CN102697703B - Piroxicam gel preparation and preparation method thereof - Google Patents
Piroxicam gel preparation and preparation method thereof Download PDFInfo
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- CN102697703B CN102697703B CN 201210168352 CN201210168352A CN102697703B CN 102697703 B CN102697703 B CN 102697703B CN 201210168352 CN201210168352 CN 201210168352 CN 201210168352 A CN201210168352 A CN 201210168352A CN 102697703 B CN102697703 B CN 102697703B
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Abstract
The invention provides a piroxicam gel preparation and a preparation method of the piroxicam gel preparation. The gel preparation comprises the following components in percentages by weight: 0.1-1% of piroxicam, 0.3-1.2% of Carbomer 940, 0.1-1% of tromethamine, 1-10% of ethanol, 6-15% of propylene glycol, 0.6-1.5% polyethylene glycol 400, 0.006-0.015%Edetate Disodium, and 1.2-2.1% of triethanolamine. Piroxicam is dissolved by using tromethamine to solve the problem that tromethamine is difficult to dissolve in water, the penetrability of piroxicam to the skin is improved, the absorption rate of piroxicam through the skin is increased, the curative effect is obviously improved by local topical administration for curing the local pain, and a novel administration method for the patients is also provided. The gel preparation is semi-solid gel having good transdermal absorption property; the piroxicam is completely dissolved and dispersed in the gel preparation, thereby facilitating the pain relief for the patient. The preparation process is simple, and the preparation is stable and reliable in quality.
Description
Invention field
The present invention relates to a kind of piroxicam gel preparation and preparation method thereof, belong to medical technical field.
Background technology
Piroxicam is first long-acting non-steroidal anti-inflammatory antirheumatic, pharmaceutical research shows, this medicine bioavailability height, and its plasma half-life reaches 36～45 h, have stronger analgesia, resist inflammation on repercussive function, its anti-inflammatory activity is greater than indometacin, Phenylbutazone, ibuprofen and aspirin etc.Be clinical treatment rheumatoid arthritis, acute sprain, tendinitis and the thrombophlebitis etc. of being widely used in.
Chinese Pharmacopoeia (version in 2005) has recorded tablet, capsule and injection, ointment and gel preparation.Wherein the oral effect of tablet and capsule slowly, to the internal organs zest big even toxigenicity.The topical administration medicine directly absorbs at the blood capillary of lesions position, reduces the dose that enters the body circulation, thereby avoids side effect such as oral absorption is causedly felt sick, vomiting, GI irritation, ulcer, has improved the concentration of lesions position simultaneously.But existing piroxicam ointment has greasy, and the patient uses compliance relatively poor.Existing piroxicam gel preparation transdermal absorption factor is not high, and curative effect is good inadequately.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art part, a kind of gel preparation of new piroxicam is provided.
Piroxicam gel preparation of the present invention comprises following component according to percentage by weight:
The preparation method of piroxicam gel preparation of the present invention may further comprise the steps: carbomer is put in the purified water of the total dosage 50% of prescription, soaked 24 hours; With trometamol put the prescription total dosage 10% water in dissolve, standby; It is even that piroxicam is put in the ethanol dispersed with stirring, adds trometamol aqueous solution stirring and dissolving, clarifies fully to solution, standby; Disodium edetate and remaining purified water stirring and dissolving is to there not being visible particle, standby; The Acritamer 940 that swelling is good is filtered through 120 purposes, propylene glycol, PEG400, disodium edetate solution and the piroxicam solution of recipe quantity is added in the carbomer, stirred 15 minutes; Triethanolamine is added in the carbomer substrate, stirred 30 minutes, pH is at 7.3-8.5 in control, stop to stir, and fill, packing namely gets the piroxicam gel preparation.
The present invention is dissolved piroxicam by adopting trometamol, thereby solve piroxicam insoluble problem in water, improve piroxicam to the penetrance of skin, the transdermal absorbance of piroxicam is improved, obviously improve by local topical administration treatment local pain curative effect, provide a kind of new route of administration for the patient simultaneously.
