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Preparation method of high-purity scutellarin crude drug

A technology of scutellarin and scutellarin, which is applied in the field of preparation of high-purity raw materials, can solve the problems of incomplete elimination, itching, rash, etc., and achieve the effects of high cost, simplified process steps, and easy selection of mechanical equipment

Active Publication Date: 2012-07-18
KUNMING LONGJIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

People take advantage of this property. Since 1984, many pharmaceutical factories have successively produced water injections on the market. Due to the different processes of each company, HPLC analysis of scutellarin raw materials shows that the content of B is between 75% and 93%. During the period, various preparations derived from it have been widely used in the treatment of cardiovascular and cerebrovascular diseases in clinic, and the curative effect is remarkable, but many adverse reactions have also occurred clinically, such as chills and fever reactions, skin itching, rash and other allergic phenomena. The occurrence of the phenomenon is mainly due to the fact that some allergenic impurities were not removed in the production process of the raw material medicine. This problem has not been solved since the breviscapine product came out for more than 30 years, and it was not gradually solved until 2004.

Method used

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  • Preparation method of high-purity scutellarin crude drug
  • Preparation method of high-purity scutellarin crude drug
  • Preparation method of high-purity scutellarin crude drug

Examples

Experimental program
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Effect test

Embodiment 1

[0030] Example 1: Weigh 6.5 kg of crude raw material with 90.25% scutellarin content in the market, add 50 L of water to stir and moisten, add 20% arginine solution while stirring, heat to boiling, adjust pH value to 8.0, add water to 130L, centrifuged, clarified and filtered, and the filtrate was respectively loaded on a polyacrylate-based macroporous resin column with a diameter of 20cm and a height of 180m, and a sample load of 650g, with a sample volume of 13L, was eluted with purified water, the pressure was 4bar, and the purity of the middle section was 99% % above the yellow clarified eluate, combined the collected liquid, added glacial acetic acid to the collected liquid to adjust the pH below 3, and after natural sedimentation for 1 hour, released the supernatant, and the precipitated suspension was input into a dryer to dry to obtain scutellarin raw material drug 3.92 kg, the purity of B as determined by HPLC is 99.4014%, such as figure 1 shown.

Embodiment 2

[0031]Example 2: Weigh commercially available crude product with scutellarin content of 87.32%, 35kg of raw material, put it in from the manhole of the liquid distribution tank, open the drain valve to release 150L of water, turn on the agitator to stir and moisten, and input 30% arginine solution at the same time While stirring, turn on the steam valve to heat to boiling, control the pH value to 8.3, open the water inlet valve again to add water to a total volume of 580L and stir well, take a sample to detect the pH value is 8.25, and the content of breviscapine is 60.5mg / ml. Open the liquid discharge valve to input the liquid medicine into the high-speed tubular centrifuge, and the centrifuged liquid is input into the clarification filter, and the clarified liquid is input into a polyacrylate-based macroporous resin column with a diameter of 50 cm and a height of 400 cm. 115L, pressure 6bar, collect the yellow clarified eluate with a purity of more than 99% in the sedimentati...

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Abstract

The invention relates to a preparation technology of a high-purity crude drug in pharmaceutics. The preparation technology comprises the steps of firstly, adding water into a breviscapinun crude product with more than 85% of scutellarin sold in the market for wetting, adding basic amino acid water solution to prepare water solution which has the pH value being 7.5-9.0 and includes 10mg-150mg / ml of breviscapinun; secondly, centrifugally clearing and filtering, taking filtrate to a macroporous resin chromatographic column taking polyacrylate as a substrate; and thirdly, adding a converting agent organic acid into collecting liquid, reducing scutellarin salt into scutellarin, naturally settling, discharging supernatant liquor, drying to obtain the high-purity scutellarin crude drug with the purity being over 99%. According to the preparation technology, as the organic solvent is not needed for recrystallization, the technology is continuous, automatic and large-scale; and more importantly, the organic solvents easy to burn and explode are avoided, and the high-purity scutellarin crude drug prepared by the preparation technology conforms to the industry policy of the national safety production.

Description

technical field [0001] The invention relates to a preparation process of high-purity crude drug in pharmacy. Background technique [0002] Breviscapine is an active ingredient of flavonoids isolated from the whole herb of Erigeron breviscapus, also known as Erigeron breviscapus, the main ingredient of which is scutellarin, also known as scutellarin, chemical name: 4′5 , 6-trihydroxyflavone-7-O-glucuronide, molecular formula: C 21 h 18 o 12 ,Molecular weight: 462.37. Scutellarin belongs to flavonoid glycosides and is insoluble in water. Because it contains carboxyl groups, it can form salts with alkali or alkaline salts, and is easily soluble in water. Discard the water-insoluble matter. People take advantage of this property. Since 1984, many pharmaceutical factories have successively produced water injections on the market. Due to the different processes of each company, HPLC analysis of scutellarin raw materials shows that the content of B is between 75% and 93%. Duri...

Claims

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Application Information

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IPC IPC(8): C07H17/07C07H1/06
Inventor 赵尔跃樊献乔樊献俄
Owner KUNMING LONGJIN PHARMA