CN105412000A - Preparation method for mupirocin ointment - Google Patents
Preparation method for mupirocin ointment Download PDFInfo
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- CN105412000A CN105412000A CN201510809721.1A CN201510809721A CN105412000A CN 105412000 A CN105412000 A CN 105412000A CN 201510809721 A CN201510809721 A CN 201510809721A CN 105412000 A CN105412000 A CN 105412000A
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- mupirocin
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Abstract
The invention discloses a preparation method for a mupirocin ointment. The mupirocin ointment is prepared from, by mass, 1-5 parts of a main drug mupirocin, 19-80 parts of polyethylene glycol 3350 and 19-80 parts of polyethylene glycol 400. The preparation method comprises the steps that the polyethylene glycol 3350 is dissolved at 80 DEG C until the solution is clear to obtain a polyethylene glycol 3350 solution; the main drug mupirocin is dispersed with the polyethylene glycol 400, the mixture is added into the polyethylene glycol 3350 solution, 80-DEG C heat preservation is performed for 30 min, low-speed stirring is performed, it is guaranteed that the main drug mupirocin is completely dissolved, and materials are obtained; cooling water is started, high-speed stirring is started at the speed of 600 r/min for 30 min in the cooling process until the materials are cooled to 55 DEG C, then a high-speed emulsification head is started, a 3000-r/min high-speed shearing state is kept until the materials are cooled to 38 DEG C, and the material is discharged and filled. According to the preparation method, the particle size of 95% of the prepared materials is smaller than 50 micrometers, and the problem that filling amount cannot be controlled in the filling process is solved.
Description
Technical field
The present invention relates to medical art, specifically a kind of preparation method of mupirocin ointment.
Background technology
Mupirocin (Mupirocin) has another name called Mupirocin, is a kind of more satisfactory skin surface antibiotic preparation, 1985 by GlaxoSmithKline PLC with " Mupirocin Ointment " (Bactroban) for trade name is introduced to the market.U.S. FDA was ratified this medicine and is used in U.S.'s listing in 1987, China was approval Sino-U.S.'s SmithKline pharmaceutical manufacturing in 1993 and sell this medicine.Mupirocin is mainly used in the bacterial skin infections disease that prevention and therapy gram-positive cocci causes, the primary cutaneous such as such as impetigo, furuncle and phyma, folliculitis infects, and the secondary skin infections disease such as eczema concurrent infection, ulcer concurrent infection, wound concurrent infection.The dominant mechanism of mupirocin antibacterial action is the protein synthesis in anti-bacteria body.
The chemistry of mupirocin is called 9-{4-[5-(2,3-epoxy-5-hydroxy-4-methyl hexyl)-3,4-dihydroxy Pentamethylene oxide .-2-bases]-3-methyl but-2-ene phthalein oxygen } n-nonanoic acid, molecular formula is C
26h
44o
90.
At present, in clinical practice, the primary formulation of mupirocin has mupirocin calcium cream (taking mupirocin calcium as active component) and mupirocin ointment (taking mupirocin as active component) two kinds.The mupirocin ointment of existing Sino-America Tianjin Shike Pharmaceutical Co., Ltd. production and selling, its active component is mupirocin, and ointment base is PEG400 (mean molecule quantity is 400, lower same) and PEG3350.Because PEG3350 is solid at normal temperatures, fusing point about 52 DEG C, and PEG400 is liquid at normal temperatures, in preparation cooling procedure, after temperature is lower than 52 DEG C, PEG3350 can XianCheng graininess be separated out, and causes that material is coarse, denseness is excessive, in pouring process, loading amount is uncontrollable, finally causes finished product character defective.
Summary of the invention
The object of the present invention is to provide the preparation method of the satisfactory mupirocin ointment of a kind of granularity.
For achieving the above object, the invention provides following technical scheme:
A preparation method for mupirocin ointment, described mupirocin ointment consists of according to the prescription of mass parts: principal agent mupirocin 1 ~ 5 part, PEG3350 19 ~ 80 parts, PEG400 19 ~ 80 parts, said method comprising the steps of:
(1) PEG3350 is dissolved to clarification at 80 DEG C, obtains PEG3350 solution, stand-by;
(2) disperseed by principal agent mupirocin PEG400, add in PEG3350 solution, 80 DEG C of insulation 30min, low rate mixing, guarantees that principal agent mupirocin dissolves completely, obtains material;
(3) open cooling water, in cooling procedure, open rapid stirring, mixing speed is 600r/min, mixing time 30min, until be cooled to 55 DEG C, then opens emulsify at a high speed head, keep the high speed shear state of 3000r/min, until material is cooled to 38 DEG C, discharging fill.
