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Pericarpium Trichosanthis or Pericarpium Trichosanthis injection liquid chromatography fingerprint test method

A technology of Gualoupi injection and a testing method, which is applied in the testing field of liquid chromatographic fingerprints, can solve problems such as inability to directly measure, and achieve strong specificity, high precision, and good reproducibility

Active Publication Date: 2007-10-24
SPH NO 1 BIOCHEM & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main component of Trichosanthes peel is amino acid, but since amino acid itself has no ultraviolet absorption, it cannot be directly determined

Method used

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  • Pericarpium Trichosanthis or Pericarpium Trichosanthis injection liquid chromatography fingerprint test method
  • Pericarpium Trichosanthis or Pericarpium Trichosanthis injection liquid chromatography fingerprint test method
  • Pericarpium Trichosanthis or Pericarpium Trichosanthis injection liquid chromatography fingerprint test method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 Determination of High Performance Liquid Chromatography Fingerprint of Melon Bamboo Peel

[0052] The specific steps are:

[0053] (1) Precisely weigh about 1g of melon skin powder, pass it through a No. 2 sieve, add 20ml of water precisely, weigh it, heat and reflux for 30 minutes, after cooling, weigh it again, make up with water to lose weight, shake well, 5000~ Centrifuge at 10,000 rpm, take the supernatant, and obtain;

[0054] (2) Prepare the following solutions:

[0055] 1mg / 1ml citrulline aqueous solution.

[0056] 0.01g / ml o-phthalaldehyde (OPA) solution: Weigh 80mg o-phthalaldehyde (OPA), add 0.4mol / L boric acid buffer (pH10.2) 7ml, acetonitrile 1ml, mercaptopropionic acid 125μl, mix well, Refrigerate until ready to use.

[0057] 0.4mol / L boric acid buffer solution (pH10.2): Prepare a 0.4mol / L solution with boric acid, adjust the pH value to 10.2 with 40% sodium hydroxide solution, and refrigerate for later use.

[0058] 0.005g / ml fluorenylmethy...

Embodiment 2

[0076] Example 2 Determination of High Performance Liquid Chromatography Fingerprint of Melon Peel and Simulated Synthesis of High Performance Liquid Chromatography Fingerprint of Melon Peel

[0077] According to the method of Example 1, nine batches of melon skin samples provided by Shanghai No. 1 Biochemical Pharmaceutical Company were tested. Record the chromatogram, as shown in Figure 4. The similarity was calculated by computer simulation similarity software, and the results are shown in Table 3.

[0078] Sample lot number

[0079] The high-performance liquid chromatography fingerprints of 9 batches of melon skin samples were simulated and synthesized by computer to obtain the high-performance liquid chromatography fingerprints of melon skin, as shown in Figure 1.

Embodiment 3

[0080] Example 3 Determination of High Performance Liquid Chromatography Fingerprint of Gualanpi Injection

[0081] According to the method of Example 1, wherein step (1) is: accurately measure 2ml of melon basket skin injection, put it in a 10ml measuring bottle, add water to dilute to the mark, and shake well; wherein, the concentration of the citrulline aqueous solution is 0.5 mg / ml, and the rest of the steps and parameters remain unchanged.

[0082] The measured HPLC fingerprint of Gualanpi Injection is shown in Figure 5. The theoretical number of pedals is 21788 based on citrulline amine peak 2. Through the positioning of 22 kinds of amino acid reference substances, it was found that Gualoupi injection contained citrulline, arginine, alanine, isoleucine, serine, leucine and phenylalanine seven kinds of amino acids. The specific performance in the fingerprint spectrum is as follows: peaks No. 1 to No. 7 in the fingerprint spectrum are serine, citrulline, alanine, arginin...

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Abstract

The invention discloses a test method of liquid spectrum finger diagram of melon, or melon injection, comprising that (1), preparing melon, or melon injection into a sample solution, (2), respectively absorbing citrulline water solution and the sample solution, to be filled into a liquid spectrometer, and using the solution of phthalaldehyde and the solution of chloride aminic acid fluorenes methyl ester to process derivatization, (3), testing liquid spetrum. The inventive test method first discloses a liquid spectrum finger diagram of melon or melon injection, with high accuracy, stability and repeatability, as one analysis test method which can control the product quality, used in product quality test. The inventive method first obtains the high-effect liquid spectrum contrast finger diagram of melon and melon injection, as diagram 1 and diagram 2.

Description

technical field [0001] The invention relates to a method for testing product quality, in particular to a method for testing the liquid chromatography fingerprint of Trichosanthes rind or Trichosanthes piss injection. Background technique [0002] Trichosanthes kirilowii Maxim or Trichosanthes rosthomii Harms is the dried and mature pericarp of Trichosanthes kirilowii Maxim or Trichosanthes rosthomii Harms. It mainly contains amino acids, and a small amount of volatile oil. [0003] Gualoupi Injection is the only medicinal preparation of Gualoupi with an approval number created by Shanghai First Biochemical Pharmaceutical Co., Ltd. in China, which is included in the national standard product. It is a sterilized aqueous solution made of Trichosanthes peel as raw material, which is extracted with water and precipitated with alcohol, and then passed through the "732" cation exchange resin of Shanghai Resin Factory. [0004] In the prior art, there is no bibliographical report ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/26G01N30/60
Inventor 陆琛黄臻辉
Owner SPH NO 1 BIOCHEM & PHARMA CO LTD
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