CN1102389C - External-use drops for ear and its prepn. method - Google Patents
External-use drops for ear and its prepn. method Download PDFInfo
- Publication number
- CN1102389C CN1102389C CN97105805A CN97105805A CN1102389C CN 1102389 C CN1102389 C CN 1102389C CN 97105805 A CN97105805 A CN 97105805A CN 97105805 A CN97105805 A CN 97105805A CN 1102389 C CN1102389 C CN 1102389C
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- Prior art keywords
- polyethylene glycol
- external
- ear
- pipemidic acid
- use drops
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Abstract
The present invention relates to an external-use drop pill for otology. The scientific recipe is formed by that propanediol, polyethylene glycol 400 and polyethylene glycol 6000 are added to fine pipemidic acid powder, and the polyethylene glycol 6000 is dissolved according to the recipe. Other raw materials are mixed, and then the mixture is uniformly mixed with meltwater of the polyethylene glycol 6000; then a normal drop pill manufacture method is utilized to produce the drop pill. The product adds an external-use drug form taking pipemidic as the base material and having the specific effect on otology, especially on otitis media suppurativa, and the external-use drug form has the advantages of quick and high curative effect and easy use.
Description
The invention belongs to the externally applied anti-inflammation medicine, particularly be a kind of to specific external-use drops for ear of suppurative otitis media and preparation method thereof.
Well-known pipemidic acid is a kind of synthetic medicine, and its bacterium spectrum is wide, and side effect is little, is mainly used to acute urinary tract infection and bacillary dysentery, also is used for biliary tract, respiratory tract infection illness etc.Instructions about how to take medicine are oral, do not see the dosage form that its local topical medicine is arranged.
The object of the invention provides a kind of pipemidic acid that contains and is aided with the external-use drug form that other adjuvants are made, and performance local application concentration height, speed be fast, act on persistent characteristics, especially to specific external-use drops for ear of suppurative otitis media and preparation method thereof.
The object of the present invention is achieved like this, is described as follows:
A kind of external-use drops for ear, make (consumption is weight percentage) by following component:
Effective range preferable range optimum range
Pipemidic acid 5-22% 8-20% 10-16%
Propylene glycol 2-15% 3-11% 4-10%
Polyethylene Glycol
4001-14% 2-10% 4-10%
Polyethylene Glycol
600055-90% 60-80% 70-76%
A kind of method for preparing external-use drops for ear, its characteristics are:
1. will gather diethanol by formula ratio
6000Place sealable container, heating and melting in 70-80 ℃ of water-bath;
2. according to formula ratio, the pipemidic acid fine powder of getting 100 mesh sieves adds third poly-, the Polyethylene Glycol
400Stir into fine and smooth pasty state, reenter above-mentioned fused Polyethylene Glycol
6000, continue in water-bath, to be heated to 70-75 ℃, until being mixed into emulsion, the impouring insulation is dripped in the system device, selects suitable water dropper for use by every ball 30mg, and the speed of dripping with per minute 75-85 splashes into in the refrigerative liquid Paraffin of ice bath, promptly obtains external-use drops for ear.
Embodiment:
External-use drops for ear is a raw material with following percentage by weight prescription:
Example 1, pipemidic acid 16%
Propylene glycol 9%
Polyethylene Glycol
40010%
Polyethylene Glycol
600065%
Example 2, pipemidic acid 10%
Propylene glycol 5%
Polyethylene Glycol
4004%
Polyethylene Glycol
600081%
Example 3, pipemidic acid 13%
Propylene glycol 7%
Polyethylene Glycol
4007%
Polyethylene Glycol
600073%
The embodiment of preparation external-use drops for ear method is as follows:
Example 1 is pressed above-mentioned Formulation Example 1 with 6.5% part of Polyethylene Glycol
6000Place container, in 73 ℃ of water-baths, be heated to fusion; Get pipemidic acid 16% and pulverize, and add the Polyethylene Glycol of 9% propylene glycol and 10% part at normal temperatures all by 100 mesh sieves
400Be mixed into fine and smooth pasty state, thinner paste joined above-mentioned fused Polyethylene Glycol
6000In, continuation is heated to 71 ℃ in water-bath, till constantly stirring into emulsion, the impouring insulation is dripped in the system device again, keep under 40-45 ℃ the condition, heavy 30mg selects suitable water dropper for use by every ball, splashes into in the refrigerative liquid Paraffin of ice bath with the speed of about 80 of per minutes, promptly forms drop pill of the present invention.
Example 2 by above-mentioned Formulation Example 2, is got 10% part of pipemidic acid and is all pulverized by 100 mesh sieves, adds 5% part of propylene glycol and 4% Polyethylene Glycol at normal temperatures
400It is standby to stir into thin pasty state after the mixing; Get 81% Polyethylene Glycol
6000Place container, in 78 ℃ of water-baths, be heated to fusion, make standby pipemidic acid propylene glycol, Polyethylene Glycol with above-mentioned then
6000Thin paste all joins Polyethylene Glycol
6000Fused solution in, and continue in water-bath, to be heated under 74 ℃ the condition, fully stir into emulsion, the impouring insulation is dripped in the system device together then, heavy 30mg selects suitable water dropper for use by every ball, splash in the refrigerative liquid Paraffin of ice bath commonly used with 80 left and right sides speed of per minute, drop pill forms and can take out.
