CN109724897A - Colloidal bismmth pectin or viscosity detection method containing colloid pectin bismuth preparation - Google Patents
Colloidal bismmth pectin or viscosity detection method containing colloid pectin bismuth preparation Download PDFInfo
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- CN109724897A CN109724897A CN201910088790.6A CN201910088790A CN109724897A CN 109724897 A CN109724897 A CN 109724897A CN 201910088790 A CN201910088790 A CN 201910088790A CN 109724897 A CN109724897 A CN 109724897A
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- pectin
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Abstract
The invention discloses a kind of colloidal bismmth pectin or the viscosity detection method containing colloid pectin bismuth preparation, it is after being dispersed with suitable quantity of water by colloidal bismmth pectin or containing colloid pectin bismuth preparation, simulated gastric fluid is added and forms full-bodied stable sol, the dynamic viscosity of the colloidal sol is measured according to the third method rotational viscometer measuring method of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015.The method of the present invention is easy quickly, result is accurate, measures dynamic viscosity in simulation human intestines and stomach's environment, the viscosity situation of colloidal bismmth pectin in human body is better reflected, to embody colloidal bismmth pectin or containing the colloid property of colloid pectin bismuth preparation.
Description
Technical field
The invention belongs to colloidal bismmth pectin quality control technology, it is related to a kind of colloidal bismmth pectin or containing colloidal bismmth pectin
The viscosity detection method of preparation.
Background technique
Colloidal bismmth pectin and its capsule are Red Star Pharmaceutical Factory, Taiyuan City, predecessor, Shanxi Zhendong Anter Biology Pharmaceutical Co., Ltd.
Pioneering drug.The drug ratifies Red Star Pharmaceutical Factory, Taiyuan City's production listing through former health ministry in July, 1992 first.
Colloidal bismmth pectin is gastric mucosa protectant, has protection gastrointestinal mucosa, kills helicobacter pylori and anastalsis, can
To promote ulcer healing, inflammation to improve, and the recurrence rate of ulcer can be reduced.Its mechanism of action is relatively strong based on colloidal bismmth pectin
Colloid property forms high viscosity colloidal sol in acid medium, can form effective protective film on stomach lining, make rotten to the corn face and ulcer
Stove is isolated with gastric acid and pepsin, is played a protective role to impaired mucous membrane, and the barrier action of stomach lining is enhanced, and promotes ulcer group
Knit reparation and healing；Can stimulation of endogenous prostaglandin and epidermal growth factor generate, accelerate ulcer surface healing and inflammation to disappear.
Therefore, colloidal bismmth pectin has preferable therapeutic effect to peptic ulcer and chronic gastritis.Further, since colloidal bismmth pectin with
The adhesiveness for being damaged mucous membrane has high selectivity, has anastalsis to hemorrhage of digestive tract.
The active constituent of Couoidal bismuth pectin capsules is " colloidal bismmth pectin ", is not " bismuth ", is not belonging to simply change acid group, more
It is not belonging to " do not change pharmacological action changes salt ".Therefore, colloidal bismmth pectin, can as a kind of completely new compound (compound)
It preferably protects stomach lining, eradicate helicobacter pylori.
Yu Xuemin etc. (colloidal bismuth petin items experimental study conclusion summarizes [J] Chinese Journal of New Drugs, 1993,2 (3):
34-36) studies have shown that An Te®Intrinsic viscosity of the Couoidal bismuth pectin capsules in simulated gastric fluid is 126, colloidal bismuth citrate
The intrinsic viscosity of potassium is 17, the former is 7.4 times of the latter.Lu Weifeng (the absorption and pharmacokinetics of Chinese Healthy Adults bismuth agent
Research Beijing [D]: China Concord Medical Science University, 2001) report peace spy®Couoidal bismuth pectin capsules human body hardly picks up,
The AUC of colloidal bismuth citrate piece0-24hrIt is that peace is special®15.6 times of Couoidal bismuth pectin capsules.Above-mentioned two index prompt, colloid
Colloidal bismuth pectin is different from the active constituent of colloidal bismuth citrate, this also explains " Chinese Pharmacopoeia clinical application notice " well
The correctness of colloidal bismmth pectin " being a kind of new colloidal bismuth preparation " this formulation in version in 2015.
