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Method for determining three active components in medicinal preparation

A technology of pharmaceutical preparations and active ingredients, applied in the field of quality control and component testing of traditional Chinese medicine, can solve the problems of lack of effective quality control of pharmaceutical preparations, achieve the effects of improving safety and reliability, broad application prospects, and ensuring quality

Active Publication Date: 2021-09-28
HEHUANG PHARMA SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] In view of the shortcomings of the prior art described above, the purpose of the present invention is to provide a method for the determination of three active ingredients in a pharmaceutical preparation, which is used to solve the problem of lack of effective control of the quality of the pharmaceutical preparation in the prior art

Method used

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  • Method for determining three active components in medicinal preparation
  • Method for determining three active components in medicinal preparation
  • Method for determining three active components in medicinal preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] 1. Preparation of the test solution

[0061] The pharmaceutical preparation samples were prepared according to the ancient method recorded in the classic famous prescription "Synopsis of the Golden Chamber", that is, the fresh lilies were washed with clean water to remove the floating water on the surface, and 7 lilies were weighed. Wash it with clean water and set it aside; take fresh rehmannia glutinosa and squeeze 200mL of fresh rehmannia glutinosa juice into a juicer and boil it for later use. Take the above-mentioned lilies, add 400mL of water to a beaker, place them in a medicine pot, heat and decoct to 200mL, filter, add the above-mentioned fresh rehmannia juice to the filtrate, stir evenly, heat and decoct to 300mL, and the product is ready.

[0062] Take 3g of the drug preparation sample, accurately weigh it, put it in a 50ml measuring bottle, add water to dissolve, and dilute to the scale constant volume, shake well, and filter through a 0.45μm microporous mem...

Embodiment 2

[0079] Methodological verification was carried out on the detection methods of catalpol, diglucoside D, and lilyoside B in the pharmaceutical preparation of the present invention, and the performance index results are as follows.

[0080] 1. Precision

[0081] Get pharmaceutical preparation sample, prepare and obtain need testing solution by step 1 in embodiment 1, press the chromatographic condition of step 3 in embodiment 1, continuous sampling analysis 6 times, measure peak area, precision specific result is shown in Table 2. The results showed that the chromatographic peak area RSDs of catalpol, diglucoside D, and lilyoside B were all less than 2.0%, which indicated that the precision of the method was good.

[0082] Table 2

[0083]

[0084] 2. Repeatability

[0085] Get the same batch of pharmaceutical preparation samples, prepare 6 parts of need testing solution in parallel according to step 1 in embodiment 1, press the chromatographic condition in step 3 in embodi...

Embodiment 3

[0109] According to 32 parts of pharmaceutical preparation samples prepared by the classic famous prescription "Synopsis of the Golden Chamber" ancient recipe, step 1 in Example 1 is used to prepare the solution for the test product, and by the chromatographic conditions of step 3 in Example 1, detect, the result As shown in Table 9. The results show that the method of the invention can measure the content of ingredients in different pharmaceutical preparations.

[0110] Table 9

[0111]

[0112] According to the requirements of the quality standards for medicinal materials established by research: fresh rehmannia glutinosa contains not less than 1.0% and 0.10% rehmanniaside D, respectively, and the average water content is 76%; The amount of water is 67%. The amount of feed and the transfer rate of each step of the preparation process are shown in Table 10 below.

[0113] Table 10

[0114]

[0115] According to the calculation: based on the average dosage, the amoun...

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Abstract

The invention provides a method for determining three active components in a medicinal preparation, which comprises the following steps: adding water to dissolve the medicinal preparation, fixing the volume, performing shaking uniformly, performing filtering, detecting the obtained test solution by high performance liquid chromatography under double detection wavelengths, and determining the contents of the three active components in the test solution: catalpol, rehmannioside D and regallily glycoside B. The method for determining the three active components in the medicinal preparation is accurate, reliable, simple, convenient, rapid and good in stability and repeatability, provides a basis for systematic evaluation and quality control of the pharmaceutical preparation, provides a research basis for reasonable development and application of the pharmaceutical preparation, can more comprehensively guarantee the quality of the medicinal preparation, improves the safety and the reliability of the medicine are improved, and has a wide application prospect.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine quality control and component detection, and relates to a method for measuring three active components in a pharmaceutical preparation, in particular to three active components in a pharmaceutical preparation: catalpol, rehmanthin D and lilyside B HPLC detection method. Background technique [0002] As the development of classic prescriptions of traditional Chinese medicine has become a research hotspot in the field of traditional Chinese medicine, relevant management departments have stipulated that classic prescriptions must be researched in strict accordance with the prescription, dosage and preparation process of ancient prescriptions. The pharmaceutical preparation of the research object of the present invention was first seen in the first part of "Synopsis of the Golden Chamber·Syndrome and Treatment of Yin and Yang Poison of Lily and Fox Confusion" by Zhang Zhongjing in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N2030/047Y02A50/30
Inventor 周宽但济修詹常森李淞明周永全张正光
Owner HEHUANG PHARMA SHANGHAI
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