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Solubility detection method for granular medicines

A detection method and granule technology, which is applied in the field of drug solubility detection, can solve problems such as poor operability and inability to accurately quantitatively detect, achieve enhanced operability, facilitate drug quality supervision, and avoid subjective arbitrariness Effect

Active Publication Date: 2012-12-12
九寨沟天然药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to provide a method for detecting the solubility of granule-formed medicines, so as to solve the problems of poor operability and incapable of accurate quantitative detection in the existing detection technology.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] (1) Take a quick quantitative filter paper with a diameter of 10cm, fold it in half and place it in a weighing bottle without lid. Put the weighing bottle and lid together in an electric thermostatic drying oven, and dry at 105℃ for 60 minutes. Take out the weighing bottle and tightly close the lid of the weighing bottle, place it in a desiccator with color-changing silica gel, cool to room temperature, open the lid of the weighing bottle, take out the filter paper, and use an analytical balance with a minimum graduation of 0.0001g Weigh the dried filter paper, put the filter paper in the weighing bottle again, dry it for 30 minutes in the same way, cool and weigh it in the same way, and dry it until it has a constant weight. Its weight is recorded as 1.3230g;

[0017] (2) Take 10g of soluble granules of some kind of traditional Chinese medicine for cold treatment, put it in a 250ml beaker, add 200ml of distilled water at 70℃~80℃, stir for 5 minutes to dissolve the soluble ...

Embodiment 2

[0022] (1) Take a quick quantitative filter paper with a diameter of 15cm, fold it in half and place it in a weighing bottle without lid. Put the weighing bottle and lid together in an electric thermostatic drying oven and dry at 103°C for 45 minutes. From the electric thermostatic drying oven Take out the weighing bottle and tightly close the lid of the weighing bottle, place it in a desiccator with color-changing silica gel, cool to room temperature, open the lid of the weighing bottle, take out the filter paper, and use an analytical balance with a minimum graduation of 0.0001g Weigh the weight of the dried filter paper, put the filter paper in the weighing bottle again, dry it for 30 minutes in the same way, cool and weigh it in the same way, and dry it until it has a constant weight. Its weight is recorded as 1.6067g;

[0023] (2) Take 10g of soluble granules of some kind of traditional Chinese medicine, put it in a 500ml beaker, add 200ml of distilled water at 70℃~80℃, stir ...

Embodiment 3

[0028] (1) Take the medium-speed quantitative filter paper with a diameter of 10cm, fold it in half and place it in a weighing bottle without capping. Put the weighing bottle and cap together in an electric thermostatic drying oven, and dry at 105°C for 50 minutes. Take the weighing bottle out of the box and tightly close the lid of the weighing bottle, place it in a desiccator with color-changing silica gel, cool to room temperature, open the lid of the weighing bottle, take out the filter paper, and analyze with a minimum graduation of 0.0001g Weigh the dried filter paper with a balance, put the filter paper in the weighing bottle again, dry it for 30 minutes in the same way, cool and weigh it in the same way, and dry it until it has a constant weight. Its weight is recorded as 1.3342g;

[0029] (2) Take 10g of a Chinese medicine soluble granule for the treatment of high blood pressure, put it in a 250ml beaker, add 200ml of distilled water at 70℃~80℃, stir for 5 minutes to diss...

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Abstract

The invention discloses a solubility detection method for granular medicines, aiming at solving the problems of weak operability and incapability in accurate quantitative detection in the traditional solubility detection technology of the granular medicines. In the invention, whether the solubility of one granular medicine is qualified or not is determined by detecting the content of insoluble impurities in the granular medicine, so that the problem that the solubility of a trace amount of tiny insoluble substances, except for a little peacoke, in a granular formulation is difficult to judge in the prior art is solved, the standard operability is greatly enhanced, the problems of seriously damaged seriousness, authority and the like of medicine inspection due to disputation and chaos generally caused by severe subjective randomness in an execution process are solved, and the quality stability of the granular formulation and the medicine quality supervision are facilitated.

Description

technical field [0001] The invention relates to a method for detecting the solubility of medicines, in particular to a method for detecting the solubility of granular medicines. Background technique [0002] Granules are a commonly used dosage form of Chinese patent medicines and chemical medicines, and are used in a large amount in clinical practice. They have been recorded in previous editions of "Chinese Pharmacopoeia". dosage form. Dissolution inspection is an important item in the quality inspection of granules. It reflects the quality indicators such as the production process of the preparation and the quality status of raw materials and excipients. The first part of the "Chinese Pharmacopoeia" 2010 edition stipulates that "take 1 bag of the test product and heat 200ml of water. , stirred for 5 minutes, and observed immediately. It should be completely dissolved or in suspension. Soluble granules should be completely dissolved, allowing slight turbidity; According to...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N5/02
Inventor 黎勇钟茂团邹波古莉唐终国杨红娟林剑
Owner 九寨沟天然药业股份有限公司
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