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Quality control method and model building method of Guangdong Zizhu based on spectrum-effect relationship

A quality control method and technology of purple beads, applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve the effect of clear characteristic peaks, scientific and perfect quality control, and avoiding the deviation of individual animals

Active Publication Date: 2018-11-30
JIANGSU KANION PHARMA CO LTD +2
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  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The object of the present invention is to aim at the lack of effective quality control methods of Guangdong Zizhu, and to provide the chemical analysis and statistical methods to carry out spectral-effect correlation research on the fingerprint of Guangdong Zizhu and the hemostatic effect in order to predict the hemostatic effect of Guangdong Zizhu. Quality inspection method to judge its quality

Method used

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  • Quality control method and model building method of Guangdong Zizhu based on spectrum-effect relationship
  • Quality control method and model building method of Guangdong Zizhu based on spectrum-effect relationship
  • Quality control method and model building method of Guangdong Zizhu based on spectrum-effect relationship

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Experimental program
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Effect test

preparation example Construction

[0069] 1. At first, adopt 9 groups of samples prepared by different preparation techniques for the test solution, and establish the fingerprint of the corresponding chromatogram with the HPLC method (such as figure 1 shown), and then the hemostatic effect was evaluated by the average hemostatic time obtained by the mouse tail-docking hemostasis method and the mouse eyeball blood collection-slide coagulation method.

[0070] 1.1 The HPLC method is used to establish the fingerprint of the corresponding chromatogram, and the chromatographic conditions are as follows:

[0071] The chromatographic column adopts Welch Material C18 column, mobile phase A is water containing 0.5% phosphoric acid, mobile phase B is chromatographic grade acetonitrile; time is 0min→5min→20min→50min→80min→110min; mobile phase A%: 95%→92 %→88%→85%→82%→82%, mobile phase B: 5%→8%→12%→15%→18%→18%, the flow rate is 1ml / min, the sampling volume is 40μl, and the sampling temperature is 20°C, column temperature ...

Embodiment 1

[0123] (1) Instruments and reagents:

[0124] Chromatography instrument: Agilent 1260 high performance liquid chromatography (HPLC) instrument; reference standard products forsythiaside B and aureoside are reference standard products provided by China Institute for Food and Drug Control (the same as above). The experimental data were statistically analyzed using SPSS 20.0 software.

[0125] Collect Jiangxi GMP medicinal material base to provide 3 batches of Guangdong Zizhu medicinal material samples, which were identified by researcher Wu Tong of Shanghai Pharmaceutical Industry Research Institute as the dry aerial part of Verbenaceae Zizhu genus Callicarpa kwangtungensis Chun, and the above medicinal materials were crushed into fine powder, Pass through a No. 4 sieve, dry, seal, and store in a freezer (-4°C). Positive control drug: Kanggongyan Capsules Batch number: Z20040083, manufacturer: Jiangxi Xinzheng Pharmaceutical Co., Ltd.; 132 ICR mice, male and female, weighing 16...

Embodiment 2

[0142] Reselect the Guangdong Zizhu traditional Chinese medicine to be detected, and the detection method is with reference to the content of Example 1; the characteristic peak area of ​​the Guangdong Zizhu to be detected is as shown in Table 10.

[0143] Table 10 Integration results of characteristic peaks and peak areas

[0144] X 1

X 2

X 3

X 4

X 5

X 6

X 7

X 8

X 9

X 10

X 11

X 12

X 13

X 14

80.9

83.3

199.0

68.9

189.8

460.1

291.4

1994.9

378.5

371.6

586.9

159.9

654.1

296.2

[0145] Use the above equations to calculate the tail-docking hemostatic effect and slide coagulation effect value of this sample, the tail-docking hemostatic efficiency ratio is 0.5958, and the slide coagulation efficiency ratio is 0.4067; then, carry out the experimental detection of this sample, and the mathematical model The detection of sample residuals and deviations between the ve...

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Abstract

The invention provides a quality control method for Callicarpa kwangtungensis based on the spectrum-activity relationship. The method comprises the following steps: 1) establishing the HPLC fingerprint of a Callicarpa kwangtungensis test sample to be detected; 2) screening out a characteristic peak; and 3) substituting the peak area of the characteristic peaks screened out in the step 2) into a spectrum-activity mathematical model for calculation, and judging the quality of Callicarpa kwangtungensis according to calculation results.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine quality standard detection, in particular to a method for controlling the quality of Guangdong Zizhu and a method for establishing a detection model. Background technique [0002] Guangdong Zizhu, derived from the Verbenaceae plant Calliscarpa kwangtungensis C., mainly grows and distributes in Zhejiang, Jiangxi, Fujian, Hubei, Sichuan, Guangzhou, Guangxi and other places in China. It is listed in the 2010 edition of "Chinese Pharmacopoeia" A newly recorded species. Clinical reports show that Guangdong Zizhu has the functions of astringent to stop bleeding, dissipate blood stasis, clear away heat and detoxify, and is mainly used to treat gynecological inflammations such as cervical erosion and bleeding, vaginitis, and cervicitis. It contains phenylethanol glycosides represented by shicroside and forsythiaside B and flavonoids represented by quercetin, among which the content o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 杨义芳余婧胡晓李丽吴春珍
Owner JIANGSU KANION PHARMA CO LTD
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