CN1449755A - Dextromethorphan hydrobromide drop pills and preparation process thereof - Google Patents
Dextromethorphan hydrobromide drop pills and preparation process thereof Download PDFInfo
- Publication number
- CN1449755A CN1449755A CN 03100844 CN03100844A CN1449755A CN 1449755 A CN1449755 A CN 1449755A CN 03100844 CN03100844 CN 03100844 CN 03100844 A CN03100844 A CN 03100844A CN 1449755 A CN1449755 A CN 1449755A
- Authority
- CN
- China
- Prior art keywords
- drop pill
- dextromethorphan hydrobromide
- preparation
- milligrams
- dextromethorphan
- 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.)
- Granted
Links
- 239000006187 pill Substances 0.000 title claims abstract description 43
- YQSHYGCCYVPRDI-UHFFFAOYSA-N (4-propan-2-ylphenyl)methanamine Chemical compound CC(C)C1=CC=C(CN)C=C1 YQSHYGCCYVPRDI-UHFFFAOYSA-N 0.000 title claims abstract description 25
- 229960003782 dextromethorphan hydrobromide Drugs 0.000 title claims abstract description 25
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims abstract description 6
- 229920000053 polysorbate 80 Polymers 0.000 claims abstract description 6
- 229920002545 silicone oil Polymers 0.000 claims description 9
- 238000002844 melting Methods 0.000 claims description 8
- 230000008018 melting Effects 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 5
- 229960001985 dextromethorphan Drugs 0.000 claims description 4
- 238000003756 stirring Methods 0.000 claims description 4
- BMYNFMYTOJXKLE-UHFFFAOYSA-N 3-azaniumyl-2-hydroxypropanoate Chemical compound NCC(O)C(O)=O BMYNFMYTOJXKLE-UHFFFAOYSA-N 0.000 claims description 3
- MKXZASYAUGDDCJ-SZMVWBNQSA-N LSM-2525 Chemical compound C1CCC[C@H]2[C@@]3([H])N(C)CC[C@]21C1=CC(OC)=CC=C1C3 MKXZASYAUGDDCJ-SZMVWBNQSA-N 0.000 claims description 3
- 238000000576 coating method Methods 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- IQXJCCZJOIKIAD-UHFFFAOYSA-N 1-(2-methoxyethoxy)hexadecane Chemical compound CCCCCCCCCCCCCCCCOCCOC IQXJCCZJOIKIAD-UHFFFAOYSA-N 0.000 claims description 2
- 229950009789 cetomacrogol 1000 Drugs 0.000 claims description 2
- 239000011248 coating agent Substances 0.000 claims description 2
- 230000005496 eutectics Effects 0.000 claims description 2
- 239000012530 fluid Substances 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims description 2
- 239000002994 raw material Substances 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 abstract description 8
- -1 methyl silinon Chemical compound 0.000 abstract description 2
- 235000011187 glycerol Nutrition 0.000 abstract 1
- 238000010438 heat treatment Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 9
- 229940079593 drug Drugs 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000000428 dust Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000009833 condensation Methods 0.000 description 1
- 230000005494 condensation Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000007500 overflow downdraw method Methods 0.000 description 1
- 239000007962 solid dispersion Substances 0.000 description 1
- 230000026676 system process Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Abstract
The present invention discloses a dextromethorphan hydrobromide dripping pills. It is made up by heating dextromethorphan hydrobromide, polyethylene glycol, glycerine and Tween-80, comelting them and retaining comelting state, drop-adding them into methyl silinon oil condensate and forming dripping pills. It is simple in preparation process and low in cost, at the same time the dissolution of said dripping pills can be reached to 90% of labelled amount within 15 min., and is higher than that of tablet. Said dripping pills can be dissolved inwater, can be substituted for solution preparation, and its stability is far better than that of solution preparation.
Description
Technical field
The present invention relates to a kind of preparation reform of common drug, particularly a kind of dextromethorphan hydrobromide drop pill.The invention still further relates to the preparation method of above-mentioned drop pill.
Background technology
Dextromethorphan hydrobromide is as a kind of common drug, and its traditional dosage form is a tablet, and the dissolution of this tablet is generally when being limited to 30 minutes, and stripping quantity is 80% of a labelled amount.Simultaneously in the production process of tablet, there is dust pollution, and the production equipment complexity, floor space is big, and cost is higher.Also have a kind of Dextromethorphan Hydrobromide Solution preparation in addition, it can be for child administration, but also has inconvenience and the bad problem of stability of carrying.
