CN105929008B - A kind of method for detecting injection Risperidone aqueous microsphere - Google Patents
A kind of method for detecting injection Risperidone aqueous microsphere Download PDFInfo
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- CN105929008B CN105929008B CN201610248191.2A CN201610248191A CN105929008B CN 105929008 B CN105929008 B CN 105929008B CN 201610248191 A CN201610248191 A CN 201610248191A CN 105929008 B CN105929008 B CN 105929008B
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- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
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- G01N27/42—Measuring deposition or liberation of materials from an electrolyte; Coulometry, i.e. measuring coulomb-equivalent of material in an electrolyte
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/416—Systems
- G01N27/42—Measuring deposition or liberation of materials from an electrolyte; Coulometry, i.e. measuring coulomb-equivalent of material in an electrolyte
- G01N27/426—Measuring deposition or liberation of materials from an electrolyte; Coulometry, i.e. measuring coulomb-equivalent of material in an electrolyte by weighing
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Abstract
The invention discloses a kind of methods for detecting injection Risperidone aqueous microsphere, after dissolution solvent and coulomb anolyte in advance titration, mixed solution dissolves injection Risperidone microballoon after taking out pre- titration, then its moisture is tested, sample is tested under relatively closed environment, greatly reduces the influence of external environment, the number and aqueous homogeneity of the water content of dissolution solvent to test result.Simple testing process, test result is accurately and reliably.Be easy to causeing sample during sample-adding the invention avoids direct sample-adding method and be adhered to injection port and the moisture in air is introduced titration cup influences test result accuracy.Avoid simultaneously dissolved outside sample-adding method (tested after being completely dissolved sample with the solvent of known moisture content) solvent water content test and solvent water content number and influence of the aqueous homogeneity to test result.
Description
Technical field
The present invention relates to a kind of method for detecting moisture, more particularly to a kind of detection injection Risperidone aqueous microsphere
Method.
Background technology
Water content is medicine preparation process and the important quality index of final product quality control.Determination of moisture generally can be divided into two
Major class, i.e. Physical Analysis Methods and chemical analysis method.The determination of moisture method of drug has expense Xiu Shi methods (volumetric method, library at present
Logical sequence method), oven drying method, hypobaric drying method, toluene method, gas chromatography etc. (2015 editions annex 0832 of Chinese Pharmacopoeia).For aqueous
The determination of moisture generally use coulometry of low (0.001%-0.1%) and expensive medication.Injection Risperidone microballoon is mainly by second
Lactide lactide copolymer and Risperidone bulk pharmaceutical chemicals composition.Chinese Pharmacopoeia (2015 editions) has recorded Vicryl Rapide
(7525) determination of moisture method, it is using chloroform as dissolution solvent, after dissolved outside, is measured using expense Xiu Shi methods, the party
Using chloroform as dissolution solvent in method, after dissolved outside, it is measured using expense Xiu Shi coulometry methods；It needs to test dissolution solvent
Water content, the moisture value of test sample could be calculated after need to being deducted as the background value of test sample moisture measurement because of dissolution solvent,
It calculates complicated.Because the water content of test sample is relatively low (about 0.1%), the number and homogeneity of the water content of dissolution solvent can influence to supply
The test result accuracy of test product.The Risperidone quality standard that Chinese Pharmacopoeia (2015 editions) records is using dry weight-loss method (drying
Method) test moisture, it is not suitable for the test of injection Risperidone microballoon.The import drugs of existing injection Risperidone microballoon
No moisture check item in registered standard (JX2012058).Determination of moisture method temporarily without document report injection Risperidone microballoon.
Invention content
The purpose of the present invention is to provide it is a kind of detect injection Risperidone aqueous microsphere method, simple testing process,
Test result is accurately and reliably.
The technical solution adopted by the present invention to solve the technical problems is：
A kind of method for detecting injection Risperidone aqueous microsphere, includes the following steps：
(1) coulomb Moisture Meter is opened, test parameter is set；
(2) pre- titration：Coulometry anolyte and pre-dried dissolution solvent are taken, by 1:0.5-1:1.5 volume ratio mixing
Add in titration cup in, call and operating procedure (1) setting test parameter, after a coulomb Moisture Meter show titrate in advance it is ready after obtain in advance
Titrating solution；Maximum starting of the practical drift value less than setting that ready i.e. coulomb Moisture Meter detects liquid in titration cup is titrated in advance
It is shown during drift value ready.
