CN105699584A - Detection method for artemether related matters - Google Patents
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- CN105699584A CN105699584A CN201610076482.8A CN201610076482A CN105699584A CN 105699584 A CN105699584 A CN 105699584A CN 201610076482 A CN201610076482 A CN 201610076482A CN 105699584 A CN105699584 A CN 105699584A
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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Abstract
The invention provides a detection method for artemether related matters. The detection method comprises the following steps: mixing an artemether raw material or an artemether preparation with a C1-C3 alcohol solvent, and then taking an alcohol solution layer as a test solution for thin layer chromatography. Compared with the prior art, the detection method provided by the invention has the advantages that the C1-C3 alcohol solvent is utilized to eliminate the influence of the solvent in the artemether raw material or preparation on the thin layer chromatography, and the quality of the artemether raw material or preparation can be accurately evaluated by detecting the content of the related matters and side products degraded in the production and storage processes of the artemether products, so that the quality of the artemether raw material and preparation can be ensured.
Description
Technical field
The invention belongs to technical field of analytical chemistry, particularly relate to the detection method of a kind of Artemether related substances。
Background technology
Artemether (artemether, ARM) molecular formula is C16H26O5, molecular weight is 298.37, shown in its structural formula such as formula (I), is the Methyl ether derivatives of arteannuin, and its antimalarial effect is 6 times of its lead compound arteannuin。Artemether takes in WHO essential drug list in nineteen ninety-five, FDA ratified Coartem sheet (Artemether 20mg/ LUMEFANTRINE 120mg) in 2009, the dosage form of current list marketing includes tablet, soft gelatin capsule, capsule and injection, in addition with the compound preparation formed with LUMEFANTRINE, its indication is mainly all kinds of malaria。But there is poorly water-soluble in Artemether, digestive tract absorbs the shortcomings such as slow, bioavailability is low。Kun Yao group produce Artemether injection, be with pure natural plant oil be solvent aseptic parenteral solution, solve this difficult problem。
Recently as the WHO great attention to artemisinin-based antimalarial drug and prescription, Artemether and preparation thereof is made to improve constantly sole mass and quality control standard。The Artemether raw material of Kun Yao group has passed through the certification of U.S. FDA and WHO at present, and Artemether preparation adopts inner controlling standard of enterprise (Q/KPC91-1) to carry out its raw materials quality of quality control assurances to be better than other like products in actual production process。But the standard performed still adopts ministry standard single page WS-111 (X-89) 90, wherein related substances not being checked, project is listed in all the time。
The existing related substances inspection method list relevant to Artemether is compared in Table 1。
Table 1 existing Artemether related substances detection method list
As shown in Table 1, existing detection method has the disadvantage in that Artemether injection that [related substances inspection method] the A item recorded in (1) at present Ph.Int42011 produces because of Kun Yao group is with Oleum Arachidis hypogaeae semen for solvent, does not consider；[related substances] B item: it is one sided for not also being suitable for Artemether injection more specifically judgment criteria, reason is employing acetone as solvent in thin layer chromatography pre-treatment, acetone is the good solvent of organic solvent and Artemether, in dilution, solvent and Artemether mix, in thin-layer developing process, the two can not efficiently separate, being embodied in principal spot gross distortion, impurity speckle may be broken down into several fleck, the judgement of interference result；(2) the related substances inspection method that USP2011 records: a, detection time are long, need to be exposed to lower 60 minutes of the uviol lamp of 254nm；B, evaluation methodology difficulty control, and 20% methanolic colour developing is based on sulphuric acid and destroys spot development under the high temperature conditions, and the observation of each speckle is not directly perceived。C, impurity speckle judge limitation, only evaluate impurity speckle CGP79147 and ZE9732, other impurity speckles do not account for；(3) the related substances inspection method that Ch.P.2010 version is recorded, is still in blank ground。
Summary of the invention
In view of this, the technical problem to be solved in the present invention is in that to provide the detection method of a kind of Artemether related substances easy and simple to handle。
