CN101947253A - External compound preparation for curing tinea corporis as well as preparation method and content measuring method thereof - Google Patents
External compound preparation for curing tinea corporis as well as preparation method and content measuring method thereof Download PDFInfo
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- CN101947253A CN101947253A CN 201010296521 CN201010296521A CN101947253A CN 101947253 A CN101947253 A CN 101947253A CN 201010296521 CN201010296521 CN 201010296521 CN 201010296521 A CN201010296521 A CN 201010296521A CN 101947253 A CN101947253 A CN 101947253A
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- 238000002360 preparation method Methods 0.000 title claims abstract description 85
- 206010005913 Body tinea Diseases 0.000 title claims abstract description 70
- 208000002474 Tinea Diseases 0.000 title claims abstract description 70
- 201000003875 tinea corporis Diseases 0.000 title claims abstract description 70
- 150000001875 compounds Chemical class 0.000 title claims abstract description 60
- 238000000034 method Methods 0.000 title claims abstract description 21
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims abstract description 101
- YGSDEFSMJLZEOE-UHFFFAOYSA-N salicylic acid Chemical compound OC(=O)C1=CC=CC=C1O YGSDEFSMJLZEOE-UHFFFAOYSA-N 0.000 claims abstract description 86
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 claims abstract description 75
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 58
- 239000005711 Benzoic acid Substances 0.000 claims abstract description 49
- 235000010233 benzoic acid Nutrition 0.000 claims abstract description 49
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 claims abstract description 43
- 229960004889 salicylic acid Drugs 0.000 claims abstract description 43
- 229940040145 liniment Drugs 0.000 claims abstract description 7
- 239000000865 liniment Substances 0.000 claims abstract description 7
- 239000000499 gel Substances 0.000 claims abstract description 4
- 239000006210 lotion Substances 0.000 claims abstract description 4
- 239000002674 ointment Substances 0.000 claims abstract description 4
- -1 patch Substances 0.000 claims abstract description 4
- 239000007921 spray Substances 0.000 claims abstract description 4
- 239000000243 solution Substances 0.000 claims description 38
- 229940098465 tincture Drugs 0.000 claims description 36
- 229910052740 iodine Inorganic materials 0.000 claims description 27
- 239000011630 iodine Substances 0.000 claims description 27
- 239000008213 purified water Substances 0.000 claims description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 27
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 claims description 26
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 26
- 238000013019 agitation Methods 0.000 claims description 24
- 239000013558 reference substance Substances 0.000 claims description 18
- 229960004756 ethanol Drugs 0.000 claims description 15
- 238000010790 dilution Methods 0.000 claims description 12
- 239000012895 dilution Substances 0.000 claims description 12
- 238000003756 stirring Methods 0.000 claims description 12
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 9
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 3
- 238000001514 detection method Methods 0.000 claims description 3
- 239000003085 diluting agent Substances 0.000 claims description 3
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 3
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 3
- 235000019800 disodium phosphate Nutrition 0.000 claims description 3
- 238000010812 external standard method Methods 0.000 claims description 3
- 239000000945 filler Substances 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims description 3
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims description 3
- 230000001105 regulatory effect Effects 0.000 claims description 3
- 239000002966 varnish Substances 0.000 claims description 3
- 238000003556 assay Methods 0.000 claims description 2
- 238000004811 liquid chromatography Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 13
- 201000010618 Tinea cruris Diseases 0.000 abstract description 9
- 239000003814 drug Substances 0.000 abstract description 8
- 201000004647 tinea pedis Diseases 0.000 abstract description 6
- 229940079593 drug Drugs 0.000 abstract description 5
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 abstract description 5
- 238000002560 therapeutic procedure Methods 0.000 abstract description 5
