CN116148373A - Pediatric benorilate vitamin B 1 Method for measuring dissolution rate of particles - Google Patents
Pediatric benorilate vitamin B 1 Method for measuring dissolution rate of particles Download PDFInfo
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- CN116148373A CN116148373A CN202211394075.3A CN202211394075A CN116148373A CN 116148373 A CN116148373 A CN 116148373A CN 202211394075 A CN202211394075 A CN 202211394075A CN 116148373 A CN116148373 A CN 116148373A
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- benorilate
- vitamin
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- 229960004277 benorilate Drugs 0.000 title claims abstract description 56
- FEJKLNWAOXSSNR-UHFFFAOYSA-N benorilate Chemical compound C1=CC(NC(=O)C)=CC=C1OC(=O)C1=CC=CC=C1OC(C)=O FEJKLNWAOXSSNR-UHFFFAOYSA-N 0.000 title claims abstract description 56
- JZRWCGZRTZMZEH-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 238000004090 dissolution Methods 0.000 title claims abstract description 39
- 238000000034 method Methods 0.000 title claims abstract description 29
- 239000002245 particle Substances 0.000 title claims abstract description 23
- 239000000243 solution Substances 0.000 claims abstract description 51
- 238000001514 detection method Methods 0.000 claims abstract description 13
- 239000012738 dissolution medium Substances 0.000 claims abstract description 9
- 239000012085 test solution Substances 0.000 claims abstract description 7
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 24
- 238000002360 preparation method Methods 0.000 claims description 18
- 229930003270 Vitamin B Natural products 0.000 claims description 15
- 235000019156 vitamin B Nutrition 0.000 claims description 15
- 239000011720 vitamin B Substances 0.000 claims description 15
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 14
- 239000007788 liquid Substances 0.000 claims description 13
- 239000012488 sample solution Substances 0.000 claims description 13
- 239000013558 reference substance Substances 0.000 claims description 12
- 238000007865 diluting Methods 0.000 claims description 10
- 238000005303 weighing Methods 0.000 claims description 10
- 239000003085 diluting agent Substances 0.000 claims description 8
- 239000000523 sample Substances 0.000 claims description 8
- 239000000945 filler Substances 0.000 claims description 7
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 229960000583 acetic acid Drugs 0.000 claims description 5
- 239000012362 glacial acetic acid Substances 0.000 claims description 5
- 239000000047 product Substances 0.000 claims description 5
- 239000012467 final product Substances 0.000 claims description 4
- 238000012360 testing method Methods 0.000 claims description 4
- 238000010812 external standard method Methods 0.000 claims description 3
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims description 3
- 239000000377 silicon dioxide Substances 0.000 claims description 3
- 238000010790 dilution Methods 0.000 claims description 2
- 239000012895 dilution Substances 0.000 claims description 2
- 229960003495 thiamine Drugs 0.000 claims 1
- 235000019157 thiamine Nutrition 0.000 claims 1
- 239000011721 thiamine Substances 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 abstract description 5
- 238000005259 measurement Methods 0.000 abstract description 4
- 238000004458 analytical method Methods 0.000 abstract description 2
- 239000003814 drug Substances 0.000 abstract description 2
- 230000002349 favourable effect Effects 0.000 abstract description 2
- 238000010586 diagram Methods 0.000 description 6
- 208000002193 Pain Diseases 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 238000000691 measurement method Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- UIERGBJEBXXIGO-UHFFFAOYSA-N thiamine mononitrate Chemical compound [O-][N+]([O-])=O.CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N UIERGBJEBXXIGO-UHFFFAOYSA-N 0.000 description 3
- 238000001914 filtration Methods 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000004811 liquid chromatography Methods 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 208000006820 Arthralgia Diseases 0.000 description 1
- 208000005171 Dysmenorrhea Diseases 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- 208000019695 Migraine disease Diseases 0.000 description 1
- 208000000112 Myalgia Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000009506 drug dissolution testing Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 206010027599 migraine Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 201000009240 nasopharyngitis Diseases 0.000 description 1
- 208000004296 neuralgia Diseases 0.000 description 1
- 229940126532 prescription medicine Drugs 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 229960000344 thiamine hydrochloride Drugs 0.000 description 1
- 235000019190 thiamine hydrochloride Nutrition 0.000 description 1
- 239000011747 thiamine hydrochloride Substances 0.000 description 1
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
- 208000004371 toothache Diseases 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a pediatric benorilate vitamin B 1 A method for measuring the dissolution rate of particles belongs to the technical field of medicine detection and analysis. The method adopts high performance liquid chromatography, comprises combining dissolution medium solution, test solution, control solution and system applicability solution, and measuring by dissolution and release degree measurement (generally 0931 second method) in the same chromatographic system for both benorilate and vitamin B 1 The dissolution rate detection is carried out, the specificity is strong, the accuracy is high, and the method is favorable for pediatric benorilate vitamin B 1 And (5) controlling the quality of the particles.
