CN100500152C - Dextromethorphan hydrobromide nose drops - Google Patents
Dextromethorphan hydrobromide nose drops Download PDFInfo
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- CN100500152C CN100500152C CNB2005101235715A CN200510123571A CN100500152C CN 100500152 C CN100500152 C CN 100500152C CN B2005101235715 A CNB2005101235715 A CN B2005101235715A CN 200510123571 A CN200510123571 A CN 200510123571A CN 100500152 C CN100500152 C CN 100500152C
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- dextromethorphan hydrobromide
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Abstract
The present invention relates to a dextromethorphan nose drops. It contains dextromethorphan, buffer agent, preservative, glycerin and thickening agent.
Description
Technical field:
The present invention relates to a kind of dextromethorphan hydrobromide pharmaceutical preparation, be particularly related to the dextromethorphan hydrobromide Collunarium, said preparation can be used for dry cough, be applicable to that the no productive cough that causes because of flu, upper respiratory tract infection, bronchial asthma and pulmonary tuberculosis etc. coughs, also can be used for because of sucking the dry cough that pungent causes.
Background technology:
Dextromethorphan hydrobromide, English name: Dextromethorphan Hydrobromide Nasal Drops chemical name is 3-methoxyl group-17-methyl-9 α ,-13 α, 14 α morphinan hydrobromate hydrates.
Have the central antitussive effect, its antitussive effect intensity is similar to codeine or stronger, does not suppress respiratory center during therapeutic dose, and no addiction does not also have analgesic activity.
Existing Suppress mainly is oral, the Collunarium that Shang Wuyou is stable.
Dextromethorphan hydrobromide is suitable for intranasal administration, can play effect immediately by the administration of this kind mode, is particularly suitable for child and violent cough person.But because the aqueous solution of dextromethorphan hydrobromide is unstable usually, particularly to unstable more under the environment of illumination and heat.The passing in time of the aqueous solution of dextromethorphan hydrobromide can be degraded and be produced certain degradation material.Because the impurity that exists in the pharmaceutical preparation can influence the toxicology characteristic of preparation in many cases, so the Dextromethorphan Hydrobromide Solution preparation that the expectation exploitation is stable obviously reduces the impurity level of its generation, stability increases, and helps improving the quality of products.
Summary of the invention:
The object of the present invention is to provide a kind of stable stable dextromethorphan hydrobromide Collunarium.
The object of the present invention is to provide a kind of stable dextromethorphan hydrobromide, buffer agent, antiseptic, glycerol, Collunarium of thickening agent of containing.
Collunarium of the present invention, its prescription is composed as follows:
1, dextromethorphan hydrobromide nasal drop
Specification: 5ml:75mg
One, prescription:
| Per 10,000 consumptions | |
| Dextromethorphan hydrobromide | 750g |
| Thickening agent (hypromellose/hyaluronate sodium/methylcellulose/carbomer/sodium carboxymethyl cellulose) | 5g～25g |
| Buffer system (phosphate-buffered system/borate buffer system) | 261～405g/0.6～12g |
| Glycerol | 50g～1500g |
| Antiseptic (merthiolate/oxybenzene esters/benzalkonium bromide/benzalkonium chloride/benzene oxygen alcohols) | 1g～30g |
| Water for injection adds to | 50L |
Preferred prescription is: per 10,000 consumptions
Dextromethorphan hydrobromide 750g
Hyaluronate sodium 5g～25g
Borate buffer system 0.6～12g
Glycerol 50g～1500g
Nipagin A 15～30g
2% sodium hydroxide solution 1.5L
Hydrochloric acid 40ml
Water for injection adds to 50L
Two, technology:
(1) takes by weighing dextromethorphan hydrobromide and add stirring and dissolving in 8～12L water for injection, can suitably heat 55～95 ℃ of dissolvings;
(2) the about 1.5L of preparation 2% sodium hydroxide solution;
(3) solution with (2) preparation adds in (1) on a small quantity, after grain to be had is separated out, slowly adds full dose (should ceaselessly stir, to avoid the crystallization caking) more therebetween, places 1～12 hour; (note: caustic lye of soda can not disposable quick adding (1) in.)