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 abstract description 4
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 abstract description 4
- 208000031888 Mycoses Diseases 0.000 abstract description 4
- 230000001225 therapeutic effect Effects 0.000 abstract description 4
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 abstract 1
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 abstract 1
- 229960004365 benzoic acid Drugs 0.000 abstract 1
- 229940116229 borneol Drugs 0.000 abstract 1
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 230000007547 defect Effects 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 abstract 1
- 239000010408 film Substances 0.000 abstract 1
- 229940041616 menthol Drugs 0.000 abstract 1
- 229960004839 potassium iodide Drugs 0.000 abstract 1
- 208000015181 infectious disease Diseases 0.000 description 5
- 230000035876 healing Effects 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 230000036285 pathological change Effects 0.000 description 3
- 231100000915 pathological change Toxicity 0.000 description 3
- 206010017533 Fungal infection Diseases 0.000 description 2
- 241000233866 Fungi Species 0.000 description 2
- 206010067197 Tinea manuum Diseases 0.000 description 2
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- LPNBBFKOUUSUDB-UHFFFAOYSA-N p-toluic acid Chemical compound CC1=CC=C(C(O)=O)C=C1 LPNBBFKOUUSUDB-UHFFFAOYSA-N 0.000 description 2
- 239000003507 refrigerant Substances 0.000 description 2
- 208000017520 skin disease Diseases 0.000 description 2
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- 230000001954 sterilising effect Effects 0.000 description 2
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- 208000003322 Coinfection Diseases 0.000 description 1
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- 201000004624 Dermatitis Diseases 0.000 description 1
- 206010048768 Dermatosis Diseases 0.000 description 1
- DKNPRRRKHAEUMW-UHFFFAOYSA-N Iodine aqueous Chemical compound [K+].I[I-]I DKNPRRRKHAEUMW-UHFFFAOYSA-N 0.000 description 1
- 206010024438 Lichenification Diseases 0.000 description 1
- 208000010195 Onychomycosis Diseases 0.000 description 1
- 208000037581 Persistent Infection Diseases 0.000 description 1
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- 210000000436 anus Anatomy 0.000 description 1
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- 238000003745 diagnosis Methods 0.000 description 1
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- 230000002349 favourable effect Effects 0.000 description 1
- 210000004392 genitalia Anatomy 0.000 description 1
- 210000004013 groin Anatomy 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 201000005882 tinea unguium Diseases 0.000 description 1
- 210000000689 upper leg Anatomy 0.000 description 1
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to an external compound preparation for curing tinea corporis as well as a preparation method and a content measuring method thereof, which solves the problems of slow therapeutic action and low curative ratio of the existing oral and injective therapy techniques in curing tinea corporis, tinea cruris, hand-foot tinea and other fungus infection diseases and the difficulties of the existing oral and injective therapy techniques that more factors and defects influence the product quality in the product production process. The external compound preparation of the invention is prepared by the following steps: dissolving benzoic acid, salicylic acid, iodine, potassium iodide, menthol and borneol with ethanol; and then respectively preparing into tinctures, linimentum, pigmentum, liniment, patch, ointment, gels, lotion, film agents and spray. In the preparation process, a closed preparation method is adopted, thereby preventing active components from volatilizing and ensuring the curative effect of drugs. The invention adopts the convenient and stable content measuring method, thereby ensuring the product quality, enabling the curative effect to be more definite, being capable of curing superficial fungus infection and having good effect for the tinea corporis, the tinea cruris and the hand-foot tinea.
Description
Technical field
The present invention relates to a kind of externally used compound preparation for the treatment of tinea corporis, the invention still further relates to content of effective assay method in the preparation method of this compound preparation and this compound preparation.
