CN105548509B - The detection method of drug quality - Google Patents
The detection method of drug quality Download PDFInfo
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- CN105548509B CN105548509B CN201610053441.7A CN201610053441A CN105548509B CN 105548509 B CN105548509 B CN 105548509B CN 201610053441 A CN201610053441 A CN 201610053441A CN 105548509 B CN105548509 B CN 105548509B
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- 239000003814 drug Substances 0.000 title claims abstract description 397
- 229940079593 drug Drugs 0.000 title claims abstract description 213
- 238000001514 detection method Methods 0.000 title claims abstract description 83
- 238000007689 inspection Methods 0.000 claims abstract description 9
- 230000000052 comparative effect Effects 0.000 claims abstract description 4
- 238000000034 method Methods 0.000 claims description 62
- 238000004090 dissolution Methods 0.000 claims description 36
- 239000007788 liquid Substances 0.000 claims description 35
- 239000012738 dissolution medium Substances 0.000 claims description 20
- 239000000243 solution Substances 0.000 claims description 18
- 238000012360 testing method Methods 0.000 claims description 18
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 17
- 238000009825 accumulation Methods 0.000 claims description 14
- 235000019647 acidic taste Nutrition 0.000 claims description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 241000208340 Araliaceae Species 0.000 claims description 6
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 claims description 6
- 235000003140 Panax quinquefolius Nutrition 0.000 claims description 6
- 235000008434 ginseng Nutrition 0.000 claims description 6
- 239000008363 phosphate buffer Substances 0.000 claims description 6
- BHZOKUMUHVTPBX-UHFFFAOYSA-M sodium acetic acid acetate Chemical compound [Na+].CC(O)=O.CC([O-])=O BHZOKUMUHVTPBX-UHFFFAOYSA-M 0.000 claims description 6
- 239000007974 sodium acetate buffer Substances 0.000 claims description 5
- 239000002002 slurry Substances 0.000 claims description 4
- 239000002253 acid Substances 0.000 claims description 3
- 238000002360 preparation method Methods 0.000 abstract description 23
- 238000012372 quality testing Methods 0.000 abstract description 9
- 238000012544 monitoring process Methods 0.000 abstract description 4
- 239000007884 disintegrant Substances 0.000 description 33
- 230000006399 behavior Effects 0.000 description 13
- 238000005260 corrosion Methods 0.000 description 7
- 230000007797 corrosion Effects 0.000 description 7
- 238000005259 measurement Methods 0.000 description 7
- 239000003153 chemical reaction reagent Substances 0.000 description 5
- 239000013256 coordination polymer Substances 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
- 230000033228 biological regulation Effects 0.000 description 3
- 239000007853 buffer solution Substances 0.000 description 3
- 239000006184 cosolvent Substances 0.000 description 3
- 241000894007 species Species 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- YLQBMQCUIZJEEH-UHFFFAOYSA-N Furan Chemical compound C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 229910019142 PO4 Inorganic materials 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000009507 drug disintegration testing Methods 0.000 description 2
- 235000013399 edible fruits Nutrition 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- YMTINGFKWWXKFG-UHFFFAOYSA-N fenofibrate Chemical compound C1=CC(OC(C)(C)C(=O)OC(C)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 YMTINGFKWWXKFG-UHFFFAOYSA-N 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 210000004051 gastric juice Anatomy 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000005457 optimization Methods 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 2
- 239000010452 phosphate Substances 0.000 description 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 2
- VKJGBAJNNALVAV-UHFFFAOYSA-M Berberine chloride (TN) Chemical compound [Cl-].C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 VKJGBAJNNALVAV-UHFFFAOYSA-M 0.000 description 1
- YCSMVPSDJIOXGN-UHFFFAOYSA-N CCCCCCCCCCCC[Na] Chemical compound CCCCCCCCCCCC[Na] YCSMVPSDJIOXGN-UHFFFAOYSA-N 0.000 description 1
- RCEAADKTGXTDOA-UHFFFAOYSA-N OS(O)(=O)=O.CCCCCCCCCCCC[Na] Chemical compound OS(O)(=O)=O.CCCCCCCCCCCC[Na] RCEAADKTGXTDOA-UHFFFAOYSA-N 0.000 description 1
- 240000007594 Oryza sativa Species 0.000 description 1
- 235000007164 Oryza sativa Nutrition 0.000 description 1
- 229920001214 Polysorbate 60 Polymers 0.000 description 1
- YUJLIIRMIAGMCQ-CIUDSAMLSA-N Ser-Leu-Ser Chemical compound [H]N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(O)=O YUJLIIRMIAGMCQ-CIUDSAMLSA-N 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 1
- 239000004327 boric acid Substances 0.000 description 1
- FFGPTBGBLSHEPO-UHFFFAOYSA-N carbamazepine Chemical compound C1=CC2=CC=CC=C2N(C(=O)N)C2=CC=CC=C21 FFGPTBGBLSHEPO-UHFFFAOYSA-N 0.000 description 1
- 229960000623 carbamazepine Drugs 0.000 description 1
- 238000005660 chlorination reaction Methods 0.000 description 1
- 239000007979 citrate buffer Substances 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 230000001186 cumulative effect Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000001934 delay Effects 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 238000005315 distribution function Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- XUFQPHANEAPEMJ-UHFFFAOYSA-N famotidine Chemical compound NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1 XUFQPHANEAPEMJ-UHFFFAOYSA-N 0.000 description 1
- 229960001596 famotidine Drugs 0.000 description 1
- 229960002297 fenofibrate Drugs 0.000 description 1
- 229960003499 fenofibrate micronized Drugs 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 238000013178 mathematical model Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- -1 polyoxyethylene lauryl ether Polymers 0.000 description 1
- 229920000259 polyoxyethylene lauryl ether Polymers 0.000 description 1
- 229960002386 prazosin hydrochloride Drugs 0.000 description 1
- WFXFYZULCQKPIP-UHFFFAOYSA-N prazosin hydrochloride Chemical compound [H+].[Cl-].N=1C(N)=C2C=C(OC)C(OC)=CC2=NC=1N(CC1)CCN1C(=O)C1=CC=CO1 WFXFYZULCQKPIP-UHFFFAOYSA-N 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 229910052938 sodium sulfate Inorganic materials 0.000 description 1
- 235000011152 sodium sulphate Nutrition 0.000 description 1
- OTNVGWMVOULBFZ-UHFFFAOYSA-N sodium;hydrochloride Chemical compound [Na].Cl OTNVGWMVOULBFZ-UHFFFAOYSA-N 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- 235000021419 vinegar Nutrition 0.000 description 1
- 239000000052 vinegar Substances 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Analytical Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The present invention relates to the detection method technical field of drug quality, it is a kind of detection method of drug quality, the detection method of the drug quality, the difference between the quality of tested medicine and the quality of Consult drug is obtained with reference to the t inspection results of the comparative result and tested medicine of tested medicine and the disintegration time limited of Consult drug.The detection method of drug quality of the present invention can reduce the quality testing cost of medicine, in addition, the detection method of drug quality of the present invention can be improved to drug quality accuracy in detection, furthermore, the detection method of drug quality of the present invention can differentiate the preparation process difference of medicine, so as to which the detection method of drug quality of the present invention detects the quality of medicine more fully hereinafter, important foundation is provided for the monitoring and improvement of drug quality.