A large amount of pharmacology and clinical data show bismuth drug class to the therapeutic effect of gastrointestinal disease and its with being damaged stomach and intestine
The adhesiveness of mucous membrane is positively correlated.And adhesiveness is related with the colloid property of drug, the good bismuth salt of colloid property can not only increase
By force to the protective effect of gastrointestinal mucosa, while being also beneficial to kill helicobacter pylori.
Viscosity can reflect out the colloid property of drug.The viscosity of colloidal bismmth pectin is bigger, the guarantor formed on gastric mucosa
Cuticula is more secured, stronger to the protective effect in rotten to the corn face and ulcer stove；Conversely, viscosity is smaller, the protection formed on gastric mucosa
Film is weaker, weaker to the protective effect in rotten to the corn face and ulcer stove.
Therefore, in order to guarantee the validity of clinical application, it is necessary to establish colloidal bismmth pectin or containing colloid pectin bismuth preparation
The detection method of middle viscosity controls the limit of its viscosity.
However, although colloidal bismmth pectin and its capsule have been recorded in " Chinese Pharmacopoeia " 2015 version two, at it
But the detection of viscosity is not included in quality standard.
Colloidal bismmth pectin viscosity has been related to it in CN 102507381A, CN 105560188A and CN 105496968A
Detection method is all according to " middle traditional Chinese medicines although the subject matter of its detection is Couoidal bismuth pectin capsules or dry suspensoid agent respectively
Allusion quotation " third method in 2010 years two annex of version, VI G viscosimetries measures the intrinsic viscosity of drug.Its determination step is
It after drug plus water dispersion and constant volume, is filtered with No. 3 sintered glass funnels, discards primary filtrate, take subsequent filtrate to be packed into clean, dry
Ubbelohde viscometer ball B in, viscosmeter is perpendicularly fixed in water bath with thermostatic control, and make water-bath liquid level be higher than ball C, place
After 15min, nozzle 1,3 is respectively connect into an emulsion tube, clamps nozzle 3, is evacuated from nozzle 1, be slowly increasing to the liquid level of filtrate
In the middle part of ball C, nozzle 3 is decontroled, then decontrol nozzle 1, filtrate is made to fall naturally in pipe, accurate recording liquid level declines from measurement line m1
To the delivery time T measured at line m2, the delivery time T of pure water is measured under similarity condition0, according to formula [η]=ln (T/T0)/C
Calculate the intrinsic viscosity [η] of filtrate.In formula, C is the concentration of bismuth in test solution, g/ml.
Not only experimental procedure is more for the detection method of above-mentioned intrinsic viscosity, and cumbersome, detection time is long, and to experiment people
The qualification of member's operation is more demanding, and measuring result error is larger.
Summary of the invention
A kind of viscosity inspection the object of the present invention is to provide simple and quick colloidal bismmth pectin or containing colloid pectin bismuth preparation
Survey method, more accurately to embody colloidal bismmth pectin or containing the colloid property of colloid pectin bismuth preparation.
Colloidal bismmth pectin of the present invention or viscosity detection method containing colloid pectin bismuth preparation are: by colloidal bismmth pectin
Or after being dispersed containing colloid pectin bismuth preparation with suitable quantity of water, simulated gastric fluid is added and forms full-bodied stable sol, according to " middle traditional Chinese medicines
Allusion quotation " the third method rotational viscometer measuring method of 0633 viscosimetry measures the power of the colloidal sol in 2015 years four general rules of version
Viscosity.
Colloidal bismmth pectin is insoluble in the organic solvents such as ethyl alcohol, agglomerates in water, but can be uniformly dispersed in water after shaking.
Meanwhile colloidal bismmth pectin being directly added into simulated gastric fluid and can not be dissolved.Therefore, the present invention needs first to be added suitable quantity of water for glue
After the dispersion of body colloidal bismuth pectin, simulated gastric fluid is added, to form stable colloidal sol for measuring its dynamic viscosity.