The invention provides the detection method of a kind of Artemether related substances, it is characterised in that including:
Artemether raw material or Artemether preparation are mixed with the alcoholic solvent of C1～C3, takes alcoholic solution layer and carry out thin layer chromatography as test liquid。
Preferably, described thin layer chromatography adopts Self-control method to carry out Control of Impurities。
Preferably, described Self-control method particularly as follows:
Test liquid is mixed with the alcoholic solvent of C1～C3, obtain mass concentration respectively 0.4%～0.6% first comparison liquid, 0.2%～0.3% second comparison liquid with 0.8%～1.2% the 3rd compare liquid；
Compare liquid, the second comparison liquid, the 3rd comparison liquid and test liquid by described first and carry out thin layer chromatography simultaneously。
Preferably, the volumetric concentration of the alcoholic solvent of described C1～C3 is 70%～100%。
Preferably, also it is centrifuged after mixing, then takes alcoholic solution layer。
Preferably, described centrifugal rotating speed is 1000～5000r/min；The centrifugal time is 2～30min。
Preferably, the concentration of described test liquid is 5～50mg/ml。
Preferably, the carrier of described thin layer chromatography is silica gel G plate or 60GMerck lamellae。
Preferably, the developing solvent of described thin layer chromatography is two or three in the petroleum ether of glacial acetic acid, ethyl acetate and 60 DEG C～90 DEG C。
Preferably, the petroleum ether of described 60 DEG C～90 DEG C, the volume ratio of ethyl acetate and glacial acetic acid are (10～30): (1～10): (0.5～5)。
The invention provides the detection method of a kind of Artemether related substances, including: Artemether raw material or Artemether preparation are mixed with the alcoholic solvent of C1～C3, takes alcoholic solution layer and carry out thin layer chromatography as test liquid。Compared with prior art, the present invention utilizes the alcoholic solvent of C1～C3 to eliminate the solvent impact on thin layer chromatography in Artemether raw material or preparation, the content of related substances and by-product thereof by detecting degraded in Artemether production and storage process, and then the quality of Artemether raw material or preparation is evaluated accurately, to ensure the quality of Artemether raw material and preparation。
Accompanying drawing explanation
Fig. 1 is that oiliness solvent and the organic solvent of Artemether injection in the embodiment of the present invention 1 dissolves 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。
Detailed description of the invention
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, it is clear that described embodiment is only a part of embodiment of the present invention, rather than whole embodiments。Based on the embodiment in the present invention, the every other embodiment that those of ordinary skill in the art obtain under not making creative work premise, broadly fall into the scope of protection of the invention。
The invention provides the detection method of a kind of Artemether related substances, including: Artemether raw material or Artemether preparation are mixed with the alcoholic solvent of C1～C3, takes alcoholic solution layer and carry out thin layer chromatography as test liquid。
Wherein, the alcoholic solvent of described C1～C3 is preferably one or more in methanol, ethanol and isopropanol, more preferably methanol, ethanol or isopropanol；The volumetric concentration of the alcoholic solvent of described C1～C3 is preferably 70%～100%, more preferably 80%～100%。
Artemether raw material or Artemether preparation are mixed with the alcoholic solvent of C1～C3, when for Artemether raw material, directly it is mixed with the alcoholic solvent of C1～C3, so as to be dissolved in alcoholic solvent, take this solution and test；When for Artemether preparation, it is preferable that mixed with the alcoholic solvent of C1～C3 by Artemether preparation, carry out ultrasonic dissolution, be fully centrifuged after mixing, separate the solvent in preparation, take alcoholic solution layer and carry out thin layer test。
Described ultrasonic power is preferably PWR%:50～100, more preferably PWR%:60～80；The described ultrasonic time is preferably 2～30min, more preferably 5～20min, is further preferably 10～20min。Fully after mixing, it is preferable that be centrifuged。Described centrifugal rotating speed is preferably 1000～5000r/min, more preferably 2000～4000r/min；The described centrifugal time is preferably 2～30min, more preferably 5～25min, is further preferably 10～20min。