(4) get in the hot water for injection that hyaluronate sodium or other thickening agent be scattered in 5～10L and be no less than 2 hours, water temperature must not be higher than 75 ℃, makes it dissolving, filters stand-by;
(5) filter (3) and take out crystal, with a small amount of water for injection crystal is washed at least 2 times after, add water to about 2Lml, reuse 40ml hydrochloric acid dissolves crystal;
(6) getting in the water for injection that sodium hydroxide 10.0g adds 600ml the dissolving back adds and regulates pH value to 5.0～7.0 in (5);
(7) merge (4) (6) two liquid, and add buffer system, glycerol;
(8) take by weighing antiseptic and add that the dissolving back adds in (7) in the 1L water for injection, and add the injection water to 50L, stir, 0.22,0.45 μ m microporous membrane tube filter filters.
(9) fill, 5ml/ props up.
Preparation of the present invention, its prescription is formed a large amount of screenings of process and is obtained, optimization process has also been passed through in its preparation, makes to reach best, reaches optimization for making, the inventor has done a large amount of work, passed through comparative experiments, screening experiment, and through zoopery, clinical experiment confirms that preparation of the present invention compared with prior art has outstanding substantive specific and obvious improvement.
The most preferred prescription composition of the present invention is listed among the embodiment.
Medicament of the present invention is easy to absorb, and formulation method is simple, and effect is good, few side effects, and good absorbing, the comfort level height, nonirritant, and also stable especially, the feedback after relevant crowd's use is shown, be subjected to people's welcome deeply.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
| Per 10,000 consumptions | |
| Dextromethorphan hydrobromide | 750g |
| Hypromellose | 5g |
| Phosphate-buffered system | 261 |
| Glycerol | 50g |
| Merthiolate | 2.5 |
| Water for injection adds to | 50L |
Technology:
(1) takes by weighing dextromethorphan hydrobromide and add stirring and dissolving in 8～12L water for injection, can suitably heat 55～95 ℃ of dissolvings;
(2) the about 1.5L of preparation 2% sodium hydroxide solution;
(3) solution with (2) preparation adds in (1) on a small quantity, after grain to be had is separated out, slowly adds full dose (should ceaselessly stir, to avoid the crystallization caking) more therebetween, places 1～12 hour; (note: caustic lye of soda can not disposable quick adding (1) in.)
(4) get in the hot water for injection that hyaluronate sodium or other thickening agent be scattered in 5～10L and be no less than 2 hours, water temperature must not be higher than 75 ℃, makes it dissolving, filters stand-by;
(5) filter (3) and take out crystal, with a small amount of water for injection crystal is washed at least 2 times after, add water to about 2L, reuse 40ml hydrochloric acid dissolves crystal;
(6) getting in the water for injection that sodium hydroxide 10.0g adds 600ml the dissolving back adds and regulates pH value to 5.0～7.0 in (5);
(7) merge (4) (6) two liquid, and add buffer system, glycerol;
(8) take by weighing antiseptic and add that the dissolving back adds in (7) in the 1L water for injection, and add the injection water to 50L, stir, 0.22,0.45 μ m microporous membrane tube filter filters.
(9) fill, 5ml/ props up.
Embodiment 2
| Per 10,000 consumptions | |
| Dextromethorphan hydrobromide | 750g |
| Hyaluronate sodium | 25g |
| The borate buffer system | 12g |
| Glycerol | 1500g |
| Methyl hydroxybenzoate | 30g |
| Water for injection adds to | 50L |
Preparation method is identical with embodiment 1.