Wherein, the simulated gastric fluid was checked according to 0921 disintegration time limited in four general rules of " Chinese Pharmacopoeia " version in 2015
What the simulated gastric fluid preparation method under method item was prepared.
Specifically, simulated gastric fluid of the present invention is prepared using pepsin, and the stomach cardia enzyme system is from pig, sheep
Or extract and be made in the stomach lining of ox, it is calculated by dry product, 10000~15000 unit containing peptic activity of stomach in every lg.
Further, the present invention is when preparing the colloidal bismmth pectin colloidal sol, the volume of used water and simulated gastric fluid
Than being 0.2~1: 1.
Further, in the colloidal bismmth pectin colloidal sol of preparation of the present invention, the content of colloidal bismmth pectin is calculated as with bismuth
0.5~2.0mg/ml.
In turn, the present invention is to measure the dynamic viscosity of the colloidal bismmth pectin colloidal sol under 20~40 DEG C of constant temperature.
It is highly preferred that after the colloidal bismmth pectin colloidal sol constant temperature is placed 15min by the present invention, then carry out the survey of dynamic viscosity
It is fixed.
Viscosity detection method provided by the present invention is suitable for the colloidal bismmth pectin bulk pharmaceutical chemicals prepared in various ways, and
Any folk prescription or compound preparation containing colloidal bismmth pectin, including conventional tablet, capsule, dispersible tablet, granule, dry suspensoid agent, dissipate
All suitable dosage forms such as agent, enteric coatel tablets, knot enteric coatel tablets, capsulae enterosolubilis, knot capsulae enterosolubilis.
After the present invention forms colloidal sol in simulated gastric fluid by colloidal bismmth pectin and containing colloid pectin bismuth preparation, according to " China
Pharmacopeia " the third method rotational viscometer measuring method of 0633 viscosimetry measures its dynamic viscosity in 2015 years four general rules of version,
Compared with using the second method Ubbelohde capillary viscometer measuring method to measure its intrinsic viscosity, detection method is easier quickly, ties
Fruit is accurate.
Instructions of taking containing colloid pectin bismuth preparation be before the meal half an hour taken with water, colloidal bismmth pectin is under one's belt actually
It is in the comprehensive function environment in gastric acid and water.Viscosity detection method of the invention is actually in simulation human intestines and stomach's environment
The dynamic viscosity of middle measurement better reflects the viscosity situation of colloidal bismmth pectin in human body.
The present invention as colloidal bismmth pectin or containing the quality detecting index of colloid pectin bismuth preparation, more can guarantee viscosity
The validity of clinical application.
Specific embodiment
Following embodiments are only the preferred technical solution of the present invention, are not used to carry out any restrictions to the present invention.For
For those skilled in the art, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made
Any modification, equivalent substitution, improvement and etc., should all be included in the protection scope of the present invention.
Instrument used in the embodiment of the present invention includes: that microcomputer type number shows viscosmeter: NDJ-8S, and Shanghai is weighed and consider in order to uphold justice instrument
Instrucment and meter plant；Assay balance: AR1530C, Ao Haosi Instrument Ltd.；Cryogenic thermostat water-bath: DC-0506W, Shanghai are weighed and consider in order to uphold justice instrument
Instrucment and meter plant.
Simulated gastric fluid used in embodiment is prepared in accordance with the following methods: being taken dilute hydrochloric acid 16.4ml, is added water about 800ml, stomach
Protease 10g, shakes up, and is diluted with water into 1000ml.Dilute hydrochloric acid therein is to take hydrochloric acid 234ml, is diluted with water to 1000ml and obtains
To the dilute hydrochloric acid solution that should be 9.5~10.5% containing HCl.
Embodiment 1: the dynamic viscosity of measurement colloidal bismmth pectin bulk pharmaceutical chemicals.
