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A detection method for Gastrodia Xingnao Capsules

A detection method and measurement method technology, applied in the field of biomedicine, can solve the problems of inability to meet the strict quality control of drugs, incomplete quality control, monitoring, etc.

Active Publication Date: 2017-07-18
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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Effect test

Embodiment 1

[0080] A detection method for Tianma Xingnao Capsule, including raw material control, preparation method control, identification method and content determination method, as follows:

[0081] First, raw material control:

[0082] Described 10,000 Tianma Xingnao capsules (batch number 20130524) are prepared from the following active ingredient weight ratio raw materials:

[0083] Gastrodia elata 3000g, Dilong 2000g, Shichangpu 3000g, Polygala 2000g, Rehmannia glutinosa 1000g, Cistanche cistanche 1000g; the above six herbs should meet the corresponding medicinal material standards in the Pharmacopoeia, and all traditional Chinese medicines should be cleaned and crushed;

[0084] Second, the preparation method control:

[0085] (1) the quality of ground dragon coarse powder is 6 times of 60% ethanol solution cold soaking for 72 hours, filtered, and the filtrate is for subsequent use;

[0086] (2) Coarse powder of four herbs of Shichangpu, Polygala, Rehmannia glutinosa and Cistan...

Embodiment 2

[0110] A detection method for Tianma Xingnao Capsule, including raw material control, preparation method control, identification method and content determination method, as follows:

[0111] First, raw material control:

[0112] Described 10,000 Tianma Xingnao capsules (batch number 20130525) are prepared from the following active ingredient weight ratio raw materials:

[0113] Gastrodia elata 3000g, Dilong 2000g, Shichangpu 3000g, Polygala 2000g, Rehmannia glutinosa 1000g, Cistanche cistanche 1000g; the above six herbs should meet the corresponding medicinal material standards in the Pharmacopoeia, and all traditional Chinese medicines should be cleaned and crushed;

[0114] Second, the preparation method control:

[0115] (1) the quality of ground dragon coarse powder is 6 times of 60% ethanol solution cold soaking for 72 hours, filtered, and the filtrate is for subsequent use;

[0116] (2) Coarse powder of four herbs of Shichangpu, Polygala, Rehmannia glutinosa and Cistan...

Embodiment 3

[0140] A detection method for Tianma Xingnao Capsule, including raw material control, preparation method control, identification method and content determination method, as follows:

[0141] First, raw material control:

[0142] Described 1,500,000 Tianma Xingnao capsules (batch number 20130545) are prepared from the following active ingredient weight ratio raw materials:

[0143] Gastrodia elata 450kg, Dilong 300kg, Shichangpu 450kg, Polygala 300kg, Rehmannia glutinosa 150kg, Cistanche cistanche 150kg; the above six herbs should meet the corresponding medicinal material standards in the Pharmacopoeia, and all traditional Chinese medicines should be cleaned and crushed;

[0144] Second, the preparation method control:

[0145] (1) the quality of ground dragon coarse powder is 6 times of 60% ethanol solution cold soaking for 72 hours, filtered, and the filtrate is for subsequent use;

[0146] (2) Coarse powder of four herbs of Shichangpu, Polygala, Rehmannia glutinosa and Cis...

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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 with the functions of nourishing the liver and kidney, calming the liver and relieving wind, dredging the collaterals and relieving pain, and used for treating the deficiency of the liver and the kidney, and the headache, dizziness, memory loss, insomnia and reaction caused by the disturbance of the liver wind. Detection method of Tianma Xingnao Capsules for dullness, tinnitus, backache and vascular dementia. Background technique [0002] Tianma Xingnao Capsule is a national medicine approved by the state. It is a national medicine approved by Z20027062, and its quality standard is WS-11293 (ZD-1293)-2002. 200410022700.7. [0003] With the advancement of science and technology and the continuous improvement of national requirements, we have re-studied Tianma Xingnao Capsules and discovered the function of Tianma Xingnao Capsules in the preventi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/90G01N30/36A61K36/8988A61K9/48A61P25/28A61P1/08A61P25/00A61P25/20A61P27/12A61K35/62
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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