CN102313687A - Method for detecting cream preparation for treating phimosis - Google Patents
Method for detecting cream preparation for treating phimosis Download PDFInfo
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- CN102313687A CN102313687A CN201110214632A CN201110214632A CN102313687A CN 102313687 A CN102313687 A CN 102313687A CN 201110214632 A CN201110214632 A CN 201110214632A CN 201110214632 A CN201110214632 A CN 201110214632A CN 102313687 A CN102313687 A CN 102313687A
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- cream preparation
- betamethasone
- phimosis
- triethanolamine
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Abstract
The invention which discloses a method for detecting a cream preparation for treating phimosis relates to the cream preparation for treating phimosis. Active components of the cream preparation comprise a therapeutically effective amount of betamethasone or pharmaceutically acceptable salts thereof, a therapeutically effective amount of premarin or pharmaceutically acceptable salts thereof, and a therapeutically effective amount of an antibiotic medicine, and the cream preparation is prepared with stearic acid, octadecanol, liquid paraffin, triethanolamine and water as accessories. The method is characterized in that chromatographic detection conditions comprise that: the chromatographic column is a long C18 column; the mobile phase is 50-70:50-30v/v of methanol: water; the flow rate is 0.5-1.5ml.min<-1>, and the detection wavelength is 239-241nm. The method for detecting the cream preparation of the invention which has the advantages of good reappearance and high detection sensitivity is helpful for controlling the quality of the detecting cream preparation.
Description
Technical field
The present invention relates to a kind of detection method of pharmaceutical preparation, in particular to a kind of detection method of treating the cream preparation of phimosis.
Background technology
Phimosis is that common clinically congenital male sex organ are unusual.It is meant that ostium praeputiale is narrow and small, or foreskin and glans penis adhesion, make foreskin can not on turn over, orificium urethrae externum and glans penis can not the persons of exposing.Often accumulating in the foreskin chamber of phimosis has smegma, and is prone to cause repeatedly foreskin balanitis or up property urinary tract infections; Long-term inflammation can cause external orifice stricture, also can bring out carcinoma of penis.
The common method of treating phimosis clinically is operation, i.e. circumcision, but circumcision has a lot of complication.The external used medicine of therefore necessary research and development treatment phimosis.
Betamethasone (English name: be a kind of strong effect glucocorticoid betamethasone), included by domestic and international pharmacopeia, be used for rheumatism, rheumatoid arthritis, lupus erythematosus, serious bronchial astehma etc. clinically.Betamethasone external curing phimosis is in clinical experimental stage abroad, does not obtain the FDA approval as yet.
Premarin (English name: conjugated estrogens); Have another name called conjugated estrogens (English name: premarin) be a kind of water-soluble natural premarin that from pregnant horse urine, extracts; Included by domestic and international pharmacopeia, be used for hypoovarianism, hypoplasia of uterus, functional uterine bleeding etc. clinically.Premarin external curing phimosis is in clinical experimental stage abroad, does not obtain the FDA approval as yet.
Yet at present the made preparation of single-activity composition is when the treatment phimosis, and cure rate is on the low side, is not suitable for clinical use.
Summary of the invention
In order to prepare the quality that the cream preparation of phimosis is treated in control, the present invention adopts following technical scheme:
One aspect of the present invention relates to a kind of cream preparation of treating phimosis; Described cream preparation active component comprises betamethasone or its pharmaceutically acceptable salt, the conjugated estrogens of treatment effective dose or the antiphlogistic of its pharmaceutically acceptable salt and treatment effective dose of treating effective dose; And use stearic acid, 18 alcohol, whiteruss, triethanolamine and water to process cream preparation as auxiliary material; It is characterized in that described detection method comprises that chromatogram detects, described chromatographic condition is chromatographic column: C
18Long column; Moving phase: 50-70: 50-30v/v methyl alcohol: water; Flow velocity: 0.5-1.5mlmin
-1Detect wavelength: 240 ± 1nm;
In a preferred implementation of the present invention, described detection method also comprises the drawing standard curve: precision pipettes 0.5mgml respectively
-1The methanol solution 0.05,0.1,0.5,1.0 of betamethasone standard items; 1.5 2.0ml uses the methanol solution constant volume in the volumetric flask of 10ml; Shake up, precision is measured 20 μ l injection liquid chromatograph, record chromatogram respectively; With the standard items peak area is ordinate, and drug quality concentration is that horizontal ordinate carries out linear regression, gets the betamethasone standard items at 2.5-100ugml
-1Linear equation.
