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Method for detecting quality of south isatis root granules

A quality inspection method, the technology of Radix isatidis, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of large differences in product quality, difficulty in identifying Radix Radix et Rhizoma granules, low extraction rate, etc., to achieve small content changes and control quality. , good repeatability

Active Publication Date: 2012-01-25
JIANGXI POZIN PHARMA
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the research on the preparation of Radix isatidis is more focused on the research on indigo and indirubin, but in fact, the extraction rate of the fat-soluble components indigo and indirubin is extremely low in the existing preparation process of boiling and alcohol precipitation, and the production is different. The product quality varies greatly between manufacturers and batch numbers. At the same time, indigo and indirubin are not effective ingredients for its heat-clearing and detoxifying effects. Therefore, it is difficult to identify fat-soluble ingredients such as indigo and indirubin as quality control indicators for its preparations. Southern Banlangen Granules

Method used

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  • Method for detecting quality of south isatis root granules
  • Method for detecting quality of south isatis root granules

Examples

Experimental program
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Embodiment 1

[0035] Example 1: Establishment of standard fingerprints of Banlangen granules.

[0036] (1) Instruments and reagents: High-performance liquid chromatography: Shimadzu LC-10ATvp high-performance liquid chromatography (SPD-M10Avp detector, CLASS-VP software); CNC ultrasonic cleaner: KQ-250DB, Kunshan Ultrasonic Instrument Ltd.; one hundred thousandth balance: Shimadzu AUW220; one ten thousandth balance: AB104-N type, Mettler-Toledo; Millipore ultrapure water meter.

[0037] Acetonitrile: Chemical Branch of Shandong Yuwang Experimental Co., Ltd.; Methanol: Shanghai Zhenxing Chemical Factory No. 1; Phosphoric acid (excellent grade): Tianjin Fine Chemicals Development Co., Ltd.; ultrapure water.

[0038] Quinazoledione reference substance: Sigma Company; Nanbanlangen Granules: provided by Jiangxi Puzheng Pharmaceutical Co., Ltd.

[0039] (2) Preparation of reference solution.

[0040] Take about 3mg of quinazoledione, weigh it accurately, put it in a 50mL volumetric flask, dil...

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Abstract

The invention discloses a method for detecting the quality of south isatis root granules and belongs to the technical field of quality control of medicines. The method comprises the following steps of: preparing a comparison product solution; preparing a test article solution; performing gradient elution; making a standard fingerprint spectrum by using quinazoline dione as a reference peak; and controlling the quality of the fingerprint spectrum. In the method, quinazoline alkaloid is selected as an index for controlling the quality of south isatis root; the quinazoline alkaloid in south isatis root crude drugs has anti-toxoid and bacteriostatic actions; and the quinazoline alkaloid is relatively stable and small in content change in the south isatis root crude drugs, a preparation process and a preparation finished product. The standard fingerprint spectrum is established by using a high-efficiency liquid phase, the characteristics of active constituents of the south isatis root are taken as the principle things, and quantization parameters are obtained by using the fingerprint spectrum. The invention has the advantages that: the method is higher in accuracy and good in stabilityand repeatability; and the quality of a preparation can be more comprehensively and effectively controlled.

Description

technical field [0001] The invention belongs to the technical field of medicine quality control, in particular, the invention relates to a fingerprint detection method of traditional Chinese medicine Nanbanlangen granules. Background technique [0002] Nanbanlangen granule is a Chinese patent medicine (Chinese medicine compound preparation) for clearing heat, detoxifying and cooling blood. It has been used in my country for many years. It has the effect of clearing heat and detoxifying. It is clinically used for febrile disease fever, heat-toxin spots, wind-heat cold, sore throat, epidemic encephalitis B, hepatitis, and mumps. The curative effect is certain. Nanbanlangen granules are prepared from Chinese medicinal materials Nanlangen and Folium Isatidis according to the conventional process of Chinese patent medicine granules. [0003] As a Chinese patent medicine, Nanbanlangen granule does not come from any single active ingredient, but its medicinal effect is basically t...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/86
Inventor 肖军平李旭康兴东吴永忠余显英张荷英
Owner JIANGXI POZIN PHARMA
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