Description
Technical field
The present invention relates to drug quality detection method technical field, is a kind of detection method of drug quality.
Background technology
Dissolution rate refers to medicine from the speed and degree of the dissolution in regulation solvent of the solid pharmaceutical preparations such as tablet, drug-eluting
Speed and how many, the power for reflecting the speed of drug effect and acting on.Dissolution rate is an important indicator of tablet quality control.
At present, in the drug dissolution continuous mode in Ch.P II, the dissolution medium species that it is used is various, the dissolution medium first kind
For water, 30.0% is accounted for；Second class is the acid solution of various concentration, accounts for 42.2%, including hydrochloric acid solution, acetum, chlorination of hydrochloric acid
Sodium solution and simulated gastric fluid etc.；Three classes are the buffer solution of various concentration and different cultivars, account for 16.3%, including phosphate, vinegar
Hydrochlorate, boric acid, citrate buffer solution etc.；4th class is the solubilizer or cosolvent solution of various concentration and kind, accounts for 7.3%,
Including lauryl sodium sulfate（Sodium lauryl sulfate, SLS）, polyoxyethylene lauryl ether, polyoxyethylene sorbitan monoleate,
Trishydroxymethylaminomethane, ethanol, isopropanol etc.；5th class is addition solubilizer or cosolvent in acid or buffer solution；6th class
4.2% is accounted for for solubilizer plus cosolvent.Also, in CP method, some medicines need to use specific dissolution medium, for example, such as
Medicine in table 1：The dissolution medium of famotidine tablets and Berberine Hydrochloride Tablets is water, Carbamazepine Tablets and Prazosin Hydrochloride Tablets
Dissolution medium is dilute hydrochloric acid, and the dissolution mediums of fenofibrate and fenofibrate micronized capsules is 1% lauryl sodium sulfate, and furan
The dissolution medium of plug rice piece is the phosphate buffer that pH is 5.8, when needing to carry out dissolution rate test to above medicine, is increased
The workload of test is added.In addition, the every batch of medicine of some species must carry out dissolution rate in a variety of difference pH dissolution mediums
Investigate, so as to add the testing cost of dissolution rate.
Disintegration time limited is the important Con trolling index of tablet, capsule and dropping pill formulation.Medicine is mainly under acidic liquid environment
By the significantly wriggling of stomach, it is disintegrated medicine, this process is similar with disintegration time limited inspection.It can be reflected by disintegration time limited
The quality of disintegrant and the amount added in preparation process, the disintegration liquid in the disintegration experiment of medicine is single at present, general provision
Disintegration liquid is water, and disintegration experiment carries out the detection of disintegration time limited using single disintegration liquid, and patient has gastric acidity mostly
Change, therefore, physiological status of the medicine in gastric juice cannot be reflected comprehensively using single disintegration liquid, be not easy to find medicine
The problem of in slaking test, bring harmful effect for the accuracy in detection of drug quality, that is, have impact on the quality testing knot of medicine
Fruit.In addition, II annex XC of Ch.P " are provided in dissolution method：All preparations for checking dissolution rate, no longer carry out disintegration time limited
Check ".
The content of the invention
The present invention provides a kind of detection method of drug quality, overcomes the deficiency of the above-mentioned prior art, it can be effective
Solve the problems, such as that existing drug quality detection method is high there are testing cost.
