CN103550142A - Medicinal solution preparation prepared from acetylcysteine clathrate and preparation method thereof - Google Patents
Medicinal solution preparation prepared from acetylcysteine clathrate and preparation method thereof Download PDFInfo
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- CN103550142A CN103550142A CN201310479947.0A CN201310479947A CN103550142A CN 103550142 A CN103550142 A CN 103550142A CN 201310479947 A CN201310479947 A CN 201310479947A CN 103550142 A CN103550142 A CN 103550142A
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- acetylcysteine
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- beta cyclodextrin
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Abstract
The invention relates to a medicinal solution preparation prepared from acetylcysteine clathrate and a preparation method thereof. according to the medicinal preparation technology, one or more than two combined medicines selected from beta-cyclodextrin or hydroxypropyl beta-cyclodextrin or PEG or an HPMC organic material are used in clathration of acetylcysteine by a clathration technology so as to prepare the medicinal solution preparation with pH of 1.5-6.5.
Description
Technical field
The present invention relates to a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof.
Background technology
Acetylcysteine (N-acetylcysteine; NAC) molecular formula is C5H9N03S; it is the acetyl compound of Cys; it contains active-SH base; for clinical conventional expectorant, be particularly useful for that the coughs such as child, old people's chronic bronchitis have sticky expectorant and the patient that is difficult for expectoration.Because acetylcysteine contains active-SH base, cause on the one hand medicine itself easily oxidized and unstable, causing on the other hand medicine itself to have abnormal flavour, is mainly tablet, capsule, granule thereby cause current domestic listing preparation, and wherein injection and oral administration solution dosage form only have imported product.
Inclusion technique: be that a kind of molecule is deposited in the complex in another kind of molecule void structure with unique forms.Enclose process is physical process but not chemical process.The outer molecule with clathration is called host molecule, by enclose, to the small-molecule substance in host molecule space, is called enclosed molecule.
1, implication: the process that forms ultra micro cryptomere dispersion in the tubular structure of drug molecule enclose or embedding beta-schardinger dextrin-(β-CD) is called to beta-cyclodextrin inclusion compound technology.
2, feature: ultrastructure, dispersion effect is good, is easy to absorb; Carrier can be absorbed by the body, utilize, without depot action, nontoxic.
Huake Bio-medical Technology Co., Ltd., Hangzhou has applied for < < many specifications acetylcysteine solution stable, the nearly neutrality of pH value and preparation method thereof > >, application number 200510049512.8 on 03 30th, 2005.The invention discloses a kind of many specifications acetylcysteine solution stable, the nearly neutrality of pH value and preparation method thereof, its stable performance, and can be for oral, spraying, injection.The present invention adopts special antioxidant and antioxygen technology, and adds pH adjusting agent, makes acetylcysteine solution stable, and pH value approaches neutral, and human body is not had to zest, can be for oral, atomization suction, intravenous drip or muscle, subcutaneous injection.
Sheng-you Medical Technology, Hangzhou City Development Co., Ltd has applied for a < < acetylcysteine injection and preparation method thereof > >, application number 200810085531.X on 03 17th, 2008.The present invention relates to a kind of acetylcysteine injection, the trometamol that it contains consistent dose; The preparation method that also relates to this injection.Acetylcysteine injection sensitization of the present invention is low, and after high temperature (115 ℃, 30 minutes) sterilizing and after long-term storage, still can keep stablizing not decomposing, and it is stable that its pH value also can keep after long-term storage.
Have no relevant report and the patent of with acetylcysteine clathrate, making injection, oral administration solution, spray, suspensoid solution medicament formulations at home and abroad.
Summary of the invention
The present invention relates to a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, the composition of medicine inclusion technique of one or two or more kinds in this drug preparation technique employing beta cyclodextrin or hydroxypropyl beta cyclodextrin or PEG or HPMC organic material is 1.5～6.5 solution medicament formulations by being prepared into pH after acetylcysteine enclose.
Described a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, it is characterized in that the weight ratio of acetylcysteine clathrate in medicine is calculated as 5%～40% with acetylcysteine, preferably acetylcysteine weight ratio 20%.
