CN107655934A - A kind of brilliant DSC quantitative analysis methods of Linezolid II types - Google Patents
A kind of brilliant DSC quantitative analysis methods of Linezolid II types Download PDFInfo
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- CN107655934A CN107655934A CN201710880828.4A CN201710880828A CN107655934A CN 107655934 A CN107655934 A CN 107655934A CN 201710880828 A CN201710880828 A CN 201710880828A CN 107655934 A CN107655934 A CN 107655934A
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- linezolid
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N25/00—Investigating or analyzing materials by the use of thermal means
- G01N25/20—Investigating or analyzing materials by the use of thermal means by investigating the development of heat, i.e. calorimetry, e.g. by measuring specific heat, by measuring thermal conductivity
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Abstract
The present invention relates to a kind of method of new DSC methods measure Linezolid II type crystalline substance contents, this method initially sets up the computation model of setting Linezolid II type crystalline substance contents, and the computation model is：Y=29.407X+2.99, R2=0.9995, wherein Y are the peak area that differential scanning calorimetry detects, X is the brilliant content of the II types of Linezolid；And the heat flow value of testing sample is determined, the peak area of heat flow value is substituted into step computation model and calculated, obtains the brilliant detection method of content of II types；This method can be used for the quality control of II type crystalline substance Linezolid tablets, can be used for the quality control that II types are brilliant in injection raw material IV type crystalline substance Linezolid bulk drugs, and specificity is good.
Description
Technical field
The present invention relates to a kind of DSC method, particularly a kind of method of DSC methods measure Linezolid II type crystalline substance contents.
Background technology
Linezolid is the antibacterials of Pfizer's research and development, multiple as caused by specified microorganisms sensitive strain available for treating
Polygamy skin and skin soft-tissue infection, community acquired pneumonia and the bacteremia to occur together, the pneumonia of nosocomial infection etc..Molecular formula
For C16H20FN3O4, it is chemical entitled：(S)-N [[3- [the fluoro- 4- of 3- (4- morpholinyls) phenyl] -2- oxo -5- oxazolidinyls] first
Base]-acetamide, its chemical structural formula is as follows：
According to patent literature, Linezolid has 14 kinds of crystal formations, and common crystal formation is I, II, III and IV type.Establish II types
The commercial significance of brilliant detection method has at 2 points.First, biological consistency evaluation is the important means for reshuffling imitation medicine.Profit
How the original of azoles amine grinds medicine as II types is stablized effective II types detection method to cater to wanting for biological consistency evaluation, it is necessary to establish
Ask.Second, the original injection product of applicant is used as bulk drug using IV types are brilliant, and IV types may convert in storage process
It is brilliant for II types, therefore, need also exist for establishing a kind of brilliant quantitative detecting method of II types, the source uniformity for bulk drug of keeping under strict control, protect
Demonstrate,prove product quality.3rd, because the content of Linezolid in Linezolid tablet is higher, therefore, the crystal formation of Linezolid is to piece
The compressibility of agent and dissolution have considerable influence.Crystal formation II is needle, and compressibility is good.
Retrieve and found in the prior art by applicant：
1) method that Application No. CN201310355693.1 Chinese invention patent discloses IV type of identifying is X diffraction powder
Last method, its X-ray powder diffraction figure of institute is at 2 θ 7.33,9.33,13.45,14.70,17.97,20.94,22.17,25.41 °
With characteristic diffraction peak.So method that those skilled in the art are usually identified from X diffraction approaches as crystal formation.
2) pharmacy of nation of present applicant China is disclosed in Application No. CN201110207573.8 patent of invention and subtracted
The method that few IV types turn crystal to II types.Meanwhile applicant is in Application No. CN201110185795.4 application for a patent for invention
In disclose with Quantitative Infrared linezolid form II and crystal formation IV ratios, but it can not exclude auxiliary material in tablet
Interference.
The content of the invention
In view of this, it is an object of the invention to provide a kind of authentication method, can be very good in Linezolid tablet
Auxiliary material and the brilliant Linezolid of II types be substantially carried out distinguishing.
