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Method for quality control of medicine containing swertia psedochinensis and milk thistle silybum marianum

A quality control method, the technology of Feiliganning, is applied in the directions of pill delivery, antiviral agents, measuring devices, etc., which can solve the problems of difficult control of product quality and so on.

Active Publication Date: 2007-07-18
SICHUAN MEDCO PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present invention aims at the shortcomings of the original Dangfei Liganning Capsules that the quality control standard is simple and the product quality is not easy to control. The determination of the content of gentiopicroside, and the TLC identification of gentiopicroside in the current medicine and the identification of silybin in milk thistle have been added on the basis of the identification of the current drug oleanolic acid, which has improved The quality control standard of Dangfei Liganning preparation, this quality control method can effectively control the quality control standard of Dangfei Liganning preparation, thus ensuring the clinical efficacy of the preparation

Method used

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  • Method for quality control of medicine containing swertia psedochinensis and milk thistle silybum marianum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0140] Embodiment 1 The quality control method of Bendangfei Liganning Capsules includes

[0141] [Prescription] Milk thistle 900g as medicine 950g

[0142] 【Preparation method】The above two flavors are taken from milk thistle and crushed. After degreasing, follow the percolation method under the extract and extract (Chinese Pharmacopoeia IO), using 80% ethanol as solvent. Slow percolation .Collect the filtrate, recover ethanol under reduced pressure, condense into a paste to obtain the total flavonoids of milk thistle, pulverize into fine powder, and set aside: 900g of the drug is gradiently extracted with 95%, 75% and 50% ethanol respectively, filtered, and combined Concentrate the filtrate to a thick paste, add 50 g of the remaining fine powder of the drug, and dry it. Make a dry extract, grind it into a fine powder, take the fine powder, milk thistle total flavonoids fine powder and an appropriate amount of auxiliary materials, mix well, and granulate. Pack into capsules ...

Embodiment 2

[0161] The quality control method of embodiment two this tablet comprises

[0162] [Prescription] Milk thistle 1200g as medicine 1267g

[0163] 【Properties】This product is a film-coated tablet, which is yellow after removing the film coating; tastes bitter.

[0164] 【identification】

[0165](1) Take this product, remove the film coat, grind finely, take 2g of fine powder, add 25ml of absolute ethanol, reflux extraction for 30 minutes, filter, and the filtrate is used as the test solution. Take another oleanolic acid reference substance. Add absolute ethanol to make a solution containing 2mg per 1ml, as the reference substance solution. Test according to thin-layer chromatography (Appendix VIB, Part I of Chinese Pharmacopoeia). Take 5 ul of each of the above-mentioned two kinds of solvents, and place them on the same silica gel thin-layer plate respectively, and develop with chloroform: acetone = 9: 1 as the developing agent. Take it out, dry it in the air, spray it with 5% ...

Embodiment 3

[0182] The quality control method of embodiment three soft capsules comprises

[0183] Properties: This product is a brown soft capsule, the content is a yellow oily liquid containing a small amount of suspended solid extract; slightly gas, bitter taste.

[0184] Inspection: should comply with the relevant provisions of capsules (Appendix IL of the Chinese Pharmacopoeia 2005 Edition)

[0185] Identification: should comply with the provisions under it (identify with the content of the first embodiment)

[0186] Assay: should meet the provisions under it (contents under the same content assay as in Example 1)

[0187] Each soft capsule contains milk thistle and silybin (C 25 h 22 o 10 ) shall not be less than 3.9mg. Contains gentiopicroside (C 16 h 20 o 9 ) shall not be less than 1.2mg.

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Abstract

A quality control method for the medicine 'Dangfeiliganning' includes such areas as testing its characters, examining its appearance, thin-layer chromatographic determination of silibinin, oleanolic acid and gentiopicroside, and measuring the contents of silibinin and gentiopicroside.

Description

technical field [0001] The invention relates to a quality control method of Dangfei Liganning preparation, belonging to the technical field of quality control of medicines. Background technique [0002] Dangfei Liganning preparation is a pure natural medicine prepared from the traditional folk medicine for treating hepatitis and the plant milk thistle introduced from West Germany in the 1970s. It can treat jaundice, acute jaundice hepatitis, infectious hepatitis, chronic hepatitis and other diseases caused by damp-heat stagnation and steaming (clinical findings can also treat hyperlipidemia and fatty liver). Its curative effect is reliable and has no side effects. Among them, "Dangfei Liganning Capsules" was published in the 17th volume of "Prescriptions of Traditional Chinese Medicine" issued by the Chinese Bureau of Standards. It has been clinically used for many years and has achieved satisfactory therapeutic effects. The current quality control is mainly based on the Da...

Claims

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Application Information

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IPC IPC(8): A61K36/28A61K9/20A61K9/48A61P1/16A61P31/12A61P31/20G01N30/90G01N30/02
Inventor 李彦朱林波秦方云
Owner SICHUAN MEDCO PHARML
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