Described a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, is characterized in that described clathrate can be one or two or more kinds the clathrate of combination enclose acetylcysteine gained in beta cyclodextrin or hydroxypropyl beta cyclodextrin or PEG or HPMC organic material PMC organic material.
Described a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, it is characterized in that described clathrate can be that one or two or more kinds combination consumption in beta cyclodextrin or hydroxypropyl beta cyclodextrin or PEG or HPMC organic material PMC organic material accounts for solution and accounts for 5%～40% of quality, preferably 20%.
Described a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, is characterized in that it is that a kind of pH is 1.5～6.5 solution medicament formulations, the solution medicament formulations that preferably pH is 4.5.
Described a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, is characterized in that solution medicament formulations can comprise injection, oral administration solution, eye drop, liquid spray.
Innovation of the present invention is to adopt one or two or more kinds the combination in beta cyclodextrin or hydroxypropyl beta cyclodextrin or PEG or HPMC organic material PMC organic material to carry out enclose acetylcysteine, greatly reduce on the one hand contacting of acetylcysteine and air and oxygen in solution, prevented oxidized, increased stability, the opposing party's bread acetylcysteine clathrate has also reduced and the contacting of light, increased stability, be finally by enclose, the stink enclose of acetylcysteine to be covered up, greatly improved the taste of pharmaceutical preparation.
Another object of the present invention is to provide the preparation method of the solution medicament formulations made from acetylcysteine clathrate.
A kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, its preparation method is as follows:
1) by batching core material list, get one or two or more kinds stirring and dissolving adjuvant and the water for pharmaceutical purposes such as combination, mucolyticum acid starting material, sodium hydroxide, essence, sweeting agent, antiseptic, stabilizing agent in qualified beta cyclodextrin or hydroxypropyl beta cyclodextrin or PEG or HPMC organic material PMC organic material;
2) in material-compound tank, add 30%～80% water for pharmaceutical purposes of batch volumes, slowly add one or two or more kinds the combination in beta cyclodextrin or hydroxypropyl beta cyclodextrin or PEG or HPMC organic material PMC organic material, stir 60min～180min and dissolve clarification completely to solution, slowly add again acetylcysteine, then slowly add sodium hydroxide to regulate pH value 1.5～6.5, stir 60min～180min and dissolve clarification completely to solution, add again after adjuvant stirring and dissolving, standardize solution, mix homogeneously, through 0.45 μ m and 0.22 μ m, filter, obtain intermediate semi-finished product;
3) intermediate semi-finished product detect qualified after, carry out fill;
4) the good qualified semi-finished product of fill are carried out outer package, warehouse-in finished product to be checked.
The specific embodiment
Below in conjunction with the specific embodiment, this Li County is further described, but this should be interpreted as to the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology realizing based on invention foregoing all belong to scope of the present invention.Adjuvant in following examples can be replaced with pharmaceutically acceptable adjuvant, or reduces, increases.
Embodiment 1
The preparation of acetylcysteine oral administration solution
1, prescription
Acetylcysteine 2000g;
Sodium hydroxide 6g;
Hydroxypropyl beta cyclodextrin 400g;
Potassium sorbate 50g;
Flavoring orange essence 20g;
Aspartame 8g;
Sodium benzoate 12g;
Purified water adds to 10000ml.
2, processing step
(1) neck material, weigh: by batching core material list get qualified mucolyticum acid starting material, hydroxypropyl beta cyclodextrin,
Sodium hydroxide, flavoring orange essence, sweeting agent (aspartame), sodium benzoate antiseptic, potassium sorbate stabilizing agent;
(2) raw material enclose dosing: 60% water for pharmaceutical purposes that adds batch volumes in material-compound tank, slowly add hydroxypropyl beta cyclodextrin, stir 120min and dissolve clarification completely to solution, slowly add again acetylcysteine, then slowly add sodium hydroxide to regulate pH value 5.0, stir 120min and dissolve clarification completely to solution
(3) add adjuvant dosing, standardize solution, filtration: add again after adjuvant stirring and dissolving, standardize solution, mix homogeneously, filters through 0.45 μ m and 0.22 μ m, obtains intermediate semi-finished product;
(4) fill, packing: intermediate semi-finished product detect qualified after, carry out fill, by the good qualified semi-finished product of fill carry out outer package, warehouse-in finished product is to be checked.