To achieve the above object, the technical scheme is that：
The Linezolid tablet is made up of Linezolid additive of tablet and bulk drug, it is characterised in that the quantitative inspection
Survey method is differential scanning calorimetry, is specially：Sample is analyzed by heater temperature programming under inert gas shielding, with
Occur the peak points of the heat flow value standard brilliant as II types are judged at 155 ± 5 DEG C, and/or heat flow value occur at 159 ± 5 DEG C
Peak points are as the standard for judgement II types crystalline substance.
Further scheme is that the Linezolid additive of tablet is：Microcrystalline cellulose and/or hydroxypropyl cellulose and/
Or any of carboxyrnethyl starch sodium and magnesium stearate or a variety of.
The benefit of this method is：II types are brilliant and each component of auxiliary material has good discrimination.Original grinds the application of pharmaceutical factory man
Prescription disclosed in CN1208058C patent is：Respectively with linezolid form II (71.43wt%), starch (7.14wt%)
When preparing tablet with microcrystalline cellulose (14.0wt%) and described adhesive, disintegrant, lubricant, based on linezolid form II
Tablet prepared by medicine, compressibility and mouldability are preferable.Using this method in the application, directly using finished tablet as detection
Sample, using result as the quality being oriented to from crystal formation angle detection compressibility and mouldability.Before this method, it can only carry out
Whether process monitoring, whether the crystal formation of bulk drug before tablet is not made for detection is crystal formation II, as occurring during before
Turn brilliant just unknown, because can not be distinguished well before raw material and auxiliary material.
Further, in described authentication method, the initial temperature of the heat temperature raising program is 30~50 DEG C, medium temperature
For 120~135 DEG C, heating rate is 5~40 DEG C/min；Medium temperature is 120~135 DEG C of 5~10min of releveling；Terminal temperature
Spend for 195~300 DEG C, heating rate is 5~40 DEG C/min.It is applicant's understanding that success or failure of this heating schedule to entirely testing
There is critically important contribution.
The second object of the present invention is the detection method of content for providing Linezolid II types crystalline substance, and this method accuracy is high,
It is and easy to detect..
To achieve the above object, the technical scheme is that：
The detection method of content of II types crystalline substance in Linezolid tablet, the Linezolid tablet are auxiliary by Linezolid tablet
Material and bulk drug composition, it is characterised in that the quantitative detecting method is differential scanning calorimetry, is specially：
A sets the computation model of Linezolid II type crystalline substance contents
The computation model is：Y=29.407X+2.99, R2=0.9995, wherein Y detect for differential scanning calorimetry
Peak area, X is the brilliant content of the II types of Linezolid；The acquisition of this computation model, we are to pass through early stage largely in fact
Test data and grope what is obtained.During whole obtain, inventor at least experienced three steps and temper.The first step, which kind of inspection selected
Survey means；Second step, grope for the differential scanning calorimetry condition of various samples (14 kinds of crystal formations, auxiliary material, tablet technique etc.)；
3rd step, data rule is looked for, establish the model and evaluation model of no error.
The measure of the heat flow value of B testing samples
Testing sample is detected with differential scanning calorimetry, the peak area of obtained heat flow value substitutes into what step A was established
Calculated in computation model, obtain the brilliant detection method of content of II types.
Further, the brilliant detection method of content of the II types in described Linezolid tablet, the Linezolid tablet are auxiliary
Expect for microcrystalline cellulose and/or hydroxypropyl cellulose and/or any of carboxyrnethyl starch sodium and magnesium stearate or a variety of.
Further, in described quantitative detecting method, the heating schedule of the differential scanning calorimetry described in step B is：Rise
Beginning temperature is 30~50 DEG C, and medium temperature is 120~135 DEG C, and heating rate is 5~40 DEG C/min；Medium temperature be 120~
135 DEG C of 5~10min of releveling；Outlet temperature is 195~300 DEG C, and heating rate is 5~40 DEG C/min.
Further, described quantitative detecting method, in step B, the peak area of described heat flow value refers to that peak points are 155
Heat flow value sum at ± 5 DEG C and 159 ± 5 DEG C.
