CN100369608C - Suspension spray for treating allergic rhinitis and its preparing method - Google Patents
Suspension spray for treating allergic rhinitis and its preparing method Download PDFInfo
- Publication number
- CN100369608C CN100369608C CNB2006100166657A CN200610016665A CN100369608C CN 100369608 C CN100369608 C CN 100369608C CN B2006100166657 A CNB2006100166657 A CN B2006100166657A CN 200610016665 A CN200610016665 A CN 200610016665A CN 100369608 C CN100369608 C CN 100369608C
- Authority
- CN
- China
- Prior art keywords
- medicine
- purified water
- suspension
- ethanol
- present
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 239000000725 suspension Substances 0.000 title claims abstract description 17
- 239000007921 spray Substances 0.000 title claims abstract description 8
- 206010039085 Rhinitis allergic Diseases 0.000 title claims abstract description 6
- 201000010105 allergic rhinitis Diseases 0.000 title claims abstract description 6
- 238000000034 method Methods 0.000 title abstract description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 33
- 239000003814 drug Substances 0.000 claims abstract description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- 238000003756 stirring Methods 0.000 claims abstract description 16
- 239000008213 purified water Substances 0.000 claims abstract description 14
- KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 claims abstract description 13
- 238000002360 preparation method Methods 0.000 claims abstract description 10
- 230000001476 alcoholic effect Effects 0.000 claims description 17
- 229960004495 beclometasone Drugs 0.000 claims description 11
- 229960004756 ethanol Drugs 0.000 claims description 10
- 238000002425 crystallisation Methods 0.000 claims description 7
- 230000008025 crystallization Effects 0.000 claims description 7
- 238000001953 recrystallisation Methods 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 5
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 3
- 239000002904 solvent Substances 0.000 abstract description 10
- 239000002552 dosage form Substances 0.000 abstract description 2
- 239000000203 mixture Substances 0.000 abstract description 2
- 229950000210 beclometasone dipropionate Drugs 0.000 abstract 2
- 239000013078 crystal Substances 0.000 abstract 1
- 238000003912 environmental pollution Methods 0.000 abstract 1
- 239000000443 aerosol Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000009472 formulation Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000003380 propellant Substances 0.000 description 1
- 102220240796 rs553605556 Human genes 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a suspension spray for treating allergic rhinitis and a preparing method thereof, which belongs to the technical field of medicine. The dosage form of the present invention is a spray. The preparation method comprises the following steps: beclomethasone dipropionate, ethanol and purified water are taken to be used; the beclomethasone dipropionate is dissolved in 50%(V/V) ethanol or anhydrous alcohol to realize that the medicine is made into ethanol solution to be used; the ethanol solution is added to the purified water when the purified water is stirred by a homogenizer at the high speed of 3000 revolutions every minute to 15000 revolutions every minute, the medicine is recrystallized in a suspension as solvent to form tiny crystals, and the purpose of suspension is realized; the mixture is continuously stirred at the same stirring speed for 1 minute to 5 minutes; stirring is stopped, and standing defoaming and constant volume are carried out to obtain the spray of the present invention. The technique of the present invention has the advantages of simplicity, convenient operation, cost reduction, no environmental pollution, etc.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of method for preparing suspension, international Patent classificating number is: A61K 51/12, A61P 11/02.
Background technology
Beclometasone is the medicine of treatment of allergic rhinitis, and its preparation of selling on market is an aerosol, and there is following shortcoming in aerosol: aerosol needs pressure vessel, and its investment of production equipment is bigger; In addition, the employed propellant of aerosol is a freon, and freon can pollute environment, so the application of aerosol has certain limitation.
Summary of the invention
The purpose of this invention is to provide that cost is low, method is simple, easy to operate, suspendible is effective, the suspension spray and the preparation method of a kind of treatment of allergic rhinitis that environment is not polluted.
One, prescription
Beclometasone 0.1g～2.0g,
Ethanol 1.0g～20.0g,
Purified water 950g～1000g;
Two, preparation method
Dosage form of the present invention is a spray; Its preparation method is as follows:
1, the medicine beclometasone of desiring to make suspension is dissolved in 50% (V/V) ethanol～dehydrated alcohol, makes this medicine make alcoholic solution, standby;
2, with purified water homogenizer at a high speed (3000 rev/mins～15000 rev/mins) stir down, to its adding step 1 alcoholic solution, make medicine recrystallization in the suspension solvent become small crystallization, reach the suspendible purpose;
3, after the adding of the alcoholic solution of step 1 finishes, continue to stir 1 minute～5 minutes with identical mixing speed;
4, stop to stir after, leave standstill froth breaking, promptly get the present invention behind the standardize solution.