And dropping pill formulation is as a kind of novel medicament preparation, and is easy because of production equipment, floor space is little, and has no dust and the low characteristics of cost, the most important thing is that the dissolution of drop pill generally all is higher than tablet.Therefore, the drop pill of various medicines occurs in succession, and the melt temperature of dextromethorphan hydrobromide is 125 degrees centigrade, and near the dulling temperature, therefore directly dripping the pill agent with the heat fusing method influences stability of drug.The present invention is by form improvement, and the form of drop pill is made in dextromethorphan hydrobromide and dressing congruent melting, kept stability of drug.
Summary of the invention
The object of the present invention is to provide a kind of dextromethorphan hydrobromide drop pill, is a kind of new Suppress.The present invention provides the preparation method of above-mentioned drop pill simultaneously, and this kind medicine is carried out the preparation reform.
Dextromethorphan hydrobromide drop pill of the present invention is that dextromethorphan hydrobromide and Polyethylene Glycol, glycerol, tween 80 are heated congruent melting, keeps the congruent melting state to splash into the drop pill that forms in the methyl-silicone oil condensed fluid.
Can contain the hydrobromic acid dextromethorphan in the above-mentioned every ball of this drop pill and be 7.5 milligrams, polyethylene glycol 6000 and be 15 milligrams, cetomacrogol 1000 0 and be 7.5 milligrams, 3.8 milligrams of glycerol, tween 80 is 0.56 milligram.
The preparation method of above-mentioned dextromethorphan hydrobromide drop pill may further comprise the steps:
A: batching: drop pill dosage and drop pill number by the desire preparation take by weighing raw material and mixing respectively;
B: congruent melting: heat and remain on 85 degrees centigrade of stirrings, mixed material is fully mixed and be the uniform colloidal state of fusing;
C: the system of dripping: above-mentioned colloidal state eutectic is remained on 85 degrees centigrade splash into and be condensed into drop pill in the methyl-silicone oil.
After said process finished, what this preparation process also comprised drop pill removed silicone oil, drying and coating process.
The temperature that keeps in this congruent melting and the system process preferably all is 85 degrees centigrade.
Dextromethorphan hydrobromide drop pill of the present invention, preparation method is simple, and cost is lower, and the dissolution of this drop pill can reach 90% of labelled amount in 15 minutes simultaneously, and dissolution is higher than tablet.This drop pill water soluble can replace solution to use, and stability but is better than solution far away.And success overcome the problem that melt temperature easy dulling influences stability of drug.
The specific embodiment
Present embodiment is that 7.5 milligrams dextromethorphan hydrobromide drop pill is an example to prepare 1000 content.
Take by weighing 7.5 gram dextromethorphan hydrobromides respectively, 15 gram polyethylene glycol 6000s, 7.5 gram cetomacrogol 1000s, 0,3.8 gram glycerol and 0.56 gram tween 80.Put into the container mix homogeneously, be heated to 85 degree, and remain on this temperature continuation stirring, make material be uniform molten state fully.
Material that then will above-mentioned molten state drips to be made in the methyl-silicone oil, makes its condensation formation ball shape.Above-mentioned material can drip 1000 pills of restriction, and every pill contains 7.5 milligrams of hydrobromic acid dextromethorphan effective ingredient.
Then the drop pill in the above-mentioned silicone oil is taken out, and remove silicone oil, form the finished product drop pill behind drying, the coating.
The fusion point of the dextromethorphan hydrobromide that the present invention uses is 125 degrees centigrade, as adopt fusion method that dextromethorphan hydrobromide is added in the fused Polyethylene Glycol, near " dulling " temperature, be easy to generate " dulling " phenomenon when being heated to 125 degrees centigrade, be unfavorable for the stable of medicine.And dextromethorphan hydrobromide very easily is dissolved in the glycerol in the time of 85 degrees centigrade.Therefore the present invention adopts and in the time of 85 degrees centigrade dextromethorphan hydrobromide is dissolved in glycerol and the Polyethylene Glycol, stirs and forms fused molecular solution, and coprecipitated again is colloidal state, belongs to solid dispersion, makes the efficacy stability of dextromethorphan hydrobromide.