Background technology
Tinea corporis is by fungus-caused a kind of infectious disease.Its source of infection mainly is the tinea manuum, tinea pedis, the clothing of tinea unguium and pollution etc.Sickness rate in China is the trend that rises year by year in recent years, and cure rate is lower, and more easily recurrence of back is because tinea corporis betides positions such as face, neck, trunk and extremity well, have a strong impact on attractive in appearancely, can both produce negative effect in various degree patient's quality of life, mental status.Tinea cruris is good sending out in the dermatosis of thigh portion, pilosity is born in around external genitalia, groin, perineal position and the anus, acute pruritus, owing to scratch, but patient's secondary dermatitis, lichenification change or secondary infection, it also is a kind of chronic infection dermatoses that is difficult to cure, because site of pathological change bears a pretty, delicate skin, therefore aspect medication, be restricted, at present, adopt methods such as oral, injection and external to the treatment of tinea corporis, tinea cruris clinically, but effect is slower usually in oral medicine, drug effect is difficult to arrive the affected part; Tinea corporis, tinea cruris mostly are local morbidity, and therefore, oral and injection is not ideal Therapeutic Method.And most medicines to influence the factor and the defective of product quality in process of production more, preparation process complexity and quality instability, the method for inspection are also quick inadequately, and the influence factor is more, poor stability can not effectively be ensured drug quality.
Summary of the invention
The present invention is in order to solve existing oral and injection for curing technology in the treatment tinea corporis, there is the problem that therapeutical effect is slow, cure rate is low in tinea cruris and influences the factor of product quality and defective is more and the not enough difficult problem efficiently of the method for inspection and a kind of externally used compound preparation for the treatment of tinea corporis and preparation method thereof and content assaying method are provided in process of producing product in the fungal infection lysises such as hands, tinea pedis.
A kind of externally used compound preparation for the treatment of tinea corporis of the present invention is by 60～140 parts in benzoic acid according to parts by weight; 40～120 parts of salicylic acid; 2～20 parts of iodine; 1～15 part of potassium iodide; 3～20 parts of Mentholums; 3～20 parts of Borneolum Syntheticums are tincture, liniment, varnish, liniment, patch, unguentum, gel, lotion, membrane or the spray of making respectively behind 20%～90% the dissolve with ethanol through mass concentration.Concrete preparation can be a tincture.
A kind of preparation method for the treatment of the externally used compound preparation of tinea corporis of the present invention is: get 100～650 parts of dehydrated alcohol and place dissolving tank, add 3～20 parts of Mentholums while stirring successively; 3～20 parts of Borneolum Syntheticums; 40～120 parts of salicylic acid; 60～140 parts in benzoic acid is stirred to dissolving fully, is filtered in the Agitation Tank with plate frame filter, and 50～350 parts dehydrated alcohol with remainder places dissolving tank again, washes away tank skin, is filtered in the Agitation Tank with plate frame filter; Extracting container in addition again, with 1～15 part of potassium iodide with the dissolving of 5～80 parts of purified water after, adding 2～20 parts of iodine stirred 10～30 minutes, the dissolving back adds in the aforementioned Agitation Tank, at the uniform velocity stirred 10～50 minutes, add purified water to 1L, continued agitation cycle 10～50 minutes, promptly get the tincture of the externally used compound preparation for the treatment of tinea corporis.
For guaranteeing that the present invention treats the quality of the externally used compound preparation tincture of tinea corporis,, provide the benzoic acid of following steps, salicylic content assaying method at the composition and the preparation method of said preparation:
Detect according to high performance liquid chromatography: step 1: be the chromatographic column of filler with octadecyl silane, make solution with 0.95～1.05mol/L sodium hydrogen phosphate and methanol with 60: 40 volume ratio, reuse phosphoric acid is regulated pH value to 5.2 ± 0.1 back as mobile phase with this solution; The detection wavelength of UV-detector is made as 226nm, and number of theoretical plate calculates by the salicylic acid peak and is not less than 3500, and salicylic acid and benzoic separating degree reach 0.95～1.05; Step 2: measure the externally used compound preparation 0.2～1.5ml of treatment tinea corporis,, again diluent is measured 2.5～5ml, with 10～30 times of the dilutions of the mobile phase described in the step 1, as need testing solution with 1000～1500 times of ethanol dilutions; Step 3: take by weighing the benzoic acid reference substance add in right amount dissolve with ethanol and the dilution make the solution that contains 0.20～0.60mg among every 1ml, the mobile phase described in the reuse step 1 is made the solution that contains 4.0～12.0 μ g among every 1ml, as the benzoic acid reference substance solution; Take by weighing that the salicylic acid reference substance adds dissolve with ethanol in right amount and the solution that contains 0.10～0.60mg among every 1ml is made in dilution, mobile phase described in the reuse step 1 is made the solution that contains 1.0～12.0 μ g among every 1ml, as the salicylic acid reference substance solution, step 4: draw the benzoic acid reference substance solution described in step 2, the step 3, salicylic acid reference substance solution each 5～10 μ l and need testing solution 10～20 μ l respectively, inject chromatograph of liquid, with calculated by peak area benzoic acid and salicylic content, promptly get benzoic acid and salicylic content by external standard method.