Description
Technical Field
The invention belongs to the technical field of medicine detection and analysis, and in particular relates to a pediatric benorilate vitamin B 1 Particle dissolution measurement method.
Background
Pediatric benorilate vitamin B 1 The granule is a non-prescription medicine for relieving fever and pain caused by common cold or influenza of children, and also for relieving pain such as pain of mild to moderate degreeHeadache, arthralgia, migraine, toothache, myalgia, neuralgia and dysmenorrhea. The product is a compound preparation, and the main ingredients are benorilate and vitamin B 1 The specification and polarity of the two components are greatly different: benorilate is 0.3 g/bag, insoluble in water; vitamin B 1 Is 3 mg/bag, and is easily dissolved in water.
The existing standard only monitors the content of two main medicinal components, the benoride adopts ultraviolet absorption coefficient method, and vitamin B 1 The term "dissolution" is not defined by liquid chromatography. And the measurement is carried out by two detection methods, so that the measurement time is increased, and the data accuracy is low.
Disclosure of Invention
The invention aims to provide a pediatric benorilate vitamin B 1 A method for measuring the dissolution rate of particles features that high-performance liquid chromatography is used to obtain the extract of benorilate and vitamin B 1 The components with large difference between two specifications and polarity are subjected to dissolution detection, so that the specificity is strong, the accuracy is high, and the method is beneficial to the pediatric benorilate vitamin B 1 The quality control of the particles solves the technical problem of detection by two methods in the prior art.
The invention is realized by the following technical scheme:
pediatric benorilate vitamin B 1 The method for measuring the dissolution rate of particles adopts a high performance liquid chromatography method, and the dissolution rate and the release rate are measured according to a dissolution rate and release rate measuring method (general rule 0931 second method), and comprises the following steps:
(1) Preparing a dissolution liquid: preparing a dissolution solution by taking a 1% sodium dodecyl sulfate solution as a dissolution medium;
(2) Preparing a sample solution, a control solution and a system applicability solution;
(3) Precisely measuring the sample solution and the reference substance solution, respectively injecting into a liquid chromatograph, recording the chromatograms, and calculating according to the external standard method and peak areas.
Preferably, the specific preparation method of the dissolution liquid comprises the following steps: 1000ml of 1% sodium dodecyl sulfate solution is taken as a dissolution medium, the rotating speed is 100 revolutions per minute, the operation is carried out according to the law, and the dissolution liquid is obtained after sampling for 45 minutes.
Preferably, the test solution comprises a benorilate test solution and vitamin B 1 A test solution;
the specific preparation method of the benorilate test sample solution comprises the following steps: precisely weighing 1ml of filtered solution, placing in a 50ml measuring flask, diluting to scale with diluent, and shaking to obtain the final product;
the vitamin B 1 The specific preparation method of the sample solution comprises the following steps: taking the filtered dissolution liquid.
The pediatric benorilate vitamin B 1 In the granule, benorilate (0.3 g) and vitamin B 1 (3 mg) specification difference 100 times, two components were quantified in the same sample solution, peak response difference was large, and vitamin B was large due to the large solubility difference of the two 1 The control substance is dissolved rapidly in the dissolution medium, but the benorilate control substance is difficult to dissolve in the dissolution medium, which is unfavorable for accurately preparing the benorilate control substance solution, so that the two component solutions are respectively prepared: vitamin B preparation by dissolution medium 1 Reference substance, vitamin B is directly measured by using dissolved liquid 1 The leaching amount; the benorilate control was prepared with methanol, and the amount of benorilate eluted was measured by diluting the solution with methanol.
