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Method for simultaneously determining multi-index ingredients of Simotang preparation and establishing fingerprint chromatogram thereof

A method of determination and fingerprint technology, which is applied in the field of construction of fingerprints of Simotang preparations, can solve the problems of single active ingredient and inability to fully reflect the quality of Simotang preparations, and achieve good reproducibility and good sample recovery rate , Excellent stability effect

Active Publication Date: 2011-10-19
HUNAN HANSEN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The technical problem to be solved by the present invention is to provide a multi-index component of Simotang preparation in order to overcome the defect that the existing quality detection method of Simotang preparation detects a single active ingredient and cannot fully reflect the quality of Simotang preparation Simultaneous determination method, and construction method of fingerprint of Simotang preparation

Method used

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  • Method for simultaneously determining multi-index ingredients of Simotang preparation and establishing fingerprint chromatogram thereof
  • Method for simultaneously determining multi-index ingredients of Simotang preparation and establishing fingerprint chromatogram thereof
  • Method for simultaneously determining multi-index ingredients of Simotang preparation and establishing fingerprint chromatogram thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 Determination of detection wavelength

[0046] 1. Materials and methods:

[0047] Test solution of Si Mo Tang preparation: 5 pieces of Si Mo Tang Oral Liquid (Hunan Hansen Pharmaceutical Co., Ltd., batch number 090436), mix well, and use a microporous filter membrane (0.45 μm, polyethersulfone, SCAA-101 water) Phase needle filter) filtered, that is, the test solution.

[0048] High performance liquid chromatography detection: accurately draw 5 μL of the test solution and inject it into the high performance liquid chromatograph for determination. Chromatographic conditions: Venusil XBP-C column 18 Column (4.6mm×250mm), column temperature is 30℃, flow rate is 1mL·min -1 , Mobile phase A is acetonitrile, mobile phase B is 0.1% by volume formic acid aqueous solution, the elution gradient is shown in Table 2, the detection wavelength is 190-400nm, and the chromatographic peaks and their retention time and peak area within 45min are recorded.

[0049] Table 2

[0050] T...

Embodiment 2

[0053] Example 2 Optimization of Chromatographic Column

[0054] 1. Materials and methods

[0055] The test solution of the Simotang preparation is the same as in Example 1.

[0056] High performance liquid chromatography detection: the column is Venusil XBP-C 18 Column (4.6mm×250mm) or Agilent ZORBAX SB-C 18 Column (4.6mm×250mm), detection wavelength is 283nm, other conditions are the same as in Example 1.

[0057] 2. Experimental results

[0058] Adopt Venusil XBP-C 18 The chromatogram obtained from the column (4.6mm×250mm) is as follows figure 1 As shown in A, using Agilent ZORBAX SB-C 18 The chromatogram obtained from the column (4.6mm×250mm) is as follows figure 1 Shown in B. Comparison of the two, using Venusil XBP-C 18 Column (4.6mm×250mm) column for chromatographic separation, the eluted chromatographic peak is more stable (see figure 1 ), so Venusil XBP-C is preferred 18 Column (4.6mm×250mm) column.

Embodiment 3

[0059] Example 3 Identification of characteristic peaks and reference peaks

[0060] 1. Materials and methods

[0061] The test solution of the Simotang preparation is the same as in Example 1.

[0062] Preparation of standard products: accurately weigh naringin, hesperidin, neohesperidin, isonaringin, norisoboldine, potassium sorbate, accurately weigh them, and add methanol to make each 1 ml each A solution containing 1mg naringin, 25μg hesperidin, 0.45mg neohesperidin, 80μg isonaringin, 45μg norisobolite, and 0.2mg potassium sorbate is a standard product.

[0063] High performance liquid chromatography detection method: accurately draw 5μl each of the standard solution and the test solution and inject them into the high performance liquid chromatograph for determination. The chromatographic column is Venusil XBP-C 18 Column (4.6mm×250mm), detection wavelength is 283nm, other conditions are the same as in Example 1.

[0064] 2. Experimental results

[0065] The chromatograms of the te...

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Abstract

The invention discloses a method for simultaneously determining multi-index ingredients of Simotang preparation, comprising the step of detecting the sample solution of the Simotang preparation by adopting high performance liquid chromatography (HPLC), wherein the chromatographic column is octadecyl silane bonded silicagel column, the flowing phase A is acetonitrile, the flowing phase B is aqueous formic acid with the volume percentage of 0.1%, gradient elution is adopted and the detection wavelength is 283nm. The invention also discloses a method for establishing fingerprint chromatogram of the Simotang preparation; by carrying out detection with the determination method and carrying out simulation with a computer, the fingerprint chromatogram of the Simotang preparation can be obtained.The determination method can be operated simply and conveniently, has strong specialization, excellent stability, precision, reproducibility and average recovery, can comprehensively detect various main effective ingredients in the Simotang preparation so as to obtain the scientific and reasonable fingerprint chromatogram of the Simotang preparation, and can wholly and exactly evaluate the effectiveness, safety, stability and quality homogenate of the Simotang preparation.

Description

Technical field [0001] The invention relates to a method for simultaneously measuring multiple index components of a Simotang preparation and a method for constructing a fingerprint map of the Simotang preparation. Background technique [0002] The traditional Chinese medicine prescription of Si Mo Tang includes four medicinal materials: Muxiang, Citrus aurantium, Wuyao and Areca. The prescription has the effects of smoothing down the qi and reducing the adverse effects, eliminating accumulation and relieving pain. It can be used for the syndrome of milk food stagnation in infants and young children (syndrome, see abdominal distension, abdominal pain, uneasy crying, anorexia, diarrhea or constipation), stagnation of qi and phagocytosis in middle-aged and elderly people. See abdominal fullness, abdominal pain, constipation), and promote the recovery of gastrointestinal function after abdominal surgery. In addition, there are reported successful cases of its use in the treatment o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/86G01N30/06A61K36/889A61P1/14
CPCA61P1/14G01N30/34G01N30/50G01N30/8686G01N2030/8809
Inventor 易跃能刘令安王长虹程雪梅杨华邓义德刘东文
Owner HUNAN HANSEN PHARMACEUTICAL CO LTD
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