletting speed is 41 ± 1KN. Tablet compression is carried out under the condition of 10 rpm, and the coating temperature is 35°C. After testing, the average hardness is 169N, the friability is -0.14%, the content uniformity is 0.59%, and the disintegration time is 6m10s.

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Abstract

The invention discloses a medicine composition with colesevelam hydrochloride and a preparation medicine of the medicine composition. The medicine composition comprises the following components in parts by mass: 1 part of colesevelam hydrochloride, 0.248-0.304 part of microcrystalline cellulose, 0.016-0.064 part of micropowder silica gel and 0.0064-0.0192 part of magnesium stearate. The medicine composition is prepared by steps including pelletizing. The process of pelletizing is dry-method pelletizing. The medicine composition disclosed by the invention is stable and reliable in quality, goodin medicine content uniformity, low in friability, moderate in hardness and good in reproducibility; and the preparation method disclosed by the invention is simple and feasible and applicable to large-scale industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing colesevelam hydrochloride and a preparation method thereof. Background technique [0002] The chemical names of colesevelam hydrochloride are: 2-propen-1-amine and epichlorohydrin, N-2-propenyl-1-decylamine and N,N,N-trimethyl-6-(2 -Acrylamino)-1-hexylamine copolymer hydrochloride, English name Colesevelamhydrochloride, is a new type of non-absorbable polymer oral drug for the treatment of hyperlipidemia developed by Gel Tex Pharmaceuticals in the United States. In the treatment of excessive serum total cholesterol (TC) or triglyceride (TG) levels, its structural formula is as follows: [0003] [0004] CN103585128A discloses a pharmaceutical composition containing colesevelam hydrochloride, which is prepared by powder direct compression method, but the fluidity of colesevelam hydrochloride bulk drug is poor, and the powder direct compression method will lead to large differences in t...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/785A61K47/38A61P3/06
CPCA61K9/2009A61K9/2054A61K9/2866A61K31/785A61P3/06
Inventor 褚襄萍尹辉府潘飞峰
Owner ZHEJIANG JINGXIN PHARMA
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