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Quality control method for TCM superfine preparation for hemorrhoids

A quality control method and excellent technology, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as incomplete detection methods, achieve good clinical efficacy, easy operation, and strong specificity

Inactive Publication Date: 2013-12-04
GUANGXI DITAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a method for identifying Zhitejia Tablets to solve the incomplete problem of the original detection method

Method used

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  • Quality control method for TCM superfine preparation for hemorrhoids
  • Quality control method for TCM superfine preparation for hemorrhoids
  • Quality control method for TCM superfine preparation for hemorrhoids

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment one: pharmacology and toxicology test of the present invention

[0025] 1. Pharmacological test: The purpose of this test is to investigate the pharmacological effects of Zhitejia Tablets, and to provide animal test basis for the clinical treatment of hemorrhoids. For this reason, anti-inflammatory, analgesic, antibacterial, hemostatic and other aspects of Zhitejia Tablets were studied and tested.

[0026] (1) Anti-inflammatory tests showed that Zhitejia Tablets had significant inhibitory effects on mouse ear swelling induced by croton oil, increase in peritoneal capillary permeability induced by acetic acid and hyperplasia of rat granulation tissue induced by cotton balls, There is a certain dose-effect relationship, showing that Zhitejia Tablet has a more significant anti-inflammatory effect.

[0027] (2) Analgesic tests showed that Zhitejia Tablets could reduce the reaction of hot plate-induced mouse foot pain and acetic acid-induced visceral pain in mice...

Embodiment 2

[0035] Embodiment two: clinical trial summary report of the present invention

[0036] 1. Test case standard

[0037] (1) Inclusion criteria

[0038] Western medicine diagnosis conforms to first and second internal hemorrhoids and thrombotic external hemorrhoids (mild); TCM dialectics belongs to the syndrome of damp heat injection; the patient's age is 18-65 years old; the patient himself signed the informed consent; he used the treatment for the disease 1 week before treatment Syndrome of Chinese and Western medicines.

[0039] (2) Exclusion criteria

[0040] 1. Those who are under 18 years old or over 65 years old, pregnant or breastfeeding women, who are allergic to this drug.

[0041] 2. Patients with severe primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematopoietic systems, and mentally ill patients.

[0042] 3. The third internal hemorrhoids, incarcerated internal hemorrhoids, connective tissue external hemorrhoids, inflammatory ext...

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Abstract

The invention provides a verification method of TCM superfine preparation for hemorrhoids and belongs to the field of drug quality control. The method includes thin-layer chromatography for garden burnet root, baical skullcap root and bitter orange and has the advantages of high specificity, fastness, operational convenience and the like; accordingly, the quality of the preparation can be controlled effectively. Clinical observations for 440 clinical cases show that the treatment group is 63.75% and 27.5% in obvious effective rate and efficiency, the total effective rate is 91.25%, and the preparation has good clinical effect in treating primary and secondary internal hemorrhoids (belonging to downward flow of damp-heat according to syndrome differentiation in traditional Chinese medicine and external hemorrhoid (belonging to downward flow of damp-heat according to syndrome differentiation in traditional Chinese medicine).

Description

technical field [0001] The invention belongs to the field of quality control of medicines, and in particular relates to a method for identifying Zhitejia Tablets. Background technique [0002] The composition of traditional Chinese medicine is complex, especially the compound prescription of traditional Chinese medicine often contains many kinds and many kinds of ingredients, forming a very complicated system. At present, the research and development of new effective parts of traditional Chinese medicine preparations and modern compound Chinese medicine preparations are increasing, and new processes and various extraction methods are used in the research and production of medicines. With the rapid development of modern analytical testing technology, equipment and instruments, TLC identification of traditional Chinese medicine has become an important means. However, most of the current prescriptions of Chinese patent medicines generally only establish the identification of a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90
Inventor 不公告发明人
Owner GUANGXI DITAI PHARMA
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