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Quality test method for hawthorn leaf medicine, hawthorn leaf extractives or products

A technology of hawthorn leaf extract and quality detection method, which is applied in the directions of drug combination, pharmaceutical formula, medical preparation containing active ingredients, etc. problems, to achieve moderate pH, high recovery and accuracy, and extended service life

Active Publication Date: 2012-07-11
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0006] The characteristic map of hawthorn leaf extract published in the 2010 edition of "Chinese Pharmacopoeia" shows that the content of hyperin, vitexin rhamnoside Content or characteristic spectrum of hawthorn leaf extract, hyperoside, vitexin rhamnoside, vitexin glucoside, vitexin and adjacent peaks cannot be completely separated, which affects the accuracy of content determination
And the pH value of the above-mentioned mobile phase is 2.6-2.8, which is relatively acidic, which is close to the lower limit of the durable pH value of the chromatographic column with silica gel-based bonded phase packing, and long-term use will affect the service life of the HPLC column.

Method used

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  • Quality test method for hawthorn leaf medicine, hawthorn leaf extractives or products
  • Quality test method for hawthorn leaf medicine, hawthorn leaf extractives or products
  • Quality test method for hawthorn leaf medicine, hawthorn leaf extractives or products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0250] Embodiment 1: Determination of hyperin in hawthorn leaf medical material

[0251]a. Preparation of reference substance solution: take about 10.55 mg of hyperin reference substance, weigh it accurately, add 45% ethanol to dissolve and dilute, and make a solution containing 21.10 μg per 1 ml;

[0252] b. Preparation of the test solution: take 1g of hawthorn leaf medicinal material fine powder, accurately weighed as 1.002g, put it in a Soxhlet extractor, add chloroform and heat under reflux to extract until the extract is colorless, discard the chloroform , the medicinal dregs are evaporated to remove chloroform, add methanol and continue to extract until colorless, the extract is evaporated to dryness, the residue is dissolved in 45% ethanol, transferred to a 50ml measuring bottle, added 45% ethanol to the mark, shaken up, and used as Test sample stock solution: get the test sample stock solution, filter, accurately measure 5ml of the continued filtrate, put it in a 25ml ...

Embodiment 2

[0259] Example 2: Determination of active ingredients in hawthorn leaf extract

[0260] Hawthorn leaf extract is recorded in "Chinese Pharmacopoeia" 2010 edition under Yixindone Tablets. Its preparation method: take 1 part by weight of the leaves of Rosaceae plant Shanlihong or Hawthorn, grind it into coarse powder, and use 6 parts by volume of ethanol for Solvent, soak for 48 hours, carry out percolation, collect the filtrate, recover ethanol under reduced pressure to a concentrated solution with a relative density of about 1.04 (60°C), add an equal amount of water to dilute, and use 1 / 6 volume parts of petroleum ether (60~ 90°C) to remove the pigment, separate the water layer, shake and extract with 0.7 parts by volume of ethyl acetate, recover the ethyl acetate under reduced pressure from the extract and concentrate to dryness to obtain the product.

[0261] a. Preparation of reference substance solution:

[0262] Hyperin reference substance solution: take about 10.33mg of...

Embodiment 3

[0271] Example 3: Determination of hyperin in total glycosides of gypenosides and total flavonoids of hawthorn leaves composition (3)

[0272] The total flavonoid composition of gypenosides and hawthorn leaves (3) preparation method: take 20 parts by weight of gypenosides and 40 parts by weight of total flavonoids of hawthorn leaves, add 120 parts by weight of starch, mix evenly, granulate with starch slurry, dry, pack into Capsules, made into 1000 capsules, ready to use.

[0273] The total glycosides of Gypenopephylloides are recorded on page 31 of the fourth volume of the State Food and Drug Administration's New Drug Standards.

[0274] a. Preparation of reference substance solution: take 10.19 mg of hyperin reference substance, accurately weigh it, add 50% ethanol to dissolve and dilute, and make a solution containing 10.19 μg per 1 ml;

[0275] b. Preparation of the test solution: Accurately weigh 0.1311g of the content of the total glycosides and hawthorn leaf flavonoids...

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Abstract

The invention provides a quality test method for hawthorn leaf medicine, hawthorn leaf extractives or products. Mobile phase composition is tetrahydrofuran-acetic acid-water-carbinol-acetonitrile. The specific composition comprises 10 volume parts to 30 volume parts of tetrahydrofuran, 0.5 volume parts to 4 volume parts of acetic acid, 60 volume parts to 89.5 volume parts of water, 0 volume part to 3 volume parts of carbinol and 0 volume part to 3 volume parts of acetonitrile. A mobile phase is matched according to the appropriation, and a potential of hydrogen (pH) value is adjusted to 3.5 to 4.4 with truethylamine. The mobile phase is used for measuring characteristic atlas of the content of hyperin, the content of rhamnosylvitexin or hawthorn leaf extractives in the hawthorn leaf medicine, the hawthorn leaf extractives and the products. Separation situations of hyperin, rhamnosylvitexin and vitexin with adjacent peaks are remarkably improved, service life of chromatographic columns is prolonged, and great significance is provided for controlling quality of the hawthorn leaf medicine, the hawthorn leaf extractives and the products.

Description

technical field [0001] The invention relates to a quality detection method, in particular to a quality detection method of hawthorn leaf medicinal materials, hawthorn leaf extracts and finished products thereof. Background technique [0002] Hawthorn leaves are included in the "Chinese Pharmacopoeia" 2010 edition, page 30. It has the effects of promoting blood circulation and removing blood stasis, regulating qi and unblocking the veins, reducing turbidity and reducing fat. For qi stagnation and blood stasis, cerebral impediment and heartache, chest tightness and suffocation, palpitation and forgetfulness, dizziness and tinnitus, hyperlipidemia syndrome. [0003] Hawthorn leaf extract is recorded in the "Chinese Pharmacopoeia" 2010 edition, page 372, which has the functions of promoting blood circulation and removing blood stasis, clearing the heart veins, regulating qi and soothing collaterals. It is used for qi stagnation and blood stasis, chest tightness, suffocation, pa...

Claims

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Application Information

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IPC IPC(8): A61K36/734G01N30/02A61P3/06A61P9/10A61K127/00
Inventor 罗琴魏胄孔繁贵王利春梁隆程志鹏
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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