Gel preparation of the present invention is the good semi-solid gel of Transdermal absorption, and piroxicam dissolves fully and is scattered in the gel, is beneficial to patient's alleviating pain.Processing technology is simple, and the quality of the pharmaceutical preparations is reliable and stable.
The specific embodiment
Embodiment 1
The piroxicam raw material is mixed with the piroxicam gel by following prescription:
Process for preparation
Carbomer is put in the purified water of the total dosage 50% of prescription, soaked 24 hours.With trometamol put the prescription total dosage 10% water in dissolve, standby.It is even that piroxicam is put in the ethanol dispersed with stirring, adds trometamol aqueous solution stirring and dissolving, clarifies fully to solution, standby.Disodium edetate and remaining purified water stirring and dissolving is to there not being visible particle, standby; The Acritamer 940 that swelling is good is filtered through 120 purposes, propylene glycol, PEG400, disodium edetate solution and the piroxicam solution of recipe quantity is added in the carbomer.Stirred 15 minutes; Triethanolamine is added in the carbomer substrate, stirred 30 minutes, pH is at 7.3-8.5 in control, stop to stir, and fill, packing namely gets the piroxicam gel.
Embodiment 2
The piroxicam raw material is mixed with the piroxicam gel by following prescription:
Carbomer is put in the purified water of the total dosage 50% of prescription, soaked 24 hours.With trometamol put the prescription total dosage 10% water in dissolve, standby.It is even that piroxicam is put in the ethanol dispersed with stirring, adds trometamol aqueous solution stirring and dissolving, clarifies fully to solution, standby.Disodium edetate and remaining purified water stirring and dissolving is to there not being visible particle, standby; The Acritamer 940 that swelling is good is filtered through 120 purposes, propylene glycol, PEG400, disodium edetate solution and the piroxicam solution of recipe quantity is added in the carbomer.Stirred 15 minutes; Triethanolamine is added in the carbomer substrate, stirred 30 minutes, pH is at 7.3-8.5 in control, stop to stir, and fill, packing namely gets the piroxicam gel.
Embodiment 3
The piroxicam raw material is mixed with the piroxicam gel by following prescription:
Carbomer is put in the purified water of the total dosage 50% of prescription, soaked 24 hours.With trometamol put the prescription total dosage 10% water in dissolve, standby.It is even that piroxicam is put in the ethanol dispersed with stirring, adds trometamol aqueous solution stirring and dissolving, clarifies fully to solution, standby.Disodium edetate and remaining purified water stirring and dissolving is to there not being visible particle, standby; The Acritamer 940 that swelling is good is filtered through 120 purposes, propylene glycol, PEG400, disodium edetate solution and the piroxicam solution of recipe quantity is added in the carbomer.Stirred 15 minutes; Triethanolamine is added in the carbomer substrate, stirred 30 minutes, pH is at 7.3-8.5 in control, stop to stir, and fill, packing namely gets the piroxicam gel.
Embodiment 4
Experimental selection is experimental provision with the Franz diffusion cell, the amount that sees through the little piglets skin that exsomatizes with piroxicam serves as to investigate index, observe the product (specification: 0.5% of embodiments of the invention 1-3,20g/ props up) and existing product (specification: 0.5%, 20g/ props up) the Transdermal absorption situation, Transdermal absorption measurement result such as table 1:
Table 1
By in-vitro percutaneous permeability test result as can be known, the piroxicam gel sample Transdermal absorption situation of embodiment 1-3 is apparently higher than existing contrast medicine, and increase transmitance in time continues to increase; 24 hours transmitance meansigma methods is 3.29%, and matched group only is 2.45%, contains gel thereby explanation gel preparation Transdermal absorption of the present invention is better than ordinary city, and the blood drug level when having increased local application has improved curative effect.
