CN101317829A - Nifedipine capsule and pill prescription and preparation thereof - Google Patents
Nifedipine capsule and pill prescription and preparation thereof Download PDFInfo
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- CN101317829A CN101317829A CNA200710111672XA CN200710111672A CN101317829A CN 101317829 A CN101317829 A CN 101317829A CN A200710111672X A CNA200710111672X A CN A200710111672XA CN 200710111672 A CN200710111672 A CN 200710111672A CN 101317829 A CN101317829 A CN 101317829A
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- nifedipine
- capsule
- soft capsule
- pill
- peg400
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Abstract
The present invention provides a prescription and a manufacturing method for nifedipine soft capsule. The prescription comprises nifedipine, a bearer of solid dispersoid, corrective agent etc. The polyethylene glycol 400 defined in the medical industry is taken as the bearer, and the insoluble nifedipine is dispersed into the bearer of the solid dispersion through the solid disperse technology to form the medicament dispersing system with the upper state. The nifedipine soft capsules are produced after the produced content is filled into the soft capsule. The nifedipine soft capsule of the present invention is stable in quality, quick in effect. The bioavailability is evidently improved. After the capsule is pierced and taken under tongue, the antihypertensive effect works in 2 minutes, so the nifedipine soft capsule is in particular suitable for the emergent sufferer with dysphagia symptom or under the particular environment, such as the elder, the carotic patient, the sufferer with elevated blood pressure before operation owing to mental strain.
Description
Technical field
The invention belongs to pharmaceutical preparation, relate to the nifedipine soft capsule dosage form of a kind of solid dispersion as content.
Background technology
The nifedipine chemical name is 2,6-dimethyl-4 (2-nitrobenzophenone)-1, and 4-dihydro-3,5-pyridinedicarboxylic acid dimethyl ester is angina pectoris and hypertension first-line treatment medicine, belongs to medical insurance Class A, the first batch of cardiovascular and cerebrovascular disease essential drugs of China.At present, the common formulations of nifedipine is tablet, hard capsule, controlled release tablet, slow releasing tablet, injection etc.Because nifedipine is water insoluble, cause the onset of common formulations tablet, hard capsule of nifedipine slow, release is incomplete, absorption difference, bioavailability is low.Therefore nifedipine tablet, hard capsule dosage form are just gradually by replacements such as controlled release tablet, slow releasing tablet, slow releasing capsule, but these dosage form onsets are slow, be unsuitable for the critical patient under dysphagia or the special environment, as before old man, coma patient, the operation because of psychentonia hypertension patient.Though injection is rapid-action, must medical personnel assist patient's poor compliance.
Soft capsule is emerging in recent years novel form, and solid dispersion is the disperse system that the medicine high degree of dispersion forms in carrier, belongs to the pharmaceutics new technique.The particle diameter of medicine in carrier is mainly used in the insoluble drug acceleration or increases stripping between 0.001～1 μ m, improves bioavailability.The common carrier of solid dispersion is Macrogol 4000, polyethylene glycol 6000, polyvinylpyrrolidone, carbamide etc., and at present, Shang Weijian has the people to use PEG400 as the carrier of the solid dispersion content in order to the preparation soft capsule.
Summary of the invention
The object of the present invention is to provide a kind of content is the nifedipine soft capsule dosage form of the solid dispersion made in PEG400 of nifedipine.
Nifedipine capsule and pill of the present invention, content consists of: nifedipine 2.5%, PEG400 87.4%, glycerol 5.0%, purified water 5.0%, Oleum menthae essence 0.1%; Or: nifedipine 5.0%, PEG400 84.9%, glycerol 5.0%, purified water 5.0%, Oleum menthae essence 0.1%.
The manufacture method of Nifedipine capsule and pill of the present invention comprises following steps:
1, weighing mixes: nifedipine is taken by weighing in proportion with PEG400 mix;
2, drug micronization: adopt ball mill or colloid mill with the nifedipine micronization;
3, glue ball: add other adjuvants, the production technology of soft capsule prepares Nifedipine capsule and pill routinely.
