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Quality control method for rhizoma gastrodiae capsule

A quality control method, Gastrodia elata technology, applied in the field of biomedicine, can solve problems such as high toxicity, affecting the preparation and efficacy of Gastrodia elata Xinnao capsules, and incomplete quality control

Active Publication Date: 2015-01-28
YUNNAN YONGZITANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent 200610138595.2 discloses a Gastrodia elata refreshing preparation and its preparation method and control method. It uses chloroform as a solvent, which is highly toxic, which is not conducive to the health of testers and the accuracy of test results; and wherein chloroform and Ethyl acetate is homogeneous and prone to emulsification, which seriously affects the test results
For the preparation method, the amount of water is too much, and a large number of ineffective ingredients are proposed during extraction, which makes the product ingredients mixed, seriously affecting the preparation and efficacy of Gastrodia Xingnao Capsules
At the same time, the quality control of the patent is not comprehensive, the quality control of the drug runs through the entire production process, and the patent only provides part of the quality control methods for the products produced, and does not conduct any inspections on the raw materials, solvents, and the medicinal materials of Dilong. monitoring, so this one-sided quality control method cannot meet the strict quality control requirements of current drugs

Method used

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  • Quality control method for rhizoma gastrodiae capsule

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] A quality control method for Gastrodia Xingnao Capsules, comprising raw material control, preparation method control, identification method and content determination method, specifically as follows:

[0082] First, raw material control:

[0083] The 10,000 Gastrodia Xingnao Capsules (batch number 20130524) are prepared from the following active ingredient weight ratio raw materials:

[0084] Gastrodia elata 3000g, Dilong 2000g, Shichangpu 3000g, Polygala 2000g, Rehmannia glutinosa 1000g, Cistanche 1000g; the above six herbs should meet the corresponding medicinal material standards in the Pharmacopoeia, and all traditional Chinese medicines need to be purified and pulverized;

[0085] Second, preparation method control:

[0086] (1) Earthworm coarse powder is cold-soaked in 60% ethanol solution of 6 times the amount for 72 hours, filtered, and the filtrate is used for subsequent use;

[0087] (2) Coarse powder of Shichangpu, polygala, Rehmannia glutinosa and Cistanche...

Embodiment 2

[0111] A quality control method for Gastrodia Xingnao Capsules, comprising raw material control, preparation method control, identification method and content determination method, specifically as follows:

[0112] First, raw material control:

[0113] The 10,000 Gastrodia Xingnao Capsules (batch number 20130525) are prepared from the following active ingredient weight ratio raw materials:

[0114] Gastrodia elata 3000g, Dilong 2000g, Shichangpu 3000g, Polygala 2000g, Rehmannia glutinosa 1000g, Cistanche 1000g; the above six herbs should meet the corresponding medicinal material standards in the Pharmacopoeia, and all traditional Chinese medicines need to be purified and pulverized;

[0115] Second, preparation method control:

[0116] (1) Earthworm coarse powder is cold-soaked in 60% ethanol solution of 6 times the amount for 72 hours, filtered, and the filtrate is used for subsequent use;

[0117] (2) Coarse powder of Shichangpu, polygala, Rehmannia glutinosa and Cistanche...

Embodiment 3

[0141] A quality control method for Gastrodia Xingnao Capsules, comprising raw material control, preparation method control, identification method and content determination method, specifically as follows:

[0142] First, raw material control:

[0143] The 1,500,000 Gastrodia Xingnao Capsules (batch number 20130545) are prepared from the following active ingredient weight ratio raw materials:

[0144] Gastrodia elata 450kg, Earthworm 300kg, Shichangpu 450kg, Polygala 300kg, Rehmannia glutinosa 150kg, Cistanche 150kg; the above six herbs should meet the corresponding medicinal material standards in the Pharmacopoeia, and all traditional Chinese medicines need to be purified and crushed;

[0145] Second, preparation method control:

[0146] (1) Earthworm coarse powder is cold-soaked in 60% ethanol solution of 6 times the amount for 72 hours, filtered, and the filtrate is used for subsequent use;

[0147] (2) Coarse powder of Shichangpu, polygala, Rehmannia glutinosa and Cistan...

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Abstract

The invention relates to a quality control method for a rhizoma gastrodiae capsule and belongs to the technical field of biomedicine. The quality control method comprises the steps of raw material control, preparation method control, an identification method and a content measurement method. Modern drug production management is integrated in quality control. The quality of drugs and solvents used in production is examined from the source. Product quality control in the production process is established, perfect product quality standards are established, the thin-layer chromatographic detection ratio is higher than national requirements, the gastrodin content is greatly increased, the increase degree reaches 28.3%, and the quality and the therapeutic effect of the drug product are ensured.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a kind of medicine which has the functions of nourishing the liver and kidney, calming the liver and relieving wind, dredging collaterals and relieving pain, and is used for treating liver and kidney deficiency, headache, dizziness, memory loss, insomnia, reaction caused by disturbance of liver wind. The quality control method of Gastrodia Xingnao Capsules for dullness, tinnitus, backache and vascular dementia. Background technique [0002] Gastrodia Xingnao Capsule is a national medicine approved by the state. It is Z20027062 and the quality standard is WS-11293 (ZD-1293)-2002. In 2005, our company obtained its invention patent with the application number 200410022700.7. [0003] With the advancement of science and technology and the continuous improvement of national requirements, we conducted further research on Gastrodia Xingnao Capsules and discovered the fu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8988A61K9/48G01N30/90G01N30/36A61P25/28A61P1/08A61P25/00A61P25/20A61P27/12A61K35/62
CPCA61K35/62A61K36/64A61K36/69A61K36/804A61K36/888A61K36/8988A61K2236/331A61K2236/39A61K2236/51A61K2236/53G01N30/02G01N30/90G01N2030/027A61K2300/00Y02A50/30
Inventor 郑金丹朱明浩杨扬张嘉硕
Owner YUNNAN YONGZITANG PHARMA
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