Method for testing content of pinoresinol diglucoside in compound eucommia bark tablet

A technology of pinoresinol diglucoside and compound eucommia tablet is applied in the directions of measuring devices, medical preparations containing active ingredients, pharmaceutical formulations, etc., and can solve the problem of inability to separate pinoresinol diglucoside, difficult filtration, and undetectable components, etc. To increase the content determination method, control the quality, and ensure the effect of curative effect

Active Publication Date: 2011-02-02
GUANGZHOU XIANGXUE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process of Compound Eucommia Tablets is made by a variety of medicinal materials using a water extraction process, so the ingredients contained in the tablet are complex, and also contain proteins, polysaccharides, etc., such as direct extraction with polar solvents such as water and methanol , the filtration is difficult, which affects the correctness of the extraction and separation of the component and the determination data
According to the method of this document, pinoresinol diglucoside cannot be separated from Compound Eucommia Tablets, and the corresponding components cannot be detected in the high performance liquid chromatography

Method used

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  • Method for testing content of pinoresinol diglucoside in compound eucommia bark tablet
  • Method for testing content of pinoresinol diglucoside in compound eucommia bark tablet
  • Method for testing content of pinoresinol diglucoside in compound eucommia bark tablet

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Experimental program
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Effect test

Embodiment 1

[0033] Determination of the content detection method of pinoresinol diglucoside in the compound eucommia ulmoides tablet of embodiment 1

[0034] The chromatographic conditions use octadecylsilane and silica gel as filler; methanol as mobile phase A and water as mobile phase B for gradient elution; detection wavelength: 230nm; flow rate: 1ml / min; theoretical The number of plates should not be less than 2000 based on the peak of pinoresinol diglucoside; the gradient elution should be carried out according to the following procedure:

[0035]

[0036] Preparation of reference substance solution Accurately weigh 14.8mg of pinoresinol diglucoside reference substance, put it in a 50ml measuring bottle, add 30% methanol to dissolve and set the volume to the mark, and obtain a 0.296mg / ml reference substance solution.

[0037] Preparation of the test solution Take compound Eucommia tablets, remove the coating, grind finely, accurately weigh 1g of the fine powder, put it in a conica...

Embodiment 2

[0056] Embodiment 2 Get the batch number 200701001 batch of compound Eucommia tablets produced by Guangzhou Xiangxue Pharmaceutical Co., Ltd., the sheet weight is 0.35 grams, and detect according to the following conditions:

[0057] (1) Chromatographic conditions: Carbooctadecylsilane and silica gel are used as filler; methanol is used as mobile phase A, and water is used as mobile phase B to carry out gradient elution with eluent composed of mobile phase B. The elution procedure is shown in Table 4; Wavelength: 230nm; flow rate: 1ml / min; the number of theoretical plates calculated based on pinoresinol diglucoside peak should not be less than 2000.

[0058] Table 4

[0059]

[0060] (2) Preparation of the reference substance solution: Accurately weigh the reference substance of pinoresinol diglucoside, add a methanol solution with a concentration of 25% by volume to prepare a solution containing 0.035 mg per 1 ml, and obtain the product.

[0061] (3) Preparation of the te...

Embodiment 3

[0064] Embodiment 3 Measure other batches of products produced by Guangzhou Xiangxue Pharmaceutical according to the method in Example 2, and the measurement results are as follows:

[0065]

[0066]

[0067] From the results of the above batches of determination, it can be seen that the content of pinoresinol diglucoside in the compound eucommia tablets is greater than 0.05 mg per tablet, and the weight of each substrate is 0.35 g.

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Abstract

The invention discloses a method for testing the content of pinoresinol diglucoside in a compound eucommia bark tablet, which belongs to a method of testing the content of an active ingredient of a medicament in the medicine field. Testing by high performance liquid chromatography, the content of the pinoresinol diglucoside in each compound eucommia bark tablet is not less than 0.05mg, the basic weight of each tablet is 0.35g, in particular octadecyl silane bonded silica is used as filler; methanol is used as a mobile phase A and water is used as a mobile phase B to carry out gradient elution; the detection wavelength is 230mum and the flow rate is 1ml/min; the theoretical plate number in the term of the pinoresinol diglucoside is not less than 2000; and20mul of reference substance solution and testing solution are respectively accurately sucked, and injected into a high performance liquid chromatograph, tested and calculated according to an external standard method to obtain the content of the pinoresinol diglucoside. The method for testing the content of the pinoresinol diglucoside has high sensitivity, and proved by an experiment, the accuracy, reproducibility, linearity, stability of the method are all meet the requirements.

Description

technical field [0001] The invention belongs to a method for measuring the content of active ingredients in traditional Chinese medicines in the field of medicine, and in particular relates to a method for measuring the content of pinoresinol diglucoside in compound eucommia tablets. Background technique [0002] Compound Eucommia tablets are made from Eucommia ulmoides, Motherwort, Uncaria, Prunella vulgaris, and Scutellaria baicalensis, and are mainly used for hypertension with kidney deficiency and liver hyperactivity. The product has a good effect of lowering blood pressure and is widely used in clinical practice. The product is included in the Chinese Ministry of Health Drug Standard Chinese Medicine Prescriptions Volume 6, page 117 WS3-B-1185-92. In the standard, there are only simple microscopic identification and color reaction to control the product quality. This kind of identification method is rough and non-specific. Product quality cannot be effectively contro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/74G01N30/06A61P9/12A61K9/20G01N30/02G01N30/36
Inventor 蔡春玲康志英连林生李小妹王德秀黄洁文
Owner GUANGZHOU XIANGXUE PHARMA CO LTD
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