The present invention adopts benzoic acid, salicylic acid, iodine, potassium iodide, Mentholum, Borneolum Syntheticum, ethanol, purified water to make a kind of externally used compound preparation for the treatment of tinea corporis.Realized the synergy of benzoic acid, salicylic acid and iodine, avoid causing accompanying infection because antimicrobial spectrum is narrow, can kill the fungus, antibacterial and the mycete that cause tinea corporis, tinea cruris simultaneously, because the present invention has selected the less medicine of zest, therefore also can treat the site of pathological change that bears a pretty, delicate skin.Add the content that effectively to control free-iodine in the time of iodine and potassium iodide, simultaneously, because the adding of Mentholum, Borneolum Syntheticum, bring into play its reducing swelling and alleviating pain, refrigerant comfortable effect, improve the skin physiology environment, reach thorough healing, alleviate the subject discomfort sense, promote the sterilization therapeutical effect of benzoic acid, iodine simultaneously, reducing stimulates the therapeutic process safety and comfort; The present invention adopts the closed method for making in preparation process, from the obtain solution to the fill, all adopt the closed operation, prevent effective ingredient volatilization, especially iodine volatilization, also prevent the ethanol volatilization, guarantee curative effect of medication, thereby make the performance curative effect that product of the present invention can be definite, reach the purpose of thorough healing tinea corporis; And adopt benzoic acid and the two kinds of Determination on content methods of salicylic acid measured simultaneously, method is simple, sensitive, reliable.The present invention can treat superficial fungal infection.Particularly to tinea corporis, tinea cruris, hands, tinea pedis effect are better.
The specific embodiment:
The specific embodiment one: a kind of externally used compound preparation for the treatment of tinea corporis of the present invention and preparation method thereof is to form according to following portions by weight: 60～140 parts in benzoic acid; 40～120 parts of salicylic acid; 2～20 parts of iodine; Potassium iodide; 1～15 part; 3～20 parts of Mentholums; 3～20 parts of Borneolum Syntheticums are to make tincture, liniment, varnish, liniment, patch, unguentum, gel, lotion, membrane, spray respectively behind 20%～90% the dissolve with ethanol through mass concentration.
The externally used compound preparation of the treatment tinea corporis of present embodiment has been realized benzoic acid, the synergy of iodine, avoid causing accompanying infection because antimicrobial spectrum is narrow, can kill simultaneously and cause tinea corporis, the fungus of tinea cruris, antibacterial, mycete, because the present invention has selected the less medicine of zest, also can treat the site of pathological change that bears a pretty, delicate skin, curative effect safety more is definite, simultaneously, because Mentholum, its reducing swelling and alleviating pain is brought into play in the adding of Borneolum Syntheticum, refrigerant comfortable effect, improve the skin physiology environment, reach thorough healing, alleviate the subject discomfort sense, promote benzoic acid simultaneously, the sterilization therapeutical effect of iodine, reducing stimulates the therapeutic process safety and comfort.
The specific embodiment two: what present embodiment and the specific embodiment one were different is: a kind of concrete preparation for the treatment of the externally used compound preparation of tinea corporis of the present invention can be a tincture.
