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Preparation technology and production method for integrated new formulation of cassia twig and oyster decoction

A production method and technology of a new dosage form are applied in the field of preparation of a new integrated dosage form of Guizhi Muli Decoction to achieve the effects of wide target distribution and strong sustained and controlled release performance.

Inactive Publication Date: 2013-01-30
SUZHOU ZHIWEITANG BIOLOGICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The domestic and foreign databases were used to search for novelties, and the following conclusions were drawn based on the reading, analysis and comparison of domestic and foreign literature: the innovation of the project of "developing new integrated dosage forms of nano-drugs with combined technology": 1) the use of nano-scale traditional Chinese medicine rich in trace elements Nanospheres, nanocapsules, polymer micelles, and solid ester nanoparticles of different particle sizes are prepared with different drug carriers such as powder, drug monomer, effective part, effective part group, traditional Chinese medicine extract, decoction concentrate, etc. , magnetic nanoparticles, immune nanoparticles, nanoemulsions, suspensions, vesicles, drug plasmids, microcapsules, nanoparticles, nanospheres, nanocapsules, etc., and then mix them and put them into soft and hard capsules at the same time Combined use and preparation of an integrated new dosage form or other types of integrated new dosage forms according to the above method; 2) Research and development of "nano-drug integrated new dosage form" by using nano-carrier combination technology and the theory of integrated traditional Chinese and Western medicine. The product has target It has the characteristics of wide distribution and strong slow and controlled release performance; there is no public report in the domestic literature, and the comprehensive technical characteristics of this project have certain novelty and innovation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The following raw materials are prepared according to the aforementioned method: extracts, nanoparticles, microcapsules, and nanoparticles.

[0056] The raw materials for making active ingredients are as follows: 9 parts of cassia twig, 9 parts of peony, 9 parts of ginger, 6 parts of licorice, 12 parts of jujube, 9 parts of keel and 9 parts of oyster.

[0057] The manufacturing process is as follows: in a GMP10000 class clean room, the extract, nanoparticles, microcapsules, and nanoparticles are mixed in a ratio of 4:2:2:2, and part of the hard capsules are used in the first part of the "Chinese Pharmacopoeia" of the 2010 edition. Standard, no auxiliary materials and preservatives are added, and hard capsules are filled with automatic capsule filling machines to make hard capsules. Then carry out internal and external packaging such as counting, bottling, sealing, pasting labels, coding, and packing. Finally, according to the production batch uniform instant sterilizat...

Embodiment 2

[0059] The following raw materials are prepared according to the aforementioned method: water decoction concentrate, nanoliposome, nanoemulsion, and microemulsion.

[0060] The raw materials for making active ingredients are as follows: 9 parts of cassia twig, 9 parts of peony, 9 parts of ginger, 6 parts of licorice, 12 parts of jujube, 9 parts of keel and 9 parts of oyster.

[0061] The manufacturing process is as follows: in a GMP10000 class clean room, the decoction concentrate, nanoliposome, nanoemulsion, and microemulsion are mixed according to the ratio of 4:2:2:2, and a preparation of the 2010 edition of "Chinese Pharmacopoeia" is used. Part of the soft capsule standard, without adding auxiliary materials and preservatives, adopts a fully automatic soft capsule filling machine to sub-pack soft capsules to make soft capsules. Then carry out internal and external packaging such as counting, bottling, sealing, pasting labels, coding, and packing. Finally, according to the...

Embodiment 3

[0063] The following raw materials are prepared according to the aforementioned method: extract, nanoparticle, and nanoemulsion.

[0064] The raw materials for making active ingredients are as follows: 9 parts of cassia twig, 9 parts of peony, 9 parts of ginger, 6 parts of licorice, 12 parts of jujube, 9 parts of keel and 9 parts of oyster.

[0065] The manufacturing process is as follows: After mixing the extract, nanoparticles, and nanoemulsions in a 4:3:3 ratio in a GMP10000 clean room, the 2010 edition of the "Chinese Pharmacopoeia" Part I of the film preparation standard is used, and the film-forming material is made of Polyvinyl alcohol, made into film. Cartoning, sealing, sticking labels, printing codes, packing and other internal and external packaging. Finally, according to the production batch uniform instant sterilization, and issue a sterilization report. The size of each film is 2-40 square centimeters, and each film is applied for 12-72 hours. The application s...

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Abstract

The present invention relates to a preparation technology and a production method for an integrated new formulation of a cassia twig and oyster decoction, wherein the raw materials of active ingredients comprise: 9 parts by weight of cassia twig, 9 parts by weight of Chinese herbaceous peony, 9 parts by weight of ginger, 6 parts by weight of licorice, 12 parts by weight of Chinese-date, 9 parts by weight of fossil bone, and 9 parts by weight of oyster. The production process of the integrated new formulation comprises the following steps of: supersonic air-jet crushing, alcohol-water extraction, ultrasonic crushing extraction, water decocting concentration, supersonic spray drying, nanometer grinding, high pressure homogenization, nano particle preparation and the like. According to the invention, the advantages, such as multi-synergism, multi-target, embodied by a nano-carrier coupling technique, are focused to be taken of. After the integrated new formulation of cassia twig and oyster decoction is subjected to scale production, the production cost can be greatly reduced, the quality of products is greatly improved and the targeting property and the sustained and controlled release performance of the medicament are enhanced. The internal and external administration of the integrated new formulation of cassia twig and oyster decoction can be realized simultaneously, and can be respectively taken in four time slices according to midnight-noon ebb-flow and qi and blood flowing rule of a human body. The integrated new formulation of cassia twig and oyster decoction can be further prepared into films and transdermal agents which are respectively stuck to different parts of a human body according to the midnight-noon ebb-flow and qi and blood flowing rule of the human body and can be directly absorbed through skin.

Description

technical field [0001] The invention relates to a preparation technology of a new integrated dosage form of Guizhi Muli Decoction, and also relates to a preparation technology of a new integrated dosage form of Guizhi Muli Decoction and a production method thereof. Background technique [0002] Due to too many chemical components, the chemical reaction of compound decoction of traditional Chinese medicine has not yet been revealed its mysterious veil, but some mysterious black boxes of medicinal effects in traditional Chinese medicine prescriptions are hidden in the decoction of traditional Chinese medicine. Traditional Chinese medicine is modernized and only uses monomers and effective parts. Chinese herbal decoction concentrate cannot be discarded! When the traditional Chinese medicine prescription is decocted in water, due to the high temperature when the prescription is decocted together and the complex chemical environment in the solution, complexation, hydrolysis, oxi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/9068A61K9/00A61P1/12A61P11/00A61P13/00A61P13/10A61P15/06A61P15/08A61P15/12A61P25/00A61P25/20A61P43/00A61K35/02A61K35/56A61K35/618
Inventor 杨洪舒
Owner SUZHOU ZHIWEITANG BIOLOGICAL TECH
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