Colloidal bismmth pectin bulk pharmaceutical chemicals 3.0g is taken, is set in beaker, adds water 100ml, stirring makes to disperse, then plus simulated gastric fluid (stomach
10000 unit of prolease activity) 400ml, it stirs evenly, beaker is perpendicularly fixed in 20 DEG C of ± 0.1 DEG C of waters bath with thermostatic control, place
After 15min, measured according to the third method rotational viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Method is measured, and measuring dynamic viscosity is 279.85mPas.
Embodiment 2: the dynamic viscosity of measurement Couoidal bismuth pectin capsules (specification 40mg, in terms of bismuth).
Couoidal bismuth pectin capsules 4.0g is taken, is set in beaker, adds water 200ml, stirring makes to disperse, then plus simulated gastric fluid (stomach egg
White 12000 unit of enzyme activity) 300ml, it stirs evenly, beaker is perpendicularly fixed in 25 DEG C of ± 0.1 DEG C of waters bath with thermostatic control, place
After 15min, measured according to the third method rotational viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Method is measured, and measuring dynamic viscosity is 250.51mPas.
Embodiment 3: the dynamic viscosity of measurement Couoidal bismuth pectin capsules (specification 50mg, in terms of bismuth).
Couoidal bismuth pectin capsules 5.0g is taken, is set in beaker, adds water 150ml, stirring makes to disperse, then plus simulated gastric fluid (stomach egg
White 15000 unit of enzyme activity) 350ml, it stirs evenly, beaker is perpendicularly fixed in 25 DEG C of ± 0.1 DEG C of waters bath with thermostatic control, place
After 15min, measured according to the third method rotational viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Method is measured, and measuring dynamic viscosity is 478.90mPas.
Embodiment 4: the dynamic viscosity of measurement Couoidal bismuth pectin capsules (specification 100mg, in terms of bismuth).
Couoidal bismuth pectin capsules 5.5g is taken, is set in beaker, adds water 120ml, stirring makes to disperse, then plus simulated gastric fluid (stomach egg
White 10000 unit of enzyme activity) 380ml, it stirs evenly, beaker is perpendicularly fixed in 37 DEG C of ± 0.1 DEG C of waters bath with thermostatic control, place
After 15min, measured according to the third method rotational viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Method is measured, and measuring dynamic viscosity is 864.07mPas.
Embodiment 5: the dynamic viscosity of measurement dispersible tablet of colloid petcin (specification 50mg, in terms of bismuth).
Dispersible tablet of colloid petcin 7.0g is taken, is set in beaker, adds water 250ml, stirring makes to disperse, then plus simulated gastric fluid (stomach
12000 unit of prolease activity) 250ml, it stirs evenly, beaker is perpendicularly fixed in 40 DEG C of ± 0.1 DEG C of waters bath with thermostatic control, place
After 15min, measured according to the third method rotational viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Method is measured, and measuring dynamic viscosity is 781.64mPas.
Embodiment 6: the dynamic viscosity of measurement colloidal bismmth pectin particle (specification 150mg, in terms of bismuth).
Colloidal bismmth pectin particle 10.0g is taken, is set in beaker, adds water 300ml, stirring makes to disperse, then plus simulated gastric fluid (stomach egg
White 15000 unit of enzyme activity) 200ml, it stirs evenly, beaker is perpendicularly fixed in 40 DEG C of ± 0.1 DEG C of waters bath with thermostatic control, place
After 15min, measured according to the third method rotational viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Method is measured, and measuring dynamic viscosity is 168.21mPas.
Embodiment 7: instrument precision test.
Colloidal bismmth pectin bulk pharmaceutical chemicals 4.0g is taken, is set in beaker, adds water 100ml, stirring makes to disperse, then plus simulated gastric fluid (stomach
12000 unit of prolease activity) 400ml, it stirs evenly, beaker is perpendicularly fixed in 25 DEG C of ± 0.1 DEG C of waters bath with thermostatic control, place
After 15min, measured according to the third method rotational viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Method is measured, replication 6 times, measure dynamic viscosity be respectively 648.0,634.6,643.4,624.6,623.5,
634.6mPas, relative standard deviation RSD=1.54%, instrument precision are good.
