Oral liquid-crystal sustained-release composition and preparation

A slow-release composition and liquid crystal technology, applied in the direction of heterocyclic compound active ingredients, drug delivery, medical preparations of non-active ingredients, etc., can solve problems affecting drug release, blood drug concentration fluctuations, preparation toxicity, etc.

Inactive Publication Date: 2009-01-21
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When using the above-mentioned sustained-release granule technology or sustained-release pill core technology to prepare sustained-release capsules, one of the main problems is that many preparation process parameters will affect the drug release rate.
The differences in these process parameters in the continuous production process will lead to large batch-to-batch and intra-batch differences in the finished product. After oral administration, there will be large fluctuations in blood drug concentration in the human body, and even serious toxicity due to the sudden release of the preparation.

Method used

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  • Oral liquid-crystal sustained-release composition and preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0122] The formula of liquid crystal sustained-release composition (sustained-release capsule) 1

[0123] Preparation Content of ingredients in each tablet (mg)

[0124] Isosorbide Mononitrate 40mg

[0125] Glyceryl Monooleate 420mg

[0126] Compritol ATO 888 25mg

[0127] Gelucire 43 / 01 25mg

[0128] Preparation:

[0129] Heat glyceryl monooleate to 45°C to melt, add isosorbide mononitrate and stir to dissolve under stirring, then add Compritol ATO888 and Gelucire 43 / 01, stir well, cool to about 40°C, fill in hard capsule shell In the process, each capsule is made into sustained-release capsules containing 40 mg of isosorbide mononitrate.

Embodiment 2

[0131] The formula of liquid crystal sustained-release composition (sustained-release capsule) 2

[0132] Preparation Content of ingredients in each tablet (mg)

[0133] Acemetacin 90mg

[0134] Glyceryl Monooleate 400mg

[0135] Compritol ATO 888 40mg

[0136] Gelucire 40 / 13 18mg

[0137] Preparation:

[0138] Heat glyceryl monooleate to 50°C to melt, add acemetacin under stirring, then add Compritol ATO 888 and Gelucire40 / 13, stir evenly, cool to about 40°C, fill in soft capsules, and make Each capsule contains acemetacin 90mg sustained-release capsules.

Embodiment 3

[0140] The formula of liquid crystal sustained-release composition (sustained-release capsule) 3

[0141] Preparation Content of ingredients in each tablet (mg)

[0142] Gliclazide 30mg

[0143] Glyceryl Monooleate 250mg

[0144] Compritol ATO 888 20mg

[0145] Polysorbate 80 15mg

[0146] Preparation:

[0147] Heat glyceryl monooleate to 60°C to melt, add gliclazide under stirring, then add Compritol ATO 888 and polysorbate 80, stir evenly, cool to about 40°C, fill in the capsule shell, and make Formed into sustained-release capsules containing 30 mg of gliclazide in each capsule.

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Abstract

The invention relates to an oral liquid crystal sustained-released composition and a preparation method thereof. Active ingredients are distributed in glyceryl monooleate and lipid material in the composition to achieve the aim of slowly releasing the medicine. The preparation method of the pharmaceutical composition is as follows: the active ingredients, glyceryl monooleate and lipid material are prepared in a moderate method; the mixture is separately loaded in a hard capsule shell or soft capsule, and the sustained-released capsule is prepared. The content of the sustained-released capsule forms liquid crystal phase after encountering water to inhibit the release of the medicine. The pharmaceutical composition of the invention has simple preparing process, the active ingredients can be sustained-release, and the parameters influencing the release are few. Therefore, the composition of the invention is more suitable for industrial production with better safety.

Description

technical field [0001] The invention relates to an oral liquid crystal slow-release composition and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The oral sustained-release preparation is a kind of oral pharmaceutical preparation that releases slowly and non-constantly as required in a prescribed release medium, and the number of medications per 24 hours is reduced from 3-4 times to 1-2 times compared with the corresponding common preparations. In order to reduce the number of administrations and reduce the fluctuation of blood drug concentration, many types of drugs are suitable for the application of slow-release preparations in clinical practice. Drugs for gastrointestinal system, such as trimebutine maleate; drugs for respiratory diseases, such as ambroxol hydrochloride, acemetacin, salbutamol sulfate; hypoglycemic drugs, such as metformin hydrochloride, gliclazide, glipizide antipyretic and ...

Claims

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Application Information

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IPC IPC(8): A61K47/14A61K47/34A61K9/52A61K31/138A61K31/137A61K31/221A61K31/34A61K31/403A61K31/404A61K31/405A61K31/4375A61K31/4545A61K31/48A61K31/542A61K31/55A61K31/7048
Inventor 张建军许梁高缘
Owner CHINA PHARM UNIV
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