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Freeze-dried powder preparation of kuh-seng native, preparation method thereof

A technology of matrine and freeze-dried powder, which is used in freeze-drying transportation, powder transportation, antiviral agent and other directions, can solve the problems of unsatisfactory resolution, affecting the accuracy of content determination, and poor peak shape of spectrum.

Active Publication Date: 2014-03-19
HARBIN ZHENBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, since matrine is a mixed base of oxymatrine and a very small amount of oxysophocarpine, the problem that this method is likely to encounter during the detection process is that the peak shape of the spectrum is not good, and the resolution cannot meet the requirements. The component peaks cannot be separated from the impurity peaks, and the tailing is serious, which affects the accuracy of content determination

Method used

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  • Freeze-dried powder preparation of kuh-seng native, preparation method thereof
  • Freeze-dried powder preparation of kuh-seng native, preparation method thereof
  • Freeze-dried powder preparation of kuh-seng native, preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0010] Weigh 100 g of Sophora flavescens coarse powder, soak it with 10 times the amount of 60% ethanol solution for 24 hours, and then carry out percolation at a flow rate of 5 ml / min. After the percolation liquid is concentrated under reduced pressure, it is dissolved with an appropriate amount of purified water, filtered, applied to AB-8 macroporous adsorption resin, and eluted with 70% ethanol solution. After recovering ethanol from the eluent, add hydrogen peroxide for oxidation until the oxidation is complete, and then add a reducing agent Reduce excess hydrogen peroxide, evaporate the solution to dryness, crystallize with acetone, and recrystallize to obtain white matrine crystals.

[0011] After testing, matrine contains oxymatrine (C 15 h 24 N 2 o 2 )99.6%.

Embodiment 2

[0013] Prescription Composition Screening Test

[0014] In view of the poor stability of the existing matrine freeze-dried powder preparations, it is considered to add antioxidants. Sodium bisulfite, edetate disodium and L-cysteine ​​hydrochloride were respectively selected for testing. Results The addition of sodium bisulfite and L-cysteine ​​hydrochloride affected the inspection of related substances in the preparation, and disodium edetate could improve the color of the preparation solution without interfering with the inspection of related substances, so it could be applied to this preparation. At the same time, a series of varieties of edetate calcium sodium edetate disodium were tested, and the results showed that edetate calcium sodium sodium was also applicable.

[0015] Further screen the amount of antioxidants. The amount of matrine and mannitol is fixed, the dosage of edetate disodium or edetate calcium sodium is 0.05%, 0.1%, 0.2%, 0.3%, 0.5%, 0.6% of the dosage o...

Embodiment 3

[0017] Preparation of matrine freeze-dried powder preparation

[0018] Weigh mannitol, add 40% of the prepared amount of water for injection, heat and stir until completely dissolved, add medicinal charcoal and boil for 15 minutes, set the volume to 50% of the prepared amount, cool to 80°C and filter to remove charcoal. Add matrine to 30% of the prepared amount of water for injection, stir to dissolve, add 2mol / L hydrochloric acid to adjust the pH value, add edetate disodium or edetate calcium sodium solution, add water for injection to 40% of the prepared amount , heated to 70-80°C, added medicinal charcoal, stirred and adsorbed for 15 minutes, and filtered to remove charcoal. Cool the mannitol solution after carbon removal to below 50°C, combine it with the matrine solution after carbon removal, add water to the full amount, stir evenly, and adjust the pH value to 4.8-6.5 with 2mol / L hydrochloric acid. After the temperature of the medicinal solution drops to room temperatur...

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Abstract

The invention provides a kurarinone freeze-dry powder preparation and a preparation method thereof. The preparation method comprises the following steps: filtering the solution of three components - kurarinone, mannitol, disodium edetate or calcio-sodium edetate in an appropriate proportion, freezing and drying, and then obtaining the freeze-dry powder preparation. Compared with the prior product, the preparation has the advantages that the stability is obviously improved, the expiry date can be as long as 24 months, and the characters of the product are not changed obviously; compared with the prior art, the preparation method is more simplified, and the production cost is saved. The invention also provides a method for detecting the content of oxymatrine in the product of kurarinone freeze-dry powder preparation. By optimizing the mobile phase and the detection condition, a highly-effective liquid-phase chromatographic detection method with better differentiation and stronger specificity is established.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicines, and in particular relates to a matrine freeze-dried powder preparation and a preparation and detection method thereof. Background technique [0002] Sophora flavescens is a perennial herb or shrub, also known as bitter bone, Sichuan ginseng, phoenix claw, and beef ginseng. Bitter is named for its taste, and ginseng is named for its fame, so it is called Sophora flavescens, which is harvested in spring and autumn. The medicinal part of Sophora flavescens is mainly the root, and the alkaloids contained in it are mainly matrine and oxymatrine. Its medicinal value has been recorded as early as in the first Chinese pharmacology book "Shen Nong's Herbal Classic". According to "Compendium of Materia Medica" records: Sophora flavescens, bitter, cold, non-toxic, has the effects of clearing away heat and detoxification, expelling wind and dampness, nourishing the middle and improving eyesight,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4375A61K9/19A61K47/18A61K47/10A61P1/16A61P31/12
Inventor 方同华项彦华周雪峰王春生岳大彪周广红席桂才代喜国
Owner HARBIN ZHENBAO PHARMA
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