Pharmacodynamic experiment:
Select for use female Cavia porcellus to set up the otitis media model, the random packet treatment with staphylococcus aureus, group B streptococcus, bacillus pyocyaneus, Bacillus proteus; Use the drop pill that contains the 2mg pipemidic acid for one group, another is organized with the positive contrast of 2.5% chloromycetin in glycerin, and the 3rd group is blank, first group is better than second group of curative effect as a result, effective percentage is greater than 90%, obvious effective rate 70%, and there were significant differences (P＜0.05) with blank.
Acute toxicity testing result: LD50＞5000mg/kg.
Clinical test results: the chloromycetin in glycerin with 2.5% is the suppurative middle ear fire of contrast treatment, with pipemidic acid drop pill group total effective rate 95.8%, average curative day 3.61 days, matched group total effective rate 65.0%, the natural law 9.25% of on average healing.
Advantage of the present invention is a lot of from the above, has at first opened up the application of pipemidic acid in surgery, increases Its novel form at otology externally applied drug dripping pill, and otitis media suppurative had special efficacy, rapid-action, drug effect Height, healing time is short, facts have proved the effect that relatively is better than chloromycetin in glycerin, and pharmacy is uncomplicated, makes With easily, be suitable for and apply.
Claims (5)
1, a kind of external-use drops for ear is characterized in that: with following percentage by weight prescription is that raw material is made: pipemidic acid 5-22%, propylene glycol 2-15%, Polyethylene Glycol
4001-14%, Polyethylene Glycol
600055-90%.
2, external-use drops for ear according to claim 1 is characterized in that: wherein the percentage by weight of each raw material is: pipemidic acid 8-20%, propylene glycol 3-11%, Polyethylene Glycol
400The 2-10 Polyethylene Glycol
600060-80%.
3, external-use drops for ear according to claim 1 is characterized in that: wherein the percentage by weight of each raw material is: pipemidic acid 10-16%, propylene glycol 4-10%, Polyethylene Glycol
4004-10%, Polyethylene Glycol
600070-76%.
4, external-use drops for ear according to claim 1 is characterized in that: wherein the percentage by weight of each raw material is: pipemidic acid 13%, propylene glycol 7%, Polyethylene Glycol
4007%, Polyethylene Glycol
600073%.
5, a kind of method for preparing external-use drops for ear is characterized in that:
1. will gather diethanol by formula ratio
6000Place sealable container, heating and melting in 70-80 ℃ of water-bath;
2. according to formula ratio, the pipemidic acid fine powder of getting 100 mesh sieves adds third poly-, the Polyethylene Glycol
400Stir into fine and smooth pasty state, reenter above-mentioned fused Polyethylene Glycol
6000, continue in water-bath, to be heated to 70-75 ℃, until being mixed into emulsion, the impouring insulation is dripped in the system device, selects suitable water dropper for use by every ball 30mg, and the speed of dripping with per minute 75-85 splashes into in the refrigerative liquid Paraffin of ice bath, promptly obtains external-use drops for ear.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97105805A CN1102389C (en) | 1997-04-23 | 1997-04-23 | External-use drops for ear and its prepn. method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97105805A CN1102389C (en) | 1997-04-23 | 1997-04-23 | External-use drops for ear and its prepn. method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1196933A CN1196933A (en) | 1998-10-28 |
| CN1102389C true CN1102389C (en) | 2003-03-05 |
Family
ID=5168104
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97105805A Expired - Fee Related CN1102389C (en) | 1997-04-23 | 1997-04-23 | External-use drops for ear and its prepn. method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1102389C (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1069197A (en) * | 1992-08-04 | 1993-02-24 | 许万山 | Control preparation of otitis media new drug and application process |
| CN1137917A (en) * | 1996-03-29 | 1996-12-18 | 王继德 | Compound jiabing ear drops and preparation method thereof |
-
1997
- 1997-04-23 CN CN97105805A patent/CN1102389C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1069197A (en) * | 1992-08-04 | 1993-02-24 | 许万山 | Control preparation of otitis media new drug and application process |
| CN1137917A (en) * | 1996-03-29 | 1996-12-18 | 王继德 | Compound jiabing ear drops and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| 中国医药工业杂志1993,24(2) 1993-02-28 钱传训等以聚醚为基质研制耳用滴丸 * |
| 中药药剂 学第一版 1986-12-31 曹春林等上 海科学技术出版社出版 * |
| 中药药剂 学第一版 1986-12-31 曹春林等上 海科学技术出版社出版;医药导报1994,13(6) 1994-06-30 侯金成等急慢性中耳炎的局部给药介绍 ;中国医药工业杂志1993,24(2) 1993-02-28 钱传训等以聚醚为基质研制耳用滴丸 * |
| 医药导报1994,13(6) 1994-06-30 侯金成等急慢性中耳炎的局部给药介绍 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1196933A (en) | 1998-10-28 |
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| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C53 | Correction of patent for invention or patent application | ||
| CB03 | Change of inventor or designer information |
Inventor after: Yu Huiqin Inventor before: Yu Huiqin |
|
| COR | Change of bibliographic data |
Free format text: CORRECT: INVENTOR; FROM: YU HUIQIN TO: YU HUIQIN |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C19 | Lapse of patent right due to non-payment of the annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |