Houttuynia cordata injection and preparation method thereof

A technology of Houttuynia cordata injection and fishy smell, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., to improve the safety of medication and reduce the effect of ruptured cell membranes

Inactive Publication Date: 2013-08-14
HUNAN ZHENGQING PHARM GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In Ministry Standard WS 3 - The [Preparation Method] item of Houttuynia cordata injection in B-3264-98 stipulates that the addition amount of polysorbate 80 is 0.5%, but the safety research shows that polysorbate 80 has a strong effect of breaking the cell membrane and causing Irritation, hemolysis and histamine release (sensitization)

Method used

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  • Houttuynia cordata injection and preparation method thereof
  • Houttuynia cordata injection and preparation method thereof
  • Houttuynia cordata injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0189] (1) According to the mass ratio of 1:2, take 2000 kg of the mixture of the upper part of the fresh Houttuynia cordata and the lower part of the Houttuynia cordata, perform steam distillation, collect 2000 liters of initial distillate, and then carry out redistillation to collect 1000 liters of heavy distillate. ;

[0190] (2) Add polysorbate 80 with a weight / volume ratio of 2.5‰ to the heavy distillate, stir for 10 minutes to dissolve, add 7 kg of sodium chloride, stir for 10 minutes to dissolve, adjust with 10% citric acid solution pH value is 5.0-6.0;

[0191] (3) Filter the redistilled liquid treated in step (2) with 0.45μm and 0.22μm filter elements, potting, and sterilizing at 115°C for 32 minutes to obtain Houttuynia cordata injection.

Embodiment 2

[0193] (1) According to the mass ratio of 1:3, take 2000 kg of the mixture of the upper part of the fresh Houttuynia and the lower part of the Houttuynia cordata, perform steam distillation, collect 1500 liters of initial distillate, and then perform redistillation to collect 850 liters of heavy distillate. ;

[0194] (2) Add polysorbate 80 with a weight / volume ratio of 2.9‰ to the heavy distillate, stir for 8 minutes to dissolve, add 7 kg of sodium chloride, stir for 10 minutes to dissolve, adjust with 10% citric acid solution pH value is 5.0-6.0;

[0195] (3) Filter the redistilled liquid treated in step (2) with 0.45μm and 0.22μm filter elements, potting, and sterilizing at 115°C for 32 minutes to obtain Houttuynia cordata injection.

Embodiment 3

[0197] (1) According to the mass ratio of 1:1.5, take 2000 kg of the mixture of the upper part of the fresh Houttuynia cordata and the lower part of the Houttuynia cordata, and conduct steam distillation to collect 2500 liters of initial distillate, and then carry out re-distillation to collect 1300 liters of heavy distillate. ;

[0198] (2) Add polysorbate 80 with a weight / volume ratio of 2.6‰ to the heavy distillate, stir for 15 minutes to dissolve, add 7 kg of sodium chloride, stir for 10 minutes to dissolve, adjust with 10% citric acid solution pH value is 5.0-6.0;

[0199] (3) Filter the redistilled liquid treated in step (2) with 0.45μm and 0.22μm filter elements, potting, and sterilizing at 115°C for 32 minutes to obtain Houttuynia cordata injection.

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Abstract

The invention discloses a houttuynia cordata injection and a preparation method thereof. According to the houttuynia cordata injection prepared by using the preparation method of the invention, the existing production process is adopted on the basis of a legal department standard, each production link and parameters are defined and detailed, and dosage of polysorbate 80 is reduced. The houttuynia cordata injection prepared by using the preparation method disclosed by the invention is stable and uniform in different batches, and a cell membrane breaking effect caused by the polysorbate 80 is reduced, irritation, hemolysis and histamine release are reduced, and medication safety is improved.

Description

[0001] The patent application of the present invention is a divisional application, the original application number is 201110205127.3, the filing date is July 21, 2011, and the title of the invention is a preparation method of Houttuynia cordata injection. Technical field: [0002] The invention relates to a preparation method of injection, in particular to a method for preparing Houttuynia cordata injection by using the whole plant of Houttuynia cordata. Background technique [0003] Houttuynia cordata is a perennial herb of the Saururus family Houttuynia cordata Thunb. The whole plant with roots, also known as Pleurotus ostreatus, purple lotus, pig nostril, nine-section lotus, etc. Its fresh plants have a pungent smell after being broken, and are widely distributed in the central, southeast and southwest provinces of my country, especially Hunan, Hubei, Sichuan, Jiangsu and other provinces are mostly. Houttuynia cordata has the effects of clearing heat and detoxifying, eliminati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K36/78A61K47/34A61P11/00A61P13/00A61P17/02
Inventor 吴飞驰仇萍彭祖仁滕健李苏翠龙宪军
Owner HUNAN ZHENGQING PHARM GRP CO LTD
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