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Quality control method for multi-wavelength fusion fingerprints in production process of Shenyi capsule bulk drug

A quality control method and fingerprint technology, applied in the field of quality control of raw materials of traditional Chinese medicine, can solve problems such as not being able to meet the safety and controllability requirements of Shenyi Capsules, and achieve perfect quality control methods and safe and reliable control Effect

Inactive Publication Date: 2019-06-25
富力
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing quality detection methods only carry out qualitative identification, quantitative detection and some physical and chemical tests, which cannot meet people's requirements for the safety and controllability of Shenyi Capsules.

Method used

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  • Quality control method for multi-wavelength fusion fingerprints in production process of Shenyi capsule bulk drug
  • Quality control method for multi-wavelength fusion fingerprints in production process of Shenyi capsule bulk drug
  • Quality control method for multi-wavelength fusion fingerprints in production process of Shenyi capsule bulk drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0175] Example 2 Determination of the content of 20(R)-ginsenoside Rg3 of the Shenyi Capsule bulk drug whose batch number is 20160502

[0176] Except that the 20(R)-ginsenoside Rg3 whose batch number is 20160502 is weighed in step 2), the others are the same as in Example 1, and the measured batch number is 20160502 in the Shenyi Capsule crude drug 20(R)-ginsenoside Rg3 content It is 95.6%; Wherein the chromatogram under 203,210,225,270,320nm is identical with embodiment 1;

Embodiment 3

[0177] Example 3 Determination of the content of 20(R)-ginsenoside Rg3 of the Shenyi Capsule bulk drug whose batch number is 20160503

[0178] Except that the 20(R)-ginsenoside Rg3 whose batch number is 20160503 is weighed in step 2), the others are the same as in Example 1, and the measured batch number is 20160503 in the Shenyi Capsule raw material drug of 20(R)-ginsenoside Rg3 content It is 95.2%; wherein the chromatograms under 203, 210, 225, 270, 320nm are the same as in Example 1; the fingerprints after full-time multi-wavelength fusion are the same as in Example 1.

[0179] The fingerprint spectrogram obtained by the quality control method of the full-time multi-wavelength fusion fingerprint of Shenyi Capsule raw material medicine of the present invention can not only be used for fingerprint qualitative analysis of Shenyi Capsule raw material medicine, but also can be used for other preparations (such as 20 (R ) - fingerprint qualitative analysis of ginsenoside Rg3 gran...

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Abstract

The invention discloses a quality control method for multi-wavelength fusion fingerprints in the production process of the Shenyi capsule bulk drug. On the basis of combination of the modern analysisand detection way with the information processing way, a comprehensive and effective quality evaluation standard is established, thereby eliminating the incompleteness of reflecting the quality of theactive ingredient as a therapeutic drug raw material and a pharmaceutic preparation containing the active ingredient by one single index; and thus the quality of the bulk drug and the preparation canbe evaluated comprehensively and clearly. According to the invention, the quality control method has advantages of simple operation, high safety and effectiveness, and high reproducibility and can beapplied to quality evaluation, quality inspection and new drug development of the Shenyi capsule bulk drug industrialization.

Description

technical field [0001] The invention relates to a quality control method of raw materials of traditional Chinese medicines, in particular to a method of quality control of raw materials of Shenyi Capsules, in particular to a method of quality control of full-time multi-wavelength fusion fingerprints of the raw materials. Background technique [0002] The diagnosis and treatment of tumors is a major problem that human beings have not overcome so far, and people have been looking for effective drugs for tumor treatment. So far, in addition to traditional surgery, chemotherapy and radiotherapy, there are also biological therapy and hyperthermia to treat tumors. These methods have made great progress within a certain range, but they still cannot achieve the goal of completely eradicating tumors. Chemotherapy drugs achieve their goals by promoting the death of tumor cells or preventing their proliferation. However, most chemotherapy drugs have extensive cytotoxicity and specifici...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
Inventor 富力惠敏鲁明明王硕刘正贤鲁岐冯雪
Owner 富力
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