Process characteristic of the present invention be the suspension solvent under the homogenizer high-speed stirred, make medicine recrystallization in the suspension solvent become small crystallization, reach the suspendible purpose, the homogenizer rotating speed is high more, the suspendible effect is good more.
The solvent of general suspension formulations mostly is water, and medicine mostly is fat-soluble.Can dissolve the characteristics that most of fat-soluble medicines also can be miscible with the water arbitrary proportion according to ethanol, the present invention is dissolved in medicine in the ethanol, make insoluble drugs make alcoholic solution, water under the homogenizer high-speed stirred, is added the medicine alcoholic solution to it, make medicine recrystallization in solvent become small crystallization, reach the suspendible purpose, the suspendible effect is fine, when the solvent viscosity is low, also can reaches the settling volume ratio and require.
Technology of the present invention have technology simple, easy to operate, reduce cost and to advantages such as environment do not pollute.
The specific embodiment:
Embodiment 1:
Get: beclometasone 0.1g,
Ethanol 5.0g,
Purified water 995g is standby;
Preparation technology:
1, beclometasone is dissolved in 90% (V/V) ethanol, makes this medicine make alcoholic solution, standby;
2, with purified water homogenizer at a high speed (5000 rev/mins) stir down, to its adding step 1 alcoholic solution, make medicine recrystallization in the suspension solvent become small crystallization, reach the suspendible purpose;
3, after the adding of the alcoholic solution of step 1 finishes, continue to stir 1 minute minute with identical mixing speed;
4, stop to stir after, leave standstill froth breaking, promptly get the present invention behind the standardize solution.
Embodiment 2:
Get: beclometasone 0.15g,
Ethanol 10.0g,
Purified water 990g is standby;
Preparation technology:
1, beclometasone is dissolved in 95% (V/V) alcohol, makes this medicine make alcoholic solution, standby;
2, with purified water homogenizer at a high speed (9000 rev/mins) stir down, to its adding step 1 alcoholic solution, make medicine recrystallization in the suspension solvent become small crystallization, reach the suspendible purpose;
3, after the adding of the alcoholic solution of step 1 finishes, continue to stir 3 minutes minutes with identical mixing speed;
4, stop to stir after, leave standstill froth breaking, promptly get the present invention behind the standardize solution.
Embodiment 3:
Get: beclometasone 0.2g,
Ethanol 20.0g,
Purified water 980g is standby;
Preparation technology:
1, beclometasone is dissolved in the dehydrated alcohol, makes this medicine make alcoholic solution, standby;
2, with purified water homogenizer at a high speed (12000 rev/mins) stir down, to its adding step 1 alcoholic solution, make medicine recrystallization in the suspension solvent become small crystallization, reach the suspendible purpose;
3, after the adding of the alcoholic solution of step 1 finishes, continue to stir 5 minutes minutes with identical mixing speed;
4, stop to stir after, leave standstill froth breaking, promptly get the present invention behind the standardize solution.