As the further scheme of the present invention: in described step (2), mixing speed is 60 ~ 120r/min.
As the further scheme of the present invention: described discharging fill obtain 95% raw meal particle size be less than 50 μm.
Compared with prior art, the invention has the beneficial effects as follows:
The present invention is by opening emulsify at a high speed head, keep high speed shear state, until material is cooled to 38 DEG C, Polyethylene Glycol 3500 in bulk precipitation fast can be prevented, guarantee that the raw meal particle size of 95% is less than 50 μm, guarantee that material is fine and smooth, avoid because material is coarse, the uncontrollable problem of loading amount in excessive the caused pouring process of denseness, final obtained material finished product character is qualified.
Detailed description of the invention
Below in conjunction with the embodiment of the present invention, be clearly and completely described the technical scheme in the embodiment of the present invention, obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art, not making the every other embodiment obtained under creative work prerequisite, belong to the scope of protection of the invention.
Embodiment 1
In the embodiment of the present invention, a kind of preparation method of mupirocin ointment, described mupirocin ointment consists of according to the prescription of mass parts: principal agent mupirocin 1 part, PEG3350 19 parts, PEG400 80 parts, said method comprising the steps of:
(1) PEG3350 is dissolved to clarification at 80 DEG C, obtains PEG3350 solution, stand-by;
(2) disperseed by principal agent mupirocin PEG400, add in PEG3350 solution, 80 DEG C of insulation 30min, low rate mixing, guarantees that principal agent mupirocin dissolves completely, obtains material;
(3) open cooling water, in cooling procedure, open rapid stirring, mixing speed is 600r/min, mixing time 30min, until be cooled to 55 DEG C, then opens emulsify at a high speed head, keep the high speed shear state of 3000r/min, until material is cooled to 38 DEG C, discharging fill.
Embodiment 2
In the embodiment of the present invention, a kind of preparation method of mupirocin ointment, described mupirocin ointment consists of according to the prescription of mass parts: principal agent mupirocin 1 part, PEG3350 80 parts, PEG400 19 parts, said method comprising the steps of:
(1) PEG3350 is dissolved to clarification at 80 DEG C, obtains PEG3350 solution, stand-by;
(2) disperseed by principal agent mupirocin PEG400, add in PEG3350 solution, 80 DEG C of insulation 30min, low rate mixing, guarantees that principal agent mupirocin dissolves completely, obtains material;
(3) open cooling water, in cooling procedure, open rapid stirring, mixing speed is 600r/min, mixing time 30min, until be cooled to 55 DEG C, then opens emulsify at a high speed head, keep the high speed shear state of 3000r/min, until material is cooled to 38 DEG C, discharging fill.
Embodiment 3
In the embodiment of the present invention, a kind of preparation method of mupirocin ointment, described mupirocin ointment consists of according to the prescription of mass parts: principal agent mupirocin 5 parts, PEG3350 48 parts, PEG400 47 parts, said method comprising the steps of:
(1) PEG3350 is dissolved to clarification at 80 DEG C, obtains PEG3350 solution, stand-by;
(2) disperseed by principal agent mupirocin PEG400, add in PEG3350 solution, 80 DEG C of insulation 30min, low rate mixing, guarantees that principal agent mupirocin dissolves completely, obtains material;
(3) open cooling water, in cooling procedure, open rapid stirring, mixing speed is 600r/min, mixing time 30min, until be cooled to 55 DEG C, then opens emulsify at a high speed head, keep the high speed shear state of 3000r/min, until material is cooled to 38 DEG C, discharging fill.
The present invention is by opening emulsify at a high speed head, keep high speed shear state, until material is cooled to 38 DEG C, Polyethylene Glycol 3500 in bulk precipitation fast can be prevented, guarantee that the raw meal particle size of 95% is less than 50 μm, guarantee that material is fine and smooth, avoid because material is coarse, the uncontrollable problem of loading amount in excessive the caused pouring process of denseness, final obtained material finished product character is qualified.
To those skilled in the art, obviously the invention is not restricted to the details of above-mentioned one exemplary embodiment, and when not deviating from spirit of the present invention or basic feature, the present invention can be realized in other specific forms.Therefore, no matter from which point, all should embodiment be regarded as exemplary, and be nonrestrictive, scope of the present invention is limited by claims instead of above-mentioned explanation, and all changes be therefore intended in the implication of the equivalency by dropping on claim and scope are included in the present invention.