The specific embodiment three: what present embodiment was different with one of specific embodiment one to two is: a kind of tincture for the treatment of the externally used compound preparation of tinea corporis of the present invention is to form according to following portions by weight: 100 parts in benzoic acid; 80 parts of salicylic acid; 6 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums; 790 parts of dehydrated alcohol; 210 parts of purified water.
The specific embodiment four: what present embodiment was different with one of specific embodiment one to three is: a kind of tincture for the treatment of the externally used compound preparation of tinea corporis of the present invention is to form according to following portions by weight: 60 parts in benzoic acid; 40 parts of salicylic acid; 20 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol, 210 parts of purified water.
The specific embodiment five: what present embodiment was different with one of specific embodiment one to four is: a kind of tincture for the treatment of the externally used compound preparation of tinea corporis of the present invention is to form according to following portions by weight: 140 parts in benzoic acid; 40 parts of salicylic acid; 20 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol, 210 parts of purified water.
The specific embodiment six: what present embodiment was different with one of specific embodiment one to five is: a kind of tincture for the treatment of the externally used compound preparation of tinea corporis of the present invention is to form according to following portions by weight: 60 parts in benzoic acid; 120 parts of salicylic acid; 2 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol, 210 parts of purified water.
The specific embodiment seven: what present embodiment was different with one of specific embodiment one to six is: a kind of tincture for the treatment of the externally used compound preparation of tinea corporis of the present invention is to form according to following portions by weight: 140 parts in benzoic acid; 40 parts of salicylic acid; 2 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol, 210 parts of purified water.
The specific embodiment eight: what present embodiment was different with one of specific embodiment one to seven is: a kind of tincture for the treatment of the externally used compound preparation of tinea corporis of the present invention is to form according to following portions by weight: 140 parts in benzoic acid; 120 parts of salicylic acid; 2 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol, 210 parts of purified water.
The specific embodiment nine: what present embodiment was different with one of specific embodiment one to eight is: a kind of tincture for the treatment of the externally used compound preparation of tinea corporis of the present invention is to form according to following portions by weight: 60 parts in benzoic acid; 120 parts of salicylic acid; 20 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol, 210 parts of purified water.
The specific embodiment ten: the present invention is a kind of to treat that benzoic acid, salicylic content assaying method are undertaken by following step in the tincture of externally used compound preparation of tinea corporis:
Detect according to liquid chromatography: step 1: be the chromatographic column of filler with octadecyl silane, make solution with 0.1mol/L sodium hydrogen phosphate and methanol with 60: 40 volume ratio, reuse phosphoric acid is regulated pH value to 5.2 ± 0.1 back as mobile phase with this solution; The detection wavelength of UV-detector is made as 226nm, and number of theoretical plate calculates by the salicylic acid peak and is not less than 3500, and salicylic acid and benzoic separating degree reach 0.95～1.05; Step 2: measure the externally used compound preparation 1ml of treatment tinea corporis,, again diluent is measured 5ml, with 20 times of the dilutions of the mobile phase described in the step 1, as need testing solution with 1250 times of ethanol dilutions; Step 3: take by weighing the benzoic acid reference substance add in right amount dissolve with ethanol and the dilution make the solution that contains 0.40mg among every 1ml, the mobile phase described in the reuse step 1 is made the solution that contains 8.0 μ g among every 1ml, as the benzoic acid reference substance solution; Take by weighing that the salicylic acid reference substance adds dissolve with ethanol in right amount and the solution that contains 0.30mg among every 1ml is made in dilution, mobile phase described in the reuse step 1 is made the solution that contains 6.0 μ g among every 1ml, as the salicylic acid reference substance solution, step 4: draw step 2 respectively, benzoic acid reference substance solution described in the step 3, salicylic acid reference substance solution each 10 μ l and need testing solution 20 μ l, inject chromatograph of liquid, with calculated by peak area benzoic acid and salicylic content, promptly get benzoic acid and salicylic content in the tincture of externally used compound preparation that the present invention treats tinea corporis by external standard method.