Claims (1)
1, a kind of preparation method of dextromethorphan hydrobromide nasal drop is characterized in that, through following steps
(1) takes by weighing dextromethorphan hydrobromide 750g and add stirring and dissolving in 8～12L water for injection, heat 55～95 ℃ of dissolvings;
(2) preparation 2% sodium hydroxide solution 1.5L;
(3) solution with (2) preparation adds in (1) on a small quantity, after grain to be had is separated out, slowly adds full dose again, ceaselessly stirs therebetween, places 1～12 hour;
(4) get in the hot water for injection that hyaluronate sodium 25g is scattered in 5～10L and be no less than 2 hours, water temperature must not be higher than 75 ℃, makes it dissolving, filters stand-by;
(5) filter (3) and take out crystal, with a small amount of water for injection crystal is washed at least 2 times after, add water to 2L, reuse 40ml hydrochloric acid dissolves crystal;
(6) getting in the water for injection that sodium hydroxide 10.0g adds 600ml the dissolving back adds and regulates pH value to 5.0～7.0 in (5);
(7) merge (4) (6) two liquid, and add borate buffer system 12g, glycerol 1500g;
(8) take by weighing methyl hydroxybenzoate 30g and add that the dissolving back adds in (7) in the 1L water for injection, and add the injection water to 50L, stir, 0.22,0.45 μ m microporous membrane tube filter filters;
(9) fill, 5ml/ props up.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101235715A CN100500152C (en) | 2005-11-21 | 2005-11-21 | Dextromethorphan hydrobromide nose drops |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101235715A CN100500152C (en) | 2005-11-21 | 2005-11-21 | Dextromethorphan hydrobromide nose drops |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1775213A CN1775213A (en) | 2006-05-24 |
| CN100500152C true CN100500152C (en) | 2009-06-17 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005101235715A Active CN100500152C (en) | 2005-11-21 | 2005-11-21 | Dextromethorphan hydrobromide nose drops |
Country Status (1)
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101011409B (en) * | 2007-02-06 | 2010-08-11 | 浙江爱生药业有限公司 | Collunarium containing vitamin B12 |
-
2005
- 2005-11-21 CN CNB2005101235715A patent/CN100500152C/en active Active
Non-Patent Citations (9)
| Title |
|---|
| 中华人民共和国药典. 国家药典委员会，666，化学工业出版社. 2000 * |
| 国家药品标准. 国家药典委员会，83，化学工业出版社. 2002 中华人民共和国药典. 国家药典委员会，666，化学工业出版社. 2000 |
| 国家药品标准. 国家药典委员会，83，化学工业出版社. 2002 * |
| 氢溴酸右美沙芬滴鼻剂镇咳的临床试验. 辛建保等.医药导报，第20卷第11期. 2001 |
| 氢溴酸右美沙芬滴鼻剂镇咳的临床试验. 辛建保等.医药导报，第20卷第11期. 2001 * |
| 氯霉素在硼酸缓冲液中的稳定性. 刘金城等.右江民族医学院学报，第16卷第1期. 1994 |
| 氯霉素在硼酸缓冲液中的稳定性. 刘金城等.右江民族医学院学报，第16卷第1期. 1994 * |
| 鼻炎愈的药剂学研究. 吴功柱等.中国药房，第10卷第2期. 1999 |
| 鼻炎愈的药剂学研究. 吴功柱等.中国药房，第10卷第2期. 1999 * |
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| Publication number | Publication date |
|---|---|
| CN1775213A (en) | 2006-05-24 |
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| 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 | ||
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| CP02 | Change in the address of a patent holder |
Address after: 430040, Hubei, Wuhan Lake East and West Silver Lake office, gold and silver, 2 Hunan Street Patentee after: Wujing Pharmacy Co., Ltd. Wuhan Address before: 430040, No. five, 1 King Road, Xin Qiao hi tech Industrial Park, Dongxihu, Hubei, Wuhan Patentee before: Wujing Pharmacy Co., Ltd. Wuhan |