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Traditional Chinese medicine preparation for treating pancreatitis, preparation method and quality standard thereof

A technique of weight and raw materials, applied in the quality standard of the Yidanshu capsule, the traditional Chinese medicine preparation for treating pancreatitis-Yidanshu capsule and its preparation, the preparation of a traditional Chinese medicine composition and the quality standard field thereof, can solve the problem of difficult long-term Use and other problems to achieve the effect of not easy to corrode and deform, easy to control process parameters, and easy to operate

Inactive Publication Date: 2009-05-13
徐有章
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to market research, patients suffering from pancreatitis and cholecystitis take western medicine and traditional Chinese medicine each account for a certain proportion. Although western medicine is effective, it is not easy to use for a long time

Method used

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  • Traditional Chinese medicine preparation for treating pancreatitis, preparation method and quality standard thereof
  • Traditional Chinese medicine preparation for treating pancreatitis, preparation method and quality standard thereof
  • Traditional Chinese medicine preparation for treating pancreatitis, preparation method and quality standard thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0055] Experimental example 1 The optimization experiment of the preparation technology of Yidanshu capsule of the present invention

[0056] 1. Investigation of extraction process parameters of turmeric, red peony root, dandelion, oyster, corydalis, rhubarb and Bupleuri

[0057] 1.1 Investigation on the extraction process parameters of oyster decoction

[0058] In the preparation process of the original Yidanshu granules, the oysters were decocted for 4 hours. In the process of decocting with water, there are mainly four influencing factors, namely, the particle size of the medicinal material, the amount of water added, the number of decoctions and the time. The decoction has been clearly defined in the original process. The times and time, so this test adopts the single factor investigation method to investigate other unspecified process parameters and optimize the best process parameters.

[0059] 1.1.1 Determination of the pulverization degree of decocted medicinal materi...

experiment example 2

[0105] Experimental Example 2 Establishment of Quality Standards for Yidanshu Capsules

[0106] One, preparation method: take each crude drug by weight: 1500 parts of turmeric, 1000 parts of red peony root, 875 parts of dandelion, 1250 parts of oyster, 750 parts of Corydalis Corydalis, 625 parts of rhubarb, 375 parts of Bupleurum; Grind the oysters, add 8 times the amount of water to decoct for 4 hours, filter, preferably using a 200-mesh nylon screen as the filter material; then filter with a ceramic membrane, wherein the ceramic membrane element is preferably CMF-M Microfiltration membrane; Membrane pore size: 0.1-0.2μm; Support material: 99% α-alumina, zirconia; Membrane material: α-alumina, zirconia; Acid and alkali resistance: pH1~14; Applicable temperature: 5~100℃, the filtrate is set aside, the residue is mixed with turmeric, dandelion, red peony root, corydalis, Bupleurum, decocted twice, add 10 times the amount of water to decoct for 3 hours for the first time, add 10...

experiment example 3

[0179] Experimental Example 3 Experiment of Stability Research of Yidanshu Capsules

[0180] According to the preparation method of Yidanshu Capsules described in Experimental Example 2, three batches of samples were prepared (batch numbers were 050301, 050302, and 050303 respectively), which were respectively placed at room temperature (temperature 25°C ± 2°C, relative humidity 45% ± 5%) and high temperature (40°C ± 2°C) and high humidity (75% ± 5%) storage conditions, the stability inspection is carried out, and the inspection method, content and results are reported as follows:

[0181] 1. Inspection content: traits, identification, water content, disintegration time limit, difference in filling volume, content determination and microbial limit.

[0182] 2. Inspection method: According to the quality standard of this product and the 2005 edition of the Chinese Pharmacopoeia.

[0183] 3. Inspection time: Under normal temperature conditions, inspect once a month, then inspec...

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Abstract

The invention discloses Yidanshu capsules, a preparation method thereof and a quality standard. The preparation method comprises the following steps: oyster shell is decocted by adding 6-10 times the weight of water, and the filtration is carried out; the residues of the oyster shell, turmeric, Mongolian dandelion herb, red paeony root, yanhusuo and Chinese thorowax root are decocted by two times by adding 8-12 times the weight of the water respectively, and decocted liquid is filtered; rhubarb is decocted by two times by adding 6-10 times the weight of the water respectively, and the decocted liquid is filtered; filtrate is merged and vacuum concentrated to a thick paste, and the drying, the smashing and the packaging into capsules are carried out. The Yidanshu capsules adopt the advanced ceramic membrane filtration technology to remove a large number of impurities, thereby being characterized by refining, high efficiency, convenient administration, etc. The invention further establishes the quality standard of the Yidanshu capsules, the quality standard is proved to have a certain exclusivity, accuracy, reproducibility and practicality through the methodology study and the quality standard can effectively control the intrinsic quality changes of products. The quality standard is greatly improved on the basis of the original standard, thereby ensuring safety, effectiveness and controllability of drug.

Description

technical field [0001] The present invention relates to a preparation of a traditional Chinese medicine composition and its quality standard, in particular to a traditional Chinese medicine preparation for treating pancreatitis-Yidanshu capsule and its preparation method. The invention also relates to the quality standard of the Yidanshu capsule, which belongs to traditional Chinese medicine field. Background technique [0002] Pancreatitis is an acute abdomen with a relatively high mortality rate, and it is classified as Shaoyang disease in the classic ancient Chinese medicine "Treatise on Febrile and Miscellaneous Diseases". The so-called triple burner in ancient books is the pancreas. Under the guidance of this theory, there have been many breakthroughs in treatment methods. According to the theory of "Internal Classics" and "Treatise on Febrile Diseases", Shaoyang disease is a disease of Sanjiao and Gallbladder. The two are interrelated and affect each other. This is ea...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/48A61P1/18G01N30/36G01N30/90A61K35/56A61K35/618
Inventor 徐有章李艳茹
Owner 徐有章
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