The technical scheme is that realized by following measures：A kind of detection method of drug quality, by following
Method carries out：Disintegration time limited of the tested medicine in the disintegration liquid of three kinds of different acidities is measured respectively, by each of tested medicine
Compared with disintegration time limited corresponding with Consult drug disintegration time limited, the disintegration liquid of three kinds of different acidities is respectively that pH value is 1.16
The water that the Acetic acid-sodium acetate buffer solution and pH value that aqueous hydrochloric acid solution, pH value to 1.20 are 3.52 to 3.59 are 5.53 to 5.91；
The drug accumulation dissolution percentage that real-time online measure tested medicine changes over time, the medicine that tested medicine is changed over time
The shape for the stripping curve that cumulative defaultlogic carries out obtaining tested medicine after data fitting using Weibull distribution model is joined
Number, the stripping quantity by the form parameter of the stripping curve of tested medicine, tested medicine be the time that mass percent is 50% and by
The stripping quantity of reagent product is that these three parameters of time that mass percent is 63.2% carry out t inspections, tested in t checkout procedures
The form parameter of the stripping curve of medicine is compared with the form parameter of the stripping curve of Consult drug, the dissolution of tested medicine
Measure be the time that mass percent is 50% with the stripping quantity of Consult drug for the time that mass percent is 50% compared with, by
The stripping quantity of reagent product is that the stripping quantity of the time that mass percent is 63.2% and Consult drug is that mass percent is 63.2%
Time be compared, wherein, real-time online measure tested medicine change over time drug accumulation dissolution percentage when, it is tested
The dissolution medium of medicine is identical with the dissolution medium of Consult drug, and the dissolution medium of tested medicine is the phosphate that pH value is 7.6
Buffer solution, dissolving-out method are slurry processes, and rotating speed is 50 revs/min；With reference to the comparison of tested medicine and the disintegration time limited of Consult drug
As a result the t inspection results with three parameters of tested medicine obtain the difference between the quality of tested medicine and the quality of Consult drug
It is different.
Here is the further optimization and/or improvements to foregoing invention technical solution：
It is above-mentioned to work as the disintegration corresponding with Consult drug of disintegration time limited of the tested medicine in the disintegration liquid of three kinds of different acidities
When time limit difference is larger, there are notable difference for the quality of tested medicine and the quality of Consult drug.
It is above-mentioned to work as the disintegration corresponding with Consult drug of disintegration time limited of the tested medicine in the disintegration liquid of three kinds of different acidities
Time limit difference is larger, and the form parameter of the stripping curve of tested medicine, the stripping quantity of tested medicine are that mass percent is
It is more than one that 50% time and the stripping quantity of tested medicine are that the time that mass percent is 63.2% has in these three parameters
When conspicuousness occurs in parameter, there are notable difference for the quality of tested medicine and the quality of Consult drug.
The above-mentioned form parameter of stripping curve when tested medicine, the stripping quantity of tested medicine are that mass percent is 50%
Time and the stripping quantity of tested medicine be the time that mass percent is 63.2% to have more than two parameters in these three parameters
When there is conspicuousness, there are notable difference for the quality of tested medicine and the quality of Consult drug.
The detection method of drug quality of the present invention combines disintegration time limited and dissolution rate examines the quality of medicine
Survey, the detection method of drug quality of the present invention reaches same to the accuracy in detection of medicine with existing quality determining method
On the premise of level, the detection method of drug quality of the present invention can reduce the quality testing cost of medicine, in addition, this
The detection method of the invention drug quality can be improved to drug quality accuracy in detection, furthermore, medicine of the present invention
The detection method of quality can differentiate the preparation process difference of medicine, so that the detection method of drug quality of the present invention
The quality of medicine is detected more fully hereinafter, and important foundation is provided for the monitoring and improvement of drug quality.
Brief description of the drawings
Attached drawing 1 is the stripping curve figure that D groups medicine is obtained according to existing quality determining method.
Attached drawing 2 for D group medicines drug quality according to the present invention the obtained stripping curve figure of detection method, also for
The actual stripping curve figure of D group medicines.
Attached drawing 3 for E group medicines drug quality according to the present invention the obtained stripping curve figure of detection method, also for
The actual stripping curve figure of E group medicines, the stripping curve figure also obtained for E groups medicine according to existing quality determining method.
Attached drawing 4 is the stripping curve figure that F groups medicine is obtained according to existing quality determining method.
Attached drawing 5 for F group medicines drug quality according to the present invention the obtained stripping curve figure of detection method, also for
The actual stripping curve figure of F group medicines.
Attached drawing 6 is G groups medicine according to the stripping curve figure obtained according to existing quality determining method.
Attached drawing 7 for G group medicines drug quality according to the present invention the obtained stripping curve figure of detection method, also for
The actual stripping curve figure of G group medicines.
Attached drawing 8 for K group medicines drug quality according to the present invention the obtained stripping curve figure of detection method, also for
The actual stripping curve figure of K group medicines, the stripping curve figure also obtained for K groups medicine according to existing quality determining method.
Attached drawing 9 is L groups medicine according to the stripping curve figure obtained according to existing quality determining method.
The stripping curve figure that attached drawing 10 obtains for the detection method of L group medicines drug quality according to the present invention,
For the actual stripping curve figure of L group medicines.
The stripping curve figure that attached drawing 11 obtains for the detection method of M group medicines drug quality according to the present invention,
For the actual stripping curve figure of M group medicines, the stripping curve figure also obtained for M groups medicine according to existing quality determining method.
Embodiment
The present invention from following embodiments limitation, can technique according to the invention scheme and actual conditions determine specifically
Embodiment.
