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Preparation technology and production method of integrative new dosage form of Rhizoma Atractylodis Macrocephalae and Radix aconiti lateralis preparata decoction

A production method and a technology of a new dosage form, which are applied in the field of the preparation of a new integrated dosage form of Shufu Decoction, can solve the problems of reducing voluntary movement, lowering body temperature, prolonging the sleep time of sodium cyclohexobarbital, etc. Controlled release performance

Inactive Publication Date: 2013-04-10
SUZHOU ZHIWEITANG BIOLOGICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0031] 2. Aconite has analgesic, sedative and effect on body temperature: Oral administration of raw aconite cold infusion in mice can prolong sleep time of cyclohexobarbital sodium, reduce voluntary movement, and lower body temperature for 2 hours, while processed Aconite has no above-mentioned effects at the same dose
[0033] 4. Observing the effects of Fuzi injection on mouse serum lysozyme activity, blood antibodies and spleen antibody cells, and on guinea pig serum complement content, it was found that it could improve mouse humoral immune function and guinea pig serum complement content, but had no effect on mouse serum lysozyme No significant effect on activity;
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

[0069] The following raw materials are prepared according to the aforementioned method: extracts, nanoparticles, microcapsules, and nanoparticles.

[0070] The composition of the raw materials used to make the active ingredients is——

[0071] 2 parts of licorice, 4 parts of Atractylodes macrocephala, 1.5 parts of aconite.

[0072] 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 sterilization, and issue a sterilization repor...

Embodiment 2

[0074] The following raw materials are prepared according to the aforementioned method: water decoction concentrate, nanoliposome, nanoemulsion, and microemulsion.

[0075] The composition of the raw materials used to make the active ingredients is——

[0076] 2 parts of licorice, 4 parts of Atractylodes macrocephala, 1.5 parts of aconite.

[0077] 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 production batch uniform instant st...

Embodiment 3

[0079] The following raw materials are prepared according to the aforementioned method: extract, nanoparticle, and nanoemulsion.

[0080] The composition of the raw materials used to make the active ingredients is——

[0081] 2 parts of licorice, 4 parts of Atractylodes macrocephala, 1.5 parts of aconite.

[0082] 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 site: neck, chest, back, abdomen, leg...

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Abstract

The invention relates to a preparation technology and a production method of an integrative new dosage form of a Rhizoma Atractylodis Macrocephalae and Radix aconiti lateralis preparata decoction. The raw materials for the effective components of the decoction comprise 2 parts by weight of licorice, 4 parts by weight of Rhizoma Atractylodis Macrocephalae and 1.5 parts by weight of Radix aconiti lateralis preparata. The production method comprises the production processes of ultrasonic airflow crushing, alcohol-water extraction, supersonic wave crushing extraction, water decoction and concentration, ultrasonic spray drying, nanometer grinding, high-pressure homogenization, nanoparticle preparation and the like. The advantages comprising multiple cooperation, multiple targeting and the like of a nanometer carrier combination technology are utilized in the invention. Great production cost reduction, great product quality improvement, medicine targeting strengthening, and medicine sustained and controlled release property strengthening are realized after the large-scale production. Internal and external administration can be simultaneously carried out, and the decoction can be respectively administrated in four time periods according to the midnight-noon ebb-flow and human qi and blood flow rules. The decoction can also be processed to prepare a film agent and a transdermal agent which are respectively plastered on different positions of a human body according to the midnight-noon ebb-flow and human qi and blood flow rules, and the effective components can be directly absorbed through skins.

Description

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

Claims

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Application Information

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IPC IPC(8): A61K36/714A61K9/00A61P1/10A61P1/14A61P29/00A61P43/00
Inventor 杨洪舒
Owner SUZHOU ZHIWEITANG BIOLOGICAL TECH
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