CN105699584B - A kind of detection method of Artemether related substances - Google Patents
A kind of detection method of Artemether related substances Download PDFInfo
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Abstract
The invention provides a kind of detection method of Artemether related substances, including：Artemether raw material or Artemether preparation are mixed with C1~C3 alcoholic solvent, take alcoholic solution layer to carry out thin-layer chromatography as test liquid.Compared with prior art, the present invention eliminates influence of the solvent to thin-layer chromatography in Artemether raw material or preparation using C1~C3 alcoholic solvent, by the content for detecting the related substances degraded in Artemether production and storage process and its accessory substance, and then the quality of Artemether raw material or preparation is accurately evaluated, to ensure the quality of Artemether raw material and preparation.
Description
Technical field
The invention belongs to technical field of analytical chemistry, more particularly to a kind of detection method of Artemether related substances.
Background technology
Artemether (artemether, ARM) molecular formula is C16H26O5, molecular weight 298.37, its structural formula such as formula (I) institute
Show, be the Methyl ether derivatives of qinghaosu, its antimalarial effect is 6 times of its lead compound qinghaosu.Artemether in
Nineteen ninety-five takes in WHO essential drug lists, and FDA ratified Coartem piece (Artemether 20mg/ LUMEFANTRINEs in 2009
120mg), the formulation of list marketing at present includes tablet, capsule and pill, capsule and injection, is answered in addition with what LUMEFANTRINE formed
Square preparation, its indication are mainly all kinds of malaria.But there is poorly water-soluble in Artemether, alimentary canal absorbs slow, bioavilability
Low shortcoming.The Artemether parenteral solution of Kun Yao groups production, is the aseptic parenteral solution using pure plant oil as solvent, solves
This problem.
Recently as great attentions of the WHO to artemisinin-based antimalarial drug and quality requirement, make Artemether and its preparation not
It is disconnected to improve sole mass and quality control standard.The Artemether raw materials of Kun Yao groups at present by U.S. FDA and WHO certification,
Artemether preparation is in actual production process using its raw material of inner controlling standard of enterprise (Q/KPC 91-1) progress quality control assurances
Quality is better than other like products.But the standard performed still uses ministry standard single page WS-111 (X-89) -90 all the time, its
In related substances inspection project is not included in.
The existing related substances inspection method list related to Artemether is relatively shown in Table 1.
The existing Artemether related substances detection method list of table 1
As shown in Table 1, existing detection method has the following disadvantages：(1) recorded at present in Ph.Int42011【Correlative
Quality inspection checking method】A items are not considered because the Artemether parenteral solution that Kun Yao groups produce is using peanut oil as solvent；【Correlative
Matter】B items：Also it is one sided not to be suitable for Artemether parenteral solution more specifically judgment criteria, and reason is in thin-layer chromatography
Use acetone as solvent in method pre-treatment, acetone is the good solvent of organic solvent and Artemether, solvent and wormwood artemisia in dilution
Methyl ether is mixed, and the two can not be efficiently separated during thin-layer developing, be embodied in principal spot gross distortion, impurity
Spot may be broken down into several flecks, disturb the judgement of result；(2) the related substances inspection method that USP2011 is recorded：
A, detection time is grown, and need to be exposed to 254nm uviol lamp lower 60 minutes；B, the difficult control of evaluation method, the colour developing of 20% methanolic
It is to destroy spot development under the high temperature conditions according to sulfuric acid, the observation of each spot is not directly perceived.C, the judge limitation of impurity spot, only
Evaluation impurity spot CGP 79147 and ZE 9732, other impurities spot do not account for；(3) correlation that Ch.P.2010 versions are recorded
Material inspection method, still in blank.
The content of the invention
In view of this, the technical problem to be solved in the present invention is to provide a kind of Artemether related substances easily to operate
Detection method.
The invention provides a kind of detection method of Artemether related substances, it is characterised in that including：
Artemether raw material or Artemether preparation are mixed with C1~C3 alcoholic solvent, take alcoholic solution layer to be carried out as test liquid
Thin-layer chromatography.
Preferably, the thin-layer chromatography carries out Control of Impurities using Self-control method.
Preferably, the Self-control method is specially：
Test liquid is mixed with C1~C3 alcoholic solvent, obtains the first control that mass concentration is respectively 0.4%~0.6%
Liquid, 0.2%~0.3% the second comparison liquid and 0.8%~1.2% the 3rd comparison liquid；
First comparison liquid, the second comparison liquid, the 3rd comparison liquid and test liquid are subjected to thin-layer chromatography simultaneously.
Preferably, the volumetric concentration of the alcoholic solvent of the C1~C3 is 70%~100%.