Embodiment 8: repetitive test.
Colloidal bismmth pectin bulk pharmaceutical chemicals, Couoidal bismuth pectin capsules (specification 100mg, in terms of bismuth), glue are prepared by the following method
Each 6 parts of the test solution of body colloidal bismuth pectin capsule (specification 50mg, in terms of bismuth), in 37 DEG C of ± 0.1 DEG C of measurement dynamic viscosities.Measurement
It the results are shown in Table 1~table 3.
Colloidal bismmth pectin bulk pharmaceutical chemicals 4.0g is taken, is set in beaker, adds water 100ml, stirring makes to disperse, then plus simulated gastric fluid (stomach
10000 unit of prolease activity) 400ml, it stirs evenly, as test solution.
Couoidal bismuth pectin capsules (specification 100mg) 4.0g is taken, is set in beaker, adds water 120ml, stirring makes to disperse, then plus people
Work gastric juice (12000 unit of peptic activity of stomach) 380ml, stirs evenly, as test solution.
Couoidal bismuth pectin capsules (specification 50mg) 5.0g is taken, is set in beaker, water 150ml is added, stirring makes to disperse, then plus manually
Gastric juice (15000 unit of peptic activity of stomach) 350ml, stirs evenly, as test solution.
As a result: colloidal bismmth pectin bulk pharmaceutical chemicals and the RSD of each 6 parts of sample measurement results of different size Couoidal bismuth pectin capsules are equal
No more than 2.0%, method repeatability is good.
Embodiment 9: the stability test of solution.
Colloidal bismmth pectin bulk pharmaceutical chemicals, Couoidal bismuth pectin capsules (specification 100mg, in terms of bismuth), glue are prepared by the following method
The test solution of body colloidal bismuth pectin capsule (specification 50mg, in terms of bismuth), at 37 DEG C ± 0.1 DEG C, respectively at 0,1,2,3,4,5,
Dynamic viscosity is measured when 6h.Measurement result is shown in Table 4~table 6.
Colloidal bismmth pectin bulk pharmaceutical chemicals 4.0g is taken, is set in beaker, adds water 120ml, stirring makes to disperse, then plus simulated gastric fluid (stomach
15000 unit of prolease activity) 380ml, it stirs evenly, as test solution.
Couoidal bismuth pectin capsules (specification 100mg) 4.0g is taken, is set in beaker, adds water 150ml, stirring makes to disperse, then plus people
Work gastric juice (10000 unit of peptic activity of stomach) 350ml, stirs evenly, as test solution.
Couoidal bismuth pectin capsules (specification 50mg) 5.0g is taken, is set in beaker, water 100ml is added, stirring makes to disperse, then plus manually
Gastric juice (12000 unit of peptic activity of stomach) 400ml, stirs evenly, as test solution.
As a result: the test solution of colloidal bismmth pectin bulk pharmaceutical chemicals and different size Couoidal bismuth pectin capsules 0,1,2,3,4,
5, the RSD of 6h measurement result shows that test solution is good in 6h internal stability no more than 2.0%.
Embodiment 10: the intrinsic viscosity of measurement colloidal bismmth pectin bulk pharmaceutical chemicals.
100ml volumetric flask is taken, 24ml water is added, manually gastric juice is settled to scale, shakes up, and obtains solvent.
It takes colloidal bismmth pectin bulk pharmaceutical chemicals 25mg in 100ml volumetric flask, adds 24ml water, shaking or ultrasound make to disperse, employment
Work gastric juice is settled to scale, obtains sample, by sample filtering, obtains prepare liquid.