The third object of the present invention, which is to provide, provides Linezolid II types the brilliant method brilliant with IV types, and its specificity is high.
To achieve the above object, the technical scheme is that：
The method that Linezolid II types are brilliant and IV types are brilliant is distinguished, detection sample is detected with differential scanning calorimetry, specifically
For：Sample is analyzed by heater temperature programming under inert gas shielding, if there is heat flow value at 155 ± 5 DEG C
There are the peak points of heat flow value at peak points and/or 159 ± 5 DEG C, then show in sample containing the Linezolid that II types are brilliant.
As further scheme, the initial temperature of the heat temperature raising program is 30~50 DEG C, medium temperature is 120~
135 DEG C, heating rate is 5~40 DEG C/min；Medium temperature is 120~135 DEG C of 5~10min of releveling；Outlet temperature is 195
~300 DEG C, heating rate is 5~40 DEG C/min.
As further scheme, the detection sample is the bulk drug of Linezolid injection.
The beneficial effects of the present invention are：The present invention eliminates the interference of auxiliary material in Linezolid piece by temperature programming,
The accuracy and repeatability of heat flow value integration are ensure that, makes the result of sample accurately and reliably, then by measuring II type crystalline contents
Compared with theoretical content, product quality is strictly controlled, ensures validity.
Linezolid bulk drug is that IV types are brilliant in parenteral solution, takes sample 10mg, wherein the IV crystalline substances for having 1% are changed into II types crystalline substance
It can accurately determine, strictly control the raw material sources of parenteral solution, ensure that the safe and effective of product.
Brief description of the drawings
Fig. 1 is the DSC figures of blank auxiliary in embodiment 1；
Fig. 2 is the DSC figures of Linezolid piece in embodiment 1；
Fig. 3 is the DSC figures of brilliant linear 1 (0.48mg) of II types in embodiment 1；
Fig. 4 is the DSC figures of brilliant linear 2 (1.13mg) of II types in embodiment 1；
Fig. 5 is the DSC figures of brilliant linear 5 (5.21mg) of II types in embodiment 1；
Fig. 6 is the DSC figures of brilliant linear 7 (9.80mg) of middle II types in embodiment 1；
The brilliant equation of linear regression figure of II types in Fig. 7 embodiments 1；
Fig. 8 is the DSC figures that IV types are brilliant in embodiment 1；
Fig. 9 is the DSC figures of the 5%II type crystalline substance rate of recovery in embodiment 2；
Figure 10 is the DSC figures for the composition that 99%IV types are brilliant and 1%II types are brilliant.
Embodiment
It detailed description of a preferred embodiment of the present invention will be given below.The reality of unreceipted actual conditions in preferred embodiment
Proved recipe method, generally according to normal condition, illustrated embodiment is to preferably be illustrated to present disclosure, but is not
Present disclosure is only limitted to illustrated embodiment.So those skilled in the art according to foregoing invention content to embodiment party
Case carries out nonessential modifications and adaptations, still falls within protection scope of the present invention.
The measure of II type crystalline substance contents in the Linezolid piece of embodiment 1
Condition determination：
Shuttle：40 μ l aluminium crucibles；Protect gas：Nitrogen, 40ml/min；
Temperature programming：30~130 DEG C, 20 DEG C/min of heating rate；130 DEG C are kept for 5 minutes；130~200 DEG C, heating speed
10 DEG C/min of rate.
Prescription information 1：The label auxiliary material of Linezolid piece is microcrystalline cellulose (weight meter accounts for 21.57%), hydroxypropyl fibre
Dimension plain (weight meter accounts for 1%), carboxyrnethyl starch sodium (weight meter accounts for 5%) and magnesium stearate (weight meter accounts for 1%), main ingredient specification are
600mg, main ingredient Linezolid account for 71.43%.
Prescription information 2：Prescription disclosed in CN1208058C patent, respectively with linezolid form II (71.43wt%),
Starch (7.14wt%) and microcrystalline cellulose (14.0wt%) and described adhesive, disintegrant, lubricant prepare tablet
Method：The empty aluminium crucibles of 40 μ l are taken, lid is taken and pricks a 1mm or so aperture, gland, as reference crucible.
