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Preparation method, quality control method and application for Chinese medicinal compound indigowoad leaf preparation

A quality control method, the technology of Folium Folium, applied in the direction of pharmaceutical formulations, antiviral agents, measuring devices, etc., can solve the problems of ineffective control of the quality of compound Folium Folium preparations, no content determination, and few quality control indicators

Active Publication Date: 2010-05-19
RONGCHANG PHARM ZIBO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the standard of the existing compound Folium Folium preparations is backward, the sucrose content is as high as 46%, and the quality control indicators are few. There are only identification items for indirubin, chlorogenic acid, and rhubarb, and there is no comprehensive content determination.
Namely the quality control method of prior art can not effectively control the quality of compound Folium Folium preparation, thereby will influence the production of product and guarantee quality

Method used

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  • Preparation method, quality control method and application for Chinese medicinal compound indigowoad leaf preparation
  • Preparation method, quality control method and application for Chinese medicinal compound indigowoad leaf preparation
  • Preparation method, quality control method and application for Chinese medicinal compound indigowoad leaf preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106] (1) Main drug preparation

[0107] Proportion of main ingredients: Daqingye 360g, Sanyinhua 180g, notopterygium 100g, ginseng 90g, rhubarb 100g.

[0108] The above medicinal materials are decocted twice with a conventional amount of water, 1 hour each time; the decoction liquid is combined, filtered, and the relative density of the filtrate is 1.08-1.32 when the filtrate is concentrated to 60°C; ethanol is added to make the alcohol content reach 50-60%. Stand still, filter, recover ethanol from the filtrate and concentrate to a clear paste with a relative density of 1.17-1.43 at 60°C, and set aside;

[0109] (2) Preparation of oral liquid

[0110] Add 2 to 3 times water to the upward step clear cream, stir well, refrigerate for ≥12 hours, filter, heat and boil the filtrate for 0.5 hours, when the temperature drops to 60°C, add preservatives, refrigerate for ≥12 hours, filter; add flavoring agent and syrup, stir well to obtain the drug stock solution, and set aside;

...

Embodiment 2

[0311] Embodiment 2 prepares granules

[0312] Proportion of main ingredients:

[0313] Daqingye 360g, honeysuckle 180g, notopterygium 90g, boxing ginseng 90g, rhubarb 90g.

[0314] The above medicinal materials are decocted twice with a conventional amount of water, 1 hour each time; the decoction liquid is combined, filtered, and the relative density of the filtrate is 1.08-1.32 when the filtrate is concentrated to 60°C; ethanol is added to make the alcohol content reach 50-60%. Stand still, filter, recover ethanol from the filtrate and concentrate to a clear paste with a relative density of 1.25-1.30 at 60°C, and set aside;

[0315] (2) Preparation of granules

[0316] Shangbuqing Paste is added with appropriate pharmaceutical excipients according to pharmaceutical routines, mixed evenly and made into granules, and dried below 60°C. The above-mentioned dosage can make 1000 parts of granules, which are packed according to the pharmaceutical specifications and sealed.

[0...

Embodiment 3

[0363] Embodiment 3 prepares capsule

[0364] Proportion of main ingredients:

[0365] 300g Daqingye, 200g Shanyinhua, 100g Qianghuo, 100g Quanshen, and 100g Rhubarb.

[0366] The above medicinal materials are decocted twice with a conventional amount of water, 1 hour each time; the decoction liquid is combined, filtered, and the relative density of the filtrate is 1.08-1.32 when the filtrate is concentrated to 60°C; ethanol is added to make the alcohol content reach 50-60%. Stand still, filter, recover ethanol from the filtrate and concentrate to a clear paste with a relative density of 1.25-1.30 at 60°C, and set aside;

[0367] Preparation of capsules

[0368] Shangbu clear paste is vacuum-dried or microwave-dried below 80°C, crushed into fine powder, mixed with suitable pharmaceutical excipients according to pharmaceutical routines, mixed and made into granules, dried, filled in empty capsules, and the above-mentioned dosage can be made into capsules 1000 capsules, packe...

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Abstract

The invention relates to a preparation method and a quality control method for a compound indigowoad leaf preparation. The preparation method comprises a step of preparing a basic remedy and a step of preparing a corresponding preparation. The basic remedy in the basic remedy preparation comprises the following compositions in part by weight: 360 to 440 parts of indigowoad leaves, 180 to 220 parts of lonicera confusa or honeysuckle flower, 90 to 110 parts of incised notopterygium rhizome, 90 to 110 parts of bistort rhizome, and 90 to 110 parts of rhubarb; the medicinal materials are decocted twice with conventional amount of water for 1 hour each time; the decoctions are mixed and filtered; the filtrate is concentrated to the relative density of between 1.08 and 1.32 at 60 DEG C; ethanol is added into the filtrate to ensure that alcohol content reaches 50 to 60 percent, the mixture is stood and is filtered, the filtrate is subjected to ethanol reclamation and is concentrated to an extract with the relative density of between 1.17 and 1.43 at 60 DEG C for later use; and the corresponding preparation is prepared according to a drug specification. The quality control method comprises the following steps of the identification of contents and the content determination of the contained compositions including the identification of the indigowoad leaves, the identification of the lonicera confusa or honeysuckle flower, the identification of the rhubarb, the identification of the incised notopterygium rhizome, the total content determination of emodin and chrysophanol in the rhubarb, and the content determination of chlorogenic acid. The methods can be applied to preparation of medicinal preparations for treating cold, influenza, parotitis and acute viral hepatitis.

Description

technical field [0001] The invention relates to a preparation and quality control method of a traditional Chinese medicine preparation, in particular to a preparation and quality control method of a compound Folium folium preparation. Background technique [0002] The compound Folium Folium preparation is a traditional Chinese medicine compound preparation already on the market, which has the effects of dispelling wind and clearing heat, detoxifying and reducing swelling, cooling blood and promoting gallbladder. Clinically, it is mainly used for cold, fever, headache, red and swollen throat, swelling and pain under the ear, hypochondriac pain and jaundice, as well as influenza, mumps, and acute viral hepatitis. However, the standard of the existing compound Folium Folium preparation is backward, the content of sucrose is as high as 46%, and the quality control indicators are few. There are only identification items of indirubin, chlorogenic acid and rhubarb, and there is no ...

Claims

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Application Information

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IPC IPC(8): A61K36/708A61P11/00A61P31/16A61P31/14A61P31/20G01N30/02G01N30/90
Inventor 郭桂秋车蕾翟勇陈树恩李钦刚肖金金寇丽丽王丽庆王中成
Owner RONGCHANG PHARM ZIBO CO LTD
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