Nifedipine capsule and pill of the present invention, customize the PEG400 of eliminating as carrier with the world of medicine, by solid dispersion technology the insoluble drug nifedipine is scattered in the solid dispersion carrier, formation contains the medicine disperse system of upper state form, make content-filledly in soft capsule, make Nifedipine capsule and pill.
Nifedipine capsule and pill of the present invention, steady quality, onset is rapid, bioavailability significantly improves, puncture sublingual administration blood pressure lowering effect onset in 2 minutes behind the soft gelatin capsule, be particularly suited for the critical patient under dysphagia or the special environment, as before old man, coma patient, the operation because of psychentonia hypertension patient.
The specific embodiment
Embodiment 1:
Take by weighing nifedipine 500g, PEG400 17480g mix homogeneously, adopt ball mill or colloid mill with the nifedipine micronization, add glycerol 1000g, purified water 1000g, Oleum menthae essence 20g mix homogeneously again, make the content of soft capsule, the production technology of soft capsule prepares 100,000 of Nifedipine capsule and pills routinely.
Embodiment 2:
Take by weighing nifedipine 1000g, PEG400 16980g mix homogeneously, adopt ball mill or colloid mill with the nifedipine micronization, add glycerol 1000g, purified water 1000g, Oleum menthae essence 20g mix homogeneously again, make the content of soft capsule, the production technology of soft capsule prepares 100,000 of Nifedipine capsule and pills routinely.
Nifedipine capsule and pill of the present invention, through 36 months room temperature reserved sample observings, steady quality all met " the quality standard of two Nifedipine capsule and pills of Chinese pharmacopoeia.
Nifedipine capsule and pill of the present invention, through a large amount of clinical trial certificates of clinical hospital, onset is rapid, bioavailability significantly improves, puncture sublingual administration blood pressure lowering effect onset in 2 minutes behind the soft gelatin capsule, be particularly suited for the critical patient under dysphagia or the special environment, as before old man, coma patient, the operation because of psychentonia hypertension patient.
List of references:
Novel pharmaceutical formulation and new technique, Lu Bin chief editor, People's Health Publisher, in January, 2000.
Claims (3)
1, a kind of Nifedipine capsule and pill is characterized in that: be that content is the solid dispersion that nifedipine is made in PEG400.
2, Nifedipine capsule and pill according to claim 1, it is characterized in that: content consists of: nifedipine 2.5%, PEG400 87.4%, glycerol 5.0%, purified water 5.0%, Oleum menthae essence 0.1%; Or: nifedipine 5.0%, PEG400 84.9%, glycerol 5.0%, purified water 5.0%, Oleum menthae essence 0.1%.
3, the manufacture method of Nifedipine capsule and pill according to claim 1 is characterized in that comprising following steps:
3.1: weighing mixes: nifedipine is taken by weighing in proportion with PEG400 mix;
3.2: drug micronization: adopt ball mill or colloid mill with the nifedipine micronization;
3.3: the glue ball: add other adjuvants, the production technology of soft capsule prepares Nifedipine capsule and pill routinely.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200710111672XA CN101317829A (en) | 2007-06-08 | 2007-06-08 | Nifedipine capsule and pill prescription and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200710111672XA CN101317829A (en) | 2007-06-08 | 2007-06-08 | Nifedipine capsule and pill prescription and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101317829A true CN101317829A (en) | 2008-12-10 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA200710111672XA Pending CN101317829A (en) | 2007-06-08 | 2007-06-08 | Nifedipine capsule and pill prescription and preparation thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101317829A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104825418A (en) * | 2015-05-07 | 2015-08-12 | 上海信谊万象药业股份有限公司 | Nifedipine soft-shell capsule and preparation method thereof |
-
2007
- 2007-06-08 CN CNA200710111672XA patent/CN101317829A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104825418A (en) * | 2015-05-07 | 2015-08-12 | 上海信谊万象药业股份有限公司 | Nifedipine soft-shell capsule and preparation method thereof |
| CN104825418B (en) * | 2015-05-07 | 2018-05-15 | 上海信谊万象药业股份有限公司 | A kind of nifedipine soft capsule and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20081210 |