(3) sample bottle is weighed：The cillin bottle, rubber plug, aluminium lid of clean dried is taken to weigh, is denoted as W1；
(4) it samples：Sample is taken to add in cillin bottle, jumps a queue, gland, weigh, be denoted as W2；
(5) dissolving of sample：The pre- titrating solution 4-6ml of step (2) is taken out from titration cup with the closed syringe of drying,
Then it is injected back into titration cup, so repeatedly 2-3 times, after then taking out pre- titrating solution 3-5ml injection steps (4) sample-adding with syringe
Cillin bottle in, be vortexed dissolving, weigh, be denoted as W3；
(6) moisture measurement：The dissolved sample of step (5) is all taken out with drying closed syringe, injection is pre-
It titrates in ready titration cup, and weight reduction weighs the weight of the sample solution of injection, is denoted as W4, according to formula sample weight=W4*
(W2-W1)/(W3-W1), the sample weight being actually added into titration cup is calculated, the sample being actually added into is inputted into coulomb Moisture Meter
Weight, test, and record test result.
Preferably, the parameter of coulomb Moisture Meter is set as in step (1)：
A, maximum starting drift value：8-20 μ g/min, incorporation time：40-80s；
B, electrode：DM143-SC, polarization current：5.0μA；
C, rotating speed：30-55%；
D, terminal：100.0mv, control zone：250mv, rate：Normally, electrolysis electrode electric current：Automatically；
E, drift value：3 μ g/min, type：Drift is opposite to be stopped, minimum time：0S, maximum time：3600S.
The parameter setting of coulomb Moisture Meter is very crucial, maximum starting drift value：Make the water of the mixed solution in titration cup
Part is down to relatively low, obtains preferable detection baseline, if value setting is too small, system be difficult to it is ready, can shadow if setting is excessive
Ring the accuracy and repeatability of test result, maximum starting drift value preferably 10 μ g/min.The preferred 60s of incorporation time.Rotating speed：It protects
The homogeneity of solution is demonstrate,proved, guarantees abundant mixing, and do not influence to measure, rotating speed preferably 45%.
Preferably, the preparation method of pre-dried dissolution solvent is：Dissolution solvent is taken to be placed in solvent bottle, and adds in and divides
Son sieve, capping are screwed, are put in drier, are placed more than 24 hours.Dissolution solvent will take supernatant to use the used time.
Preferably, the dosage of molecular sieve is to add the molecular sieve of 2g-10g per 100mL dissolution solvents.
Preferably, the dissolution solvent is selected from one or more of chloroform, dichloromethane, dimethylformamide.
Preferably, the sampling amount of sample is in the range of 0.1-0.5g in step (4).
The present invention titrates dissolution solvent and coulomb anolyte in advance, and the two, which can react, consumes moisture, excludes moisture interference,
Mixed solution dissolves injection Risperidone microballoon after taking out pre- titration, then tests its moisture, sample is relatively closed
It is tested under environment, greatly reduces external environment, the number of the water content of dissolution solvent and aqueous homogeneity to test result
Influence.Simple testing process, test result is accurately and reliably.It is easily made during sample-adding the invention avoids direct sample-adding method
Being adhered to injection port into sample and the moisture in air is introduced titration cup influences test result accuracy.Avoid outside simultaneously
Dissolving sample-adding method (tested after being completely dissolved sample with the solvent of known moisture content) solvent water content test and solvent it is aqueous
Amount number and influence of the aqueous homogeneity to test result.
The beneficial effects of the invention are as follows：Simple testing process, test result is accurately and reliably.The invention avoids be directly loaded
Method, which be easy to cause sample during sample-adding and is adhered to injection port and the moisture in air is introduced titration cup, influences test result
Accuracy.Avoiding dissolved outside sample-adding method simultaneously, that solvent (is tested) after being completely dissolved sample with the solvent of known moisture content is aqueous
The influence of the test of amount and the number and aqueous homogeneity of solvent water content to test result.
Specific embodiment
Below by specific embodiment, technical scheme of the present invention is described in further detail.
In the present invention, if not refering in particular to, used raw material and equipment etc. are commercially available or commonly used in the art.
Method in following embodiments is the conventional method of this field unless otherwise instructed.
Material and instrument
1st, test sample：Injection Risperidone microballoon (commercially available).
2nd, reagent：Chloroform (chromatographically pure, ACS), dichloromethane (chromatographically pure, ACS), dimethylformamide (chromatographically pure,
The world), coulometry anolyte (fluka, article No.：34820), molecular sieve (Merck KGaA, article No.：1.05704.0250).