After centrifugal, take alcoholic solution layer and carry out thin layer chromatography as test liquid；The concentration of described test liquid is preferably 5～50mg/ml, more preferably 10～40mg/ml, is further preferably 10～30mg/ml；In described thin layer chromatography, the volume of point sample is preferably 5～20 μ l, more preferably 5～15 μ l, is further preferably 8～12 μ l, it is most preferred that be 10 μ l；The carrier of described thin layer chromatography is carrier well known to those skilled in the art, there is no special restriction, is preferably silica gel G plate or 60GMerck lamellae in the present invention；The developing solvent of described thin layer chromatography is preferably two or three in the petroleum ether of glacial acetic acid, ethyl acetate and 60 DEG C～90 DEG C, more preferably the mixed liquor of ethyl acetate and the petroleum ether of 60 DEG C～90 DEG C or glacial acetic acid, ethyl acetate and 60 DEG C～90 DEG C the mixed liquor of petroleum ether；The volume ratio of described ethyl acetate and the petroleum ether of 60 DEG C～90 DEG C is preferably (1～10): (5～20), it is more preferably (2～8): (5～15), it is further preferably (2～5): (5～10), it is most preferred that for 3:7；Described glacial acetic acid, ethyl acetate and 60 DEG C～90 DEG C the volume ratio of petroleum ether be preferably (0.5～5): (1～10): (10～30), it is more preferably (1～3): (2～8): (15～25), it is further preferably (2～3): (3～6): (16～22), it is most preferred that for 2.5:5:20；Launch, after drying, it is preferable that develop the color with vanillin-sulphuric acid solution；The concentration of described vanillin-sulphuric acid solution is preferably 0.5%～10%, more preferably 2%～8%, is further preferably 3%～7%, is further preferably 4%～6%, it is most preferred that be 5%。
Preferably employ Self-control method according to thin layer chromatography of the present invention and carry out Control of Impurities。Described Self-control method preferably particularly as follows: test liquid mix with the alcoholic solvent of C1～C3, obtain mass concentration respectively 0.4%～0.6% the first comparison liquid, the second of 0.2%～0.3% compare liquid and 0.8%～1.2% the 3rd compare liquid；Compare liquid, the second comparison liquid, the 3rd comparison liquid and test liquid by described first and carry out thin layer chromatography simultaneously。Wherein, the alcoholic solvent of described C1～C3 is same as above, does not repeat them here；The mass concentration of described first comparison liquid is preferably 0.45%～0.55%, more preferably 0.5%；The mass concentration of described second comparison liquid is preferably 0.25%；The mass concentration of described 3rd comparison liquid is preferably 0.9%～1.1%, more preferably 1%。The comparison liquid that in the present invention, more preferably first preparation mass concentration is high, the comparison liquid that then recycling mass concentration is high prepares the comparison liquid that mass concentration is low。
The present invention utilizes the alcoholic solvent of C1～C3 to eliminate the solvent impact on thin layer chromatography in preparation, the content of related substances and by-product thereof by detecting degraded in Artemether production and storage process, and then the quality of Artemether raw material or preparation is evaluated accurately, to ensure the quality of Artemether raw material and preparation。
In order to further illustrate the present invention, below in conjunction with embodiment, the detection method of a kind of Artemether related substances provided by the invention is described in detail。
Reagent used in following example is commercially available。
Embodiment 1
The each 1ml of oiliness solvent taking 5 parts of Artemether preparations and Artemether injection is respectively placed in 5 test tubes, as shown in Figure 1, each addition 8ml methanol (from left to right the 1st) is distinguished from left to right successively in each test tube, 8ml ethanol (from left to right the 2nd), 8ml acetone (from left to right the 3rd), 8ml isopropanol (from left to right the 4th), 8ml n-butyl alcohol (from left to right the 5th), then stand 1 hour after making two kinds of solvent shake wells in each test tube to be sufficiently mixed, it can be seen that the alcohol of 1～3 carbon atom and the oiliness solvent layering dissolving Artemether are substantially the good solvents separating oiliness solvent, and add in two test tubes of acetone and n-butyl alcohol (from the from left to right the 3rd and the 5th), acetone be completely dissolved with oiliness solvent with n-butyl alcohol together with not stratified, illustrate that acetone and n-butyl alcohol can not be used for separating Artemether preparation--the oiliness solvent of Artemether injection。
Embodiment 2