Preferably, also centrifuged after mixing, then take alcoholic solution layer.
Preferably, the rotating speed of the centrifugation is 1000~5000r/min；The time of centrifugation is 2~30min.
Preferably, the concentration of the test liquid is 5~50mg/ml.
Preferably, the carrier of the thin-layer chromatography is silica G plate or 60G Merck lamellaes.
Preferably, the solvent of the thin-layer chromatography is in glacial acetic acid, ethyl acetate and 60 DEG C~90 DEG C of petroleum ether
Two or three.
Preferably, the volume ratio of described 60 DEG C~90 DEG C of petroleum ether, ethyl acetate and glacial acetic acid is (10~30)：(1~
10)：(0.5~5).
The invention provides a kind of detection method of Artemether related substances, including：By Artemether raw material or Artemether system
Agent mixes with C1~C3 alcoholic solvent, takes alcoholic solution layer to carry out thin-layer chromatography as test liquid.Compared with prior art, it is of the invention
Influence of the solvent to thin-layer chromatography in Artemether raw material or preparation is eliminated using C1~C3 alcoholic solvent, is produced by detecting Artemether
The related substances and its content of accessory substance degraded in product production and storage process, and then to the quality of Artemether raw material or preparation
Accurately evaluated, to ensure the quality of Artemether raw material and preparation.
Brief description of the drawings
Fig. 1 is that oiliness solvent and the organic solvent of Artemether parenteral solution in the embodiment of the present invention 1 dissolve each other lab diagram；
Fig. 2 is the thin-layer chromatography chromatogram of the embodiment of the present invention 2；
Fig. 3 is the thin-layer chromatography chromatogram of the embodiment of the present invention 3；
Fig. 4 is the thin-layer chromatography chromatogram of the embodiment of the present invention 4 and embodiment 7；
Fig. 5 is the thin-layer chromatography chromatogram of the embodiment of the present invention 5；
Fig. 6 is the thin-layer chromatography chromatogram of the embodiment of the present invention 6.
Embodiment
Below in conjunction with the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described,
Obviously, described embodiment is only part of the embodiment of the present invention, rather than whole embodiments.Based in the present invention
Embodiment, the every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made, all
Belong to the scope of protection of the invention.
The invention provides a kind of detection method of Artemether related substances, including：By Artemether raw material or Artemether system
Agent mixes with C1~C3 alcoholic solvent, takes alcoholic solution layer to carry out thin-layer chromatography as test liquid.
Wherein, the alcoholic solvent of the C1~C3 is preferably the one or more in methanol, ethanol and isopropanol, more preferably
Methanol, ethanol or isopropanol；The volumetric concentration of the alcoholic solvent of the C1~C3 is preferably 70%~100%, and more preferably 80%
~100%.
Artemether raw material or Artemether preparation are mixed with C1~C3 alcoholic solvent, when for Artemether raw material when, directly will
It is mixed with C1~C3 alcoholic solvent, is allowed to be dissolved in alcoholic solvent, takes this solution to be tested；When for Artemether preparation when, it is excellent
Choosing mixes Artemether preparation with C1~C3 alcoholic solvent, carries out ultrasonic dissolution, is centrifuged after fully mixing, is separated in preparation
Solvent, take alcoholic solution layer carry out thin layer experiment.
The ultrasonic power is preferably PWR%：50~100, more preferably PWR%：60~80；The ultrasonic time
Preferably 2~30min, more preferably 5~20min, it is further preferably 10~20min.After fully mixing, preferably centrifuged.Institute
The rotating speed for stating centrifugation is preferably 1000~5000r/min, more preferably 2000~4000r/min；The time of the centrifugation is preferred
It is further preferably 10~20min for 2~30min, more preferably 5~25min.
