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Method for controlling quality of Runzao Zhiyang tablet

A quality control method and moisturizing technology, which can be used in medical preparations containing active ingredients, measuring devices, pharmaceutical formulations, etc., and can solve the problems of large interference of mulberry leaf thin-layer chromatography, long inspection period, different preparation technology and auxiliary materials, etc. problem, to achieve the effect of good mulberry leaf thin-layer chromatography separation, shortened inspection period and good preparation quality

Inactive Publication Date: 2009-11-11
唐弟光
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Capsules of this variety are easy to absorb moisture, are not easy to store, and cannot meet the needs of clinical medication. Therefore, we have changed its dosage form into tablets. The extraction process is the same as that of tablets, but the preparation process and excipients are different. It is necessary to formulate feasible quality control methods to ensure Guarantee product quality and clinical efficacy
In addition, in the original capsule standard, there is a long TLC test period for matrine, and the highly toxic benzene is used in the developing agent. The TLC of mulberry leaves interferes greatly, and the content of emodin in the content determination item is low, so it is difficult to effectively control the quality of this product. and other issues, it is also necessary to conduct further research on quality control methods to improve

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0023] Experimental Example 1: The TLC feature identification of Sophora flavescens.

[0024] In the TLC identification of Sophora flavescens in the quality standard of capsules, the preparation time of the test sample is too long, which is not conducive to the progress of the experiment. In addition, the reagent used in the development system - benzene is highly toxic and not conducive to environmental protection. However, the extraction method contained in the invention is simple and feasible, and the expansion system is replaced by toluene with less toxicity, which can also separate the spots well.

[0025] The following extraction methods were tested: take 4 tablets of this product, remove the film coat, grind finely, add 25ml of dichloromethane, 0.5ml of concentrated ammonia test solution, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add anhydrous Dissolve in 2ml of ethanol as the test solution. Results The spots in the chromatogram of ...

experiment example 2

[0027] Experimental example 2: It is the identification of TLC characteristics of mulberry leaves.

[0028] The TLC identification method of mulberry leaves in the capsule quality standard is greatly disturbed by impurities and difficult to observe, but the TLC separation effect of the storage method of the present invention is good, the spots are round and round, the reproducibility and specificity are good, and the negative control has no interference .

[0029] The following extraction and purification methods were compared and tested: ①Take 4 tablets of this product, remove the film coat, grind finely, add 20ml of ethanol, ultrasonically treat for 1 hour, filter, evaporate the filtrate to dryness, add 2ml of absolute ethanol to dissolve the residue, and use it as The test solution. ②Take 4 tablets of this product, remove the film coating, grind finely, add 20ml of ethanol, heat and reflux for 1 hour, let cool, filter, evaporate the filtrate to dryness, add 20ml of water t...

experiment example 3

[0031] Experimental Example 3: Determination of Matrine Content

[0032] Because the content of emodin in the preparation is low, less than 1 / 10,000, and the quality controllability is insufficient, the present invention newly establishes a method for determining the content of matrine in the preparation. The test results show that the separation effect is good under the selected conditions, and the methodological investigations such as linearity, stability, repeatability, and recovery rate all meet the requirements of content determination, and can be used as indicators for controlling the quality of this preparation. The test results are as follows:

[0033] 1. Solution Preparation

[0034] Preparation of reference substance solution: Accurately weigh 10.22 mg of matrine reference substance, put it in a 10ml measuring bottle, add methanol to dissolve and dilute to the mark, shake up, accurately measure 0.5ml and put it in a 10ml measuring bottle, add acetonitrile-methanol (...

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Abstract

The invention discloses a method for controlling the quality of a traditional Chinese medicine preparation-Runzao Zhiyang tablet. The quality control method includes the steps of adopting the thin-layer chromatography to identify kuh-seng and mulberry leaves and adopting the high performance liquid chromatography to determine the content of matrine in the preparation. The quality control method is reliable and feasible, and can guarantee the product quality and the clinical efficacy.

Description

field of invention [0001] The invention relates to a quality control method for traditional Chinese medicine preparations, in particular to a quality control method for Runzaozhiyang Tablets. Background technique [0002] The prescription of Runzaozhiyang Tablets comes from the variety Runzaozhiyang Capsules recorded on page 397 of "The Local Standards of Chinese Proprietary Medicines Increased National Standards" (Ophthalmology, Otolaryngology, Skin Volume) and the standard code is WS-10029-(ZD-0029) -2002, it has the functions of nourishing blood and nourishing yin, dispelling wind and relieving itching, moistening intestines and laxative, and is used for skin itching, acne and constipation caused by blood deficiency and wind dryness. The prescription of Runzao Zhiyang Tablets is: Polygonum multiflorum 291g, Polygonum multiflorum 265g, Rehmannia glutinosa 429g, Mulberry leaves 291g, Sophora flavescens 291g, Red live hemp 150g; The preparation method is: take the above six ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/804A61K9/28A61P17/04A61P17/10A61P1/10G01N30/36G01N30/90
Inventor 粟华生梁月钊唐弟光陈晓军李品莫少红吴伟谢琳
Owner 唐弟光
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