In a preferred implementation of the present invention, described auxiliary material is stearic acid 10-14w/w%, 18 pure 3-5w/w%, whiteruss 4-8w/w%, triethanolamine 1-2w/w%.
In a preferred implementation of the present invention, described auxiliary material is stearic acid 11-13w/w%, 18 pure 3.5-4.5w/w%, whiteruss 5-7w/w%, triethanolamine 1-1.5w/w%.
In a preferred implementation of the present invention, described antiphlogistic is an erythromycin.
In a preferred implementation of the present invention, described detection method also comprises granularity Detection: it is an amount of to get these article, is coated with straticulation; The thin layer area is equivalent to the cover glass area; Be coated with three altogether,, all must not detect particle greater than 180um according to granularity and the inspection of particle size distribution method.
In a preferred implementation of the present invention, described detection method comprises that also microbial limit detects.
The detection method favorable reproducibility of cream preparation of the present invention, detection sensitivity is high, helps to control the quality of cream preparation.
Description of drawings
Fig. 1: betamethasone standard items chromatogram;
Fig. 2: cream preparation test sample chromatogram of the present invention.
Embodiment
1.1 prescription
Betamethasone 0.05g, conjugated estrogens 0.1g, erythromycin 0.01g, stearic acid 12%, 18 alcohol 4%, whiteruss 6.25%, triethanolamine 1.25%, purified water adds to total amount 100g.
1.2 preparation
Join vessel in heating to 80 ℃ ± 1 ℃ respectively by oil phase substrate stearic acid, 18 alcohol, whiteruss, the albolene of recipe quantity and different factor levels; Medicine, triethanolamine and purified water are added in another container dissolving and are heated to 80 ℃ ± 1 ℃; Slowly add water in the oil phase; The limit edged stirs, and solidifies promptly to emulsifiable paste to get.
Cream preparation indication of the present invention: be used for the treatment of phimosis and redundant prepuce.Local topical is got these article and is applied to preputial orifice of penis skin in right amount, and every day 3 times, treating for 6 weeks continuously is a course of treatment.
Use phimosis pine cream preparation treatment phimosis in children 120 examples of the present invention in Lanzhou University's second hospital's Urology Surgery year February in November, 2004 to 2006; Age 2-12 year; Average 6.5 years old, glans penis was wrapped in the foreskin fully before the treatment, foreskin can't on turn over and appear orificium urethrae externum.Use phimosis of the present invention pine emulsifiable paste to treat after the course of treatment, foreskin can on turn in coronary sulcus, glans penis exposes and is regarded as curing, through statistics, cure rate is 87.5%.
It is an amount of that [inspection] granularity is got these article, is coated with straticulation, and the thin layer area is equivalent to the cover glass area, is coated with three altogether, according to granularity and particle size distribution method (2010 editions Chinese Pharmacopoeia appendix IX E first methods) inspection, all must not detect the particle greater than 180um.
Loading amount should be up to specification according to minimum fill inspection technique (2010 editions Chinese Pharmacopoeia appendix X F) inspection.
Microbial limit should be up to specification according to microbial limit test (2010 editions Chinese Pharmacopoeia appendix XI J) inspection.
[assay] measured according to high performance liquid chromatography (2010 editions Chinese Pharmacopoeia appendix V D).
Chromatographic condition chromatographic column: C
18Long column; Moving phase: methyl alcohol: water (60: 40); Flow velocity: 1ml min
-1Detect wavelength: 240nm; Column temperature: 30 ℃; Sample size: 20ul.
The drafting of typical curve precision respectively pipettes 0.5mgml
-1The methanol solution 0.05,0.1,0.5,1.0 of betamethasone standard items; 1.5 2.0ml uses the methanol solution constant volume in the volumetric flask of 10ml; Shake up, precision is measured 20 μ l injection liquid chromatograph, record chromatogram respectively; With standard items peak area (A) is ordinate, and drug quality concentration (ρ) is carried out linear regression for horizontal ordinate, gets the betamethasone standard items at 2.5-100ugml
-1Linear equation.
Determination method is got these article an amount of (being equivalent to betamethasone 1mg approximately), and accurate the title decides, and puts in the 50ml measuring bottle, and it is an amount of to add methyl alcohol; Put in 80 ℃ of water-baths and heated 2 minutes, jolting makes the betamethasone dissolving, puts and is chilled to room temperature; Be diluted to scale with methyl alcohol, shake up, put in the ice bath and cooled off 2 hours; Filter with organic phase filter membrane (0.22 μ m) rapidly, discard filtrating 10ml just, get subsequent filtrate as need testing solution; Precision is measured 20 μ l and is injected liquid chromatograph, and the record chromatogram is brought the sample peak area into linear equation and calculated, and promptly gets.
