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Quality control method of Fenqing Wulin pill

A quality control method and solution technology, applied in the directions of medical preparations containing active ingredients, material separation, analysis of materials, etc., can solve problems such as non-conformance, active ingredients control product quality, affect product quality and curative effect, etc., to improve production. Efficiency, Assurance of Safety and Effectiveness

Active Publication Date: 2009-07-29
BEIJING ASIA EAST BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Although the prescription has the quality control method of distinguishing Wulin pills, it is limited to microscopic identification. This method can only control the product quality from the cell level of the original medicinal materials, but cannot control the product quality from the level of active ingredients, which will affect the quality of the product. The quality and curative effect of the product are not conducive to the standardized production of drugs and the improvement of production efficiency, and are not in line with the development trend of modern Chinese medicine.

Method used

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  • Quality control method of Fenqing Wulin pill
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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0060] Experimental Example 1 Research on Qualitative Detection Method of Rhubarb

[0061] 1, the preferred of ether ultrasonic extraction time in the preparation of detection method a sample solution of the present invention:

[0062] Get Fenqing Wulin pills (prepared according to the prescription and method of Example 1) 5g in total 5 parts, grind finely, use ether ultrasonic extraction for different times, filter, measure emodin content wherein, the results are shown in the following table:

[0063] Table 1 Ether ultrasonic time optimization experiment results

[0064] Ultrasonic time (min)

5

10

15

20

Emodin content (mg)

63.3

95.2

95.6

95.7

[0065] It can be seen from Table 1 that the emodin can be completely extracted by ultrasonication of ether for 10 minutes, so the preferred ultrasonic time for the preparation of the sample solution in this experiment is 10 minutes.

[0066] 2. The optimal ratio o...

experiment example 2

[0078] Experimental example 2. Research on the qualitative detection method of berberine hydrochloride

[0079] 1. The optimization of methanol ultrasonic extraction time in the preparation of detection method b sample solution of the present invention:

[0080] Take the dregs after ether extraction in Experimental Example 1, evaporate the ether, add 30ml of methanol for ultrasonic treatment for different times, filter, and measure the content of berberine hydrochloride wherein, the results are shown in the following table:

[0081] Table 4 Methanol Ultrasonic Time Optimization Experimental Results

[0082] Ultrasonic time (min)

10

20

30

40

Content of berberine hydrochloride (mg)

10.3

15.9

19.2

19.5

[0083] It can be seen from Table 4 that the berberine hydrochloride can be completely extracted by ultrasonication of ether for 30 minutes, so the preferred ultrasonic time in this experiment is 30 minutes. ...

experiment example 3

[0097] Experimental example 3. Qualitative detection test research of geniposide

[0098] 1. The optimal ratio of developer dosage in detection method c of the present invention:

[0099] Take each 5 μl of the test product solution under the item of Experimental Example 2 and the reference medicinal material solution prepared by the same method, and place them on different silica gel G thin-layer plates, and use ethyl acetate-formic acid-water ratio of 10:2:0.5, 10 : 1.5: 0.5, 10: 0.5: 0.5, 10: 0.3: 0.5, develop with developer, take it out, dry it, spray with 10% ethanol sulfuric acid solution, heat at 105°C, observe the development of each spot of the test sample on each thin-layer plate The results are shown in the table below:

[0100] Table 7 Optimal experimental results of developer dosage ratio

[0101] Developing agent ratio

10∶2∶0.5、

10∶1.5∶0.5

10∶1.0∶0.5

10∶0.5∶0.5

10∶0.3∶0.5

Expand the effect

very poor

Differenc...

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Abstract

The invention discloses a quality control method for clear wulin pill. The method adopts the thin-layer qualitative detection of rheum officinale, berberine hydrochloride, Gardenoside and aristolochic acid, and also adopts the qualitative detection of the content of rheum emodin. Therefore, the method guarantees the safety and efficacy of medicines, improves the quality of products, and is convenient for standardization production of the products.

Description

technical field [0001] The invention relates to a quality control method of traditional Chinese medicine, in particular to a quality control method of Fenqing Wulin Pills. Background technique [0002] The prescription of Fenqing Wulin Pills comes from page 393 of "Chinese Pharmacopoeia 2005 Edition". It is used for gonorrhea caused by damp-heat injection, symptoms include yellow and red urine, frequent urination and urgency, burning and astringent pain in the urethra. The prescription of Fenqing Wulin Pill is as follows: [0003] Akebia 80g Plantago Seeds (stir-fried with salt) 40g Scutellaria baicalensis 80g [0004] Poria cocos 40g Poria cocos 40g Phellodendron 40g [0005] Rhubarb 120g Store 40g Qumai 40g [0006] Anemarrhena 40g Alisma 40g Gardenia 40g [0007] Licorice 20g Talc 80g [0008] The preparation method is: [0009] The above fourteen flavors, except talc, and the other thirteen flavors such as Guan Mu Tong are ground into fine powder, sieved, and mi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8964A61P13/00G01N30/90G01N30/02A61K33/12
Inventor 付立家付建家
Owner BEIJING ASIA EAST BIO PHARMA CO LTD
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