3rd, instrument：C20 coulombs of Moisture Meters (Mei Teletuo benefits company of Switzerland), XP205 electronic analytical balance (sensibility reciprocals
0.00001g, Mei Teletuo benefits company of Switzerland), ML204/02 electronic analytical balances (sensibility reciprocal 0.0001g, Switzerland Mei Teletuo
Benefit company), 5ml syringes, injection needle 80*0.8mm.Total embodiment：
A kind of method for detecting injection Risperidone aqueous microsphere, includes the following steps：
(1) coulomb Moisture Meter is opened, test parameter is set, parameter is set as：
A, maximum starting drift value：8-20 μ g/min, incorporation time：40-80s；
B, electrode：DM143-SC, polarization current：5.0μA；
C, rotating speed：30-55%；
D, terminal：100.0mv, control zone：250mv, rate：Normally, electrolysis electrode electric current：Automatically；
E, drift value：3 μ g/min, type：Drift is opposite to be stopped, minimum time：0S, maximum time：3600S.
(2) pre- titration：Coulometry anolyte and pre-dried dissolution solvent are taken, by 1:0.5-1:1.5 volume ratio mixing
Add in titration cup in, call and operating procedure (1) setting test parameter, after a coulomb Moisture Meter show titrate in advance it is ready after obtain in advance
Titrating solution；The preparation method of pre-dried dissolution solvent is：Dissolution solvent is taken to be placed in solvent bottle, and adds in molecular sieve, is capped
It screws, puts in drier, place more than 24 hours.The dosage of molecular sieve is to add the molecular sieve of 2g-10g per 100mL dissolution solvents.
The dissolution solvent is selected from one or more of chloroform, dichloromethane, dimethylformamide.
(3) sample bottle is weighed：The cillin bottle, rubber plug, aluminium lid of clean dried is taken to weigh, is denoted as W1。
(4) it samples：0.1-0.5g samples is taken to add in cillin bottle, jumps a queue, gland, weigh, be denoted as W2。
(5) dissolving of sample：The pre- titrating solution 4-6ml of step (2) is taken out from titration cup with the closed syringe of drying,
Then it is injected back into titration cup, so repeatedly 2-3 times, after then taking out pre- titrating solution 3-5ml injection steps (4) sample-adding with syringe
Cillin bottle in, be vortexed dissolving, weigh, be denoted as W3。
(6) moisture measurement：The dissolved sample of step (5) is all taken out with drying closed syringe, injection is pre-
It titrates in ready titration cup, and weight reduction weighs the weight of the sample solution of injection, is denoted as W4, according to formula sample weight=W4*
(W2-W1)/(W3-W1), the sample weight being actually added into titration cup is calculated, the sample being actually added into is inputted into coulomb Moisture Meter
Weight, test, and record test result.
Illustrate the specific implementation of the present invention with preferred embodiment below：
Specific embodiment 1：
A kind of method for detecting injection Risperidone aqueous microsphere, includes the following steps：
(1) coulomb Moisture Meter is opened, edits instrument parameter, parameter is set as：
A, maximum starting drift value：10 μ g/min, incorporation time：60s；
B, electrode：DM143-SC, polarization current：5.0μA；
C, rotating speed：45%；
D, terminal：100.0mv, control zone：250mv, rate：Normally, electrolysis electrode electric current：Automatically；
E, drift value：3 μ g/min, type：Drift is opposite to be stopped, minimum time：0S, maximum time：3600S.
(2) pre- titration：Coulometry Moisture Meter is ready, takes coulometry anolyte 50mL and pre-dried chloroform 50mL,
By 1:1 volume ratio mixing is added in titration cup, is called the test parameter of simultaneously operating procedure (1) setting, is treated that a coulomb Moisture Meter is shown
Show that pre- titration obtains pre- titrating solution after ready；The preparation method of pre-dried chloroform is：200mL chloroforms is taken to be placed in solvent bottle, and
10g molecular sieves are added in, capping is screwed, put in drier, is placed more than 24 hours.