Take three kinds of Artemether injection (respectively sample A, B and C) appropriate, three kinds of samples are separately added into that dehydrated alcohol is ultrasonic makes abundant dissolving, centrifugal, separate solvent and take dehydrated alcohol layer as test liquid, the concentration of test liquid is 10mg/ml；Precision take test liquid add dehydrated alcohol make in 1ml containing 0.05mg solution as first compare liquid, precision takes the first comparison liquid 5ml in 10ml measuring bottle, add dehydrated alcohol be diluted in 1ml containing 0.025mg Artemether solution as second compare liquid, adopt Self-control method carry out thin layer chromatography analysis。Lamellae: 60GMerck lamellae；Developing solvent: petroleum ether (60 DEG C～90 DEG C)-ethyl acetate (7:3)；Developer: 5% vanillin-sulfuric acid solution；Point sample volume: 10 μ l。Testing according to " thin layer chromatography ", with petroleum ether (60 DEG C～90 DEG C) ,-ethyl acetate (7:3) is for developing solvent, after expansion, dry, spray, with 5% vanillin-sulfuric acid solution, is inspected in the sunlight, is obtained thin layer chromatogram as shown in Figure 2, wherein A1 is the first comparison liquid of sample A, A2 is the second comparison liquid of sample A, and B1 is the first comparison liquid of sample B, and B2 is the second comparison liquid of sample B, C1 is the first comparison liquid of sample C, and C2 is the second comparison liquid of sample C。
As shown in Figure 2: solvent separates with sample completely, principal spot is interference-free, rounding ovalize
Embodiment 3
The Artemether preparation taking low frequency radiation process respectively makes abundant dissolving with the Artemether preparation addition EtOH Sonicate processed through high temperature sterilize, centrifugal, separate solvent and take alcohol layer as test liquid, the concentration of (the Artemether preparation that low frequency radiation processes is test sample A, and the Artemether preparation processed through high temperature sterilize is test sample B) two kinds of test liquids is 10mg/ml；Precision take test liquid add ethanol make in 1ml containing 0.05mg solution as first compare liquid, precision takes the first comparison liquid 5ml in 10ml measuring bottle, adding ethanol dilution becomes the solution containing 0.025mg Artemether in 1ml to compare liquid as second, precision takes test liquid 1ml in 100ml measuring bottle, add ethanol dilution and become the 1ml solution containing 0.1mg, compare liquid as the 3rd, adopt Self-control method to carry out TLC test。Lamellae: 60GMerck lamellae；Developing solvent: petroleum ether (60～90 DEG C)-ethyl acetate (7:3)；Developer: 5% vanillin-sulfuric acid solution；Point sample volume: 10 μ l。Test according to " thin layer chromatography ", with petroleum ether (60 DEG C～90 DEG C)-ethyl acetate (7:3) for developing solvent, after expansion, dry, spray is with 5% vanillin-sulfuric acid solution, inspect in the sunlight, obtain thin layer chromatogram as shown in Figure 3, wherein A1 is the first comparison liquid of test liquid A, and A2 is the second comparison liquid of test liquid A, and A3 is the 3rd comparison liquid of test liquid A, B1 is the first comparison liquid of test liquid B, B2 is the second comparison liquid of test liquid B, and B3 is the 3rd comparison liquid of test liquid B, and C is the 1ml of the ethanol dissolving Artemether reference substance solution containing 0.1mg。
As shown in Figure 3: solvent separates with sample completely, principal spot is interference-free, rounding ovalize。The position consistency of the position of Artemether principal spot and Artemether reference substance principal spot in preparation。
Embodiment 4
Take three batches of raw materials (MFB20141011, MFB20141012, MFB20141015 produce) a collection of middle addition Artemether impurity CGP and ZE and single CGP and ZE contrast wherein by Kun Yao group, what produce with aseptic filtration faces by brand-new Artemether injection (20140521) and placed the Artemether injection comparison of 8 days by the good room temperature of Ethanol Treatment simultaneously, carry out thin layer chromatography, obtain thin layer chromatography chromatogram as shown in Figure 4。
As shown in Figure 4: the three batches of raw materials, injection, the ZE color added in the raw material of ZE, position all compare the consistent of speckle with ZE。Tentatively judge impurity ZE, Rf:0.35。
Without CGP in raw material and injection, the CGP speckle added in the raw material (MFB20141011+ZE+CGP) of CGP compares speckle position consistency with CGP, does not develop the color all in mimeograph vestige。
The speckle that 20140521 (existing process) show with 20140521 (room temperature is placed 8 days) has obvious difference, many impure points and clearly in the sample of 20140521 (room temperature is placed 8 days)。The stability of preliminary examinations ethanol sample dissolution: the sample ambient temperatare that ethanol dissolves is put 8 days has unstability。
Embodiment 5