After centrifugation, alcoholic solution layer is taken to carry out thin-layer chromatography as test liquid；The concentration of the test liquid is preferably 5~
50mg/ml, more preferably 10~40mg/ml, it is further preferably 10~30mg/ml；The volume of point sample is preferred in the thin-layer chromatography
It is further preferably 8~12 μ l for 5~20 μ l, more preferably 5~15 μ l, most preferably 10 μ l；The carrier of the thin-layer chromatography is this
Carrier known to art personnel, has no special limitation, is preferably silica G plate or 60G Merck thin in the present invention
Laminate；The solvent of the thin-layer chromatography be preferably two kinds in glacial acetic acid, ethyl acetate and 60 DEG C~90 DEG C of petroleum ether or
Three kinds, the more preferably mixed liquor or glacial acetic acid of ethyl acetate and 60 DEG C~90 DEG C of petroleum ether, ethyl acetate and 60 DEG C~90
DEG C petroleum ether mixed liquor；The volume ratio of the ethyl acetate and 60 DEG C~90 DEG C of petroleum ether is preferably (1~10)：(5~
20), more preferably (2~8)：(5~15), it is further preferably (2~5)：(5~10), most preferably 3:7；The glacial acetic acid, acetic acid
The volume ratio of ethyl ester and 60 DEG C~90 DEG C of petroleum ether is preferably (0.5~5)：(1~10)：(10~30), more preferably (1~
3)：(2~8)：(15~25), it is further preferably (2~3)：(3~6)：(16~22), most preferably 2.5:5:20；Expansion, dries
Afterwards, preferably developed the color with vanillin-sulphuric acid solution；The concentration of the vanillin-sulphuric acid solution is preferably 0.5%~10%, more preferably
For 2%~8%, it is further preferably 3%~7%, is further preferably 4%~6%, most preferably 5%.
Control of Impurities is preferably carried out using Self-control method according to thin-layer chromatography of the present invention.The Self-control method is excellent
Choosing is specially：Test liquid is mixed with C1~C3 alcoholic solvent, obtains the first couple that mass concentration is respectively 0.4%~0.6%
According to liquid, 0.2%~0.3% the second comparison liquid and 0.8%~1.2% the 3rd comparison liquid；By first comparison liquid, second
Comparison liquid, the 3rd comparison liquid and test liquid carry out thin-layer chromatography simultaneously.Wherein, the alcoholic solvent of the C1~C3 is same as above,
This is repeated no more；The mass concentration of first comparison liquid is preferably 0.45%~0.55%, and more preferably 0.5%；Described
The mass concentration of two comparison liquids is preferably 0.25%；The mass concentration of 3rd comparison liquid is preferably 0.9%~1.1%, more
Preferably 1%.The high comparison liquid of mass concentration is more preferably first prepared in the present invention, then recycles the high comparison liquid of mass concentration
Prepare the low comparison liquid of mass concentration.
The present invention eliminates influence of the solvent to thin-layer chromatography in preparation using C1~C3 alcoholic solvent, by detecting Artemether
The related substances and its content of accessory substance degraded in production and storage process, and then to the matter of Artemether raw material or preparation
Amount is accurately evaluated, to ensure the quality of Artemether raw material and preparation.
In order to further illustrate the present invention, with reference to embodiments to a kind of Artemether related substances provided by the invention
Detection method is described in detail.
Reagent used is commercially available in following examples.
Embodiment 1
Each 1ml of oiliness solvent of the i.e. Artemether parenteral solution of 5 parts of Artemether preparations is taken to be respectively placed in 5 test tubes, such as Fig. 1 institutes
Show, from left to right in each branch test tube successively distinguish each addition 8ml methanol (from left to right the 1st), 8ml ethanol (from left to right the 2nd),
8ml acetone (from left to right the 3rd), 8ml isopropanols (from left to right the 4th), 8ml n-butanols (from left to right the 5th), then by each branch test tube
Two kinds of solvent shake wells make to stand 1 hour after being sufficiently mixed, it can be seen that the alcohol of 1~3 carbon atom and dissolving Artemether
The layering of oiliness solvent be substantially the good solvent for separating oiliness solvent, and add in two test tubes of acetone and n-butanol (from a left side
Play the 3rd and play the 5th), acetone and n-butanol be completely dissolved with oiliness solvent together with it is not stratified, illustrate acetone and n-butanol
Can not be used for separating Artemether preparation -- the oiliness solvent of Artemether parenteral solution.
Embodiment 2
Take three kinds of Artemether parenteral solutions (being respectively sample A, B and C) in right amount, three kinds of samples are separately added into absolute ethyl alcohol and surpassed
Sound makes fully to dissolve, centrifugation, and separation solvent takes absolute ethyl alcohol layer, and as test liquid, the concentration of test liquid is 10mg/ml；Precision takes
Test liquid adds absolute ethyl alcohol that the solution for containing 0.05mg in 1ml is made as the first comparison liquid, precision take the first comparison liquid 5ml in
10ml measuring bottles, absolute ethyl alcohol is added to be diluted to the solution for containing 0.025mg Artemethers in 1ml as the second comparison liquid, using itself
Counter point carries out thin layer chromatography analysis.Lamellae：60G Merck lamellaes；Solvent：Petroleum ether (60 DEG C~90 DEG C)-acetic acid
Ethyl ester (7:3)；Developer：5% vanillin-sulfuric acid solution；Point sample volume：10μl.Tested according to " thin-layered chromatography ", with petroleum ether
(60 DEG C~90 DEG C)-ethyl acetate (7:3) it is solvent, after expansion, dries, sprays with 5% vanillin-sulfuric acid solution, in the sunlight
Inspect, obtain thin layer chromatogram as shown in Fig. 2 wherein A1 is sample A the first comparison liquid, A2 compares for the second of sample A
Liquid, B1 are sample B the first comparison liquid, and B2 is sample B the second comparison liquid, and C1 is sample C the first comparison liquid, and C2 is sample
C the second comparison liquid.