Preferably, the control solution comprises a benorilate control solution and vitamin B 1 A control solution;
the specific preparation method of the benorilate control solution comprises the following steps: taking 15mg of benorilate reference substance, precisely weighing, placing into a 50ml measuring flask, adding a diluent for dissolution and dilution to a scale, shaking uniformly, precisely weighing 1ml, placing into a 50ml measuring flask, diluting to the scale with the diluent, and shaking uniformly to obtain the product;
the vitamin B 1 The specific preparation method of the control solution comprises the following steps: 15mg of thiamine nitrate is taken, precisely weighed, placed in a 100ml measuring flask, dissolved with 1% sodium dodecyl sulfate solution to fix volume, precisely removed 1ml, placed in a 50ml measuring flask, diluted with 1% sodium dodecyl sulfate solution to fix volume, and then obtained;
the system applicability solution is characterized in that the theoretical plate number is not less than 3000 calculated according to the benorilate peak.
The above-mentioned quiltIn vitamin B 1 The (thiamine hydrochloride) reference substance has strong hygroscopicity and may cause weighing error, and thiamine nitrate is considered as vitamin B 1 To ensure the accuracy of the test.
Preferably, the diluent is a methanol solution.
Preferably, the chromatographic conditions are as follows:
octadecylsilane chemically bonded silica is used as a filler; acetonitrile-methanol-water-glacial acetic acid is taken as a mobile phase; the flow rate is 1.0ml/min; the column temperature is 35 ℃; the detection wavelength is 244nm; the sample volume was 10. Mu.l.
Vitamin B due to maximum absorption of benorilate around 240nm 1 Has maximum absorption near 244nm due to vitamin B 1 The specification is smaller, so 244nm is used as the detection wavelength in order to ensure the accuracy of the detection result.
Preferably, the filler has a specification of 4.6mm×150mm and a filler particle diameter of 5 μm.
Preferably, the volume ratio of acetonitrile-methanol-water-glacial acetic acid is 37:36:27:0.3.
Preferably, the mobile phase contains sodium dodecyl sulfate with a mass fraction of 0.35%.
Compared with the prior art, the invention has at least the following technical effects:
the invention provides a pediatric benorilate vitamin B 1 A method for measuring the dissolution rate of particles by high performance liquid chromatography includes such steps as simultaneously comparing benorilate with vitamin B in a same chromatographic system 1 The dissolution rate detection is carried out, the specificity is strong, the accuracy is high, and the method is favorable for pediatric benorilate vitamin B 1 And (5) controlling the quality of the particles.
Drawings
FIG. 1 is a schematic diagram of a chromatographic profile of a benorilate control;
FIG. 2 is a schematic diagram of a chromatographic pattern of benorilate for a batch 210701 of samples;
FIG. 3 is vitamin B 1 A chromatographic diagram of a reference substance;
FIG. 4 is a 210701 batch of sample vitamin B 1 A chromatographic schematic.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to the following examples, which are to be construed as merely illustrative and not limitative of the scope of the invention, but are not intended to limit the scope of the invention to the specific conditions set forth in the examples, either as conventional or manufacturer-suggested, nor are reagents or apparatus employed to identify manufacturers as conventional products available for commercial purchase.
The technical scheme of a specific implementation mode of the invention is as follows:
pediatric benorilate vitamin B 1 The method for measuring the dissolution rate of particles, which is measured by a high performance liquid chromatography and a dissolution rate and release rate measurement method (general rule 0931 second method), comprises:
1. chromatographic conditions
Octadecylsilane chemically bonded silica was used as filler (4.6X250 mm,5 μm);
acetonitrile-methanol-water-glacial acetic acid (volume ratio: 37:36:27:0.3) (containing sodium dodecyl sulfate 0.35%) is used as a mobile phase;
the flow rate is 1.0ml/min; the column temperature is 35 ℃; the detection wavelength is 244nm; the sample volume was 10. Mu.l.
2. Solution preparation
2.1 preparation of the dissolution solution
1000ml of 1% sodium dodecyl sulfate solution is taken as a dissolution medium, the rotating speed is 100 revolutions per minute, the operation is carried out according to the law, and the dissolution liquid is obtained after sampling for 45 minutes.