With reference to embodiment, the invention will be further described：
Embodiment 1：The detection method of the drug quality, carries out as follows：Respectively measure tested medicine at three kinds not
With the disintegration time limited in the disintegration liquid of acidity, by disintegration time limited corresponding with Consult drug each disintegration time limited of tested medicine into
Row compares, the disintegration liquids of three kinds of different acidities be respectively pH value be 1.16 to 1.20 aqueous hydrochloric acid solution, pH value be 3.52 to
3.59 Acetic acid-sodium acetate buffer solution and pH value is 5.53 to 5.91 water；Real-time online measure tested medicine changes over time
Drug accumulation dissolution percentage, the drug accumulation dissolution percentage that tested medicine is changed over time uses Weibull distribution mould
The form parameter of the stripping curve of tested medicine is obtained after type progress data fitting, the shape of the stripping curve of tested medicine is joined
Number, the stripping quantity of tested medicine are that the stripping quantity of time that mass percent is 50% and tested medicine is that mass percent is
63.2% time, these three parameters carried out t inspections, in t checkout procedures, the form parameter and ginseng of the stripping curve of tested medicine
Be compared according to the form parameter of the stripping curve of medicine, the stripping quantity of tested medicine be mass percent be 50% time with
The stripping quantity of Consult drug is to be compared the time that mass percent is 50%, and the stripping quantity of tested medicine is mass percent
Compared with being the time that mass percent is 63.2% with the stripping quantity of Consult drug for 63.2% time, wherein, exist in real time
During the drug accumulation dissolution percentage that line measure tested medicine changes over time, the dissolution medium of tested medicine and Consult drug
Dissolution medium is identical, and the dissolution medium of tested medicine is the phosphate buffer that pH value is 7.6, and dissolving-out method is slurry processes, rotating speed
For 50 revs/min；Examined with reference to the comparative result of tested medicine and the disintegration time limited of Consult drug and the t of three parameters of tested medicine
Test result and obtain the difference between the quality of tested medicine and the quality of Consult drug.Weibull distribution model（Weibull moulds
Type）For existing known technology.The expression formula of classical weibull models is y=1-exp [- (t-)m/], in classical weibull
In the expression formula of mathematical model, y is drug accumulation dissolution percentage,For scale parameter,For location parameter, m joins for shape
Number, 1 is the maximum of distribution function.The present invention is surveying the dissolution rate of medicine（Medicine can be simulated close to small intestine extreme environment
（The phosphate buffer of pH 7.6）Physiological status）When, it is used uniformly the phosphate buffer that pH value is 7.6 and is situated between as dissolution
Matter, simplifies existing basis《Chinese Pharmacopoeia》Regulation according to the species of medicine select dissolution medium triviality, be convenient for
The measure of dissolution rate, in addition, the testing cost of dissolution rate can be reduced, so as to reduce the inspection of drug quality of the present invention
Testing cost of the survey method to medicine.Meanwhile the present invention tests tested medicine at three kinds when testing the disintegration time limited of medicine
Disintegration time limited in different disintegration liquids（By disintegration time mensuration, the normal and low hydrochloric acid in gastric juice of medicine under one's belt can be simulated（Suffer from
Person）The physiological status of environment）, the system of medicine can be reflected by disintegration time limited of the tested medicine in three kinds of different disintegration liquids
The quality problems of agent technique and the medicine, it follows that the detection method of the drug quality described in the present embodiment can be more
The quality of medicine is comprehensively detected, important foundation is provided for the monitoring and improvement of drug quality.
Embodiment 2：The detection method of the drug quality, carries out as follows：Respectively measure tested medicine at three kinds not
With the disintegration time limited in the disintegration liquid of acidity, by disintegration time limited corresponding with Consult drug each disintegration time limited of tested medicine into
Row compares, the disintegration liquids of three kinds of different acidities be respectively the aqueous hydrochloric acid solution, pH value that pH value is 1.16 or 1.20 be 3.52 or
3.59 Acetic acid-sodium acetate buffer solution and pH value is 5.53 or 5.91 water；Real-time online measure tested medicine changes over time
Drug accumulation dissolution percentage, the drug accumulation dissolution percentage that tested medicine is changed over time uses Weibull distribution mould
The form parameter of the stripping curve of tested medicine is obtained after type progress data fitting, the shape of the stripping curve of tested medicine is joined
Number, the stripping quantity of tested medicine are that the stripping quantity of time that mass percent is 50% and tested medicine is that mass percent is
63.2% time, these three parameters carried out t inspections, in t checkout procedures, the form parameter and ginseng of the stripping curve of tested medicine
Be compared according to the form parameter of the stripping curve of medicine, the stripping quantity of tested medicine be mass percent be 50% time with
The stripping quantity of Consult drug is to be compared the time that mass percent is 50%, and the stripping quantity of tested medicine is mass percent
Compared with being the time that mass percent is 63.2% with the stripping quantity of Consult drug for 63.2% time, wherein, exist in real time
During the drug accumulation dissolution percentage that line measure tested medicine changes over time, the dissolution medium of tested medicine and Consult drug
Dissolution medium is identical, and the dissolution medium of tested medicine is the phosphate buffer that pH value is 7.6, and dissolving-out method is slurry processes, rotating speed
For 50 revs/min；Examined with reference to the comparative result of tested medicine and the disintegration time limited of Consult drug and the t of three parameters of tested medicine
Test result and obtain the difference between the quality of tested medicine and the quality of Consult drug.
Embodiment 3：As the optimization of above-described embodiment, the disintegration in disintegration liquid of the tested medicine in three kinds of different acidities
When time limit disintegration time limited difference corresponding with Consult drug is larger, the quality of tested medicine and the quality of Consult drug exist substantially
Difference.
Embodiment 4：It is with the difference of embodiment 3, when in disintegration liquid of the tested medicine in three kinds of different acidities
Corresponding with Consult drug disintegration time limited disintegration time limited difference is larger, and the form parameter of the stripping curve of tested medicine, by
The stripping quantity of reagent product is that the stripping quantity of the time that mass percent is 50% and tested medicine is that mass percent is 63.2%
When having the more than one parameter conspicuousness occur in these three parameters of time, the quality of tested medicine and the quality of Consult drug are deposited
In notable difference.