Present embodiment para Toluic Acid, salicylic content have been made qualification, guarantee content of effective in the product of the present invention, thereby make the performance curative effect that product of the present invention can be definite, reach the purpose of thorough healing tinea corporis, and measure benzoic acid and salicylic content simultaneously, method is simple, sensitive, reliable.
The specific embodiment 11: the preparation method of tincture that the present invention is a kind of to treat the externally used compound preparation of tinea corporis is: get 100～650 parts of dehydrated alcohol and place dissolving tank, add 3～20 parts of Mentholums while stirring successively; 3～20 parts of Borneolum Syntheticums; 40～120 parts of salicylic acid; 60～140 parts in benzoic acid is stirred to dissolving fully, is filtered in the Agitation Tank with plate frame filter, and 50～350 parts dehydrated alcohol with remainder places dissolving tank again, washes away tank skin, is filtered in the Agitation Tank with plate frame filter; Extracting container in addition again, with 1～15 part of potassium iodide with the dissolving of 5～80 parts of purified water after, adding 2～20 parts of iodine stirred 10～30 minutes, the dissolving back adds in the aforementioned Agitation Tank, at the uniform velocity stirred 10～50 minutes, add purified water to 1L, continued agitation cycle 10～50 minutes, promptly get the tincture that the present invention treats the externally used compound preparation of tinea corporis.
The preparation method of the externally used compound preparation of the treatment tinea corporis of present embodiment adopts overall process closed method for making, from the obtain solution to the fill, all adopts the closed operation, prevent effective ingredient volatilization, especially iodine volatilization, also prevent the ethanol volatilization, guarantee effective ingredient, thereby guarantee curative effect.
The specific embodiment 12: what present embodiment and the specific embodiment 11 were different is: the preparation method of tincture that the present invention is a kind of to treat the externally used compound preparation of tinea corporis is: get 130 parts of dehydrated alcohol and place dissolving tank, add 10 parts of Mentholums, 10 parts of Borneolum Syntheticums, 80 parts of salicylic acid, 100 parts of benzoic acid while stirring successively, be stirred to dissolving fully, be filtered in the Agitation Tank with plate frame filter, 80 parts dehydrated alcohol with remainder places dissolving tank again, wash away tank skin, be filtered in the Agitation Tank with leaf filter; Extracting container in addition again, with 4 parts of potassium iodide with 20 parts of purified water dissolvings after, add 6 parts of iodine stirrings 20 minutes, the dissolving back adds in the aforementioned Agitation Tank, at the uniform velocity stirs 30 minutes, adds purified water to 1L, continue agitation cycle 30 minutes, and promptly got the tincture that the present invention treats the externally used compound preparation of tinea corporis.
The specific embodiment 13: what present embodiment was different with one of specific embodiment 11 to 12 is: the preparation method of tincture that the present invention is a kind of to treat the externally used compound preparation of tinea corporis is: get 615 parts of dehydrated alcohol and place dissolving tank, add 10 parts of Mentholums, 10 parts of Borneolum Syntheticums, 80 parts of salicylic acid, 100 parts of benzoic acid while stirring successively, be stirred to dissolving fully, be filtered in the Agitation Tank with plate frame filter, 330 parts dehydrated alcohol with remainder places dissolving tank again, wash away tank skin, be filtered in the Agitation Tank with leaf filter; Extracting container in addition again, with 4 parts of potassium iodide with 20 parts of purified water dissolvings after, add 6 parts of iodine stirrings 20 minutes, the dissolving back adds in the aforementioned Agitation Tank, at the uniform velocity stirs 30 minutes, adds purified water to 1L, continue agitation cycle 30 minutes, and promptly got the tincture that the present invention treats the externally used compound preparation of tinea corporis.
