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Gel ointment with effect of treating cirrhosis ascites as well as preparation method and detection method thereof

A technology for liver cirrhosis ascites and gel ointment, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, active ingredients of hydroxyl compounds, etc. Comprehensive response to gel ointment, inability to effectively control and ensure clinical efficacy and other issues

Inactive Publication Date: 2018-06-01
常熟雷允上制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional Chinese medicine has rich experience and good curative effect in the treatment of liver cirrhosis ascites. The external treatment of traditional Chinese medicine on the umbilical cord is unique and has good effects, but there is no mature product for applying the umbilical cord to clinical practice.
And in the prior art, the quality detection method about the gel ointment is relatively single, fails to objectively and comprehensively reflect the quality of the gel ointment, can not effectively control and guarantee the clinical efficacy

Method used

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  • Gel ointment with effect of treating cirrhosis ascites as well as preparation method and detection method thereof
  • Gel ointment with effect of treating cirrhosis ascites as well as preparation method and detection method thereof
  • Gel ointment with effect of treating cirrhosis ascites as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] 1. A gel ointment with the effect of curing liver cirrhosis and ascites, which is made of traditional Chinese medicine and auxiliary materials:

[0073] The composition of the traditional Chinese medicine is: 1000 parts of raw rhubarb, 1000 parts of kansui, 1000 parts of raspberry seeds, 1000 parts of cloves, 200 parts of agarwood, 40 parts of borneol, and 4 parts of artificial musk;

[0074] The auxiliary materials are composed of 800 parts of partially neutralized sodium polyacrylate, 600 parts of crospovidone, 350 parts of polyvinylpyrrolidone, 25 parts of aluminum glycolate, 6g of edetate disodium, 4000g of glycerol, and 35g of L-tartaric acid. , 2000g purified water, 200g ethanol, 3000g 35% ethanol.

Embodiment 2

[0076] 1. A preparation method of a gel ointment with the effect of curing liver cirrhosis and ascites, which comprises the following steps:

[0077] (1) Take 1000 parts of raw rhubarb, 1000 parts of kansui, 1000 parts of raspberry seed and 200 parts of agarwood according to the weight parts of claim 1 or 2, add 10 times the volume of 70% ethanol, and heat and reflux for extraction 2 times, 1 hour each time to obtain the extract, recover the ethanol, concentrate, and dry under reduced pressure to obtain the extract powder;

[0078] (2) Take 1000 parts of cloves, crush them into 20 mesh coarse powder, add 8 times the amount of water, soak for 40 minutes, and then extract by steam distillation for 6 hours to collect the volatile oil of cloves;

[0079] (3) Stir and dissolve the extract powder of step (1) with 35% ethanol by volume, then add 600 parts of crospovidone and stir evenly to obtain phase A;

[0080] Then dissolve 40 parts of borneol and 4 parts of artificial musk in ethanol, a...

Embodiment 3

[0103] Example 3 Pharmacodynamic test

[0104] 1. Gel ointment reduces ascites in DMN-induced ascites in mice with liver cirrhosis

[0105] 90 male ICR mice weighing 18-20g, DMN was injected intraperitoneally at a dose of 10μg / kg mouse body weight for 3 consecutive days a week for 4 weeks. Fifty ICR mice with ascites formation judged by B-ultrasound were randomly divided into 5 groups: model control group, placebo control group, and low, medium, and high-dose gel ointment groups prepared in Example 2 of the present invention. Group of 10 animals. At the same time, 10 normal mice of the same age were selected as the normal group. According to the crude drug content of the gel ointment 86.6mg / cm 2 Plaster, converted into gel ointment of corresponding area for administration. Low dose 326.5mg crude drug / kg rat weight (gel ointment area 0.125cm 2 , Equivalent to 5 times the clinical daily dosage per kilogram of body weight of 65kg adult); medium dose of 652.9mg crude drug / kg mouse w...

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Abstract

The invention discloses gel ointment with an effect of treating cirrhosis ascites as well as a preparation method and a detection method thereof. The method comprises the steps of performing qualitative identification on artificial musk by a gas chromatographic method, performing thin-layer identification on clove, performing content measurement on raw rhubarb by a high-performance liquid chromatography method and performing content measurement on borneol by a gas chromatographic method. For various defects in the detection method in the prior art, the optimal gas chromatography qualitative identification and thin-layer identification method and a method for detection active components (comprising flowing phase composition and detection of analysis conditions such as wavelength, a chromatographic column and column temperature) are screened out through a large amount of experiments. Experimental verification indicates that by the detection method provided by the invention, the quality of the traditional Chinese medicine composition for treating the cirrhosis ascites can be detected and evaluated comprehensively, objectively and accurately, and an important significance in guaranteeing the clinical curative effect is achieved.

Description

Technical field [0001] The present invention relates to the technical field of traditional Chinese medicine preparations, in particular to a gel ointment with the effect of curing liver cirrhosis and ascites, and a preparation method and detection method thereof. Background technique [0002] Ascites due to cirrhosis is a common clinical disease that seriously endangers life and health. The commonly used treatment methods include diuretics, albumin, antibiotics, etc., but these methods have problems such as electrolyte imbalance or high cost, and they are less effective for refractory ascites. Non-pharmaceutical methods, such as puncture to discharge ascites, intravenous reinfusion of ascites concentration, etc., have a faster and better effect on refractory ascites, but are easy to cause infection, electrolyte disturbances or abnormal circulatory functions, and require certain facilities, so they are not very useful Convenience. Therefore, ascites due to liver cirrhosis is sti...

Claims

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Application Information

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IPC IPC(8): A61K36/835A61K9/70A61K47/32A61P1/16A61P7/10G01N30/90G01N30/02G01N30/06A61K31/045A61K35/55
CPCA61K9/7023A61K31/045A61K35/55A61K36/31A61K36/47A61K36/61A61K36/708A61K36/835A61K47/32A61K2236/331A61K2236/333A61K2236/39G01N30/02G01N30/06G01N30/90A61K2300/00
Inventor 顾治平王恒斌阙瑞艳陈力建孙华周荣
Owner 常熟雷允上制药有限公司
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