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Osmotic pump controlled release capsule case and preparation thereof

An osmotic pump controlled release and capsule shell technology, applied in the field of medicine, can solve the problems of no controlled release effect, prescription, complex process, etc., and achieve the effects of stable curative effect, slow release, and small toxic and side effects

Inactive Publication Date: 2008-11-12
WENZHOU MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] For osmotic pump preparations, there are (1) single-layer core osmotic pump tablets of insoluble drugs and their preparation methods (ZL 2004100818412.4), (2) sodium ferulate osmotic pump controlled release preparations and their preparation methods (ZL03144250.1 ), (3) scutellarin osmotic pump controlled release preparation (ZL 200310108570.4) and other patent authorizations, but all of them are prepared into osmotic pump tablets, the prescription and process are complicated; the patents of related capsules also include (1) a capsule body and Its preparation method and use (ZL 00124811.1), (2) plant fiber hard capsule shell and its preparation method (ZL 200510059670.1), (3) baloxacin capsule and its preparation method (ZL200510105798.7) and other authorizations, but the research content It is also limited to coating the ordinary capsule shell, or replacing the ordinary capsule capsule material gelatin with a plant-based water-soluble capsule shell material, or filling the drug into the ordinary capsule shell, and has no controlled release effect

Method used

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  • Osmotic pump controlled release capsule case and preparation thereof
  • Osmotic pump controlled release capsule case and preparation thereof
  • Osmotic pump controlled release capsule case and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Capsule Shell Composition:

[0029] Cellulose acetate 15g

[0030] Polyethylene glycol-200 1.5g

[0031] Tributyl Citrate 1.5g

[0032] Titanium dioxide 0.5g

[0033] Appropriate amount of gelatin

[0034]

[0035] Prepared capsule shells 100 capsules

[0036] Preparation process: first dissolve cellulose acetate in acetone, add polyethylene glycol and tributyl citrate as plasticizers, put weighed titanium dioxide into it, stir well, and let stand to remove air bubbles. The blank is made by dipping in glue, dried, and a drug release hole with a diameter of 1.0 mm is prepared on the capsule body by mechanical drilling, sealed with gelatin solution, dried, pulled out, cut, and sorted to obtain the osmotic pump capsule shell.

[0037] Take paracetamol as the model drug, paracetamol: sodium chloride = 2: 1 mixture, paracetamol is 100mg, fills in the capsule shell with powder form, carries out drug release test in water, release conditio...

Embodiment 2

[0039] Capsule Shell Composition:

[0040] Cellulose acetate 15g

[0041] Castor Oil 2.0g

[0042] Triethyl citrate 1.0g

[0043] Appropriate amount of gelatin

[0044]

[0045] Prepared capsule shells 100 capsules

[0046] Preparation process: first dissolve cellulose acetate in acetone, add castor oil and triethyl citrate as plasticizers, the preparation process is the same as Example 1, and prepare a diameter of 0.5 on the capsule body and capsule cap by mechanical punching method. mm drug release hole, seal the gelatin solution and dry, pull out the shell, cut, arrange, and obtain the capsule shell of the osmotic pump.

[0047] Take paracetamol as model medicine, paracetamol: sucrose=1: 1 mixes, paracetamol is 100mg, fills in this capsule, carries out drug release test in water, release condition is: distilled water 900ml, temperature 37 ℃ ± 0.5 ℃, rotating speed 100r / min, the drug release curve see image 3 .

Embodiment 3

[0049] Capsule Shell Composition:

[0050] Ethylcellulose 25g

[0051] Polyethylene glycol-400 2.0g

[0052] Dibutyl phthalate 1.5g

[0053] Titanium dioxide 0.5g

[0054] Appropriate amount of gelatin

[0055]

[0056] Prepared capsule shells 100 capsules

[0057] Preparation process: first dissolve ethyl cellulose in 95% ethanol, add polyethylene glycol-400 and dibutyl phthalate as plasticizers, add titanium dioxide and stir well, the preparation process is the same as Example 1, and mechanically beat Hole method A drug release hole with a diameter of 1.0 mm is prepared on the capsule body and sealed with gelatin solution.

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Abstract

The invention relates to an osmotic pump-controlled release capsule shell and a preparation method thereof. The capsule shell has a simple preparation technology and wide drug selection range, and can ensure that drugs achieve the controlled release effect. The osmotic pump-controlled release capsule shell consists of a capsule cap and a capsule body and is provided with a drug release hole for filling chemical drugs, traditional Chinese medicine, biological drugs and so on, can control the release rate of the drugs, and ensure that the release rate of the drugs is constant. The osmotic pump-controlled release capsule shell can adopt the prior capsule shell preparation method to prepare; the drug release hole with a certain hole diameter is prepared on the capsule shell by laser, mechanical or appropriate methods; as shown in a drug filling test, the capsule shell has the characteristic of ensuring that the release rate of the drugs is constant.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a capsule shell of a novel osmotic pump controlled-release capsule dosage form and a preparation method thereof. The capsule of the invention can be used for filling chemical medicines, traditional Chinese medicines, biological products, etc., and can control the drug release rate, and the drug release rate is constant. Background technique [0002] The research and development of sustained / controlled release preparations has become a hot spot in the research and development of medicine in the world today. The sustained / controlled release preparation can provide the human body with an appropriate blood drug concentration within a predetermined period as required, reduce the number of doses and obtain a good therapeutic effect. Its important feature is that it can keep the human body at the effective blood concentration for a long time, instead of dropping rapidly like ordinary...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K47/32A61K47/34A61K47/36A61K47/38A61J3/07
Inventor 傅红兴曹高忠吴明钗黄鹏周碧涛潘榕赵应征杨伟李剑波厉星王艺
Owner WENZHOU MEDICAL UNIV
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