Claims (1)
1. the preparation method of the suspension spray of a treatment of allergic rhinitis may further comprise the steps:
1. it is standby to get 0.1～2.0 part of beclometasone, 1.0～20.0 parts of ethanol, 950～1000 parts of purified water;
2. the medicine beclometasone of desiring to make suspension is dissolved in 50% ethanol～dehydrated alcohol, makes this medicine make alcoholic solution, standby;
3. with purified water under 3000 rev/mins～15000 rev/mins homogenizer high-speed stirred, add 2. alcoholic solution of step to it, make medicine recrystallization in purified water become small crystallization, reach the suspendible purpose;
4. after step alcoholic solution adding 2. finishes, continue to stir 1 minute～5 minutes with identical mixing speed;
5. after stopping to stir, leave standstill froth breaking, behind the standardize solution promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100166657A CN100369608C (en) | 2006-03-15 | 2006-03-15 | Suspension spray for treating allergic rhinitis and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100166657A CN100369608C (en) | 2006-03-15 | 2006-03-15 | Suspension spray for treating allergic rhinitis and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1857277A CN1857277A (en) | 2006-11-08 |
| CN100369608C true CN100369608C (en) | 2008-02-20 |
Family
ID=37296265
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100166657A Expired - Fee Related CN100369608C (en) | 2006-03-15 | 2006-03-15 | Suspension spray for treating allergic rhinitis and its preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100369608C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100446770C (en) * | 2007-01-10 | 2008-12-31 | 上海现代药物制剂工程研究中心有限公司 | Peclomethasone Propionate Water Spray |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0775484A1 (en) * | 1992-07-31 | 1997-05-28 | Glaxo Group Limited | Surfactant free aerosol formulations containing bezlomethsone dipropionate |
| WO2001010409A1 (en) * | 1999-08-07 | 2001-02-15 | Glaxo Wellcome Kabushiki Kaisha | Aqueous nasal formulation |
-
2006
- 2006-03-15 CN CNB2006100166657A patent/CN100369608C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0775484A1 (en) * | 1992-07-31 | 1997-05-28 | Glaxo Group Limited | Surfactant free aerosol formulations containing bezlomethsone dipropionate |
| WO2001010409A1 (en) * | 1999-08-07 | 2001-02-15 | Glaxo Wellcome Kabushiki Kaisha | Aqueous nasal formulation |
Non-Patent Citations (5)
| Title |
|---|
| 丙酸倍氯米松鼻喷雾剂治疗变应性鼻炎64例临床观察. 蒋源，王玮，黑燕等.山东大学基础医学院学报，第16卷第5期. 2002 * |
| 两产地二丙酸倍氯米松鼻喷雾剂治疗过敏性鼻炎的双盲平行对照试验. 张宏誉，王良录，岳凤敏等.中国医学科学院学报，第17卷第5期. 1995 * |
| 伯克纳治疗过敏性鼻炎100例临床研究. 林子萍，陈智斌，时海波.药学进展，第22卷第3期. 1998 * |
| 伯克纳鼻喷雾剂治疗儿童过敏性鼻炎58例疗效观察. 高雪，徐青.黔南民族医专学报，第15卷第3期. 2002 * |
| 新品世界. 中国药店，第2000卷第2期. 2000 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1857277A (en) | 2006-11-08 |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: XIUZHENG PHARMACEUTICAL GROUP BEIJING XIUZHENG PHARMACEUTICAL CO.,LTD. Assignor: Xiu Laigui Contract fulfillment period: 2008.6.28 to 2018.6.27 Contract record no.: 2009110000066 Denomination of invention: Suspension spray for treating allergic rhinitis and its preparing method Granted publication date: 20080220 License type: Exclusive license Record date: 20090505 |
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| LIC | Patent licence contract for exploitation submitted for record |
Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.6.28 TO 2018.6.27; CHANGE OF CONTRACT Name of requester: XIUZHENG PHARMACEUTICAL INDUSTRY GROUP BEIJING XIU Effective date: 20090505 |
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| EC01 | Cancellation of recordation of patent licensing contract |
Assignee: XIUZHENG PHARMACEUTICAL GROUP BEIJING XIUZHENG PHARMACEUTICAL CO.,LTD. Assignor: Xiu Laigui Contract record no.: 2009110000066 Date of cancellation: 20150319 |
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| LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20061108 Assignee: JILIN XIUZHENG PHARMACEUTICAL NEW MEDICINE DEVELOPMENT Co.,Ltd. Assignor: Xiu Laigui Contract record no.: 2015220000007 Denomination of invention: Suspension spray for treating allergic rhinitis and its preparing method Granted publication date: 20080220 License type: Exclusive License Record date: 20150327 |
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| LICC | Enforcement, change and cancellation of record of contracts on the licence for exploitation of a patent or utility model | ||
| ASS | Succession or assignment of patent right |
Owner name: XIUZHENG PHARMACEUTICAL GROUP HOIDING CO., LTD. Free format text: FORMER OWNER: XIU LAIGUI Effective date: 20150525 |
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| C41 | Transfer of patent application or patent right or utility model | ||
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Free format text: CORRECT: ADDRESS; FROM: 130012 CHANGCHUN, JILIN PROVINCE TO: 134000 TONGHUA, JILIN PROVINCE |
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| TR01 | Transfer of patent right |
Effective date of registration: 20150525 Address after: 134000 amendment 39, Jilin, Tonghua Patentee after: Xiuzheng Pharmaceutical Group Co.,Ltd. Address before: 130012 No. 2426 Qianjin Street, Changchun hi tech Development Zone, Jilin, China Patentee before: Xiu Laigui |
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| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20080220 |
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| CF01 | Termination of patent right due to non-payment of annual fee |