The specific embodiment 14: what present embodiment was different with one of specific embodiment 11 to 13 is: the preparation method of tincture that the present invention is a kind of to treat the externally used compound preparation of tinea corporis is: get 513 parts of dehydrated alcohol and place dissolving tank, add 10 parts of Mentholums, 10 parts of Borneolum Syntheticums, 80 parts of salicylic acid, 100 parts of benzoic acid while stirring successively, be stirred to dissolving fully, be filtered in the Agitation Tank with plate frame filter, 277 parts dehydrated alcohol with remainder places dissolving tank again, wash away tank skin, be filtered in the Agitation Tank with leaf filter; Extracting container in addition again, with 4 parts of potassium iodide with 20 parts of purified water dissolvings after, add 6 parts of iodine stirrings 20 minutes, the dissolving back adds in the aforementioned Agitation Tank, at the uniform velocity stirs 30 minutes, adds purified water to 1L, continue agitation cycle 30 minutes, and promptly got the tincture that the present invention treats the externally used compound preparation of tinea corporis.
A kind of externally used compound preparation for the treatment of tinea corporis of present embodiment preparation is about to suitability for industrialized production, is " going choosing " brand with the trade mark that uses, and must obtain favorable economic benefit.
Table 1 is treated the detailed content of clinical pharmacodynamics report of tincture of the externally used compound preparation of tinea corporis for present embodiment preparation a kind of, all can cure the occur together tinea manuum, tinea pedis etc. of tinea corporis, and wherein the state of an illness is diagnosed and accepted and believed the diagnosis that regular hospital provides.Treat by the patient to 50 18～40 years old age of example, the clinical cure rate of tincture that present embodiment preparation a kind of treats the externally used compound preparation of tinea corporis is 96%, and effective percentage is 100%.
Table 1
Claims (10)
1. externally used compound preparation for the treatment of tinea corporis, it is characterized in that: it is by 60～140 parts in benzoic acid according to parts by weight; 40～120 parts of salicylic acid; 2～20 parts of iodine; 1～15 part of potassium iodide; 3～20 parts of Mentholums; 3～20 parts of Borneolum Syntheticums are tincture, liniment, varnish, liniment, patch, unguentum, gel, lotion, membrane or the spray of making respectively behind 20%～90% the dissolve with ethanol through mass concentration.
2. according to the described a kind of externally used compound preparation for the treatment of tinea corporis of claim 1, the tincture that it is characterized in that treating the externally used compound preparation of tinea corporis is to form according to following portions by weight: 100 parts in benzoic acid; 80 parts of salicylic acid; 6 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol and 210 parts of purified water.
3. according to the described a kind of externally used compound preparation for the treatment of tinea corporis of claim 1, the tincture that it is characterized in that treating the externally used compound preparation of tinea corporis is to form according to following portions by weight: 60 parts in benzoic acid; 40 parts of salicylic acid; 20 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol and 210 parts of purified water.
4. according to the described a kind of externally used compound preparation for the treatment of tinea corporis of claim 1, the tincture that it is characterized in that treating the externally used compound preparation of tinea corporis is to form according to following portions by weight: 140 parts in benzoic acid; 40 parts of salicylic acid; 20 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol and 210 parts of purified water.
5. according to the described a kind of externally used compound preparation for the treatment of tinea corporis of claim 1, the tincture that it is characterized in that treating the externally used compound preparation of tinea corporis is to form according to following portions by weight: 60 parts in benzoic acid; 120 parts of salicylic acid; 2 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol and 210 parts of purified water.
6. according to the described a kind of externally used compound preparation for the treatment of tinea corporis of claim 1, the tincture that it is characterized in that treating the externally used compound preparation of tinea corporis is to form according to following portions by weight: 140 parts in benzoic acid; 40 parts of salicylic acid; 2 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol and 210 parts of purified water.
7. according to the described a kind of externally used compound preparation for the treatment of tinea corporis of claim 1, the tincture that it is characterized in that treating the externally used compound preparation of tinea corporis is to form according to following portions by weight: 140 parts in benzoic acid; 120 parts of salicylic acid; 2 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol and 210 parts of purified water.