The blank auxiliary 10mg of prescription information 1 is taken, it is accurately weighed, 40 μ l aluminium crucibles are put, lid is taken and pricks 1mm or so
Aperture, gland, blank auxiliary sample preparation are completed, determine in accordance with the law, see Fig. 1.The blank auxiliary 10mg of prescription information 2 is taken, it is accurate
It is weighed, 40 μ l aluminium crucibles are put, lid is taken and pricks a 1mm or so aperture, gland, blank auxiliary sample preparation is completed, surveyed in accordance with the law
It is fixed, see Fig. 1.
Linezolid 10 is taken, removes coating respectively, it is finely ground and mix, take sample appropriate, it is accurately weighed, put 40 μ l aluminium earthenwares
Crucible, take lid and prick a 1mm or so aperture, gland, prepared by test sample completes, and parallel determination 6 times, are shown in Fig. 2 in accordance with the law, integrate
To heat flow value and bring standard curve calculating into, as a result see the table below.
Take the brilliant Linezolid reference substance of II types appropriate, take 0.5mg, 1mg, 2mg, 3mg, 5mg, 7.5mg and 10mg respectively,
It is accurately weighed, to put in 40 μ l aluminium crucibles, take lid and prick a 1mm or so aperture, gland, standard curve sample preparation is completed,
Detect in accordance with the law, see Fig. 3~6, then linear regression is carried out with the heat flow value sum of peak points and weight, see Fig. 7.
The Linezolid 5mg that IV types are brilliant is taken, it is accurately weighed, 40 μ l aluminium crucibles are put, lid is taken and to prick a 1mm or so small
Hole, gland, the sample preparation of IV type crystalline substances are completed, determine in accordance with the law, see Fig. 8.
Interpretation of result：Prescription information 1 and blank auxiliary in prescription information 2 and IV type crystalline substance Linezolids are at 130~170 DEG C
Suction exothermic peak is had no, does not influence the brilliant measure of II types.So
II type crystalline substances linear relationship in the range of 0.5~10mg is good, R>0.999, Linezolid piece II type crystalline substances measure content
For 72.48% (main ingredient accounts for the weight ratio of label), HPLC measures Linezolid content, and (main ingredient accounts for the weight of label for 72.21%
Than), measurement result is accurate.
The Linezolid piece recovery experiment of embodiment 2
Condition determination：
Shuttle：40 μ l aluminium crucibles；Protect gas：Nitrogen, 40ml/min；
Temperature programming：30~130 DEG C, 20 DEG C/min of heating rate；130 DEG C are kept for 5 minutes；130~200 DEG C, heating speed
10 DEG C/min of rate.
Blank auxiliary：Microcrystalline cellulose, hydroxypropyl cellulose, carboxyrnethyl starch sodium and magnesium stearate
Method：The empty aluminium crucibles of 40 μ l are taken, lid is taken and pricks a 1mm or so aperture, gland, as reference crucible.
Take Linezolid blank auxiliary and II type crystalline substance Linezolid reference substances, according to main ingredient ratio be respectively 5%, 10%,
20%th, 30%, 50%, 60% and 80% it is well mixed with auxiliary material, then takes the Linezolid composition 10mg mixed respectively, essence
It is close weighed, 40 μ l aluminium crucibles are put, lid is taken and pricks a 1mm or so aperture, gland, complete the preparation of test sample, detect in accordance with the law
Sample, see Fig. 9 (5% sample drawing), then the heat flow value at peak points is integrated and brings standard curve calculating into.
Take the brilliant Linezolid reference substance of II types appropriate, take 0.5mg, 1mg, 2mg, 3mg, 5mg, 7.5mg and 10mg respectively,
It is accurately weighed, to put in 40 μ l aluminium crucibles, take lid and prick a 1mm or so aperture, gland, standard curve sample preparation is completed,
Detect in accordance with the law, then linear regression is carried out with the heat flow value sum of peak points and quality.
