CN104224760A - Preparation method of salbutamol sulfate aerosol inhalation solution - Google Patents
Preparation method of salbutamol sulfate aerosol inhalation solution Download PDFInfo
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- CN104224760A CN104224760A CN201310246299.4A CN201310246299A CN104224760A CN 104224760 A CN104224760 A CN 104224760A CN 201310246299 A CN201310246299 A CN 201310246299A CN 104224760 A CN104224760 A CN 104224760A
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Abstract
The invention discloses a preparation method of a salbutamol sulfate aerosol inhalation solution. The preparation method comprises the following steps: S1, adding 700 thousand ml of water for injection in a hermetic preparation tank for later use; S2, dissolving benzalkonium chloride with hot water for injection in advance, adding a benzalkonium chloride solution into a preparation barrel, and uniformly stirring; S3, adding water for nitrogen filling injection to 320 thousand ml and stirring for 15 minutes to be uniformly stirred; S4, adding water for nitrogen filling injection to full dose, and stirring for 15 minutes to be uniformly stirred; S5, filtering with a 0.35 mu m polyether sulfone microporous filtration membrane until the solution is clarified; S6, sampling and testing the content and pH value of an intermediate, covering the preparation barrel, and introducing nitrogen into the liquid medicine to protect; and S7, filtering the liquid medicine in a liquid storage barrel by a 0.22 mu m polyether sulfone microporous filtration membrane, sampling and examining visible foreign matters, and inputting the qualified visible foreign matters into a liquid storage container for encapsulation. The production quality of the salbutamol sulfate aerosol inhalation solution is effectively improved.
Description
Technical field
The present invention relates to a kind of salbutamol sulfate aerosol inhalation solution, particularly relate to a kind of manufacture method of salbutamol sulfate aerosol inhalation solution.
Background technology
According to standard newly-increased in " Chinese Pharmacopoeia " 2010 version first enlarged edition (on October 1st, 2012 plays enforcement), Related substance is carried out to salbutamol sulfate aerosol inhalation solution.In put procedure, find that there is related substance and can increase along with the prolongation of time (single maximum contaminant and total impurities all can increase).Afterwards by little sample testing, sample is filled to a series of investigations such as nitrogen, lucifuge, meta-acid, meta-alkali.Compared with normal process, have obvious increase except finding sample (PH5.1) related substance being always assorted in the basic conditions, other condition is in 60 DEG C of tests, 10 days equal no significant differences.The quality of production of present salbutamol sulfate aerosol inhalation solution is low.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of manufacture method of salbutamol sulfate aerosol inhalation solution, and it improves the quality of production of salbutamol sulfate aerosol inhalation solution effectively.
The present invention solves above-mentioned technical problem by following technical proposals: a kind of manufacture method of salbutamol sulfate aerosol inhalation solution, and it is characterized in that, it comprises the following steps:
Step one, adds the water for injection of 700,000 ml in airtight preparing tank for subsequent use, passes into nitrogen 60 minutes, and detect the residual oxygen rate≤1.3mg/L of water for injection, water temperature controls at 25-30 DEG C; In preparation bucket, add above-mentioned water for injection 280,000 ml, add salbutamol sulfate and sodium chloride, stirring and dissolving;
Step 2, dissolves the hot water for injection of benzalkonium chloride in advance; Benza is added in above-mentioned preparation bucket, stir;
Step 3, adds logical nitrogen water for injection to 32 ten thousand ml, stirs 15 minutes, makes it even;
Step 4, adds logical nitrogen water for injection to full dose, stirs 15 minutes, makes it even;
Step 5, is filtered to clear and bright with 0.35 μm of polyethersulfone millipore filter;
Step 6, intermediates content and pH value are surveyed in sampling, and preparation bucket is added a cover, and medicinal liquid leads to nitrogen protection; Until every all qualified after, medicinal liquid is filtered into liquid receiver, adds a cover logical nitrogen protection;
Step 7, the medicinal liquid in liquid receiver filters through 0.22 μm of polyethersulfone millipore filter, and after visible foreign matters passed examination is done in sampling, input Liquid storage container is for embedding.
Positive progressive effect of the present invention is: the present invention improves the quality of production of salbutamol sulfate aerosol inhalation solution effectively.
Detailed description of the invention
The manufacture method of salbutamol sulfate aerosol inhalation solution of the present invention comprises the following steps:
Step one, adds the water for injection of 700,000 ml in airtight preparing tank for subsequent use, passes into nitrogen 60 minutes, and detect the residual oxygen rate≤1.3mg/L of water for injection, water temperature controls at 25-30 DEG C; In preparation bucket, add above-mentioned water for injection 280,000 ml, add salbutamol sulfate and sodium chloride, stirring and dissolving.Because albuterol is oxidizable, so first logical nitrogen protection, and the related substance of this product has impact to temperature, so strictly will control water temperature.