8. according to the described a kind of externally used compound preparation for the treatment of tinea corporis of claim 1, the tincture that it is characterized in that treating the externally used compound preparation of tinea corporis is to form according to following portions by weight: 60 parts in benzoic acid; 120 parts of salicylic acid; 20 parts of iodine; 4 parts of potassium iodide; 10 parts of Mentholums; 10 parts of Borneolum Syntheticums, 790 parts of dehydrated alcohol and 210 parts of purified water.
9. a kind of preparation method for the treatment of the externally used compound preparation of tinea corporis as claimed in claim 1, it is characterized in that: the preparation method of the tincture of described a kind of externally used compound preparation for the treatment of tinea corporis is: get 100～650 parts of dehydrated alcohol and place dissolving tank, add 3～20 parts of Mentholums while stirring successively; 3～20 parts of Borneolum Syntheticums; 40～120 parts of salicylic acid; 60～140 parts in benzoic acid is stirred to dissolving fully, is filtered in the Agitation Tank with plate frame filter, and 50～350 parts dehydrated alcohol with remainder places dissolving tank again, washes away tank skin, is filtered in the Agitation Tank with plate frame filter; Extracting container in addition again, with 1～15 part of potassium iodide with the dissolving of 5～80 parts of purified water after, adding 2～20 parts of iodine stirred 10～30 minutes, the dissolving back adds in the aforementioned Agitation Tank, at the uniform velocity stirred 10～50 minutes, add purified water to 1L, continued agitation cycle 10～50 minutes, promptly get the tincture of the externally used compound preparation for the treatment of tinea corporis.
10. a kind of content assaying method for the treatment of the externally used compound preparation of tinea corporis as claimed in claim 1, it is characterized in that: a kind of middle benzoic acid, salicylic acid content assay method of tincture of externally used compound preparation for the treatment of tinea corporis are: detect according to liquid chromatography: step 1: be the chromatographic column of filler with octadecyl silane, make solution with 0.95～1.05mol/L sodium hydrogen phosphate and methanol with 60: 40 volume ratio, reuse phosphoric acid is regulated pH value to 5.2 ± 0.1 back as mobile phase with this solution; The detection wavelength of UV-detector is made as 226nm, and number of theoretical plate calculates by the salicylic acid peak and is not less than 3500, and salicylic acid and benzoic separating degree reach 0.95～1.05; Step 2: measure the externally used compound preparation 0.2～1.5ml of treatment tinea corporis,, again diluent is measured 2.5～5ml, with 10～30 times of the dilutions of the mobile phase described in the step 1, as need testing solution with 1000～1500 times of ethanol dilutions; Step 3: take by weighing the benzoic acid reference substance add in right amount dissolve with ethanol and the dilution make the solution that contains 0.20～0.60mg among every 1ml, the mobile phase described in the reuse step 1 is made the solution that contains 4.0～12.0 μ g among every 1ml, as the benzoic acid reference substance solution; Take by weighing that the salicylic acid reference substance adds dissolve with ethanol in right amount and the solution that contains 0.10～0.60mg among every 1ml is made in dilution, mobile phase described in the reuse step 1 is made the solution that contains 1.0～12.0 μ g among every 1ml, as the salicylic acid reference substance solution, step 4: draw the benzoic acid reference substance solution described in step 2, the step 3, salicylic acid reference substance solution each 5～10 μ l and need testing solution 10～20 μ l respectively, inject chromatograph of liquid, with calculated by peak area benzoic acid and salicylic content, promptly get benzoic acid and salicylic content by external standard method.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102788863A (en) * | 2012-05-18 | 2012-11-21 | 贵州神奇药业股份有限公司 | Detection method of compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1436557A (en) * | 2002-02-03 | 2003-08-20 | 沈志强 | Disinfectant |
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| CN1436557A (en) * | 2002-02-03 | 2003-08-20 | 沈志强 | Disinfectant |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102788863A (en) * | 2012-05-18 | 2012-11-21 | 贵州神奇药业股份有限公司 | Detection method of compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment |
| CN102788863B (en) * | 2012-05-18 | 2014-04-23 | 贵州神奇药业股份有限公司 | Detection method of compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment |
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