2.2 preparation of sample solutions
Preparation of a benorilate test solution: taking out proper amount of the dissolved solution, filtering, precisely measuring 1ml of the continuous filtrate, placing into a 50ml measuring flask, diluting to scale with methanol, and shaking uniformly to obtain the final product.
Vitamin B 1 Preparing a test solution: and (5) taking out a proper amount of the dissolved solution, and filtering to obtain the product.
2.3 preparation of control solution
Preparation of benorilate control solution: taking about 15mg of benorilate reference substance, precisely weighing, placing into a 50ml measuring flask, adding methanol for dissolving and diluting to scale, shaking uniformly, precisely measuring 1ml, placing into a 50ml measuring flask, diluting to scale with methanol, and shaking uniformly to obtain the final product.
Vitamin B 1 Preparing a reference substance solution: taking about 15mg of thiamine nitrate reference substance, precisely weighing, placing into a 100ml measuring flask, dissolving with 1% sodium dodecyl sulfate solution to a certain volume, precisely transferring 1ml, placing into a 50ml measuring flask, and diluting with 1% sodium dodecyl sulfate solution to a certain volume.
3. System applicability requirements
The theoretical plate number is not less than 3000 calculated as benorilate peak.
4. Measurement method
Precisely measuring the sample solution and the reference substance solution, respectively injecting into a liquid chromatograph, and recording the chromatograms. Calculated as peak area according to the external standard method.
5. Methodological verification
For pediatric benorilate vitamin B 1 The particle dissolution testing method is used for performing specificity and system precision, filter membrane adsorptivity, solution stability, accuracy, linearity and range, precision and durability verification tests, and the conclusion is as follows:
example 1:
the technical scheme flow of the specific implementation mode is adopted.
And (3) experimental detection:
batch: 210701
Sample 6 bags were taken, each sample was taken, and the samples and the related materials were prepared and treated in the same manner as in example 1, and then measured. The experimental sample source: diao group is a capital pharmaceutical Co.
The measurement results show that:
the above table results show:
FIG. 1 shows a schematic diagram of a chromatographic profile of a benorilate control;
as shown in fig. 2, there is a schematic diagram of a chromatographic profile of benorilate in 210701 batches.
The chromatogram shows: the dissolved solution diluted by methanol can effectively detect the benorilate component without the interference of miscellaneous peaks.
As shown in FIG. 3, is vitamin B 1 A chromatographic diagram of a reference substance;
as shown in fig. 4, vitamin B was found to be a 210701 batch sample 1 A chromatographic schematic.
The chromatogram shows: the undiluted stock solution can effectively detect vitamin B 1 The components and no impurity peak interference, i.e. the method can detect the benorilate and the vitamin B simultaneously under the same liquid chromatography system 1 The specificity is strong, and the accuracy is high.
Finally, it should be noted that: the foregoing description is only of the preferred embodiments of the invention and is not intended to limit the scope of the invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. Pediatric benorilate vitamin B 1 The method for measuring the dissolution rate of particles is characterized by comprising the following steps of:
(1) Preparing a dissolution liquid: preparing a dissolution solution by taking a 1% sodium dodecyl sulfate solution as a dissolution medium;
(2) Preparing a sample solution, a control solution and a system applicability solution;
(3) Precisely measuring the sample solution and the reference substance solution, respectively injecting into a liquid chromatograph, recording the chromatograms, and calculating according to the external standard method and peak areas.
2. Pediatric benorilate vitamin B according to claim 1 1 The method for measuring the dissolution rate of the particles is characterized by comprising the following specific preparation method of the dissolution liquid: 1000ml of 1% sodium dodecyl sulfate solution is taken as a dissolution medium, the rotating speed is 100 revolutions per minute, the operation is carried out according to the law, and the dissolution liquid is obtained after sampling for 45 minutes.
3. Pediatric benorilate vitamin B according to claim 1 1 The method for measuring the dissolution rate of particles is characterized in that the sample solution comprises a benorilate sample solution and vitamin B 1 A test solution;
the specific preparation method of the benorilate test sample solution comprises the following steps: precisely weighing 1ml of filtered solution, placing in a 50ml measuring flask, diluting to scale with diluent, and shaking to obtain the final product;
the vitamin B 1 The specific preparation method of the sample solution comprises the following steps: taking the filtered dissolution liquid.