The dissolution of drop pill of the present invention can reach in the time of 15 minutes, and stripping quantity reaches more than 90% of labelled amount, and its dissolution is significantly better than tablet.The dissolution that passes through six months effective ingredient of accelerated test when relative humidity 75% (40 degrees centigrade and) does not simultaneously change.And this drop pill can be water-soluble, forms solution, can be used as solution and take.
Claims (4)
1. a dextromethorphan hydrobromide drop pill is characterized in that: be that dextromethorphan hydrobromide and Polyethylene Glycol, glycerol, tween 80 are heated congruent melting, keep the congruent melting state to splash into the drop pill that forms in the methyl-silicone oil condensed fluid.
2. dextromethorphan hydrobromide drop pill according to claim 1 is characterized in that: containing the hydrobromic acid dextromethorphan in the every ball of this drop pill and be 7.5 milligrams, polyethylene glycol 6000 and be 15 milligrams, cetomacrogol 1000 0 and be 7.5 milligrams, 3.8 milligrams of glycerol, tween 80 is 0.56 milligram.
3. the preparation method of the described dextromethorphan hydrobromide drop pill of claim 1 is characterized in that may further comprise the steps:
A: batching: drop pill dosage and drop pill number by the desire preparation take by weighing raw material and mixing respectively;
B: congruent melting: heat and remain on 85 degrees centigrade of stirrings, mixed material is fully mixed and be the uniform colloidal state of fusing;
C: the system of dripping: above-mentioned colloidal state eutectic is remained on 85 degrees centigrade splash into and be condensed into drop pill in the methyl-silicone oil.
4. the preparation method of dextromethorphan hydrobromide drop pill according to claim 3 is characterized in that: this preparation process also comprises the process of removing silicone oil, drying and coating of drop pill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03100844 CN1200709C (en) | 2003-01-23 | 2003-01-23 | Dextromethorphan hydrobromide drop pills and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03100844 CN1200709C (en) | 2003-01-23 | 2003-01-23 | Dextromethorphan hydrobromide drop pills and preparation process thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1449755A true CN1449755A (en) | 2003-10-22 |
| CN1200709C CN1200709C (en) | 2005-05-11 |
Family
ID=28683903
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03100844 Expired - Lifetime CN1200709C (en) | 2003-01-23 | 2003-01-23 | Dextromethorphan hydrobromide drop pills and preparation process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1200709C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101023947B (en) * | 2006-02-24 | 2012-10-31 | 宝血纯化科技股份有限公司 | Methods and compositions for bactericide, bacteriostatic and anti-inflammation |
-
2003
- 2003-01-23 CN CN 03100844 patent/CN1200709C/en not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101023947B (en) * | 2006-02-24 | 2012-10-31 | 宝血纯化科技股份有限公司 | Methods and compositions for bactericide, bacteriostatic and anti-inflammation |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1200709C (en) | 2005-05-11 |
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Legal Events
| 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 | ||
| ASS | Succession or assignment of patent right |
Owner name: YUWANG PHARMACEUTICAL CO., LTD., SHANDONG PROV. Free format text: FORMER OWNER: ZHANG YICHENG Effective date: 20140909 Free format text: FORMER OWNER: LIU XIQIAN Effective date: 20140909 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| C53 | Correction of patent of invention or patent application | ||
| CB03 | Change of inventor or designer information |
Inventor after: Liu Xiqian Inventor after: Fan Shuqin Inventor after: Liu Rucui Inventor before: Zhang Yicheng Inventor before: Liu Xiqian |
|
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 010010 HOHHOT, INNER MONGOLIA AUTONOMOUS REGION TO: 251200 DEZHOU, SHANDONG PROVINCE Free format text: CORRECT: INVENTOR; FROM: ZHANG YICHENG LIU XIQIAN TO: LIU XIQIAN FAN SHUQIN LIU RUCUI |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20140909 Address after: 251200 Shandong city of Yucheng province thoroughfare Road No. 2731 Patentee after: SHANDONG YUWANG PHARMACEUTICAL CO.,LTD. Address before: 010010 the Inner Mongolia Autonomous Region Hohhot, 412 Wuda Road Patentee before: Zhang Yicheng Patentee before: Liu Xiqian |
|
| CX01 | Expiry of patent term |
Granted publication date: 20050511 |
|
| CX01 | Expiry of patent term |