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A kind of detection method of pharmaceutical composition

A detection method and composition technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of high requirements for instruments and equipment, complex operation of internal standard quantitative detection methods, low accuracy of external standard quantitative methods, etc., to achieve exclusive Strong, conducive to quality control, stable baseline effect

Active Publication Date: 2018-10-26
SICHUAN JISHENGTANG PHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Danshu Capsules contains alcohols, ketones, esters, terpenes and other active ingredients of volatile oils. At present, its detection method is mainly gas chromatography detection method. However, gas chromatography detection method has high requirements for equipment, and its The internal standard quantitative detection method is complex to operate, and the external standard quantitative method is less accurate

Method used

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  • A kind of detection method of pharmaceutical composition
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  • A kind of detection method of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Example 1 Danshu Capsule Detection Method

[0062] Sample preparation method: Take 350mg of the contents of Danshu Capsules into a 25ml measuring bottle, accurately weigh, accurately add 10ml of chromatographic ethanol, weigh the weight, ultrasonically treat for 40 minutes, let cool, weigh again, and use chromatographic ethanol to make up for the loss weight, shake well, filter, and take the filtrate, that is.

[0063] Chromatographic conditions: chromatographic column Kromasil Cl8 column (250mm × 4.6mm, 5μm), mobile phase is methanol and water, gradient elution (0 ~ 10min, methanol concentration from 20% to 40%; 10 ~ 15min, methanol concentration from 40% % increased to 75%, 15-20min methanol concentration decreased from 75% to 65%, 20-30min methanol concentration decreased to 20%), detection wavelength 217, 238, 254, 288nm; column temperature is 40 ℃; flow rate 1.0mL· min -1 ; The injection volume was 10 μl.

[0064] Prepare the sample solution according to the abo...

Embodiment 2

[0065] Example two Danshu capsule detection method

[0066] Sample preparation method: Take 350mg of the contents of Danshu Capsules into a 25ml measuring bottle, accurately weigh, accurately add 10ml of chromatographic ethanol, weigh the weight, ultrasonically treat for 40 minutes, let cool, weigh again, and use chromatographic ethanol to make up for the loss weight, shake well, filter, and take the filtrate, that is.

[0067] Chromatographic conditions: chromatographic column Kromasil Cl8 column (250mm×4.6mm, 5μm), mobile phase is methanol and water (80:20), elution time is 60min. Detection wavelength 217, 238, 254, 288nm; column temperature 40°C; flow rate 1.0mL min -1 ; The injection volume was 10 μl.

[0068] Prepare the sample solution according to the above method, and carry out liquid chromatography detection, diagram 2-1 It is the test result of menthol furan, Figure 2-2 is the test result of carvone, Figure 2-3 is the pulegone detection result, Figure 2-4 I...

Embodiment 3

[0069] Example Three Danshu Capsules Liquid Chromatography Detection

[0070] Sample preparation method: Take 350mg of the contents of Danshu Capsules into a 25ml measuring bottle, accurately weigh, accurately add 10ml of chromatographic ethanol, weigh the weight, ultrasonically treat for 40 minutes, let cool, weigh again, and use chromatographic ethanol to make up for the loss weight, shake well, filter, and take the filtrate, that is.

[0071] Chromatographic conditions: chromatographic column Kromasil Cl8 column (250mm×4.6mm, 5μm), mobile phase is methanol and water (50:50), elution time is 60min. Detection wavelength 217, 238, 254, 288nm; column temperature 40°C; flow rate 1.0mL min -1 ; The injection volume was 10 μl.

[0072] Prepare the sample solution according to the above method, and carry out liquid chromatography detection, Figure 3-1 It is the test result of menthol furan, Figure 3-2 is the test result of carvone, Figure 3-3 is the pulegone detection resul...

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Abstract

The present invention provides a pharmaceutical composition content detection method, a liquid chromatography method is used for solution of a to-be-tested sample solution and a reference solution, liquid chromatography conditions are as follows: octadecylsilane bonded silica gel is used as a filler; acetonitrile is used as a mobile phase A, water is used as a mobile phase B, contents of menthofuran, carvone, pulegone and menthone in a to-be-tested sample can be detected by use of gradient elution and an external standard method, wherein a pharmaceutical composition is Danshu Capsules or dementholized peppermint oil, the pharmaceutical composition content detection method has the advantages of good component separation degree and stable baseline, can be used for effective detection and quantification of indicator active ingredients, is more accurate in test results and good in repeatability and stability, and is more conducive to the pharmaceutical composition quality control.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a detection method of a drug composition. Background technique [0002] Mint is widely distributed in various parts of my country, such as Yunnan, Jiangsu, Zhejiang, Jiangxi, etc. are all produced. China is one of the main export countries of peppermint oil and menthol. Mentha oil (Oleum Menthae Dementholatum) is the main chemical component in Peppermint. It is a traditional Chinese medicine, which has the effects of cooling and relieving itching, anti-inflammatory and analgesic, expectorant, choleretic, and stone-dissolving [Liu Hongjie et al., Peppermint Oil research progress, Shandong University of Traditional Chinese Medicine Journal 2006, 30 (6): 502-505], mainly used clinically to treat chronic cholecystitis [Han Jie et al., clinical observation of 25 cases of chronic cholecystitis treated with Danshu Capsules, Chinese patent medicine, 2007, 29(1): Instructions CN102210742B3...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 柯潇白晓春邬智刚
Owner SICHUAN JISHENGTANG PHARMLS
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