Method for detecting Simotang preparation

A detection method, the technology of Simotang, which is applied in the direction of separation method, chemical instrument and method, measuring device, etc., can solve the problems that have not yet been seen to measure Simotang preparations at the same time, and achieve economical, effective and reliable analysis method, peak purity Good, simple quality control results

Active Publication Date: 2012-02-08
HUNAN HANSEN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, there has been no report on the method for the simultaneous determination of arecoline, synephrine and norisoboldine in Simotang preparations

Method used

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  • Method for detecting Simotang preparation
  • Method for detecting Simotang preparation
  • Method for detecting Simotang preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 System Applicability

[0037] 1. Sample preparation

[0038] Reference substance solution: Take the reference substances of arecoline hydrobromide, synephrine, and norisobordine respectively, accurately weigh them, add methanol to dissolve, and prepare 0.5 mg of arecoline hydrobromide, synephrine, and Lin 0.5mg, norisoboldine 0.4mg solution, as the reference substance stock solution. Accurately draw appropriate amounts of the three stock solutions, and dilute them with methanol into 1ml of a reference solution containing 50 μg of arecoline hydrobromide, 50 μg of synephrine, and 40 μg of norisoboldine.

[0039] The test solution of Simotang oral liquid: get 5 Simotang oral liquids, mix well, filter with 0.45 μm microporous membrane (0.45 μm, polyethersulfone, SCAA-101 aqueous needle filter), take Continue the filtrate, that is.

[0040] 2. Chromatographic method

[0041] (1) Method 1

[0042] Elution condition 1:

[0043] The chromatographic column is ...

Embodiment 2

[0068] Embodiment 2 durability test

[0069] 1. The influence of column temperature

[0070] Experimental method: get the need testing solution of the Simotang oral liquid of embodiment 1, analyze under the condition of column temperature 30 ℃, 35 ℃ and 40 ℃ respectively, other conditions are the same as method 1 elution condition 3 in embodiment 1.

[0071] Experimental results: The chromatogram is as follows Figure 4 shown. Depend on Figure 4 It can be seen that when the column temperature is between 30 and 40°C, it has a certain influence on the retention time of the chromatographic peak, but has little effect on the separation of the target chromatographic peak. When the column temperature is 40°C, the separation time is the shortest. Therefore, the column temperature of 30-40°C is applicable to the determination of Method 1.

[0072] 2. The influence of velocity

[0073] Experimental method: get the need testing solution of the Simotang oral liquid of embodiment 1...

Embodiment 3

[0076] Embodiment 3 methodological verification

[0077] 1. Standard curve and linear range

[0078] Accurately draw appropriate amounts of synephrine, arecoline hydrobromide and norisoboldine reference substance stock solutions respectively, and dilute with methanol to form a series of mixed reference substance standard solutions as shown in Table 6.

[0079] Table 6 mixed reference substance series standard solution

[0080] Mixed reference standard solution

1

2

3

4

5

6

7

Synephrine (μg mL -1 )

2.55

5.10

25.5

51.0

102.0

153.0

255

Arecoline hydrobromide (μg mL -1 )

1.30

2.60

13.0

26.0

52.0

154.0

208.0

Norisoboldine (μg mL -1 )

2.015

4.03

20.16

40.32

80.64

120.96

201.6

[0081] Precisely draw 10 μL of the standard solution of the mixed reference substance and inject it...

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Abstract

The invention discloses a method for detecting a Simotang preparation. The method is characterized in that: high performance liquid chromatography detection is carried out on a test sample of the Simotang preparation, and a chromatographic condition is selected from one of the following two modes: a mode 1 is characterized in that: the chromatographic column is a strongly cationic exchange chromatographic column, the mobile phase comprises methanol and an aqueous solution with a volume percentage of 0.2% and a pH value of 3.8 according to a volume ratio of 40-80:60-20, and the detection wavelength is 215nm; and a mode 2 is characterized in that: the chromatographic column is an octadecylsilane bonded silica gel column, the mobile phase comprises methanol and an aqueous solution of SDS and with a mass percentage of 0.1% according to a volume ratio of 50:50, the flow velocity is in a gradient mode, and the detection wavelength is 230nm. The method of the invention, which allows three alkaloid components of arecolidine, synephrine and norisobolidine in the Simotang preparation to be simultaneously determined, the resolution of chromatographic peaks, a theoretic stage number, a symmetry factor, and the peak purity obtained through the method to be good, and a linear relation between the concentration and the peak area to be good in a large concentration range, has the advantages of excellent precision, repeatability and accuracy.

Description

technical field [0001] The invention relates to a detection method of Simotang preparation. Background technique [0002] Chinese patent medicine Simo Decoction is a proven prescription for quickly eliminating gastrointestinal stagnation and enhancing digestive function. The main ingredients of this prescription include woody, aurantium, black medicine and betel nut and other medicines. Among them, woody fragrance and aurantium citrus promote qi and neutralize the stomach, betel nut reduces adverse qi, black medicine dispels cold and relieves pain. All medicines are used in combination to play the effects of promoting qi stagnation, reducing swelling and relieving pain. Clinically, it is mainly used for stagnation of milk and food in infants and young children, qi stagnation and food accumulation in middle-aged and elderly people, and to promote the recovery of gastrointestinal function after abdominal surgery and postpartum. Simo Decoction was used to prevent and treat i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/36G01N30/06G01N30/60A61K36/889A61P1/14
CPCA61P1/14B01D15/34B01D15/362G01N2030/8813
Inventor 刘令安易跃能王长虹程雪梅
Owner HUNAN HANSEN PHARMACEUTICAL CO LTD
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