Method for measuring content of superfine powder preparation in five retentions powder

A technology of ultrafine powder and determination method, which is applied in the direction of medical preparations containing active ingredients, anti-inflammatory agents, measuring devices, etc., and can solve problems such as single quality standards and no simultaneous detection of multiple components

Inactive Publication Date: 2010-09-01
HUNAN UNIV OF CHINESE MEDICINE +1
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Problems solved by technology

[0004] Wujisan is a classic prescription that has been used for thousands of years. Its quality standard has only identification items, and the unused content is used to control the quality of the finished product. The quality standard is single
Obviously, in view of the complexity of the components of the traditional Chinese medicine composition, the prior art does not provide a method for simultaneous detection of multiple components in the prescription

Method used

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  • Method for measuring content of superfine powder preparation in five retentions powder
  • Method for measuring content of superfine powder preparation in five retentions powder
  • Method for measuring content of superfine powder preparation in five retentions powder

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Experimental program
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Effect test

Embodiment 1 5

[0018] The content determination of 11 kinds of indicators in the Wujisan superfine powder preparation of embodiment 1

[0019] 1. Chromatographic conditions:

[0020] Chromatographic column: Octadecyl silica gel column ((5.0μm, 250mm×4.6mm)

[0021] Mobile phase A is 0.35% (v / v) phosphoric acid aqueous solution; B is acetonitrile; gradient elution: 0-15min, 7-18% B; 15-38min, 18-30% B; 38-42min, 30-41% B; 42~45min, 41-55%B; 46~65min, 55-62%B; 65~75min, 62-75%B; 75~80min, 75-90%B; 80~85min, 90-93%B B; 85-95 min, 93-93% B. The column temperature is 30°C; the flow rate is 1ml / min; the detection wavelength of each control index is shown in Table 1. Flow rate: 1.0mlmin -1 .

[0022] Detection wavelength: the variable wavelength method is adopted, that is, the maximum absorption wavelength of the corresponding index component is used at the retention time position of each index component. See Table 1.

[0023] Table 1 Simultaneously detect the detection wavelength of 11 inde...

Embodiment 2

[0032] Embodiment 2 linear relationship investigation

[0033] Dilute the mixed solution of 11 kinds of reference substances to 6 concentration levels, accurately draw 5 μl into the liquid chromatograph, and record the chromatogram. Take the peak area of ​​ephedrine hydrochloride, paeoniflorin, liquiritin, ferulic acid, naringin, hesperidin, cinnamon aldehyde, imperatorin, glycyrrhizinic acid, magnolol, and honokiol as the ordinate respectively ( Y), reference substance solution injection concentration (μl / ml) is abscissa (X) and carries out linear regression, and the regression equation is shown in Table 2. All regression equations showed a good linear relationship within the detection range (r 2 >0.9993).

[0034] Table 211 Regression data and minimum detection limit of components (n=6).

[0035]

Embodiment 3

[0036] Embodiment 3 precision investigation

[0037] Take Wujisan ultrafine powder preparation solution under the above-mentioned chromatographic conditions to carry out intra-day precision and inter-day precision tests. The intraday precision test uses the sample solutions of three concentrations to repeat the test 5 times in one day, and the interday precision test is performed once in three consecutive days. The results are shown in Table 3, and the R.S.D. of the 11 main components are all less than 5%. It shows that the method has good precision.

[0038] Table 3 precision test

[0039]

[0040]

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Abstract

The invention relates to a method for measuring the content of a superfine powder preparation in a Chinese patent medicament, which is characterized in that 11 content control indexes are selected, a high performance liquid chromatography is adopted and the same content measuring method is adopted to simultaneously measure the content of indexes of 11 chemical components in five retentions powder. The method comprises chromatographic conditions and system applicability tests, and limitation to preparation content of reference substance solution. The method has the advantages of relative simplicity, accuracy and high repeatability, and is suitable for comprehensively evaluating the quality of a five retentions powder compound preparation.

Description

technical field [0001] The invention relates to a method for determining the content of a Chinese patent medicine in an ultrafine powder preparation, in particular to the content determination of index components in the Wujisan ultrafine powder preparation. Background technique [0002] Drug quality standards are the qualitative basis of drug inspection and technical supervision laws. In a certain sense, the quality of drugs is closely related to the quality of quality standards. As one of the key contents of traditional Chinese medicine quality standards, content determination can be found in To a large extent control the quality of medicines. Traditional Chinese medicine compound often contains many types and ingredients, and the determination of only a single ingredient is largely one-sided. Therefore, it is necessary to establish multi-index content determination in the quality standards of traditional Chinese medicine compound to realize the control of most component i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/9068A61P1/08A61P1/14A61P29/00A61P15/00G01N30/36
Inventor 蔡光先王宇红匡建军蔡萍
Owner HUNAN UNIV OF CHINESE MEDICINE
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