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Method for improving content uniformity of medicaments

A uniformity and drug technology, which is applied in the direction of drug combination, pharmaceutical formula, medical preparations containing active ingredients, etc., can solve the problems of many influencing factors, complicated operation methods, and narrow usability, so as to improve content uniformity, operation The method is simple and the conditions are easy to control the effect

Active Publication Date: 2015-10-07
ZHONGXING PHARM CO LTD JIANGSU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the operation method is complicated, there are many influencing factors, and the applicability is narrow.
[0005] The content uniformity of pre-drug preparations cannot be controlled, so that the clinical efficacy of the drug cannot be guaranteed, especially for preparations with trace active ingredients in the prescription, it is difficult to ensure uniform drug content

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1 A method for improving the uniformity of clonidine hydrochloride in Zhenju Jiangya Tablets.

[0019] In this embodiment, Zhenju Jiangya tablet is taken as an example, its standard number is YBZ00522006, and its prescription content is: 100 g of wild chrysanthemum flower ointment powder 100 g of nacre powder 100 g of clonidine hydrochloride 30 mg of hydrochlorothiazide 5 g of rutin 20 g.

[0020] The traditional method for preparing Zhenju Jiangya Tablets is as follows: take wild chrysanthemum paste powder, nacre powder, hydrochlorothiazide, and rutin and mix them evenly; in addition, take an appropriate amount of clonidine hydrochloride and dissolve them in ethanol; Repeated stirring, 30-mesh granulation, drying at 60 degrees, adding magnesium stearate, mixing evenly, and pressing into 1000 tablets. Each tablet of the above products contains 0.03 mg of clonidine hydrochloride. After determination, using this method, the content uniformity of clonidine hydro...

Embodiment 2

[0022] Embodiment 2 A method for improving the uniformity of chlorpheniramine maleate in Shunqi Huatan Tablets.

[0023] This embodiment takes Shunqi Huatan Tablet as an example, its standard number is WS-10869 (ZD-0869)-2002-2011Z, and the prescription content is: Vitex japonica 1300.0g, pine cone 1566.7g, plantain 1041.7g, licorice 130.0 g, aminophylline 13.3g and chlorpheniramine maleate 0.5g.

[0024] Its traditional preparation method is as follows: take Vitex vetex, pine cone, plantain, licorice and aminophylline and mix well, and then take an appropriate amount of chlorpheniramine forate and dissolve it in absolute ethanol, and evenly mix the absolute ethanol liquid into the above-mentioned mixture powder, stirred repeatedly, granulated at 30 mesh, dried at 60 degrees, added magnesium stearate, mixed uniformly, pressed into 1000 tablets, each containing 0.0005g of chlorpheniramine maleate.

[0025] The present invention adopts following method to improve the uniformity...

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PUM

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Abstract

The invention discloses a method for improving the content uniformity of medicaments, comprising the following steps: (1) adding a trace medicament in the formula to be treated into a solvent, and dissolving the trace medicament in the formula at 15-25 DEG C by using a microwave technology to obtain a solution of the trace medicament; (2) crushing other raw medicaments in the formula under a sealed condition at a low temperature, and homogeneously mixing the medicament powder under the condition that the sizes of the particles are consistent; and (3) mixing the raw powder obtained in (2) with other formula accessories uniformly, and spraying the solution of the trace medicament at a high speed while stirring, till the mixture is completely prepared into an appropriate soft material. By adopting the microwave solid-liquid fusion and solid-solid sealed low-temperature crushing and homogeneous mixing technology, not only the stability of the medicaments is greatly improved, but also the content uniformity of the medicaments is also greatly improved; and the operation method is simple, the application range is wide, and the conditions are easy to control.

Description

technical field [0001] The invention belongs to the field of material processing, and in particular relates to a method for improving the uniformity of drug content. Background technique [0002] Ensuring the continuous and stable production of drugs that meet the intended use and registration requirements is one of the main purposes of my country's implementation of the 2010 version of the Good Manufacturing Practice of Drugs (GMP). However, due to differences in raw materials, production processes, production status, and GMP implementation, the quality of pharmaceutical tablets is uneven. It is one of the difficulties that the pharmaceutical field has been facing to provide a basis for the formulation of a quality uniformity control program in the production process of pharmaceutical tablets and to improve the quality uniformity of pharmaceutical tablets. [0003] Patent 201110388425.0 discloses a method for improving the uniformity of strychnine in Gujin Wan capsule nuxs...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/287A61K36/85A61P9/12A61P11/10A61K35/618A61K31/549A61K31/4168A61K31/522A61K31/4402A61K31/7048
Inventor 武俊明邓廷丽
Owner ZHONGXING PHARM CO LTD JIANGSU