Step 2, dissolves the hot water for injection of benzalkonium chloride in advance; Benza is added in above-mentioned preparation bucket, stir;
Step 3, adds logical nitrogen water for injection to 32 ten thousand ml, stirs 15 minutes, makes it even.Debugging pH value, to 3.2-3.4, regulates with 0.01mol/L dilute sulfuric acid; Logical nitrogen protection, controls the growth of its related substance;
Step 4, adds logical nitrogen water for injection to full dose, stirs 15 minutes, makes it even; PH value can regulate with 0.01mol/L dilute sulfuric acid;
Step 5, is filtered to clear and bright with 0.35 μm of polyethersulfone millipore filter;
Step 6, intermediates content and pH value are surveyed in sampling, and preparation bucket is added a cover, and medicinal liquid leads to nitrogen protection; Until every all qualified after, medicinal liquid is filtered into liquid receiver, adds a cover, logical nitrogen protection;
Step 7, the medicinal liquid in liquid receiver filters through 0.22 μm of polyethersulfone millipore filter, and after visible foreign matters passed examination is done in sampling, input Liquid storage container is for embedding.
The present invention improves the quality of production of salbutamol sulfate aerosol inhalation solution effectively.
Although the foregoing describe the specific embodiment of the present invention, it will be understood by those of skill in the art that these only illustrate, under the prerequisite not deviating from principle of the present invention and essence, various changes or modifications can be made to these embodiments.Therefore, protection scope of the present invention is defined by the appended claims.
Claims (1)
1. a manufacture method for salbutamol sulfate aerosol inhalation solution, is characterized in that, it comprises the following steps:
Step one, adds the water for injection of 700,000 ml in airtight preparing tank for subsequent use, passes into nitrogen 60 minutes, and detect the residual oxygen rate≤1.3mg/L of water for injection, water temperature controls at 25-30 DEG C; In preparation bucket, add above-mentioned water for injection 280,000 ml, add salbutamol sulfate and sodium chloride, stirring and dissolving;
Step 2, dissolves the hot water for injection of benzalkonium chloride in advance; Benza is added in above-mentioned preparation bucket, stir;
Step 3, adds logical nitrogen water for injection to 32 ten thousand ml, stirs 15 minutes, makes it even;
Step 4, adds logical nitrogen water for injection to full dose, stirs 15 minutes, makes it even;
Step 5, is filtered to clear and bright with 0.35 μm of polyethersulfone millipore filter;
Step 6, intermediates content and pH value are surveyed in sampling, and preparation bucket is added a cover, and medicinal liquid leads to nitrogen protection; Until every all qualified after, medicinal liquid is filtered into liquid receiver, adds a cover logical nitrogen protection;
Step 7, the medicinal liquid in liquid receiver filters through 0.22 μm of polyethersulfone millipore filter, and after visible foreign matters passed examination is done in sampling, input Liquid storage container is for embedding.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310246299.4A CN104224760A (en) | 2013-06-20 | 2013-06-20 | Preparation method of salbutamol sulfate aerosol inhalation solution |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310246299.4A CN104224760A (en) | 2013-06-20 | 2013-06-20 | Preparation method of salbutamol sulfate aerosol inhalation solution |
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| CN104224760A true CN104224760A (en) | 2014-12-24 |
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| CN201310246299.4A Pending CN104224760A (en) | 2013-06-20 | 2013-06-20 | Preparation method of salbutamol sulfate aerosol inhalation solution |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105832712A (en) * | 2016-05-12 | 2016-08-10 | 河北仁合益康药业有限公司 | Salbutamol sulfate solution composition for inhaling and preparation method thereof |
| CN106727322A (en) * | 2017-02-14 | 2017-05-31 | 杭州百诚医药科技股份有限公司 | Suction salbutamol sulfate solution and preparation method thereof |
| CN108883079A (en) * | 2016-03-15 | 2018-11-23 | 广东东阳光药业有限公司 | Spray, spraying device and spray assembly |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1720036A (en) * | 2001-10-26 | 2006-01-11 | 德艾公司 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| CN101874772A (en) * | 2010-05-31 | 2010-11-03 | 青岛华仁药业股份有限公司 | Preparation process for soft bag injection and product |
-
2013
- 2013-06-20 CN CN201310246299.4A patent/CN104224760A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1720036A (en) * | 2001-10-26 | 2006-01-11 | 德艾公司 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| CN101874772A (en) * | 2010-05-31 | 2010-11-03 | 青岛华仁药业股份有限公司 | Preparation process for soft bag injection and product |
Non-Patent Citations (1)
| Title |
|---|
| 武平平等: "雾化吸入治疗老年性哮喘58例护理体会", 《中国现代药物应用》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108883079A (en) * | 2016-03-15 | 2018-11-23 | 广东东阳光药业有限公司 | Spray, spraying device and spray assembly |
| CN105832712A (en) * | 2016-05-12 | 2016-08-10 | 河北仁合益康药业有限公司 | Salbutamol sulfate solution composition for inhaling and preparation method thereof |
| CN106727322A (en) * | 2017-02-14 | 2017-05-31 | 杭州百诚医药科技股份有限公司 | Suction salbutamol sulfate solution and preparation method thereof |
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Application publication date: 20141224 |
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