4. Pediatric benorilate vitamin B according to claim 1 1 A method for measuring the dissolution rate of particles, characterized in that the control solution comprises a benorilate control solution and vitamin B 1 A control solution;
the specific preparation method of the benorilate control solution comprises the following steps: taking 15mg of benorilate reference substance, precisely weighing, placing into a 50ml measuring flask, adding a diluent for dissolution and dilution to a scale, shaking uniformly, precisely weighing 1ml, placing into a 50ml measuring flask, diluting to the scale with the diluent, and shaking uniformly to obtain the product;
the vitamin B 1 The specific preparation method of the control solution comprises the following steps: taking thiamine nitrate15mg, precisely weighing, placing into a 100ml measuring flask, dissolving with 1% sodium dodecyl sulfate solution to constant volume, precisely transferring 1ml, placing into a 50ml measuring flask, and diluting with 1% sodium dodecyl sulfate solution to constant volume;
the system applicability solution is characterized in that the theoretical plate number is not less than 3000 calculated according to the benorilate peak.
5. A pediatric benorilate vitamin B according to claim 3 or 4 1 The method for measuring the dissolution rate of particles is characterized in that the diluent is methanol solution.
6. Pediatric benorilate vitamin B according to claim 1 1 The method for measuring the dissolution rate of particles is characterized in that the chromatographic conditions are as follows:
octadecylsilane chemically bonded silica is used as a filler; acetonitrile-methanol-water-glacial acetic acid is taken as a mobile phase; the flow rate is 1.0ml/min; the column temperature is 35 ℃; the detection wavelength is 244nm; the sample volume was 10. Mu.l.
7. A pediatric benorilate vitamin B according to claim 6 1 The method for measuring the dissolution rate of particles is characterized in that the specification of the filler is 4.6mm multiplied by 150mm, and the particle size of the filler is 5 mu m.
8. A pediatric benorilate vitamin B according to claim 6 1 The method for measuring the dissolution rate of the particles is characterized in that the volume ratio of acetonitrile-methanol-water-glacial acetic acid is 37:36:27:0.3.
9. A pediatric benorilate vitamin B according to claim 6 1 The method for measuring the dissolution rate of particles is characterized in that the mobile phase contains 0.35% of sodium dodecyl sulfate by mass.
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Citations (1)
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CN108535386A (en) * | 2018-06-29 | 2018-09-14 | 常州制药厂有限公司 | The method for measuring 5 kinds of component dissolution rates in FUFANG LIXUEPING PIAN with ultra-performance liquid chromatography |
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CN108535386A (en) * | 2018-06-29 | 2018-09-14 | 常州制药厂有限公司 | The method for measuring 5 kinds of component dissolution rates in FUFANG LIXUEPING PIAN with ultra-performance liquid chromatography |
Non-Patent Citations (7)
Title |
---|
刘思聪 等: "制备工艺对维生素B1片溶出行为的影响", 工艺设备, vol. 46, no. 11, 30 November 2020 (2020-11-30), pages 56 - 57 * |
叶爱琴: "复合维生素B片中维生素B2溶出度测定方法研究", 温州医科大学学报, vol. 50, no. 5, 31 May 2020 (2020-05-31), pages 406 - 410 * |
李丽 等: "小儿贝诺酯维B1颗粒含量测定方法的改进", 中国社区医师(综合版), vol. 9, no. 24, 31 December 2007 (2007-12-31), pages 16 * |
梅旭辉 等: "食品药品化妆品监督管理大全", 30 June 2004, 湖北科学技术出版社, pages: 496 - 498 * |
纪世彬: "高效液相色谱-二极管阵列检测器法测定复合维生素B片中5种组分的溶出度", 安徽医药, vol. 24, no. 8, 31 August 2020 (2020-08-31), pages 1512 - 1514 * |
陈宗岱, 等: "贝诺酯片溶出度与人体内血药浓度相关性的研究", 药物分析杂志, vol. 22, no. 1, 31 January 2002 (2002-01-31), pages 55 - 58 * |
顾秋琴: "高效液相色谱法测定小儿贝诺酯维生素B1颗粒的含量", 中国药师, vol. 13, no. 4, 30 April 2010 (2010-04-30), pages 517 - 519 * |
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