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Cardio-cerebral refreshing sustained-release soft capsules and preparation method thereof

A soft capsule and sustained-release technology, which is applied in the field of sustained-release preparations containing active ingredients of traditional Chinese medicine and its preparation, can solve the problems of difficult to control and constant sustained release in the early stage, and achieve effectiveness and safety, maintain blood drug concentration, The effect of less frequent doses

Active Publication Date: 2011-06-29
SHINEWAY PHARMA GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to aim at the common problems of the existing Xinnaoqing Soft Capsules that the pre-release is fast and it is difficult to control the constant sustained release, to provide a drug release that can be uniform and constant, prolong the drug action time, and avoid peaks and valleys. Xinnaoqing sustained-release soft capsules that are beneficial to ensure the effectiveness and safety of the drug; and a preparation method of the drug is provided at the same time

Method used

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  • Cardio-cerebral refreshing sustained-release soft capsules and preparation method thereof
  • Cardio-cerebral refreshing sustained-release soft capsules and preparation method thereof
  • Cardio-cerebral refreshing sustained-release soft capsules and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0029] Example 1: Prepare 1000 Xinnaoqing sustained-release soft capsules.

[0030] (a) Weigh 390g safflower oil, 3g borneol, 17g vitamin E, vitamin B 6 5g; glyceryl monostearate 300g, soybean oil 100g;

[0031] (b) Combine 260g safflower oil with borneol and vitamin B 6 , vitamin E, and grind and mix together; grind and mix the remaining safflower oil, glycerol monostearate and soybean oil; then mix the two, pass through a 80-100 mesh sieve, and make the contents of the capsule thing;

[0032] (c) Prepare the capsule shell: first melt 1000g of gelatin, add 50g of hydroxypropylmethylcellulose into the gelatin, and stir well;

[0033] (d) Compress or drip the contents into soft capsules with the above-mentioned capsule shell, shape the capsule, wash the pills, and dry them to obtain the product.

[0034] The prepared sustained-release soft capsules can achieve zero-order release after one hour of release and can be effectively sustained-release.

Embodiment 2

[0035] Example 2: Prepare 1000 Xinnaoqing Soft Capsules.

[0036] (a) Weigh raw and auxiliary materials:

[0037] Safflower oil 390g, borneol 3g, vitamin E 17g, vitamin B 6 5g, polyethylene glycol 400 400g, ethyl cellulose 70g, beeswax 50g;

[0038] (b) Combine 195g safflower oil with borneol and vitamin B 6 Grind and mix with vitamin E;

[0039] (c) Grinding and mixing the remaining amount of safflower oil together with ethyl cellulose and beeswax; then mixing the two, passing through a 100-mesh sieve to make the contents of the capsule;

[0040] (d) preparing the capsule shell: first melt 1000g of gelatin, add 500g of polyvinylpyrrolidone into the gelatin, and stir well;

[0041] (e) Using the above-mentioned capsule shell to compress or drop the contents into soft capsules, shape the capsules, wash the pills, and dry them to obtain the product.

[0042] The sustained-release soft capsule described in this example has a higher release rate in vitro, and the drug can be ...

Embodiment 3

[0044] (a) Weigh raw and auxiliary materials:

[0045] Safflower oil 390g, borneol 3g, vitamin E 17g, vitamin B 6 5g, polyethylene glycol 400 260g, polyvinylpyrrolidone 80g, hypromellose 90g;

[0046] (b) Combine 195g safflower oil with borneol and vitamin B 6 , vitamin E, grind and mix together;

[0047] (c) Grinding and mixing the remaining amount of safflower oil with polyethylene glycol 400, polyvinylpyrrolidone, and hypromellose;

[0048] (d) mix the mixture prepared in step b and step c, and pass through a 100-mesh sieve to make the contents of the capsule;

[0049] (d) prepare capsule shell: first melt 1000g gelatin, add 500g water-soluble chitosan in gelatin, stir;

[0050] (e) Using the above-mentioned capsule shell to compress or drop the contents into soft capsules, shape the capsules, wash the pills, and dry them to obtain the product.

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Abstract

The invention discloses cardio-cerebral refreshing sustained-release soft capsules and a preparation method thereof. The sustained-release soft capsules contain capsule shells and contents, wherein the contents contain the following active pharmaceutical ingredients in mass ratio: 390 parts of safflower oil, 3 parts of borneol, 17 parts of vitamin E and 65 parts of vitamin B; and the contents contain the following raw materials in parts by weight: 4.15 parts of active pharmaceutical ingredients and 2-8 parts of sustained-release coating material, wherein the sustained-release coating material is one or mixture of polyethylene glycol (PEG) and glyceryl monostearate based on an arbitrary proportion. The preparation method mainly comprises the following steps: grinding and evenly mixing 1 / 2-2 / 3 of the safflower oil in the active pharmaceutical ingredients and the other active pharmaceutical ingredients, and then, grinding and evenly mixing the residual safflower oil, the sustained-release coating material and a dispersing agent or a diluting agent; and evenly mixing the two obtained mixtures, and sieving with a 80-100 mesh sieve to obtain the capsule contents. The sustained-release soft capsules provided by the invention have the advantages that drug release can keep uniform and constant, drug action time can be prolonged, and a peak valley phenomenon can be avoided.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a slow-release preparation containing active ingredients of traditional Chinese medicines and a preparation method thereof. Background technique [0002] Xinnaoqing Soft Capsule is a compound preparation of traditional Chinese and Western medicine mainly based on traditional Chinese medicine. The active ingredients in Xinnaoqing Soft Capsules are safflower oil, borneol, vitamin E, and vitamin B 6 ; Its dosage ratio is 390 parts of safflower oil, 3 parts of borneol, 17 parts of vitamin E, vitamin B 6 5 servings. The safflower oil in the active ingredient of the medicine contains a variety of essential unsaturated fatty acids that the human body cannot synthesize by itself. It can not only lower cholesterol, but also combine with cholesterol, reduce the deposition of cholesterol on the blood vessel wall, effectively prevent and treat hypertension,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/286A61K9/52A61P9/10A61P25/00A61K31/045A61K31/355A61K31/4415
Inventor 孔德宪姜海魏峰
Owner SHINEWAY PHARMA GRP LTD
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