Process for preparing novel formulation of integrative traditional Chinese medicine and production method thereof

A production method and an integrated technology, applied in pharmaceutical formulations, drug delivery, medical preparations containing active ingredients, etc., to achieve the effect of wide target distribution

Inactive Publication Date: 2011-06-22
SUZHOU ZHIWEITANG BIOLOGICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there are no identical or sim

Method used

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Examples

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Comparison scheme
Effect test

Embodiment 1

[0040] Prepare the following APIs according to the aforementioned method:

[0041] Extract, freeze-dried powder, nanoparticles, microcapsules, nanoparticles.

[0042] The manufacturing process is as follows:

[0043] After mixing the extract, nanoparticles, microcapsules, and nanoparticles in a GMP10000 clean room at a ratio of 2:2:2:2:2, the latest version of the "Chinese Pharmacopoeia" preparation part of the hard capsule standard is adopted, and no excipients are added. , Antiseptic, use full automatic capsule filling machine to fill hard capsules to make hard capsules. Then carry out internal and external packaging such as counting, bottling, sealing, sticking labels, coding, and packing. Finally, uniform instant sterilization according to the production batch, and issue a sterilization report.

Embodiment 2

[0045] Prepare the following APIs according to the aforementioned method:

[0046] Decoction concentrate, nano liposome, nano emulsion, microemulsion, nano suspension.

[0047] The manufacturing process is as follows:

[0048] After mixing the decoction concentrate, nanoliposomes, nanoemulsion, microemulsion, and nanosuspension in a GMP10000 clean room at a ratio of 5:1:1:1:2:1, use the latest version of the "Chinese Pharmacopoeia" preparation Some soft capsules are standard, no auxiliary materials and preservatives are added, and the soft capsules are divided into soft capsules by the automatic soft capsule filling machine. Then carry out internal and external packaging such as counting, bottling, sealing, sticking labels, coding, and packing. Finally, uniform instant sterilization according to the production batch, and issue a sterilization report.

Embodiment 3

[0050] Prepare the following APIs according to the aforementioned method:

[0051] Extracts, solid lipid nanoparticles, nanoemulsions.

[0052] The manufacturing process is as follows:

[0053] After mixing the extract, solid lipid nanoparticles, and nanoemulsions in a 4:3:3 ratio in a GMP10000 clean room, the latest version of the "Chinese Pharmacopoeia" preparation part of the film standard is adopted, and the film forming material uses polyvinyl alcohol. Make a film. Then carry out inner and outer packaging such as boxing, sealing, sticking labels, coding, and boxing. Finally, uniform instant sterilization according to the production batch, and issue a sterilization report.

[0054] From the above description, it can be seen that the substantial innovation and breakthrough of the present invention is the key to the combination of Chinese and Western medicine theories of nanometer Chinese medicine compound. At the same time, the use of nano-carrier combined technology and the the...

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Abstract

The invention relates to a process for preparing a novel formulation of an integrative traditional Chinese medicine and a production method thereof. Traditional Chinese medicine simple recipe, traditional Chinese medicine compound recipe, integrated Chinese and western medicine compound recipe and integrated Chinese and western medicine composition are prepared by utilizing a nanometer vector combination process. The production method comprises the following steps of extracting with alcohol-water, crushing and extracting in an ultrasonic manner, extracting in a microwave manner, decocting in water and condensing, spraying and drying, homogenizing under high pressure, grinding to be nanometer particles, preparing the nanometer particles and the like. The invention pays attention to the advantages of nanometer traditional Chinese medicine, such as multiple synergism, multiple targets and the like. After the novel formulation disclosed by the invention is produced in an industrial scale, the production cost can be greatly reduced, the quality of the product can be improved, and the target performance and the controlled release performance of the medicines are stronger.

Description

Technical field [0001] The present invention relates to an integrated new dosage form of Chinese medicine, and the present invention also relates to a preparation technology and a production method of the new integrated Chinese medicine dosage form. Background technique [0002] The development level of new drugs and new dosage forms can reflect the economic and technological strength of a country's pharmaceutical industry. my country's drug management laws and regulations stipulate that changing the dosage form is managed as a new drug research. [0003] The main form of TCM clinical use is compound prescriptions of TCM. It is a specific application of TCM principles and prescriptions. It embodies the holistic view of TCM treatment, such as strengthening the body and removing evils, treating both the symptoms and the root causes, system theory and the rule of syndrome differentiation. It is multi-system and multi-target. And multi-level treatment methods that play a full range of...

Claims

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Application Information

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