As shown in Figure 2：Solvent and sample separation are complete, and principal spot is interference-free, and rounding is oval
Embodiment 3
Take the Artemether preparation that low frequency radiation is handled to add ethanol with the Artemether preparation handled through high-temperature sterilization respectively to surpass
Sound makes fully to dissolve, centrifugation, and separation solvent takes alcohol layer, and as test liquid, (the Artemether preparation of low frequency radiation processing is for trying
Product A, the Artemether preparation handled through high-temperature sterilization is test sample B) concentration of two kinds of test liquids is 10mg/ml；Precision is taken for trying
Liquid adds ethanol that the solution for containing 0.05mg in 1ml is made as the first comparison liquid, and precision takes the first comparison liquid 5ml in 10ml amounts
Bottle, add ethanol to be diluted to the solution for containing 0.025mg Artemethers in 1ml as the second comparison liquid, precision take test liquid 1ml in
100ml measuring bottles, add ethanol to be diluted to solution of the 1ml containing 0.1mg, as the 3rd comparison liquid, thin layer is carried out using Self-control method
Chromatography test.Lamellae：60G Merck lamellaes；Solvent：Petroleum ether (60~90 DEG C)-ethyl acetate (7:3)；Developer：
5% vanillin-sulfuric acid solution；Point sample volume：10μl.Tested according to " thin-layered chromatography ", with petroleum ether (60 DEG C~90 DEG C)-acetic acid
Ethyl ester (7:3) it is solvent, after expansion, dries, sprays with 5% vanillin-sulfuric acid solution, inspect in the sunlight, obtain thin layer color
Spectrogram is as shown in figure 3, wherein A1 is test liquid A the first comparison liquid, and A2 is test liquid A the second comparison liquid, and A3 is test liquid A
The 3rd comparison liquid, B1 is test liquid B the first comparison liquid, and B2 is test liquid B the second comparison liquid, and B3 is the of test liquid B
Three comparison liquids, C are Artemether reference substance solutions of the 1ml containing 0.1mg of ethanol dissolving.
As shown in Figure 3：Solvent and sample separation are complete, and principal spot is interference-free, and rounding is oval.Artemether in preparation
The position of principal spot and the position consistency of Artemether reference substance principal spot.
Embodiment 4
Take three batches of raw materials (MFB20141011, MFB20141012, MFB20141015 produce by Kun Yao groups) wherein
A collection of middle addition Artemether impurity CGP and ZE and single CGP and ZE is contrasted, while is faced with what aseptic filtration produced with brand-new wormwood artemisia
Methyl ether parenteral solution (20140521) and with the good room temperature of Ethanol Treatment placed 8 days Artemether parenteral solution compare, carry out thin layer
Analysis, it is as shown in Figure 4 to obtain thin-layer chromatography chromatogram.
As shown in Figure 4：Three batches of raw materials, parenteral solution, added ZE colors in ZE raw material, position and ZE control spots one
Cause.Tentatively judge impurity ZE, Rf：0.35.
Without CGP in raw material and parenteral solution, the CGP spots and CGP in CGP raw material (MFB20141011+ZE+CGP) are added
Spot position consistency is compareed, it is in mimeograph vestige not develop the color.
20140521 (now handling) and the spot of 20140521 (room temperature is placed 8 days) displays have obvious difference,
More impure points and apparent in the sample of 20140521 (room temperatures place 8 days).Preliminary examinations ethanol sample dissolution it is steady
It is qualitative：The sample room temperature decentralization of ethanol dissolving, which is put 8 days, has unstability.