As a result it is as follows：
Sample recovery rate between 90~105% scopes, meet content detection requirement, method accurately and reliably, available for profit
How in azoles amine piece II type crystalline substance contents measure.
II type crystalline substance assays in the parenteral solution bulk drug Linezolid IV type crystalline substance bulk drugs of embodiment 3
Condition determination：
Shuttle：40 μ l aluminium crucibles；Protect gas：Nitrogen, 40ml/min；Temperature programming：30~130 DEG C, heating rate
20℃/min；130 DEG C are kept for 5 minutes；130~200 DEG C, 10 DEG C/min of heating rate.
Method：The empty aluminium crucibles of 40 μ l are taken, lid is taken and pricks a 1mm or so aperture, gland, as reference crucible.
IV type crystalline substance Linezolids 10mg is taken, it is accurately weighed, put in 40 μ l aluminium crucibles, take lid and to prick a 1mm or so small
Hole, gland, sample preparation are completed, determine in accordance with the law, see Fig. 5.
II type crystalline substance Linezolid 0.1mg, 0.2mg, 0.3mg, 0.5mg, 1mg, 2mg, 3mg, 5mg and 10mg are taken respectively, essence
It is close weighed, to put in 40 μ l aluminium crucibles, take lid and prick a 1mm or so aperture, gland, standard curve sample preparation is completed, according to
Method detects, then carries out linear regression with the peak area sum of peak points and quality.
Recovery experiment：Take Linezolid IV types brilliant and II type crystalline substance reference substances, according to II types ratio 1%, 2%, 3%, 5%,
10%th, 20%, 30% and 50% blank auxiliary (prescription information 1) is well mixed, then takes the Linezolid group mixed respectively
Compound 10mg, it is accurately weighed, 40 μ l aluminium crucibles are put, lid is taken and pricks a 1mm or so aperture, gland, complete the system of test sample
It is standby, sample is detected in accordance with the law, sees Figure 10 (1% II type crystalline substances sample drawing), then the heat flow value at peak points is integrated and brings standard into
Curve calculates.
As a result it is as follows：
Sample recovery rate between 90~105% scopes, meet content detection requirement, method accurately and reliably, available for profit
How in azoles amine in IV type crystalline substance bulk drugs II type crystalline substance contents measure.
Finally illustrate, the above embodiments are merely illustrative of the technical solutions of the present invention and it is unrestricted, although with reference to compared with
The present invention is described in detail good embodiment, it will be understood by those within the art that, can be to the skill of the present invention
Art scheme is modified or equivalent substitution, and without departing from the objective and scope of technical solution of the present invention, it all should cover at this
Among the right of invention.
Claims (10)
1. the authentication method of the II types crystalline substance in Linezolid tablet, the Linezolid tablet is by Linezolid additive of tablet and original
Expect medicine composition, it is characterised in that the quantitative detecting method is differential scanning calorimetry, is specially：Under inert gas shielding
Sample is analyzed by heater temperature programming, the peak points for occurring heat flow value using at 155 ± 5 DEG C are used as the mark for judging II types crystalline substance
Occur the peak points of heat flow value at standard, and/or 159 ± 5 DEG C as the standard for judgement II types crystalline substance.
2. authentication method according to claim 1, it is characterised in that the Linezolid additive of tablet is：Microcrystalline cellulose
Element and/or hydroxypropyl cellulose and/or any of carboxyrnethyl starch sodium and magnesium stearate or a variety of.
3. authentication method according to claim 1, it is characterised in that the initial temperature of the heat temperature raising program be 30~
50 DEG C, medium temperature is 120~135 DEG C, and heating rate is 5~40 DEG C/min；Medium temperature be 120~135 DEG C of relevelings 5~
10min；Outlet temperature is 195~300 DEG C, and heating rate is 5~40 DEG C/min.