Taking the Artemether injection that filtration sterilization produces appropriate, add ethanol and make in every 1ml the solution containing 10mg, ultrasonic (PWR%:80) processes 5 minutes, centrifugal 10 minutes (4000 revs/min), takes supernatant as test liquid。Precision measures comparison liquid (0.25%) containing 0.025mg Artemether in test liquid preparation 1ml, comparison liquid (0.5%) containing 0.05mg Artemether in 1ml, Artemether comparison liquid (1.0%) containing 0.10mg Artemether in 1ml。Take each 10 μ l points of above-mentioned solution on same silica gel G plate (suggestion uses 60GMerck plate), after air dries, after being placed in chromatography cylinder saturated 15 minutes, launch [developing solvent: petroleum ether-ethyl acetate-glacial acetic acid (20:5:2.5)]。Then lamellae is placed in air and dries, with 5% vanillin-sulfuric acid solution injection colour developing, observe under fluorescent light。Record chromatogram such as Fig. 5。
Embodiment 6
Taking the Artemether injection that high temperature sterilize produces appropriate, add ethanol and make in every 1ml the solution containing 10mg, ultrasonic (PWR%:80) processes 5 minutes, centrifugal 10 minutes (4000 revs/min), takes supernatant as test liquid。Precision measures comparison liquid (0.25%) containing 0.025mg Artemether in test liquid preparation 1ml, comparison liquid (0.5%) containing 0.05mg Artemether in 1ml, Artemether comparison liquid (1.0%) containing 0.10mg Artemether in 1ml。Take each 10 μ l points of above-mentioned solution on same silica gel G plate (suggestion uses 60GMerck plate), after air dries, after being placed in chromatography cylinder saturated 15 minutes, launch [developing solvent: petroleum ether-ethyl acetate-glacial acetic acid (20:5:2.5)]。Then lamellae is placed in air and dries, with 5% vanillin-sulfuric acid solution injection colour developing, observe under fluorescent light。Record chromatogram such as Fig. 6。
Embodiment 7
Take Artemether appropriate, add ethanol and make in every 1ml the solution containing 10mg as need testing solution。Precision measures comparison liquid (0.25%) containing 0.025mg Artemether in need testing solution preparation 1ml, comparison liquid (0.5%) containing 0.05mg Artemether in 1ml, Artemether comparison liquid (1.0%) containing 0.10mg Artemether in 1ml。Take each 10 μ l points of above-mentioned solution on same silica gel G plate (suggestion uses 60GMerck plate), after air dries, after being placed in chromatography cylinder saturated 15 minutes, launch [developing solvent: petroleum ether-ethyl acetate-glacial acetic acid (20:5:2.5)]。Then lamellae is placed in air and dries, with 5% vanillin-sulfuric acid solution injection colour developing, observe under fluorescent light。In record chromatogram such as Fig. 4 shown in MFB20141011。
Claims (10)
1. the detection method of an Artemether related substances, it is characterised in that including:
Artemether raw material or Artemether preparation are mixed with the alcoholic solvent of C1～C3, takes alcoholic solution layer and carry out thin layer chromatography as test liquid。
2. detection method according to claim 1, it is characterised in that described thin layer chromatography adopts Self-control method to carry out Control of Impurities。
3. detection method according to claim 2, it is characterised in that described Self-control method particularly as follows:
Test liquid is mixed with the alcoholic solvent of C1～C3, obtain mass concentration respectively 0.4%～0.6% first comparison liquid, 0.2%～0.3% second comparison liquid with 0.8%～1.2% the 3rd compare liquid；
Compare liquid, the second comparison liquid, the 3rd comparison liquid and test liquid by described first and carry out thin layer chromatography simultaneously。
4. detection method according to claim 1, it is characterised in that the volumetric concentration of the alcoholic solvent of described C1～C3 is 70%～100%。
5. detection method according to claim 1, it is characterised in that be also centrifuged after mixing, then takes alcoholic solution layer。
6. detection method according to claim 5, it is characterised in that described centrifugal rotating speed is 1000～5000r/min；The centrifugal time is 2～30min。
7. detection method according to claim 1, it is characterised in that the concentration of described test liquid is 5～50mg/ml。
8. detection method according to claim 1, it is characterised in that the carrier of described thin layer chromatography is silica gel G plate or 60GMerck lamellae。
9. detection method according to claim 1, it is characterised in that the developing solvent of described thin layer chromatography is two or three in the petroleum ether of glacial acetic acid, ethyl acetate and 60 DEG C～90 DEG C。
10. detection method according to claim 9, it is characterised in that the volume ratio of the petroleum ether of described 60 DEG C～90 DEG C, ethyl acetate and glacial acetic acid is (10～30): (1～10): (0.5～5)。
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| CN108362690A (en) * | 2018-01-10 | 2018-08-03 | 广西大学 | A kind of method of quick discriminating red sandalwood and dyestuff red sandalwood |
| CN114184698A (en) * | 2021-12-03 | 2022-03-15 | 张家港威胜生物医药有限公司 | High performance liquid chromatography for detecting content of beta-artemether and related substances |
| 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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