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Mind-tranquilizing brain-replenishing soft capsule, its preparation process and quality control method

A soft capsule and brain-invigorating technology, applied in capsule delivery, pharmaceutical formulations, nervous system diseases, etc., can solve the problems of low yield, easy to contaminate bacteria, immature traditional Chinese medicine, etc., to achieve enhanced stability, easy portability, and quality assurance Effect

Inactive Publication Date: 2006-07-12
孙志强
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 1. The validity period of oral liquid is short, and the active ingredients exist in liquid form, which is easy to be contaminated with bacteria;
[0005] 2. Long-term storage of oral liquid is unstable and prone to precipitation
[0006] 3. Oral liquid has high requirements on clarity and low yield
[0013] Soft capsules are soft and good ways to solve the above problems, but because soft capsules are applied to chemical medicines or health products based on monomer components always, they are still immature in Chinese medicine, and it is more difficult to apply to the preparation of Chinese and Western compound medicines. Difficult to find technical hints about making "Anshen Bunao Ye" into soft capsules after searching the literature. Therefore, it is necessary to study the formula and solve related technical problems such as its shape, stability, and drug loading.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Take 3750g of vegetable oil, heat it to 60℃~70℃ and keep it warm, take 150g of beeswax and cut it into small pieces, add it to the vegetable oil, stir to dissolve, take 2600g of extract powder and add it to the vegetable oil solution, mix well and pass through a 100-mesh sieve to make a liquid medicine . Take 10Kg of gelatin, add it into 9Kg of purified water under stirring, and keep stirring at a stable temperature of 40°C to 50°C. After the gelatin is completely dissolved, add 4kg of glycerin, 1.2Kg of sorbitol, 1Kg of polyethylene glycol, 250g of red iron oxide, 250g of sodium metabisulfite and 200g of ethylparaben, mix evenly, keep warm and stir, and make a capsule material. The above-mentioned medicinal liquid and capsule material are compressed into 10000 soft capsules on a soft capsule pressing machine.

Embodiment 2

[0044] Get polyethylene glycol 3600g, propylene glycol 300g and mix evenly, take extract powder 2600g and add, after mixing evenly, pass through a 100-mesh sieve to make a liquid medicine. Take 10Kg of gelatin, add it into 9Kg of purified water under stirring, and keep stirring at a stable temperature of 40°C to 50°C. After the gelatin is completely dissolved, add 4kg of glycerin, 1.2Kg of sorbitol, 1Kg of polyethylene glycol, 250g of red iron oxide, 250g of sodium metabisulfite and 200g of ethylparaben, mix evenly, keep warm and stir, and make a capsule material. The above-mentioned medicinal liquid and capsule material are compressed into 10000 soft capsules on a soft capsule pressing machine.

Embodiment 3

[0046] Qualitative identification

[0047] Take 5g of the content of this product, add 25ml of methanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 20ml of water to dissolve the residue, extract twice with petroleum ether, 15ml each time, discard the petroleum ether solution, add hydrochloric acid to the water solution 2ml, 20ml of chloroform, extracted for 1 hour under reflux in a water bath, cooled to room temperature, placed in a separatory funnel, separated the chloroform layer, extracted the aqueous solution with 15ml of chloroform once, combined the chloroform solution, evaporated to dryness, added 2ml of methanol to the residue to dissolve, and used as Test solution. Another appropriate amount of emodin reference substance was added and dissolved in methanol to make a reference substance solution containing 0.5 mg per 1 ml. According to the thin-layer chromatography ("Chinese Pharmacopoeia" 2000 edition, an appendix VI B) test, ...

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PUM

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Abstract

The invention provides a soft capsule for calming the nerves and nourishing the brain, which is prepared from concrete powder, suspension auxiliary agent and light-screening agent. The invention also discloses the process for preparing the soft capsule and its quality control method.

Description

technical field [0001] The invention relates to a traditional Chinese medicine soft capsule, a preparation method and a quality control method thereof, and belongs to the field of traditional Chinese medicines. Background technique [0002] "Anshen Bunao Ye", a Chinese patent medicine variety recorded in the third volume of "Drug Standards of the Ministry of Health of the People's Republic of China" (Chinese Medicine Prescriptions), has the effects of promoting essence, tonifying marrow, and enhancing brain power. It is used for neurasthenia, insomnia, and forgetfulness. , Headache, has been widely used in clinical, has a relatively ideal effect. [0003] But also there are following deficiencies: [0004] 1. The validity period of oral liquid is short, and the active ingredients exist in liquid form, which is easy to be contaminated with bacteria; [0005] 2. Long-term storage of oral liquid is unstable and prone to precipitation. [0006] 3. Oral liquid has high require...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/9068A61K9/48A61P25/20A61P25/00
Inventor 张红
Owner 孙志强
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