4. the detection method of content of the II types crystalline substance in Linezolid tablet, the Linezolid tablet is by Linezolid additive of tablet
Formed with bulk drug, it is characterised in that the quantitative detecting method is differential scanning calorimetry, is specially：
A sets the computation model of Linezolid II type crystalline substance contents
The computation model is：Y=29.407X+2.99, R2=0.9995, wherein Y are the peak that differential scanning calorimetry detects
Area, X are the brilliant content of the II types of Linezolid；
The measure of the heat flow value of B testing samples
Testing sample is detected with differential scanning calorimetry, the peak area of obtained heat flow value substitutes into the calculating that step A is established
Calculated in model, obtain the brilliant detection method of content of II types.
5. the detection method of content of the II types crystalline substance in Linezolid tablet according to claim 1, it is characterized in that：The profit
How azoles amine additive of tablet is any in microcrystalline cellulose and/or hydroxypropyl cellulose and/or carboxyrnethyl starch sodium and magnesium stearate
Kind is a variety of.
6. quantitative detecting method according to claim 4, it is characterised in that differential scanning calorimetry described in step B
Heating schedule is：Initial temperature is 30~50 DEG C, and medium temperature is 120~135 DEG C, and heating rate is 5~40 DEG C/min；It is middle
Temperature is 120~135 DEG C of 5~10min of releveling；Outlet temperature is 195~300 DEG C, and heating rate is 5~40 DEG C/min.
7. quantitative detecting method according to claim 4, it is characterised in that in step B, the peak area of described heat flow value
Refer to peak points for the heat flow value sum at 155 ± 5 DEG C and 159 ± 5 DEG C.
8. distinguish the method that Linezolid II types are brilliant and IV types are brilliant, it is characterised in that sample differential scanning calorimetry will be detected
Detection, it is specially：Sample is analyzed by heater temperature programming under inert gas shielding, if occurring heat at 155 ± 5 DEG C
There are the peak points of heat flow value at the peak points of flow valuve and/or 159 ± 5 DEG C, then show in sample containing the brilliant profit of II types how azoles
Amine.
9. according to the method for claim 8, it is characterised in that the initial temperature of the heat temperature raising program is 30~50
DEG C, medium temperature is 120~135 DEG C, and heating rate is 5~40 DEG C/min；Medium temperature be 120~135 DEG C of relevelings 5~
10min；Outlet temperature is 195~300 DEG C, and heating rate is 5~40 DEG C/min.
10. according to the method for claim 8, it is characterised in that the detection sample is the raw material of Linezolid injection
Medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710880828.4A CN107655934A (en) | 2017-09-26 | 2017-09-26 | A kind of brilliant DSC quantitative analysis methods of Linezolid II types |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710880828.4A CN107655934A (en) | 2017-09-26 | 2017-09-26 | A kind of brilliant DSC quantitative analysis methods of Linezolid II types |
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| CN201710880828.4A Pending CN107655934A (en) | 2017-09-26 | 2017-09-26 | A kind of brilliant DSC quantitative analysis methods of Linezolid II types |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102866126A (en) * | 2011-07-05 | 2013-01-09 | 重庆华邦制药股份有限公司 | Method for measuring crystal form proportion in compound in quantitative mode |
| CN106727396A (en) * | 2016-11-22 | 2017-05-31 | 湖北广济药业股份有限公司 | A kind of II crystal linezolid piece and preparation method thereof |
-
2017
- 2017-09-26 CN CN201710880828.4A patent/CN107655934A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102866126A (en) * | 2011-07-05 | 2013-01-09 | 重庆华邦制药股份有限公司 | Method for measuring crystal form proportion in compound in quantitative mode |
| CN106727396A (en) * | 2016-11-22 | 2017-05-31 | 湖北广济药业股份有限公司 | A kind of II crystal linezolid piece and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| ELISABETTA MACCARONI,ET AL: "Polymorphism of linezolid: A combined single-crystal,powder diffraction and NMR study", 《INTERNATIONAL JOURNAL OF PHARMACEUTICS》 * |
| 肖燕，等: "固体药物晶型定量分析方法", 《石油化工》 * |
| 金朝辉，等: "药物晶型多态性及其测定、评价方法", 《中国药房》 * |
| 马乐伟，等: "药物晶型定量分析方法的研究进展", 《药学学报》 * |
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