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Quality control method for capsules with functions of dispelling wind and removing toxicity

A technology of Shufengjiedu capsules and detection methods, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as difficult to reflect the overall quality of medicines, and achieve monitoring in all aspects, perfect quality control methods, and good reproducibility Effect

Active Publication Date: 2015-02-04
安徽济人药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The implementation standard of Shufeng Jiedu Capsules is the State Food and Drug Administration standard YBZ00652009. In this standard, only the TLC scanning method is used to determine the content of emodin, and the TLC method is used to qualitatively identify Forsythia, Verbena and Bupleurum, which is difficult to reflect the drug overall quality of

Method used

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  • Quality control method for capsules with functions of dispelling wind and removing toxicity
  • Quality control method for capsules with functions of dispelling wind and removing toxicity
  • Quality control method for capsules with functions of dispelling wind and removing toxicity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 Using HPLC to establish a multi-component assay method for the contents of Shufengjiedu capsules

[0052] Preparation of mixed reference solution: Accurately weigh 4.80 mg of Verbenain, 4.46 mg of Verbenain, 5.96 mg of Polydatin, 2.94 mg of Forsythiaside A, 10.56 mg of Verbacoside, and 10.30 mg of Monoammonium Glycyrrhizinate , Emodin 2.66mg, respectively into 25ml measuring bottles, dissolved in methanol and diluted to the mark, shaken well, as a stock solution. Precisely measure 5ml each of the reference substance stock solution into a 10ml measuring bottle, dilute to the mark with methanol, and shake well to obtain a mixed reference substance solution.

[0053] Preparation of the test solution: put the content of Shufengjiedu capsules into a powder in a mortar, weigh 1.000g of the powder, place it in a 100ml round bottom flask, add 25ml of 70% ethanol aqueous solution, weigh, reflux for 2 hours, and cool After weighing, make up the weight loss with 70% e...

Embodiment 2

[0061] The investigation of need testing solution preparation method in the multi-component detection method of embodiment 2

[0062] 1. Inspection of extraction methods

[0063] Weigh 3 parts of the contents of Shufengjiedu capsules, add appropriate amount of 70% ethanol, respectively adopt ultrasonic, reflux, Soxhlet extraction, and filter to obtain the test solution, and carry out the test under the determined conditions. The content calculation results of the relevant components are shown in table 3.

[0064] Table 3 Inspection results of extraction methods

[0065]

[0066] Comparing the three extraction methods, it can be seen that the reflux extraction has the highest efficiency, so the reflux extraction method is selected.

[0067] 2. Investigation of extraction solvent

[0068] Weigh 3 parts of 1.000g Shufengjiedu Capsule powder in parallel, add 25ml of 50%, 70%, and 90% ethanol solution respectively, reflux extraction for 2 hours, filter to obtain the test so...

Embodiment 3

[0084] Example 3 Methodological investigation of multi-component detection method

[0085] (1) Precision test

[0086] Adopt the operation and condition identical with embodiment 1, get about 1.000g of sample, accurately weigh, process by need testing solution preparation method, precision draw need testing solution 10 μ l, inject high performance liquid chromatograph, in above-mentioned chromatographic condition 6 consecutive injections under the following conditions, the RSD values ​​of verbenin, verbenin, polydatin, forsythiaside A, verbascoside, glycyrrhizin monoammonium salt, and emodin were 2.53%, 2.18%, 2.76%, and 2.87, respectively. %, 2.19%, 1.33%, 1.97%. The precision is good.

[0087] (2) Stability investigation

[0088] Using the same operation and conditions as in Example 1, take about 1.000 g of the sample, prepare and extract according to the test solution, inject samples at 0, 1, 3, 6, 9, 12, and 24 hours respectively, and measure under the above-mentioned...

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Abstract

The invention provides a detection method for capsules with functions of dispelling wind and removing toxicity. The detection method is used for detecting hastatoside, verbenalin, polydatin, forsythiaside A, verbascoside, glabrolide monoammonium salt and rheum emodin in the capsules simultaneously with a high-efficiency liquid chromatography, wherein the high-efficiency liquid chromatography is performed under following conditions: a chromatographic column adopts octadecyl-silane-bonded silica gel as a filling material; mobile phases comprise a mobile phase A which is acetonitrile and a mobile phase B which is an acidic aqueous solution, and gradient elution is carried out; the flow velocity is 1.0ml / min; the column temperature is 30 DEG C; the detection wavelength is 210nm-400nm; and the number of theoretical plates is calculated according to rheum emodin peaks, and is not less than 5000. According to the detection method provided by the invention, the content of seven active components such as hastatoside, verbenalin, polydatin, forsythiaside A, verbascoside, glabrolide monoammonium salt and rheum emodin in the capsules can be detected simultaneously, so that the active components of the capsules with functions of dispelling wind and removing toxicity can be comprehensively represented. The detection method has the characteristics of high precision, stability and repeatability.

Description

technical field [0001] The invention relates to the technical field of drug analysis and detection, and relates to a detection method for Shufengjiedu capsules, in particular to a detection method for simultaneously detecting multiple components of the Shufengjiedu capsules by using high performance liquid chromatography (HPLC). Background technique [0002] Modern drugs have three characteristics: stability and uniformity, safety and effectiveness, among which stability and uniformity are the basis for drug safety and effectiveness. The stability and uniformity of drugs mainly comes from two links: the whole process control of drug preparation process and the scientific evaluation of drug quality standards. Traditional Chinese medicine is a complex system consisting of multiple components and factors, and the diversity and complexity of its chemical components is a difficulty in quality control. Selecting the chemical components associated with the prescription functions a...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 朱月信张铁军杨景生刘素香白雪邢雪飞丁连峰
Owner 安徽济人药业股份有限公司
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