In addition, be to be understood that, although this description is described according to embodiment, but not each embodiment only comprises an independently technical scheme, this narrating mode of description is only for clarity sake, those skilled in the art should by description integrally, and the technical scheme in each embodiment also through appropriately combined, can form other embodiments that it will be appreciated by those skilled in the art that.
Claims (3)
1. the preparation method of a mupirocin ointment, described mupirocin ointment consists of according to the prescription of mass parts: principal agent mupirocin 1 ~ 5 part, PEG3350 19 ~ 80 parts, PEG400 19 ~ 80 parts, it is characterized in that, said method comprising the steps of:
(1) PEG3350 is dissolved to clarification at 80 DEG C, obtains PEG3350 solution, stand-by;
(2) disperseed by principal agent mupirocin PEG400, add in PEG3350 solution, 80 DEG C of insulation 10min, low rate mixing, guarantees that principal agent mupirocin dissolves completely, obtains material;
(3) open cooling water, in cooling procedure, open rapid stirring, mixing speed is 600r/min, mixing time 30min, until be cooled to 55 DEG C, then opens emulsify at a high speed head, keep the high speed shear state of 3000r/min, until material is cooled to 38 DEG C, discharging fill.
2. the preparation method of mupirocin ointment according to claim 1, is characterized in that, in described step (2), mixing speed is 60 ~ 120r/min.
3. the preparation method of mupirocin ointment according to claim 1, is characterized in that, described discharging fill obtain 95% raw meal particle size be less than 50 μm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510809721.1A CN105412000A (en) | 2015-11-23 | 2015-11-23 | Preparation method for mupirocin ointment |
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| CN201510809721.1A CN105412000A (en) | 2015-11-23 | 2015-11-23 | Preparation method for mupirocin ointment |
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| CN105412000A true CN105412000A (en) | 2016-03-23 |
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| CN201510809721.1A Pending CN105412000A (en) | 2015-11-23 | 2015-11-23 | Preparation method for mupirocin ointment |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110787128A (en) * | 2019-12-17 | 2020-02-14 | 福元药业有限公司 | Mupirocin ointment and preparation method thereof |
| CN113520994A (en) * | 2021-08-12 | 2021-10-22 | 福元药业有限公司 | Mupirocin ointment preparation |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102335122A (en) * | 2011-06-21 | 2012-02-01 | 北京协和药厂 | Mupirocin ointment and preparation method thereof |
| CN102871955A (en) * | 2012-10-29 | 2013-01-16 | 杭州朱养心药业有限公司 | Ointment medicament composition containing mupirocin |
| CN102885763A (en) * | 2012-10-29 | 2013-01-23 | 杭州朱养心药业有限公司 | Novel mupirocin ointment pharmaceutical composition |
| CN104644474A (en) * | 2015-02-06 | 2015-05-27 | 深圳唯美度生物科技有限公司 | Foot-protecting gel with moistening and anti-cracking effects |
-
2015
- 2015-11-23 CN CN201510809721.1A patent/CN105412000A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102335122A (en) * | 2011-06-21 | 2012-02-01 | 北京协和药厂 | Mupirocin ointment and preparation method thereof |
| CN102871955A (en) * | 2012-10-29 | 2013-01-16 | 杭州朱养心药业有限公司 | Ointment medicament composition containing mupirocin |
| CN102885763A (en) * | 2012-10-29 | 2013-01-23 | 杭州朱养心药业有限公司 | Novel mupirocin ointment pharmaceutical composition |
| CN104644474A (en) * | 2015-02-06 | 2015-05-27 | 深圳唯美度生物科技有限公司 | Foot-protecting gel with moistening and anti-cracking effects |
Non-Patent Citations (2)
| Title |
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| 任晓文: "《药物制剂工艺及设备类型》", 31 January 2010, 化学工业出版社 * |
| 张绪峤: "《药物制剂设备与车间工艺设计》", 31 July 2000, 中国医药科技出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110787128A (en) * | 2019-12-17 | 2020-02-14 | 福元药业有限公司 | Mupirocin ointment and preparation method thereof |
| WO2021120268A1 (en) * | 2019-12-17 | 2021-06-24 | 福元药业有限公司 | Mupirocine ointment and preparation method therefor |
| CN113520994A (en) * | 2021-08-12 | 2021-10-22 | 福元药业有限公司 | Mupirocin ointment preparation |
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