Prepare liquid is filtered through No. 3 sintered glass funnels, primary filtrate is discarded, subsequent filtrate 20ml is taken to be placed in Ubbelohde viscometer
It in ball B, is vertically fixed in 25 DEG C ± 1 DEG C of water bath with thermostatic control, stands 15min, with 3 top of clamp Ubbelohde viscometer nozzle
Rubber tube, liquid is drawn by the nozzle 1 of Ubbelohde viscometer, liquid level is reached more than in the middle part of the bead of top, it is viscous to unclamp Ubbelohde
The clip of degree meter nozzle 3, makes the liquid free-falling in Ubbelohde viscometer pipe 1, records liquid level from m1 scale and drops to m2 scale
Time, repetitive operation 2 times, 2 times measurement result difference must not exceed 0.1s, takes the average value of measurement result twice, is denoted as T.
It takes 20ml solvent as blank, repeats above operation, measured value is answered identical twice, is denoted as T0。
Actually measured T=9.1490min, T0=9.2010min, the delivery time of blank solution are greater than the stream of sample solution instead
Time out, if according to calculation formula [η]=ln (T/T of intrinsic viscosity0)/C, calculate sample solution intrinsic viscosity value be-
152.43, illustrate the second method Ubbelohde capillary viscometer of 0633 viscosimetry in four general rules of " Chinese Pharmacopoeia " version in 2015
Measuring method is not suitable for the viscosity measurement of the colloidal bismmth pectin dispersed with water of the present invention and simulated gastric fluid.
Claims (6)
1. a kind of colloidal bismmth pectin or the viscosity detection method containing colloid pectin bismuth preparation are by colloidal bismmth pectin or fruit containing colloid
After glue bismuth preparation is dispersed with suitable quantity of water, simulated gastric fluid is added and forms full-bodied stable sol, according to " Chinese Pharmacopoeia " 2015
The third method rotational viscometer measuring method of 0633 viscosimetry measures the dynamic viscosity of the colloidal sol in four general rules of version.
2. viscosity detection method according to claim 1, it is characterized in that the simulated gastric fluid is according to " Chinese Pharmacopoeia "
Simulated gastric fluid preparation method in four general rules of version in 2015 under 0921 disintegration time limit test item is prepared.
3. viscosity detection method according to claim 1, it is characterized in that the volume ratio of the water and simulated gastric fluid be 0.2~
1∶1。
4. viscosity detection method according to claim 1, it is characterized in that in the colloidal bismmth pectin colloidal sol, colloidal bismmth pectin
Content 0.5~2.0mg/ml is calculated as with bismuth.
5. viscosity detection method according to claim 1, it is characterized in that under 20~40 DEG C of constant temperature described in measurement
The dynamic viscosity of colloidal bismmth pectin colloidal sol.
6. viscosity detection method according to claim 1, it is characterized in that the colloidal bismmth pectin colloidal sol constant temperature is placed
After 15min, then carry out the measurement of dynamic viscosity.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112067506A (en) * | 2020-09-22 | 2020-12-11 | 北京鑫开元医药科技有限公司 | Method for measuring viscosity of bismuth potassium citrate-containing preparation |
| CN112285040A (en) * | 2020-09-16 | 2021-01-29 | 北京鑫开元医药科技有限公司 | Method for determining free bismuth in bismuth-containing preparation |
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| CN105496968A (en) * | 2015-04-07 | 2016-04-20 | 湖南华纳大药厂股份有限公司 | Control method for quality and safety of colloidal bismuth pectin pharmaceutical composition |
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2019
- 2019-01-30 CN CN201910088790.6A patent/CN109724897A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105496968A (en) * | 2015-04-07 | 2016-04-20 | 湖南华纳大药厂股份有限公司 | Control method for quality and safety of colloidal bismuth pectin pharmaceutical composition |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112285040A (en) * | 2020-09-16 | 2021-01-29 | 北京鑫开元医药科技有限公司 | Method for determining free bismuth in bismuth-containing preparation |
| CN112067506A (en) * | 2020-09-22 | 2020-12-11 | 北京鑫开元医药科技有限公司 | Method for measuring viscosity of bismuth potassium citrate-containing preparation |
| CN112067506B (en) * | 2020-09-22 | 2024-02-13 | 北京鑫开元医药科技有限公司 | Viscosity measurement method of bismuth potassium citrate-containing preparation |
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Application publication date: 20190507 |