Embodiment 5：It is with the difference of embodiment 3 and embodiment 4, when the shape ginseng of the stripping curve of tested medicine
Number, the stripping quantity of tested medicine are that the stripping quantity of time that mass percent is 50% and tested medicine is that mass percent is
When thering are more than two parameters conspicuousness occur in these three parameters of 63.2% time, the quality and Consult drug of tested medicine
Quality there are notable difference.
Using the detection method and existing quality determining method of drug quality of the present invention to 7 groups of totally 30 kinds of by reagents
The quality of product is detected, and the specification of 30 kinds of tested medicines and corresponding Consult drug is as shown in table 1.
Detection content
（1）30 kinds of tested medicines are obtained using the detection method of drug quality of the present invention and corresponding with reference to medicine
The Acetic acid-sodium acetate buffer solution and pH value that aqueous hydrochloric acid solution that product are 1.16 to 1.20 in pH value, pH value are 3.52 to 3.59 be
The disintegration time limited of 5.53 to 5.91 water（±s, min）, disintegration time limited is as shown in table 2, in table 2,30 kinds of tested medicines and
The Acetic acid-sodium acetate that aqueous hydrochloric acid solution that corresponding Consult drug is 1.16 to 1.20 in pH value, pH value are 3.52 to 3.59 delays
Fliud flushing and pH value are sequentially denoted as T for the disintegration time limited of 5.53 to 5.91 waterHCl、THAcAnd Tw, in table 2, symbol " △ " represents
Consult drug；" * " represents said preparation drug-eluting is up to 85% in 15min in " name of an article symbol ", other symbol " * " table of numeral in table 2
Show the tested medicine and Consult drug（△）When comparing, the disintegration time limited of tested medicine is the disintegration more than or less than Consult drug
The disintegration time limited of the 90% of time limit, the i.e. tested medicine differs larger with the disintegration time limited of Consult drug；The other symbol of the numeral of table 2
" ▲ " expression is compared with factory with the disintegration time limited between a collection of three kinds of disintegration liquids of medicine, and disintegration time limited is less than disintegration time limited most
Be worth greatly 90% or more than disintegration in limited time limit minimum value 90%.
（2）Using the detection method of drug quality of the present invention（This method）Obtain 30 kinds of tested medicines and corresponding
Consult drug stripping curve form parameter（m）, the stripping curve of 30 kinds of tested medicines and corresponding Consult drug
Form parameter（m）, medicine stripping quantity be time that mass percent is 50%（t50,min）Stripping quantity with medicine is quality hundred
Divide than the time for 63.2%（td,min）As shown in table 3, m, t50And tdData use±sForm expression, use is existing
Quality determining method（CP method）30 kinds of tested medicines and corresponding Consult drug are carried out dissolution rate test obtain it is each with
The drug accumulation dissolution percentage of time change, during dissolution rate test is carried out, each tested medicine and corresponding
The dissolution medium of Consult drug is according to 2010 editions《Chinese Pharmacopoeia》Regulation selection, changed over time what is obtained according to CP method
Drug accumulation dissolution percentage using Weibull distribution model fitting after obtain the form parameter of stripping curve（m）, 30 kinds
The form parameter of the stripping curve of tested medicine and corresponding Consult drug（m）, medicine stripping quantity be that mass percent is
50% time（t50,min）Stripping quantity with medicine is the time that mass percent is 63.2%（td, min）As shown in table 3, m,
t50And tdData use±sForm expression, to m, the t obtained using CP method50And tdThree parameters carry out t inspections, when
There is two or more parameter conspicuousness occur in three parameters（P ＜ 0.05)）When, illustrate that the quality of tested medicine and Consult drug is deposited
In notable difference, in table 3, symbol " △ " represents Consult drug；" * " represents medicine medicine in 15min in " name of an article symbol "
Thing dissolution is up to 85%, and the other symbol " * " of numeral represents to examine by t, the parameter and Consult drug of the tested medicine（△）Corresponding ginseng
When number compares, there is conspicuousness (p ＜ 0.05) in the parameter of the tested medicine.
By 7 groups of tested medicines and the detection method and medicine of corresponding Consult drug drug quality according to the present invention
The stripping curve and the actual stripping curve of medicine that the dissolution rate that allusion quotation method obtains is fitted by Weibull distribution model are such as
Shown in brief description of the drawings.
Interpretation of result
（1）For D group tested medicines, by the data of table 2 can be seen that tested medicine DT2 relative to DT1-1,
For DT1-2, DT1-3 and DT3, the T of DT2HClT compared with DR, DT1-1, DT1-2, DT1-3 and DT3HClLong is more, is collapsed at three kinds
Solve in liquid, the T of DT2HAcCompare THClAnd TwIt is short, illustrate disintegration behaviors of the DT2 in three kinds of disintegration liquids relative to DR, DT1-1,
The disintegration behavior difference of DT1-2, DT1-3 and DT3 in three kinds of disintegration liquids is larger, illustrates uses of the DT2 in preparation process
The addition of disintegrant and disintegrant and the disintegrant of the use of Consult drug and other tested medicines in preparation process
And the addition difference of disintegrant is larger；
It can be seen from Table 3 that using drug quality of the present invention detection method when, DT1-2 and DT1-3 have
There is conspicuousness in two parameters, and it is obvious poor to illustrate that the dissolved corrosion of DT1-2 and DT1-3 exists with the dissolved corrosion of Consult drug DR
It is different, the t of DT2dThere is conspicuousness, with reference to the disintegration time limited analysis result of DT2, illustrate the quality of DT2 and the matter of Consult drug DR
Amount is there are notable difference, so that illustrate the quality of DT1-2, DT1-3 and DT2 and the quality of Consult drug DR there are notable difference,
Meanwhile the stripping curve that this group of medicine is obtained using the detection method of drug quality of the present invention（As shown in Figure 1）With it
Actual stripping curve is identical；
During using existing quality determining method, three parameters of DT1-2, DT1-3, DT2 do not occur conspicuousness, i.e. basis
Notable difference is not present in existing quality determining method, the quality of tested medicine DT1-2, DT1-3, DT2 and the quality of Consult drug,
Meanwhile this group of medicine uses the stripping curve that existing quality determining method obtains（As shown in Figure 2）Do not kissed with the stripping curve of Fig. 1
Close；
DT1-1 and DT3 is using the detection method of drug quality of the present invention and the detection of existing quality determining method
As a result.