(3) sample bottle is weighed：5mL cillin bottles, rubber plug, the aluminium lid of clean dried is taken to weigh, is denoted as W1(7.89168g)。
(4) it samples：Sample (injection Risperidone microballoon) is taken to add in cillin bottle, jumps a queue, gland, weigh, be denoted as W2
(8.26061g)。
(5) dissolving of sample：Step is taken out from titration cup with the closed 5ml belt length needle applicators of drying
(2) pre- titrating solution 5ml, is then injected back into titration cup, so repeatedly 2-3 times, until the system of coulometry Moisture Meter
It is ready, it is then taken out with syringe in the cillin bottle after pre- titrating solution injection step (4) sample-addings of about 4mL, be vortexed dissolving, claims
Weight, is denoted as W3(14.52882g)。
(6) moisture measurement：The dissolved sample of step (5) is all taken out with drying closed syringe, injection is pre-
It titrates in ready titration cup, and weight reduction weighs the weight of the sample solution of injection, is denoted as W4(6.54410g), according to formula
Sample weight=W4*(W2-W1)/(W3-W1), the sample weight (0.36376g) being actually added into titration cup is calculated, to coulomb Moisture Meter
It is middle to input the example weight being actually added into, test, and record test result：Moisture：0.16%.
Specific embodiment 2：
A kind of method for detecting injection Risperidone aqueous microsphere, includes the following steps：
(1) coulomb Moisture Meter is opened, edits instrument parameter, parameter when coulomb Moisture Meter tests moisture is set as：
A, maximum starting drift value：10 μ g/min, incorporation time：60s；
B, electrode：DM143-SC, polarization current：5.0μA；
C, rotating speed：45%；
D, terminal：100.0mv, control zone：250mv, rate：Normally, electrolysis electrode electric current：Automatically；
E, drift value：3 μ g/min, type：Drift is opposite to be stopped, minimum time：0S, maximum time：3600S.
(2) pre- titration：Coulometry moisture titration is ready, takes coulometry anolyte 50mL and pre-dried dichloromethane
Alkane 40mL, by 1:0.8 volume ratio mixing is added in titration cup, is called the test parameter of simultaneously operating procedure (1) setting, is treated coulomb
Moisture Meter show titrate in advance it is ready after pre- titrating solution；The preparation method of pre-dried dichloromethane is：Take 200mL dichloromethane
It is placed in solvent bottle, and adds in 10g molecular sieves, capping screws, and puts in drier, places more than 24 hours.
(3) sample bottle is weighed：5mL cillin bottles, rubber plug, the aluminium lid of clean dried is taken to weigh, is denoted as W1(7.9291g)。
(4) it samples：Sample (injection Risperidone microballoon) is taken to add in cillin bottle, jumps a queue, gland, weigh, be denoted as W2
(8.2237g)。
(5) dissolving of sample：Step is taken out from titration cup with the closed 5ml belt length needle applicators of drying
(2) pre- titrating solution 5ml, is then injected back into titration cup, so repeatedly 2-3 times, until coulometry Moisture Meter is
It unites ready.Then it is taken out with syringe in the cillin bottle after pre- titrating solution injection step (4) sample-addings of about 4mL, be vortexed dissolving,
It weighs, is denoted as W3(14.4577g)。
(6) moisture measurement：The dissolved sample of step (5) is all taken out with drying closed syringe, injection is pre-
It titrates in the titration cup completed, and weight reduction weighs the weight of the sample solution of injection, is denoted as W4(6.3302g), according to formula
Sample weight=W4*(W2-W1)/(W3-W1), the sample weight (0.2856g) being actually added into titration cup is calculated, into coulomb Moisture Meter
The example weight being actually added into, test are inputted, and records test result：Moisture：0.37%.
Specific embodiment 3：
A kind of method for detecting injection Risperidone aqueous microsphere, includes the following steps：
(1) coulomb Moisture Meter is opened, edits instrument parameter, parameter when coulomb Moisture Meter tests moisture is set as：
A, maximum starting drift value：10 μ g/min, incorporation time：60s；
B, electrode：DM143-SC, polarization current：5.0μA；
C, rotating speed：45%；
D, terminal：100.0mv, control zone：250mv, rate：Normally, electrolysis electrode electric current：Automatically；
E, drift value：3 μ g/min, type：Drift is opposite to be stopped, minimum time：0S, maximum time：3600S.
(2) pre- titration：Coulometry moisture titration is ready, takes coulometry anolyte 50mL and pre-dried dimethyl
Formamide 60mL, by 1:1.2 volume ratio mixing is added in titration cup, is called the test parameter of simultaneously operating procedure (1) setting, is treated
Coulomb Moisture Meter show titrate in advance it is ready after obtain pre- titrating solution；The preparation method of pre-dried dimethylformamide is：Take 200mL
Dimethylformamide is placed in solvent bottle, and adds in 10g molecular sieves, and capping screws, and puts in drier, is placed more than 24 hours.
