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Content detection method of traditional Chinese medicine preparation solid-intestine capsule for treating chronic diarrhea

A technology for traditional Chinese medicine preparations and chronic diarrhea, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and drug combinations, etc., can solve the problems of complexity, difficulty, and increased detection of index components, and achieve high accuracy and stable quality. , process stable and consistent effect

Active Publication Date: 2012-03-21
津药达仁堂集团股份有限公司达仁堂制药厂
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Compound Chinese patent medicines composed of multi-flavored traditional Chinese medicines contain more complex ingredients. Some chemical ingredients will interact with each other in the compound recipe compatibility and preparation, and the content will change greatly, which increases the difficulty of the detection of index ingredients.

Method used

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  • Content detection method of traditional Chinese medicine preparation solid-intestine capsule for treating chronic diarrhea
  • Content detection method of traditional Chinese medicine preparation solid-intestine capsule for treating chronic diarrhea
  • Content detection method of traditional Chinese medicine preparation solid-intestine capsule for treating chronic diarrhea

Examples

Experimental program
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Effect test

Embodiment 1

[0026] Recipe: Chishizhi (calcined) 500 parts Coptidis 250 parts Phellodendron 250 parts Myrobalan (pitted) 250 parts Nutmeg (steamed) 250 parts Magnolia officinalis (burned) 250 parts Jianqu 250 parts Evodia rutaecarpa (made) 200 parts Cinnamon 200 parts 250 parts of dried ginger 200 parts of Chinese prickly ash 200 parts of chuanxiong

[0027] Preparation method: mix the above fifteen crude drugs according to the ratio of the prescription amount, select to remove sundries, wash with water to remove sediment, dry, grind into fine powder, mix well, add appropriate amount of water, make granules, dry, and granulate , divided into capsules, that is. (From the authorized Guchang Capsule, patent number: ZL200510014980.1)

Embodiment 2

[0029] normal method

[0030] The content detection method of Guchang capsule, its method step is:

[0031] (1) Microscopic identification:

[0032] Take a small amount of the contents of Guchang Capsules and observe under a microscope: the bast fibers are bright yellow, bundled or scattered, and some are connected with stone cells, in the form of spindles or spindles, with oblique pointed ends, blunt rounded or narrow, 136 cm long ~185 μm, diameter 27~37 μm, wall thickness, lignification, pore grooves are obvious, parenchyma cells around fiber bundles contain square crystals of calcium oxalate, forming crystal fibers, square crystals are very dense, walls of cells containing crystals are unevenly lignified thickened.

[0033] ⑵ TLC ​​identification of Chuanxiong:

[0034] Take 2 g of the contents of Guchang Capsules, add 10 ml of ethyl acetate, ultrasonically extract for 20 minutes, filter, and the filtrate is used as the test solution. Another 0.2 g of Chuanxiong referen...

Embodiment 3

[0048] Determination of Myrobalan and Galla by HPLC:

[0049] The prescription of Guchang Capsules contains gallnut and myrobalan, and its main component is tannin. Therefore, the method of determining gallic acid after hydrochloric acid hydrolysis is used to determine the content of tannin in the sample.

[0050] ①Preparation of reference substance solution: Take an appropriate amount of gallic acid reference substance, weigh it accurately, add 50% methanol to make a solution containing 40 μg of gallic acid per 1 ml, and obtain it. The liquid chromatography test results are shown in figure 1 .

[0051] ②Preparation of the test solution: Take the content of Guchang Capsules under the item of difference in filling volume, mix well, grind finely, take 0.25g, accurately weigh, accurately add 50ml of 4mol / L hydrochloric acid, weigh, place in boiling water bath Heated and refluxed for 4 hours, let cool, weighed again, made up for the lost weight with 4mol / L hydrochloric acid, cen...

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Abstract

The invention relates to a content detection method of a traditional Chinese medicine preparation solid-intestine capsule for treating chronic diarrhea, which comprises the steps of identification and content determination. The content determination method comprises the following steps: determining magnolia by adopting a high-performance liquid chromatography and determining myrobalan and gallnutby adopting the high-performance liquid chromatography. The content detection method is characterized in that the solid-intestine capsule prescription contains gallnut and myrobalan and takes tannin as a main component, and the content of the tannin in a sample is determined by adopting a method that the hydrochloric acid is firstly hydrolyzed and the gallic acid is determined. As the solid-intestine capsule is raw powder medicine, the transfer rate is calculated by 90 percent, and the content limitation is determined as follows: the myrobalan and the gallnut contained in each capsule are calculated by gallic acid C7H6O5 and are not less than 13.5 mg. On the basis of <new drug becoming standard>, a method for determining the content of the gallic acid in the myrobalan and the gallnut by adopting the high-performance liquid chromatography is additionally available. Through the revised content standard, the controllability of the drug content standard is improved, and the intrinsic content of the product is ensured. Therefore, the content detection method has the significant security significance in promoting the product sale, increasing the market competitiveness of the product andensuring patients to administrate medicines safely.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to a detection method for solid preparations of traditional Chinese medicines, more specifically, a method for detecting the content of Guchang Capsules, a traditional Chinese medicine preparation for treating chronic diarrhea. Background technique [0002] With the continuous development of the economy, traditional Chinese medicine has received more and more attention from the world. Traditional Chinese medicine is developed under the guidance of traditional Chinese medicine theory. The raw materials are mostly natural materials such as grass roots, bark, minerals, animals, etc., with a wide range of sources and complex components. Compared with Western medicine, it is indeed more difficult to control the content of Chinese medicine, because the ingredients in Chinese medicine are very complex, and different growth locations and climate changes may l...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/36A61K36/9068A61P1/12A61K33/26A61K35/56A61K35/64A61K35/618
Inventor 江永萍刘彤宋立平项芳韩晓辰
Owner 津药达仁堂集团股份有限公司达仁堂制药厂
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