Thus illustrate, the accuracy in detection of the detection method of drug quality of the present invention to DT1-2, DT1-3, DT2
Higher than the existing quality determining method of use to its accuracy in detection.
（2）For E group tested medicines, the T of tested medicine ET1-1 is can be seen that by the data of table 2HAcIt is shorter,
Illustrate that disintegration behaviors of the ET1-1 in three kinds of disintegration liquids differs greatly, the disintegration time limited of ET1-2 and ET2 in three kinds of disintegration liquids is equal
Comparatively fast, illustrate that the disintegration behavior of ET1-2 and ET2 in three kinds of disintegration liquids is not much different, and ET1-1, ET1-2 and ET2 and ginseng
According to medicine ER disintegration time limited difference it is larger, illustrate the use of ET1-1, ET1-2 and ET2 in preparation process disintegrant and
The addition of disintegrant and the disintegrant and disintegrant of the use of Consult drug and other tested medicines in preparation process
Addition difference it is larger；
It can be seen from Table 3 that using drug quality of the present invention detection method when, ET1-1, ET1-2 and ET2
Three parameters there is conspicuousness, illustrate the quality of ET1-1, ET1-2 and ET2 and the quality of Consult drug exist it is obvious poor
It is different；This group of medicine is using the detection method of drug quality of the present invention as its actual stripping curve（As shown in Figure 3）；
While it can be seen from Table 3 that, the testing result using existing quality determining method to ET1-1, ET1-2 and ET2
Consistent with the testing result of the detection method using drug quality of the present invention, this group of medicine uses existing quality testing side
The stripping curve that method obtains is as the stripping curve in Fig. 3；
Illustrate existing with using to the testing result of this group of medicine using the detection method of drug quality of the present invention
The testing result of quality determining method is identical.
（3）For F group tested medicines, the T of FT2-1 is can be seen that by the data of table 2HClAnd TwAnd FT2-2
Disintegration time limited in three kinds of disintegration liquids differs larger with the disintegration time limited of Consult drug FR, illustrates collapsing for FT2-1 and FT2-2
Solution behavior differs larger with the disintegration behavior of Consult drug FR, in three kinds of disintegration liquids, the T of FT1-1HClIt is shorter, the T of FT2-1HAc
It is shorter, illustrate that FT1-1 and FT2-1 are different in the disintegration behavior of three kinds of disintegration liquids, further illustrate the system of FT1-1 and FT2-1
Agent technique is unstable, addition and the reference of the disintegrant and disintegrant of the use of FT2-1 and FT2-2 in preparation process
The disintegrant of use of the medicine in preparation process and the addition difference of disintegrant are larger；
Using drug quality of the present invention detection method when, it can be seen from Table 3 that, FT1-1, FT1-2, FT2-
Three parameters of 1 and FT2-2 do not occur conspicuousness, illustrate dissolved corrosion and the reference of FT1-1, FT1-2, FT2-1 and FT2-2
The dissolved corrosion of medicine FR does not have significant difference, and combines the disintegration time limited analysis result of FT2-1 and FT2-2, illustrates by reagent
The quality of product FT2-1 and FT2-2 and the quality of FR have notable difference, meanwhile, using the detection of drug quality of the present invention
The stripping curve that method obtains is identical with the stripping curve of actual medicine（As shown in Figure 4）.
During using existing quality determining method, it can be seen from Table 3 that, three of FT1-1, FT1-2, FT2-1 and FT2-2
Parameter does not occur conspicuousness, illustrates the dissolved corrosion of FT1-1, FT1-2, FT2-1 and FT2-2 and the dissolution row of Consult drug FR
For no significant difference, i.e. the quality of FT1-1, FT1-2, FT2-1 and FT2-2 and the quality of FR does not have notable difference, this group of medicine
Product use the stripping curve that existing quality determining method obtains（As shown in Figure 5）It is inconsistent with the stripping curve shown in Fig. 4,
So that the detection method for illustrating to use drug quality of the present invention is to the accuracy in detection of FT2-1 and FT2-2
Higher than the accuracy in detection using existing quality determining method.
（4）For G group tested medicines, it can be seen that by the data of table 2 in three kinds of disintegration liquids, the T of GT2HAc
It is shorter, illustrate that the preparation process of GT2 is unstable, the T of GT3wThan Consult drug and other tested medicines GT1-1, GT1-2,
The T of GT1-3 and GT2wIt is shorter, illustrate the use of GT2 and GT3 in preparation process disintegrant and disintegrant addition with
The disintegrant of the use of Consult drug and other tested medicines in preparation process and the addition difference of disintegrant are larger；
Using drug quality of the present invention detection method when, it can be seen from Table 3 that, GT2 and GT3 have two
There is conspicuousness in parameter, illustrates the dissolved corrosion of GT2 and GT3 and the dissolved corrosion of Gr there are significant difference, with reference to GT2 and GT3
Disintegration time limited analysis result, illustrate that there are notable difference, GT1-1, GT1-2, GT1-3 for the quality of GT2 and GT3 and the quality of Gr
Parameter do not occur conspicuousness, according to the disintegration time limited data of GT1-1, GT1-2, GT1-3, tested medicine GT1-1,
The quality of GT1-2, GT1-3 and Gr's is not present notable difference, meanwhile, using the detection method of drug quality of the present invention
Obtained stripping curve is identical with the stripping curve of actual medicine（As shown in Figure 6）；
During using existing quality determining method, it can be seen from Table 3 that, GT2 has two parameters conspicuousness occur, and GT3
Parameter do not occur conspicuousness, illustrate the quality of GT2 and the quality of Gr there are notable difference, and the quality of GT3 and the matter of Gr
Notable difference is not present in amount, and GT3 uses the stripping curve of existing quality determining method（As shown in Figure 7）It can be seen with Fig. 6 contrasts
Go out, GT3 is inconsistent using the stripping curve of existing quality determining method and its actual stripping curve, so as to illustrate using the present invention
It is accurate using the detection of existing quality determining method that the detection method of the drug quality is higher than the accuracy in detection of GT3
Degree.