(3) sample bottle is weighed：5mL cillin bottles, rubber plug, the aluminium lid of clean dried is taken to weigh, is denoted as W1(7.9185g)。
(4) it samples：Sample (injection Risperidone microballoon) is taken to add in cillin bottle, jumps a queue, gland, weigh, be denoted as W2
(8.3950g)。
(5) dissolving of sample：The pre- of step (2) is taken out from titration cup with the closed 5ml belt length needle applicators of drying
Titrating solution 5ml, is then injected back into titration cup, so repeatedly 2-3 times, until the system readiness of coulometry Moisture Meter.Then
It is taken out with syringe in the cillin bottle after pre- titrating solution injection step (4) sample-addings of about 4mL, be vortexed dissolving, weighs, is denoted as W3
(14.3696g)。
(6) moisture measurement：The dissolved sample of step (5) is all taken out with drying closed syringe, injection is pre-
It titrates in the titration cup completed, and weight reduction weighs the weight of the sample solution of injection, is denoted as W4(6.0287g), according to formula
Sample weight=W4*(W2-W1)/(W3-W1), the sample weight (0.4453g) being actually added into titration cup is calculated, into coulomb Moisture Meter
The example weight being actually added into, test are inputted, and records test result：Moisture：0.22%.
Embodiment described above is a kind of preferable scheme of the present invention, and not the present invention is made in any form
Limitation also has other variants and remodeling under the premise of without departing from the technical solution recorded in claim.
Claims (6)
- A kind of 1. method for detecting injection Risperidone aqueous microsphere, which is characterized in that include the following steps：(1) coulomb Moisture Meter is opened, test parameter is set；(2) pre- titration：Coulometry anolyte and pre-dried dissolution solvent are taken, by 1:0.5-1:1.5 volume ratio mixing adds in In titration cup, call and the test parameter of operating procedure (1) setting, after a coulomb Moisture Meter show titrate in advance it is ready after must titrate in advance Liquid；(3) sample bottle is weighed：The cillin bottle, rubber plug, aluminium lid of clean dried is taken to weigh, is denoted as W1；(4) it samples：Sample is taken to add in cillin bottle, jumps a queue, gland, weigh, be denoted as W2；(5) dissolving of sample：The pre- titrating solution 4-6ml of step (2) is taken out from titration cup with the closed syringe of drying, then It is injected back into titration cup, so repeatedly 2-3 times, the west after pre- titrating solution 3-5ml injection steps (4) sample-adding is then taken out with syringe In woods bottle, be vortexed dissolving, weighs, is denoted as W3；(6) moisture measurement：The dissolved sample of step (5) is all taken out with drying closed syringe, injection titrates in advance In ready titration cup, and weight reduction weighs the weight of the sample solution of injection, is denoted as W4, according to formula sample weight=W4*(W2- W1)/(W3-W1), the sample weight being actually added into titration cup is calculated, the example weight being actually added into is inputted into coulomb Moisture Meter, Test, and record test result.
- A kind of 2. method for detecting injection Risperidone aqueous microsphere according to claim 1, which is characterized in that step (1) parameter of coulomb Moisture Meter is set as in：A, maximum starting drift value：8-20 μ g/min, incorporation time：40-80s；B, electrode：DM143-SC, polarization current：5.0μA；C, rotating speed：30-55%；D, terminal：100.0mv, control zone：250mv, rate：Normally, electrolysis electrode electric current：Automatically；E, drift value：3 μ g/min, type：Drift is opposite to be stopped, minimum time：0S, maximum time：3600S.
- 3. a kind of method for detecting injection Risperidone aqueous microsphere according to claim 1 or 2, which is characterized in that pre- The preparation method of dry dissolution solvent is：Dissolution solvent is taken to be placed in solvent bottle, and adds in molecular sieve, capping screws, and puts dry In dry device, place more than 24 hours.
- 4. a kind of method for detecting injection Risperidone aqueous microsphere according to claim 3, it is characterised in that：Molecular sieve Dosage be to add the molecular sieve of 2g-10g per 100mL dissolution solvents.
- 5. a kind of method for detecting injection Risperidone aqueous microsphere according to claim 1 or 2, it is characterised in that：Institute It states dissolution solvent and is selected from one or more of chloroform, dichloromethane, dimethylformamide.
- 6. a kind of method for detecting injection Risperidone aqueous microsphere according to claim 1 or 2, it is characterised in that：Step Suddenly in (4) sampling amount of sample in the range of 0.1-0.5g.
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| CN103558335A (en) * | 2013-11-05 | 2014-02-05 | 山东圣泉化工股份有限公司 | Method for determining modified Karl Fischer water |
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