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Quality standard for traditional Chinese medicine formula granules

A technology of traditional Chinese medicine formula granules and quality standards, which is applied in the field of biomedicine and can solve the problems of formula granules without unified scientific and controllable quality standards, gaps left by fake and inferior products, and confusion in application and management.

Inactive Publication Date: 2017-01-11
天津市药品检验所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the thin-layer chromatography identification of the three formula granules, the sampling amount of the test product is different from each manufacturer, so it is difficult to accurately judge the identification results
[0010] It can be seen from Table 1 and Table 2 that there is no uniform, scientific, controllable, and feasible quality standard for the formula granules of the same variety, which will inevitably cause confusion in application and management, leaving gaps for the manufacture of fake and inferior products

Method used

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  • Quality standard for traditional Chinese medicine formula granules
  • Quality standard for traditional Chinese medicine formula granules
  • Quality standard for traditional Chinese medicine formula granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The quality standard of implementing example 1 Salvia miltiorrhiza formula granules

[0018] 【 Chinese name 】Salvia miltiorrhiza formula granules

[0019] 【 Chinese Pinyin 】Danshen Peifang Keli

[0020] 【 source 】 This product is a formula granule of Salvia miltiorrhiza in the 2010 edition of "Chinese Pharmacopoeia".

[0021] 【 character 】 This product is yellow-brown to tan granules; slightly gas, slightly bitter and astringent taste.

[0022] 【 identify 】 Take 0.2g of the powder of this product, add 25ml of 75% methanol, heat to reflux for 1 hour, filter, and concentrate the filtrate to 1ml as the test solution. Another 1.0 g of Danshen reference drug was taken, and the reference drug solution was prepared in the same way. Then take salvianolic acid B reference substance, add 75% methanol to make a solution containing 2mg per 1ml, as the reference substance solution. Then take tanshinone Ⅱ A reference substance, add 75% methanol to make a solution contain...

Embodiment 2

[0036] The quality standard of implementation example 2 angelica formula granules

[0037] 【 Chinese name 】 Angelica Formula Granules

[0038] 【 Chinese Pinyin 】 Danggui Peifang Keli

[0039] 【 source 】 This product is a formula granule of Angelica sinensis in the 2010 edition of "Chinese Pharmacopoeia".

[0040] 【 character 】 This product is yellow to brown granules; fragrant, sweet, pungent and slightly bitter.

[0041] 【 identify 】 Take 2g of this product powder, add 50ml of 1% sodium bicarbonate solution, sonicate for 30 minutes, centrifuge, take the supernatant, adjust the pH value to 2-3 with dilute salt, shake and extract with ether 3 times, 20ml each time , Combine the ether solution, evaporate to dryness, add methanol 1ml to dissolve the residue, and use it as the test solution. Take another 0.5g of Angelica reference medicinal material, add 50ml of 1% sodium bicarbonate solution, and make the reference medicinal material solution in the same way. Then ta...

Embodiment 4

[0068] The quality standard of implementation example 4 Ophiopogon japonicus formula granules

[0069] 【 Chinese name 】Ophiopogon japonicus formula granules

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Abstract

Traditional Chinese medicine formula granules are a new product, can replace traditional Chinese medicine decoction pieces for compatibility of traditional Chinese medicine decoctions, have the advantages of being convenient, time-saving, land-saving, small-dosage, and the like, are increasingly welcomed by patients, and are undoubtedly a favorable to the people. But traditional Chinese medicine formula granules have no uniform national quality standards and no uniform industry standards, so that confusion in circulation and use of the traditional Chinese medicine formula granules is caused. With the release of production and application of the traditional Chinese medicine decoction piece granules, the confusion in circulation and use of the traditional Chinese medicine formula granules is more severe. A uniform, controllable and feasible quality standard for the traditional Chinese medicine formula granules is researched and established based on the confusion in circulation and use of the traditional Chinese medicine formula granules, and the uniform, controllable and feasible quality standard for the traditional Chinese medicine formula granules is facilitates normal and healthy development of the traditional Chinese medicine formula granules, and can ensure safe and effective drug use of the patients.

Description

[0001] Technical field: biomedicine. Background technique [0002] Traditional Chinese medicine formula granules are a new type of product, which are derived from Chinese herbal medicine pieces, decocted, concentrated and granulated. Traditional Chinese medicine formula granules have many advantages. They can be used instead of traditional Chinese medicine decoction pieces, and can be taken in combination with decoction. The patient is exempted from the cumbersome process of decocting the decoction, saving time and effort, taking it conveniently, taking it immediately after brewing, and greatly reducing the dosage. Traditional Chinese medicine formula granules do bring a lot of convenience to patients. At the same time, it also brings convenience to the Chinese pharmacists in the Chinese pharmacy of the hospital, reduces the labor intensity of the Chinese pharmacists, and makes the amount of the prepared Chinese medicine prescription more accurate. More importantly, it has c...

Claims

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Application Information

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IPC IPC(8): G01N30/90
Inventor 邵建强林立军郭成明刘雪莹王杰孔伶俐魏吉成吕归宝华伟仪闫冬周军郑新元刘冰
Owner 天津市药品检验所
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