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Method for measuring content of selfheal oral liquid

A determination method, the technology of Prunella vulgaris, applied in the field of determination of the content of Prunella vulgaris oral liquid, can solve the problems of high total flavonoid content, inappropriate index components, and low content, and achieve good stability, easy quality control, and scientific detection methods Effect

Inactive Publication Date: 2010-03-03
GUIYANG XINTIAN PHARMA CO LTD
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  • Claims
  • Application Information

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Problems solved by technology

During the detection process, it was found that the HPLC method for detecting hyperoside has the following disadvantages: 1. The content of hyperoside in Prunella vulgaris Oral Liquid is too low, generally only about 0.11-0.20mg / 10ml, while the standard stipulates that It should not be less than 0.10mg / 10ml, which is not appropriate as an index component for the determination of the content of Prunella vulgaris Oral Liquid; 2. The content of total flavonoids in this product is high, and hyperoside is one of them, with a relatively complex structure and low content , it is difficult to separate in liquid chromatography, so the resolution of the hyperoside chromatographic peak in the sample is often only about 1.0, which affects the accuracy of the test results and is not conducive to the control of product quality

Method used

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  • Method for measuring content of selfheal oral liquid
  • Method for measuring content of selfheal oral liquid
  • Method for measuring content of selfheal oral liquid

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preparation example Construction

[0026] 3. Preparation of reference solution

[0027] Reference substance solution 1. Accurately weigh 24.46mg of rosmarinic acid reference substance, put it in a 50ml measuring bottle, add 50% methanol to dissolve and dilute to the mark, shake well, and obtain a solution containing 0.475mg per 1ml (purity is calculated as 97%) ).

[0028] Reference substance solution ② Precisely draw 20ml of the above reference substance solution, put it in a 50ml measuring bottle, add 50% methanol to dilute to the mark, shake well, and obtain a solution containing 0.19mg per 1ml.

[0029] 4. Chromatographic condition test

[0030] 4.1 Chromatographic column: Octadecylsilane bonded silica gel as filler (Agilent C18, 250mm×4.6mm, 5μm)

[0031] 4.2 Flow rate: 1.0ml / min

[0032] 4.3 Detection wavelength: 330nm (Refer to Chin J Pharm Anal 2006, 3 Analysis method of rosmarinic acid in Prunella vulgaris)

[0033] 4.4 Column temperature: 25°C

[0034] 4.5 Mobile phase: The mobile phase in the or...

Embodiment

[0093] A method for assaying the content of Prunella vulgaris Oral Liquid, comprising the simultaneous determination of total flavonoids and rosmarinic acid in the same system, the steps are as follows:

[0094] (1) Preparation of total flavonoid reference substance solution Precisely weigh 20 mg of rutin reference substance dried under reduced pressure at 120°C to constant weight, put it in a 10ml measuring bottle, add 5ml of methanol, put it on a water bath to slightly heat to dissolve, let cool, Add methanol to dilute to the mark, shake well, accurately measure 5ml, put it in a 50ml measuring bottle, add water to dilute to the mark, shake well to obtain (every 1ml contains rutin 0.2mg).

[0095] Preparation of standard curve Precisely measure 1.0ml, 2.0ml, 3.0ml, 4.0ml, 5.0ml and 6.0ml of the reference substance solution, put them in 25ml measuring bottles respectively, add water to 6ml each, add 1ml of 5% sodium nitrite solution, mix Mix well, let stand for 6 minutes, add ...

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Abstract

The invention discloses a method for measuring the content of selfheal oral liquid, which comprises the steps of: measuring rosmarinic acid according to high performance liquid chromatography; takingoctadecylsilane chemically bonded silica as a bulking agent, taking methanol-0.5% formic acid (40:60) as a mobile phase, wherein the detection wavelength is 330nm, and the number of theoretical plateis not less than 3000; precisely weighing a proper amount of the reference substance of the formic acid, adding 50% methanol to prepare a solution containing 0.2mg per 1ml, thus obtaining the solution; precisely weighing 2ml of the product, placing the product in a measuring bottle of 25ml, adding 50% methanol for dissolving, diluting the mixture to the scale, shaking evenly, filtering, and takinga subsequent filtrate, thus obtaining the solution; and precisely absorbing 10Mul of reference substance solution and 10Mul of test substance solution respectively, injecting the solutions into liquid chromatograph for measurement, thus obtaining the result. The method has high tested component content, and good stability, and is beneficial to the control on product quality.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, in particular to a method for determining the content of Prunella vulgaris oral liquid. Background technique [0002] Prunella vulgaris Oral Liquid is prescription Prunella vulgaris 800g, preparation method: take 800g Prunella vulgaris, add water and decoct three times, 2 hours each time, combine the decoction, filter, the filtrate is concentrated to about 800ml, stand for 24 hours, filter, the filtrate Add 250g of sucrose and 3g of sodium benzoate, heat to dissolve, add water to adjust the total amount to 1000ml, stir well, refrigerate for 24 hours, filter, pot, pack 10ml in each tube, sterilize, and get ready. The existing quality standard of Prunella vulgaris Oral Liquid is the national drug standard WS3-224(Z-224)-2003(Z). Under the content determination item in the standard, it is stipulated that the total flavonoid content should be detected by ultraviolet spectropho...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/536A61P7/02G01N30/36
Inventor 董大伦
Owner GUIYANG XINTIAN PHARMA CO LTD
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