Using existing quality determining method to the quality measurements of GT1-1, GT1-2, GT1-3 and GT2 with using this hair
The quality measurements of the detection method of the bright drug quality are identical.
（5）For K group tested medicines, it can be seen that KT2-1, KT2-2 and KT3 by the data of table 2 and collapsed at three kinds
Solve disintegration time limited in liquid with reference to Formulation K r there are notable difference, and the T of KT2-2wCompare THAcIt is shorter（The preparation of KT2-2
Technique is unstable）, illustrate that the disintegration behavior of KT2-1, KT2-2 and KT3 differ larger with the disintegration behavior of Consult drug, that is, say
The addition of the disintegrant used and disintegrant of bright KT2-1, KT2-2 and KT3 in preparation process and Consult drug KR with
And the disintegrant of use of other tested medicines in preparation process and the addition of disintegrant differ larger；
Using drug quality of the present invention detection method when, it can be seen from Table 3 that, KT1-1, KT1-2, KT2-
1st, KT2-2 and KT3 has two parameters conspicuousness occur, with reference to the disintegration time limited of KT1-1, KT1-2, KT2-1, KT2-2 and KT3
Analysis result understands that notable difference is not present in the quality of KT1-1, KT1-2, KT2-1, KT2-2 and KT3 and the quality of Kr, and
It is identical with the stripping curve of actual medicine using the stripping curve that the detection method of drug quality of the present invention obtains（Such as figure
Shown in 8）；
During using existing quality determining method, it can be seen from Table 3 that, KT1-1, KT1-2, KT2-1, KT2-2 and KT3 are equal
There are two parameters conspicuousness occur, illustrate that there is no bright for the quality of KT1-1, KT1-2, KT2-1, KT2-2 and KT3 and the quality of Kr
Significant difference is different, and the stripping curve obtained using existing quality determining method（As shown in Figure 8）With the stripping curve of actual medicine
（As shown in Figure 8）It coincide.
Illustrate using the detection method of drug quality of the present invention to the quality measurements of K group tested medicines with adopting
It is identical to the quality measurements of K group tested medicines with existing quality determining method.
（6）For L group tested medicines, the T of LT1-1 and LT1-2HAcT than Consult drug LRHAcIt is shorter, explanation
The disintegration behavior of LT1-1 and LT1-2 differs larger with the disintegration behavior of Consult drug Lr, that is, illustrates prepared by LT1-1 and LT1-2
During use disintegrant and disintegrant addition and uses of the Consult drug Lr in preparation process disintegrant
And the addition difference of disintegrant is larger；
Using drug quality of the present invention detection method when, it can be seen from Table 3 that, LT1-1 and LT1-2 are only
There is a parameter conspicuousness occur, according to the disintegration time limited analysis result of LT1-1 and LT1-2, the matter of LT1-1 and LT1-2
Amount and the quality of Lr are there are notable difference, and the stripping curve for using the detection method of drug quality of the present invention to obtain
It is identical with the stripping curve of actual medicine（As shown in Figure 9）；
During using existing quality determining method, it can be seen from Table 3 that, LT1-1 and LT1-2 only have a parameter to occur
Conspicuousness, illustrates that notable difference is not present in the quality of LT1-1 and LT1-2 and the quality of Lr, and uses existing quality testing side
The stripping curve that method obtains（As shown in Figure 10）Misfitted with the stripping curve of actual medicine；
Illustrate high using quality testing accuracy of the detection method of drug quality of the present invention to L group tested medicines
In using quality testing accuracy of the existing quality determining method to L group tested medicines.