Claims (2)
1. a piroxicam gel preparation is characterized in that, comprises following component according to percentage by weight:
。
2. the preparation method of piroxicam gel preparation as claimed in claim 1 is characterized in that, may further comprise the steps: carbomer is put in the pure water of the total dosage 50% of prescription, soaked 24 hours; With trometamol put the prescription total dosage 10% water in dissolve, standby; It is even that piroxicam is put in the ethanol dispersed with stirring, adds trometamol aqueous solution stirring and dissolving, clarifies fully to solution, standby; Disodium edetate and remaining pure water stirring and dissolving is to there not being visible particle, standby; The Acritamer 940 that swelling is good is filtered through 120 purposes, propylene glycol, PEG400, disodium edetate solution and the piroxicam solution of recipe quantity is added in the carbomer, stirred 15 minutes; Triethanolamine is added in the carbomer substrate, stirred 30 minutes, pH is at 7.3-8.5 in control, stop to stir, and fill, packing namely gets the piroxicam gel preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 201210168352 CN102697703B (en) | 2012-05-28 | 2012-05-28 | Piroxicam gel preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210168352 CN102697703B (en) | 2012-05-28 | 2012-05-28 | Piroxicam gel preparation and preparation method thereof |
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| Publication Number | Publication Date |
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| CN102697703A CN102697703A (en) | 2012-10-03 |
| CN102697703B true CN102697703B (en) | 2013-09-11 |
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| CN 201210168352 Active CN102697703B (en) | 2012-05-28 | 2012-05-28 | Piroxicam gel preparation and preparation method thereof |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103989628A (en) * | 2014-05-20 | 2014-08-20 | 王俊国 | Etoricoxib gel preparation and preparation method thereof |
| CN106420672A (en) * | 2016-11-06 | 2017-02-22 | 成都先先先生物科技有限公司 | Piroxicam film coating agent and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258458A (en) * | 2011-07-06 | 2011-11-30 | 陕西新药技术开发中心 | Rectal in-situ gel for abating fever and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2189499A (en) * | 1998-02-09 | 1999-08-23 | Chong Kun Dang Pharmaceutical Corp. | Piroxicam-containing hydroalcoholic gel composition |
| JP2005047906A (en) * | 2003-07-16 | 2005-02-24 | Taisho Pharmaceut Co Ltd | Anti-inflammatory/analgesic composition for external application |
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2012
- 2012-05-28 CN CN 201210168352 patent/CN102697703B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258458A (en) * | 2011-07-06 | 2011-11-30 | 陕西新药技术开发中心 | Rectal in-situ gel for abating fever and preparation method thereof |
Non-Patent Citations (6)
| Title |
|---|
| Rathapon A-sasutjarit et al.Viscoelastic Properties of Carbopol 940 Gels and Their Relationships to Piroxicam Diffusion Coefficients in Gel Bases.《Pharmaceutical Research》.2005,第22卷(第12期),2134-2140页. |
| Viscoelastic Properties of Carbopol 940 Gels and Their Relationships to Piroxicam Diffusion Coefficients in Gel Bases;Rathapon A-sasutjarit et al;《Pharmaceutical Research》;20051231;第22卷(第12期);2134-2140页 * |
| 两种吡罗昔康凝胶体外经皮行为的比较;董平 等;《上海医药》;20101231;第31卷(第8期);377-379页 * |
| 董平 等.两种吡罗昔康凝胶体外经皮行为的比较.《上海医药》.2010,第31卷(第8期),377-379页. |
| 董平 等.透皮促进剂对吡罗昔康经皮渗透的影响及吡罗昔康凝胶剂体外透皮性质评价.《中国临床药学杂志》.2010,第19卷(第5期),276-279页. |
| 透皮促进剂对吡罗昔康经皮渗透的影响及吡罗昔康凝胶剂体外透皮性质评价;董平 等;《中国临床药学杂志》;20101231;第19卷(第5期);276-279页 * |
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| CN102697703A (en) | 2012-10-03 |
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Address after: 225453 No. 8, Zhong Dan Road, Hongqiao Town, Taixing, Jiangsu. Patentee after: Jiangsu Xiaolin Pharmaceutical Co., Ltd. Address before: 225453 No. 8, Zhong Dan Road, seven Wei Town, Taixing City, Taizhou, Jiangsu Patentee before: Jiangsu Zhongdan Pharmaceutical Co., Ltd. |
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