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Preparation process of integration-type novel formulation of SHENGHUA decoction and a production method thereof

A production method and new dosage form technology, which is applied in the field of preparation of integrated new dosage forms of Shenghua Decoction, to achieve the effect of strong slow and controlled release performance and wide target distribution

Inactive Publication Date: 2013-01-02
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

[0067] The following raw materials are prepared according to the aforementioned method: extracts, nanoparticles, microcapsules, and nanoparticles.

[0068] The composition of the raw materials used to make the active ingredients is——

[0069] 24 parts of angelica, 9 parts of Chuanxiong, 6 parts of peach kernel, 2 parts of dried ginger, and 2 parts of roasted licorice.

[0070] 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 s...

Embodiment 2

[0072] The following raw materials are prepared according to the aforementioned method: water decoction concentrate, nanoliposome, nanoemulsion, and microemulsion.

[0073] The composition of the raw materials used to make the active ingredients is——

[0074] 24 parts of angelica, 9 parts of Chuanxiong, 6 parts of peach kernel, 2 parts of dried ginger, and 2 parts of roasted licorice.

[0075] 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, accor...

Embodiment 3

[0077] The following raw materials are prepared according to the aforementioned method: extract, nanoparticle, and nanoemulsion.

[0078] The composition of the raw materials used to make the active ingredients is——

[0079] 24 parts of angelica, 9 parts of Chuanxiong, 6 parts of peach kernel, 2 parts of dried ginger, and 2 parts of roasted licorice.

[0080] 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 ap...

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Abstract

The invention relates to a preparation process of integration-type novel formulation of SHENGHUA decoction and a production method thereof. The effective components of the novel formulation are made from the following raw materials (by weight parts): Angelica sinensis 24, Ligusticum chuanxiong 9, Semen Persicae (Prunus persica and / or Prunus davidiana) 6, dried Zingiber officinale 2, and Radix Glycyrrhizae Preparata 2. The production method includes the steps of supersonic airstream pulverization, alcohol-water extraction, ultrasonic pulverization and extraction, water decoction and concentration, supersonic spray-drying, nano-scale grinding, high-pressure emulsion and homogenization and nanoparticle preparation. The production method integrates the advantageous of the nano-carrier combination technique, such as multi-component synergism and multi-target. The large-scale production can greatly reduce the production cost, greatly improve the product quality and enhance the target property and sustained / controlled-release property of drugs. The novel formulation is administered by oral intake and external application during four time periods respectively based on the midnight-noon tidal flow and human qi-blood flow rule. The novel formulation is also processed to membranes and transdermal delivery agents which are applied to different parts of human body respectively according to the midnight-noon tidal flow and human qi-blood flow rule and can be directly absorbed by the skin.

Description

technical field [0001] The invention relates to a preparation technology of a new integrated dosage form of Shenghua Decoction, and also relates to a preparation technology of a new integrated dosage form of Shenghua 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, oxidation...

Claims

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Application Information

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IPC IPC(8): A61K36/9068A61K9/00A61P15/00
Inventor 杨洪舒
Owner SUZHOU ZHIWEITANG BIOLOGICAL TECH
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