3, study on the stability
(1) by bis-appendix requirements of version < < Chinese Pharmacopoeia > > in 2010, under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%, place 6 months, accelerate to investigate for 6 months, detect its appearance character, pH, mucolyticum acid content.
Investigation result is as follows:
Accelerated stability is investigated 6 months check result tables
Through accelerating 6 months, respectively at the 0th, 1,2,3,6 month, take a sample to check, result is accelerated sample and 0 month character outward appearance, pH, material content after 6 months and is not all found significant change, shows that acetylcysteine after enclose is prepared into good mouthfeel after oral administration solution, steady quality.
Embodiment 2
Acetylcysteine injection preparation
1, prescription
Acetylcysteine 1000g;
Editic acid 60g;
Sodium hydroxide 6g;
HP-β-CD 1000g;
Water for injection adds to 10000ml.
2, processing step
(1) neck material, weighing: by batching core material list, get qualified mucolyticum acid starting material, hydroxypropyl beta cyclodextrin, editic acid, sodium hydroxide;
(2) raw material enclose dosing: 60% water for pharmaceutical purposes that adds batch volumes in material-compound tank, slowly add hydroxypropyl beta cyclodextrin, stir 120min and dissolve clarification completely to solution, slowly add again acetylcysteine, then slowly add sodium hydroxide to regulate pH value 6.5, stir 120min and dissolve clarification completely to solution
(3) add adjuvant dosing, standardize solution, filtration: add again after adjuvant stirring and dissolving, standardize solution, mix homogeneously, filters through 0.45 μ m and 0.22 μ m, obtains intermediate semi-finished product;
(4) fill, packing: intermediate semi-finished product detect qualified after, carry out fill, by the good qualified semi-finished product of fill carry out outer package, warehouse-in finished product is to be checked.
3, study on the stability
(1) by bis-appendix requirements of version < < Chinese Pharmacopoeia > > in 2010, under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%, place 6 months, accelerate to investigate for 6 months, detect its appearance character, pH, mucolyticum acid content.
Investigation result is as follows:
Accelerated stability is investigated 6 months check result tables
Through accelerating 6 months, to take a sample to check respectively at the 0th, 1,2,3,6 month, result is accelerated sample and 0 month character outward appearance, pH, material content after 6 months and is not all found significant change, shows the acetylcysteine injection steady quality after enclose.
Embodiment 3
The preparation of acetylcysteine mouth spray
1, prescription
Acetylcysteine 2000g;
Sodium hydroxide 380g;
PEG2000 100g；
Potassium sorbate 40g;
Strawberry essence 16g;
Sucralose 6g;
Sodium benzoate 12g;
Purified water adds to 10000ml.
2, processing step
(1) neck material, weighing: by batching core material list, get qualified PEG2000, mucolyticum acid starting material, sodium hydroxide, strawberry essence, sweeting agent (sucralose), sodium benzoate antiseptic, potassium sorbate stabilizing agent etc.;
(2) raw material enclose dosing: 50% water for pharmaceutical purposes that adds batch volumes in material-compound tank, slowly add PEG2000, stir 180min and dissolve clarification completely to solution, slowly add again acetylcysteine, then slowly add sodium hydroxide to regulate pH value 4.5, stir 180min and dissolve clarification completely to solution
(3) add adjuvant dosing, standardize solution, filtration: add again after adjuvant stirring and dissolving, standardize solution, mix homogeneously, filters through 0.45 μ m and 0.22 μ m, obtains intermediate semi-finished product;
(4) fill, packing: intermediate semi-finished product detect qualified after, carry out fill in the medicinal bottle of sprayer unit, by the good qualified semi-finished product of fill carry out outer package, warehouse-in finished product is to be checked.