Between sample and other components good degree of separation being arranged under the selected chromatogram flow phase condition, satisfy exclusive, accurate, the accurate and sensitive requirement of content detection, referring to Figure of description 1 and 2.
Should be understood that, concerning those of ordinary skills, can improve or conversion, and all these improvement and conversion all should belong to the protection domain of accompanying claims of the present invention according to above-mentioned explanation.
Claims (7)
1. detection method of treating the cream preparation of phimosis; Wherein the cream preparation active component comprises betamethasone or its pharmaceutically acceptable salt, the conjugated estrogens of treatment effective dose or the antiphlogistic of its pharmaceutically acceptable salt and treatment effective dose of treating effective dose; And use stearic acid, 18 alcohol, whiteruss, triethanolamine and water to process cream preparation as auxiliary material; It is characterized in that described detection method comprises that chromatogram detects, described chromatographic condition is chromatographic column: C
18Long column; Moving phase: 50-70: 50-30v/v methyl alcohol: water; Flow velocity: 0.5-1.5mlmin
-1Detect wavelength: 240 ± 1nm.
2. detection method according to claim 1, described detection method also comprises the drawing standard curve: the accurate respectively methanol solution 0.05,0.1 that pipettes 0.5mgml-1 betamethasone standard items; 0.5,1.0,1.5; 2.0ml in the volumetric flask of 10ml, use the methanol solution constant volume, shake up; Precision is measured 20 μ l injection liquid chromatograph respectively, and the record chromatogram is an ordinate with the standard items peak area; Drug quality concentration is that horizontal ordinate carries out linear regression, gets the betamethasone standard items at 2.5-100ugml
-1Linear equation.
3. detection method according to claim 1 and 2, described auxiliary material are stearic acid 10-14w/w%, 18 pure 3-5w/w%, whiteruss 4-8w/w%, triethanolamine 1-2w/w%.
4. detection method according to claim 1 and 2, described auxiliary material are stearic acid 11-13w/w%, 18 pure 3.5-4.5w/w%, whiteruss 5-7w/w%, triethanolamine 1-1.5w/w%.
5. according to any described detection method of claim 1-4, it is characterized in that described antiphlogistic is an erythromycin.
6. detection method according to claim 5 is characterized in that described detection method also comprises granularity Detection: it is an amount of to get these article, is coated with straticulation; The thin layer area is equivalent to the cover glass area; Be coated with three altogether,, all must not detect particle greater than 180um according to granularity and the inspection of particle size distribution method.
7. detection method according to claim 5 is characterized in that described detection method comprises that also microbial limit detects.
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| CN201110214632A CN102313687A (en) | 2011-07-29 | 2011-07-29 | Method for detecting cream preparation for treating phimosis |
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| CN201110214632A CN102313687A (en) | 2011-07-29 | 2011-07-29 | Method for detecting cream preparation for treating phimosis |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104198609A (en) * | 2014-09-10 | 2014-12-10 | 重庆华邦制药有限公司 | Method for extracting compounds with pregnane mother nucleus structure from compositions |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101169396A (en) * | 2007-05-10 | 2008-04-30 | 广东省保化检测中心有限公司 | Cosmetic product betamethasone high efficiency liquid chromatography detection method |
| CN101750457A (en) * | 2009-12-04 | 2010-06-23 | 兰州大学 | Method for measuring ciclopirox olamine |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101169396A (en) * | 2007-05-10 | 2008-04-30 | 广东省保化检测中心有限公司 | Cosmetic product betamethasone high efficiency liquid chromatography detection method |
| CN101750457A (en) * | 2009-12-04 | 2010-06-23 | 兰州大学 | Method for measuring ciclopirox olamine |
Non-Patent Citations (2)
| Title |
|---|
| 孙程: "《小儿包茎的局部类固醇治疗-40例临床疗效分析》", 《中国优秀硕士学位论文全文数据库》, 31 January 2004 (2004-01-31) * |
| 苏金龙: "《包茎松凝胶的制备及质量控制》", 《中国药师》, 31 December 2008 (2008-12-31), pages 1057 - 1059 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104198609A (en) * | 2014-09-10 | 2014-12-10 | 重庆华邦制药有限公司 | Method for extracting compounds with pregnane mother nucleus structure from compositions |
| CN104198609B (en) * | 2014-09-10 | 2016-08-24 | 重庆华邦制药有限公司 | The method of the compound with pregnane mother nucleus structure is extracted from composition |
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Application publication date: 20120111 |