Embodiment 5
The Artemether parenteral solution for taking filtration sterilization to produce is appropriate, adds ethanol that the solution containing 10mg in every 1ml is made, ultrasound
(PWR%:80) handle 5 minutes, centrifuge 10 minutes (4000 revs/min), take supernatant as test liquid.Precision measures test liquid
The comparison liquid (0.25%) of the Artemether containing 0.025mg in 1ml is prepared, the comparison liquid (0.5%) of the Artemether containing 0.05mg in 1ml,
The Artemether comparison liquid (1.0%) of the Artemether containing 0.10mg in 1ml.Take each 10 μ l points of above-mentioned solution in same silica G plate (it is recommended that
Use 60G Merck plates) on, after being dried in air, it is placed in saturation in chromatography cylinder and after 15 minutes, deploys [solvent：Petroleum ether-
Ethyl acetate-glacial acetic acid (20:5:2.5)].Then lamellae is placed in air and dried, sprayed with 5% vanillin-sulfuric acid solution
Colour developing, is observed under fluorescent light.Record chromatogram such as Fig. 5.
Embodiment 6
The Artemether parenteral solution for taking high-temperature sterilization to produce is appropriate, adds ethanol that the solution containing 10mg in every 1ml is made, ultrasound
(PWR%:80) handle 5 minutes, centrifuge 10 minutes (4000 revs/min), take supernatant as test liquid.Precision measures test liquid
The comparison liquid (0.25%) of the Artemether containing 0.025mg in 1ml is prepared, the comparison liquid (0.5%) of the Artemether containing 0.05mg in 1ml,
The Artemether comparison liquid (1.0%) of the Artemether containing 0.10mg in 1ml.Take each 10 μ l points of above-mentioned solution in same silica G plate (it is recommended that
Use 60G Merck plates) on, after being dried in air, it is placed in saturation in chromatography cylinder and after 15 minutes, deploys [solvent：Petroleum ether-
Ethyl acetate-glacial acetic acid (20:5:2.5)].Then lamellae is placed in air and dried, sprayed with 5% vanillin-sulfuric acid solution
Colour developing, is observed under fluorescent light.Record chromatogram such as Fig. 6.
Embodiment 7
Take Artemether appropriate, add ethanol that the solution containing 10mg is made in every 1ml as need testing solution.Precision is measured for examination
Product solution prepares the comparison liquid (0.25%) of the Artemether containing 0.025mg in 1ml, the comparison liquid of the Artemether containing 0.05mg in 1ml
(0.5%), in 1ml the Artemether containing 0.10mg Artemether comparison liquid (1.0%).Each 10 μ l points of above-mentioned solution are taken in same silica gel
On G plates (it is recommended that using 60G Merck plates), after being dried in air, it is placed in saturation in chromatography cylinder and after 15 minutes, deploys [solvent：
Petroleum ether-ethyl acetate-glacial acetic acid (20:5:2.5)].Then lamellae is placed in air and dried, with 5% vanillin-sulfuric acid
Solution injection colour developing, is observed under fluorescent light.Chromatogram is recorded as shown in MFB20141011 in Fig. 4.
Claims (5)
- A kind of 1. detection method of Artemether related substances, it is characterised in that including：Artemether preparation is mixed with C1 ~ C3 alcoholic solvent, ultrasound is carried out, is centrifuged after fully mixing, separated in preparation Solvent, take alcoholic solution layer to carry out thin-layer chromatography as test liquid, expansion, after drying, developed the color with vanillin-sulphuric acid solution；It is described thin The carrier analysed layer by layer is silica G plate or 60 G Merck lamellaes；The solvent of the thin-layer chromatography is glacial acetic acid, ethyl acetate With 60 DEG C ~ 90 DEG C of petroleum ether；The volume ratio of described 60 DEG C ~ 90 DEG C of petroleum ether, ethyl acetate and glacial acetic acid is（10~30）： （1~10）：（0.5~5）；The Artemether preparation is the aseptic parenteral solution using pure plant oil as solvent.
- 2. detection method according to claim 1, it is characterised in that the thin-layer chromatography is carried out miscellaneous using Self-control method Quality Control system.
- 3. detection method according to claim 2, it is characterised in that the Self-control method is specially：Test liquid is mixed with C1 ~ C3 alcoholic solvent, obtains the first comparison liquid that mass concentration is respectively 0.4% ~ 0.6%, 0.2% ~ 0.3% the second comparison liquid and 0.8% ~ 1.2% the 3rd comparison liquid；First comparison liquid, the second comparison liquid, the 3rd comparison liquid and test liquid are subjected to thin-layer chromatography simultaneously.
- 4. detection method according to claim 1, it is characterised in that the rotating speed of the centrifugation is 1000 ~ 5000 r/min； The time of centrifugation is 2 ~ 30 min.
- 5. detection method according to claim 1, it is characterised in that the concentration of the test liquid is 5 ~ 50 mg/ml.
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| CN114184698B (en) * | 2021-12-03 | 2023-09-29 | 威胜生物医药(苏州)股份有限公司 | High performance liquid chromatography for detecting content of beta-artemether and related substances |
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