（7）For M group tested medicines, it can be seen that by the data of table 2 compared with Consult drug Mr, MT1-1,
The disintegration time limited of MT1-2, MT1-3 and MT3 in three kinds of disintegration liquids is slow, the disintegration of MT2-1 and MT2-2 in three kinds of disintegration liquids
Disintegration time limited of the time limit with Consult drug Mr in three kinds of disintegration liquids is close, illustrates the disintegration of MT1-1, MT1-2, MT1-3 and MT3
Behavior differs larger with the disintegration behavior of Consult drug Mr, that is, illustrates MT1-1, MT1-2, MT1-3 and MT3 in preparation process
The disintegrant of use and the addition of disintegrant with Consult drug Mr and other tested medicines adopting in preparation process
The addition of disintegrant and disintegrant difference is larger, and the disintegrant of the use of MT2-1 and MT2-2 in preparation process
And the addition of disintegrant and the use of Consult drug MR and other tested medicines in preparation process disintegrant and
The addition of disintegrant is not much different；
Using drug quality of the present invention detection method when, it can be seen from Table 3 that, MT1-1, MT1-2, MT1-
3 and MT3 has two parameters conspicuousness occur, can with reference to the disintegration time limited analysis result of MT1-1, MT1-2, MT1-3 and MT3
Know, there are notable difference, MT2-1 and MT2-2 are equal with the quality of Consult drug Mr for the quality of MT1-1, MT1-2, MT1-3 and MT3
There is not parameter conspicuousness occur, according to the disintegration time limited analysis result of MT2-1 and MT2-2, the quality of MT2-1 and MT2-2
With the quality of Consult drug Mr it is not present notable difference, and is obtained using the detection method of drug quality of the present invention
Stripping curve is identical with the stripping curve of actual medicine（As shown in figure 11）；
During using existing quality determining method, it can be seen from Table 3 that, MT1-1, MT1-2, MT1-3 and MT3 have two
There is conspicuousness in parameter, and it is obvious poor to illustrate that the quality of MT1-1, MT1-2, MT1-3 and MT3 exist with the quality of Consult drug Mr
It is different, the quality measurements of MT2-1 and MT2-2 and the quality testing knot of the detection method using drug quality of the present invention
Fruit is consistent, and the stripping curve obtained using existing quality determining method（As shown in figure 11）With the stripping curve of actual medicine
It coincide；
Illustrate using the detection method of drug quality of the present invention to the quality measurements of M group tested medicines with adopting
It is identical to the quality measurements of M group tested medicines with existing quality determining method.
In conclusion the detection method of drug quality of the present invention combines the matter of disintegration time limited and dissolution rate to medicine
Amount is detected, the accuracy in detection and existing quality determining method of the detection method of drug quality of the present invention to medicine
Under the premise of reaching same level of, the detection method of drug quality of the present invention can reduce the quality testing of medicine into
This, in addition, the detection method of drug quality of the present invention can be improved to drug quality accuracy in detection, furthermore, this hair
The detection method of the bright drug quality can differentiate the preparation process difference of medicine, so that drug quality of the present invention
Detection method detect the quality of medicine more fully hereinafter, provide important foundation for the monitoring and improvement of drug quality.
Above technical characteristic constitutes the embodiment of the present invention, it, can basis with stronger adaptability and implementation result
It is actually needed and increases and decreases non-essential technical characteristic, meets the needs of different situations.
Claims (3)
1. a kind of detection method of drug quality, it is characterised in that carry out as follows：Tested medicine is measured respectively at three kinds
Disintegration time limited in the disintegration liquid of different acidity, by disintegration time limited corresponding with Consult drug each disintegration time limited of tested medicine
Be compared, the disintegration liquids of three kinds of different acidities be respectively pH value be 1.16 to 1.20 aqueous hydrochloric acid solution, pH value be 3.52 to
3.59 Acetic acid-sodium acetate buffer solution and pH value is 5.53 to 5.91 water；Real-time online measure tested medicine changes over time
Drug accumulation dissolution percentage, the drug accumulation dissolution percentage that tested medicine is changed over time uses Weibull distribution mould
The form parameter of the stripping curve of tested medicine is obtained after type progress data fitting, the shape of the stripping curve of tested medicine is joined
Number, the stripping quantity of tested medicine are that the stripping quantity of time that mass percent is 50% and tested medicine is that mass percent is
63.2% time, these three parameters carried out t inspections, in t checkout procedures, the form parameter and ginseng of the stripping curve of tested medicine
Be compared according to the form parameter of the stripping curve of medicine, the stripping quantity of tested medicine be mass percent be 50% time with
The stripping quantity of Consult drug is to be compared the time that mass percent is 50%, and the stripping quantity of tested medicine is mass percent
Compared with being the time that mass percent is 63.2% with the stripping quantity of Consult drug for 63.2% time, wherein, exist in real time
During the drug accumulation dissolution percentage that line measure tested medicine changes over time, the dissolution medium of tested medicine and Consult drug
Dissolution medium is identical, and the dissolution medium of tested medicine is the phosphate buffer that pH value is 7.6, and dissolving-out method is slurry processes, rotating speed
For 50 revs/min；Examined with reference to the comparative result of tested medicine and the disintegration time limited of Consult drug and the t of three parameters of tested medicine
Test result and obtain the difference between the quality of tested medicine and the quality of Consult drug.
2. the detection method of drug quality according to claim 1, it is characterised in that when tested medicine is in three kinds of different acid
When disintegration time limited disintegration time limited difference corresponding with Consult drug in the disintegration liquid of degree is larger, the quality of tested medicine and reference
There are notable difference for the quality of medicine；I.e.：The stripping quantity of form parameter, tested medicine when the stripping curve of tested medicine is matter
The time and the stripping quantity of tested medicine that amount percentage is 50% are to have in these three parameters the time that mass percent is 63.2%
When conspicuousness occurs in more than one parameter, there are notable difference for the quality of tested medicine and the quality of Consult drug.
3. the detection method of drug quality according to claim 1, it is characterised in that when the stripping curve of tested medicine
Form parameter, the stripping quantity of tested medicine are that the stripping quantity of the time that mass percent is 50% and tested medicine is quality percentage
When there is conspicuousness than there is more than two parameters in the time for 63.2% these three parameters, the quality of tested medicine and reference
There are notable difference for the quality of medicine.
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| CN102100706A (en) * | 2009-12-18 | 2011-06-22 | 中国科学院大连化学物理研究所 | Method for evaluating quality of Chinese patent medicament by using metabonomics |
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| CN102100706A (en) * | 2009-12-18 | 2011-06-22 | 中国科学院大连化学物理研究所 | Method for evaluating quality of Chinese patent medicament by using metabonomics |
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| 氯雷他定制剂在多pH溶出介质中的溶出行为研究;刘屹;《中国优秀硕士论文全文数据库》;20130615(第06期);第5、30-46页 * |
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