3, study on the stability
(1) by bis-appendix requirements of version < < Chinese Pharmacopoeia > > in 2010, under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%, place 6 months, accelerate to investigate for 6 months, detect its appearance character, pH, mucolyticum acid content.
Investigation result is as follows:
Accelerated stability is investigated 6 months check result tables
Through accelerating 6 months, to take a sample to check respectively at the 0th, 1,2,3,6 month, result is accelerated sample and 0 month character outward appearance, pH, material content after 6 months and is not all found significant change, shows the acetylcysteine spray steady quality after enclose.
Embodiment 4
The preparation of acetylcysteine mouth eye drop
1, prescription
Acetylcysteine 2000g;
Editic acid 80g;
HMPC 100g；
Sodium borate 16g;
Sodium benzoate 12g;
Purified water adds to 10000ml.
2, processing step
(1) neck material, weighing: by batching core material list, get qualified mucolyticum acid starting material, editic acid, sodium borate, HMPC, sodium benzoate antiseptic etc.;
(2) raw material enclose dosing: 70% water for pharmaceutical purposes that adds batch volumes in material-compound tank, slowly add HMPC, stir 100min and dissolve clarification completely to solution, slowly add again acetylcysteine, then slowly add sodium borate to regulate pH value 6.5, stir 120min and dissolve clarification completely to solution
(3) add adjuvant dosing, standardize solution, filtration: add again after adjuvant stirring and dissolving, standardize solution, mix homogeneously, filters through 0.45 μ m and 0.22 μ m, obtains intermediate semi-finished product;
(4) fill, packing: intermediate semi-finished product detect qualified after, carry out fill in eyedrops bottle, by the good qualified semi-finished product of fill carry out outer package, warehouse-in finished product is to be checked.
3, study on the stability
(1) by bis-appendix requirements of version < < Chinese Pharmacopoeia > > in 2010, under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%, place 6 months, accelerate to investigate for 6 months, detect its appearance character, pH, mucolyticum acid content.
Investigation result is as follows:
Accelerated stability is investigated 6 months check result tables
Through accelerating 6 months, to take a sample to check respectively at the 0th, 1,2,3,6 month, result is accelerated sample and 0 month character outward appearance, pH, material content after 6 months and is not all found significant change, shows the acetylcysteine eye drop steady quality after enclose.
Claims (7)
1. the present invention relates to a kind of solution medicament formulations made from acetylcysteine clathrate and preparation method thereof, it is characterized in that it is 1.5～6.5 solution medicament formulations by being prepared into pH after acetylcysteine enclose that this drug preparation technique adopts one or two or more kinds the composition of medicine inclusion technique in beta cyclodextrin or hydroxypropyl beta cyclodextrin or PEG or HPMC organic material.
2. a kind of solution medicament formulations made from acetylcysteine clathrate as claimed in claim 1 and preparation method thereof, it is characterized in that the weight ratio of acetylcysteine clathrate in medicine is calculated as 5%～40% with acetylcysteine, preferably acetylcysteine weight ratio 20%.
3. a kind of solution medicament formulations made from acetylcysteine clathrate as claimed in claim 1 and preparation method thereof, is characterized in that described clathrate can be one or two or more kinds the clathrate of combination enclose acetylcysteine gained in beta cyclodextrin, hydroxypropyl beta cyclodextrin, PEG, HPMC organic material.
4. a kind of solution medicament formulations made from acetylcysteine clathrate as claimed in claim 3 and preparation method thereof, it is characterized in that described clathrate can be that one or two or more kinds combination consumption in beta cyclodextrin, hydroxypropyl beta cyclodextrin, PEG, HPMC organic material accounts for solution and accounts for 5%～40% of quality, preferably 20%.
5. a kind of solution medicament formulations made from acetylcysteine clathrate as claimed in claim 1 and preparation method thereof, is characterized in that it is that a kind of pH is 1.5～6.5 solution medicament formulations, the solution medicament formulations that preferably pH is 4.5.
6. a kind of solution medicament formulations made from acetylcysteine clathrate as claimed in claim 4 and preparation method thereof, is characterized in that solution medicament formulations can comprise injection, oral administration solution, eye drop, liquid spray.
7. a kind of solution medicament formulations made from acetylcysteine clathrate as claimed in claim 1 and preparation method thereof, is characterized in that its preparation method is as follows:
1) by batching core material list, get one or two or more kinds stirring and dissolving adjuvant and the water for pharmaceutical purposes such as combination, mucolyticum acid starting material, sodium hydroxide, essence, sweeting agent, antiseptic, stabilizing agent in qualified beta cyclodextrin, hydroxypropyl beta cyclodextrin, PEG, HPMC organic material;
2) in material-compound tank, add 30%～80% water for pharmaceutical purposes of batch volumes, slowly add one or two or more kinds the combination in beta cyclodextrin, hydroxypropyl beta cyclodextrin, PEG, HPMC organic material, stir 60min～180min and dissolve clarification completely to solution, slowly add again acetylcysteine, then slowly add sodium hydroxide to regulate pH value 1.5～6.5, stir 60min～180min and dissolve clarification completely to solution, add again after adjuvant stirring and dissolving, through 0.45 μ m and 0.22 μ m, filter, obtain intermediate semi-finished product;
3) intermediate semi-finished product detect qualified after, carry out fill;
4) the good qualified semi-finished product of fill are carried out outer package, warehouse-in finished product to be checked.
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| CN201310479947.0A CN103550142A (en) | 2013-10-15 | 2013-10-15 | Medicinal solution preparation prepared from acetylcysteine clathrate and preparation method thereof |
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| CN201310479947.0A CN103550142A (en) | 2013-10-15 | 2013-10-15 | Medicinal solution preparation prepared from acetylcysteine clathrate and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113318075A (en) * | 2021-06-24 | 2021-08-31 | 四川普锐特药业有限公司 | Acetylcysteine solution and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0839528A1 (en) * | 1996-10-29 | 1998-05-06 | Staroil Limited | Mouth-soluble compositions containing N-acetylcysteine and cyclodextrin |
| KR20040079012A (en) * | 2003-03-06 | 2004-09-14 | 주식회사 서울제약 | Acetylcysteine oral dosage forms |
| CN101947211A (en) * | 2010-08-28 | 2011-01-19 | 浙江金华康恩贝生物制药有限公司 | Method for preparing acetylcysteine effervescent tablet |
| CN102233139A (en) * | 2010-04-21 | 2011-11-09 | 重庆健能医药开发有限公司 | Acetylcysteine effervescent tablet and preparation method and application thereof |
| CN103191080A (en) * | 2013-04-24 | 2013-07-10 | 程刚 | Acetylcysteine effervescent tablet |
-
2013
- 2013-10-15 CN CN201310479947.0A patent/CN103550142A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0839528A1 (en) * | 1996-10-29 | 1998-05-06 | Staroil Limited | Mouth-soluble compositions containing N-acetylcysteine and cyclodextrin |
| KR20040079012A (en) * | 2003-03-06 | 2004-09-14 | 주식회사 서울제약 | Acetylcysteine oral dosage forms |
| CN102233139A (en) * | 2010-04-21 | 2011-11-09 | 重庆健能医药开发有限公司 | Acetylcysteine effervescent tablet and preparation method and application thereof |
| CN101947211A (en) * | 2010-08-28 | 2011-01-19 | 浙江金华康恩贝生物制药有限公司 | Method for preparing acetylcysteine effervescent tablet |
| CN103191080A (en) * | 2013-04-24 | 2013-07-10 | 程刚 | Acetylcysteine effervescent tablet |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113318075A (en) * | 2021-06-24 | 2021-08-31 | 四川普锐特药业有限公司 | Acetylcysteine solution and preparation method thereof |
| CN113318075B (en) * | 2021-06-24 | 2022-09-13 | 四川普锐特药业有限公司 | Acetylcysteine solution and preparation method thereof |
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Application publication date: 20140205 |