CN103969376A - Quality standard testing method for borneol and fructus gardeniae pain-relieving aerosol - Google Patents
Quality standard testing method for borneol and fructus gardeniae pain-relieving aerosol Download PDFInfo
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Abstract
The invention discloses a quality standard testing method for a borneol and fructus gardeniae pain-relieving aerosol with a changed propellant. The quality standard testing method is improved on the basis of an existing quality standard, a pretreatment method for performing qualitative identification on drugs is modified, an item of checking the content of ethanol and an item of checking the content of fructus gardeniae by HPLC (High Performance Liquid Chromatography) are added, the content of ethanol in the pain-relieving aerosol is not lower than 60%, one milliliter of pain-relieving aerosol contains fructus gardeniae of not lower than 0.40mg metered by geniposide C17H24010, and the spraying rate of the pain-relieving aerosol is not lower than 0.80g/s. According to the quality standard testing method, a drug detection result is accurate, the control on drug quality is intensified, and the drug safety is further improved.
Description
Technical field
The present invention relates to a kind of detection method of Chinese medicine, particularly change the grieved aerosol quality standard detecting method of ice Cape jasmine after propellant.
Background technology
The grieved aerosol of ice Cape jasmine is a kind of aerosol for the treatment of burn, traumatic injury, and for clearing heat and detoxicating cool blood, promoting blood circulation, removing blood stasis and relieving pain, also can be used for shallow II degree burn, is made up of liquid, propellant, pressure vessel and valve.The propellant adopting in the grieved aerosol of existing ice Cape jasmine mostly is freon (F
12), but freon has destruction to atmospheric ozone layer, therefore, need to replace existing freon propellant with the propellant of other environmental protection.The patent No. is 201210071687.9, the Chinese patent application that name is called the grieved aerosol of ice Cape jasmine has solved the problems referred to above, replace freon with the propellant of other environmental protection, but existing quality standard is to formulate for the aerosol that adopts freon propellant, the inapplicable processing that contains the propellant aerosol beyond freon of processing in early stage to medicine in quality standard.Improper to processing the early stage of medicine, can cause the inaccurate of drug test result, thereby cause the uncontrollable of drug quality.In existing quality standard (WS-10325 (ZD-0325)-2002-2011Z), only comprise qualitative detection to rheum officinale, cape jasmine, vomiting nut, borneol and the quantitative detection of vomiting nut simultaneously, but there is no the mensuration item of the inspection of drug solvent content and the cape jasmine content of reaction medicine inherent quality index, cannot ensure aborning the quality of product.
Summary of the invention
The invention provides the detection method of the grieved aerosol quality standard of ice Cape jasmine, object is to solve prior art problem, the pre-treating method of on the basis of existing quality standard, quality assurance of drug being differentiated is revised, and increases amount of alcohol check item and adopt high performance liquid chromatography (HPLC) method to detect the detection of cape jasmine content.
The present invention deal with problems adopt technical scheme be:
The grieved aerosol quality standard detecting method of ice Cape jasmine, comprises
Prescription: rheum officinale 80g, cape jasmine 50g, Glabrous Sarcandra Herb 100g, dried rhizome of rehmannia 40g, dalbergia wood 30g, fragrant-flowered garlic root 60g, Semen Strychni 40g, peach kernel 30g, turpentine 30g, rhizoma zingiberis 30g, Chinese prickly ash 30g, bush 50g, camphortree root 30g, masson pine branchlet-tip 40g, camphor 40g, borneol 30g;
Preparation method: above ten Six-element medicines, except camphor, borneol, the 12 taste medicines such as rheum officinale, vomiting nut and all the other Glabrous Sarcandra Herbs are dry at 60 DEG C respectively, be ground into meal, be solvent with 90% ethanol respectively, rheum officinale medicinal powder is collected percolate 80ml, and vomiting nut medicinal powder is collected percolate 120ml, and the 12 taste medicines such as Glabrous Sarcandra Herb are collected percolate 600ml.Merge above-mentioned three kinds of percolates, camphorate, borneol, after dissolving, add again ethyl cellulose 36g, azone 10ml, propylene glycol 3.5ml, mix, add 90% ethanol to 1000ml, packing, be pressed into propellant HFA-134a, sealing, obtain, it is characterized in that: the pre-treating method that quality assurance of drug is differentiated is revised, and increase amount of alcohol check item and utilize the detection of HPLC to cape jasmine content detection, limit amount of alcohol in liquid and should be not less than 60%, every 1ml liquid contains cape jasmine in Gardenoside C17H24010, must not be lower than 0.40mg, medical liquid spraying speed is not less than 0.80g/s.
The pre-treating method that quality assurance of drug is differentiated: get this product and remove cap, to cooling placement in the environment of 5 DEG C 30 minutes, bore an aperture on aluminium lid, after gas discharges, collect liquid, ultrasonic 1-2 hour, leaves standstill 5 hours.
Amount of alcohol inspection method; get this product and remove cap; to cooling placement in the environment of 5 DEG C 30 minutes; bore an aperture on aluminium lid, after gas discharges, collects liquid to tool plug triangular flask; the ultrasonic 1-2 hour of tool plug; leave standstill 5 hours, then sample, should be not less than 60% (annex IXM of Chinese Pharmacopoeia version in 2010); Injection rate should be not less than 0.80g/s (annex IZ of Chinese Pharmacopoeia version in 2010);
Other should meet regulation relevant under aerosol item (annex IZ of Chinese Pharmacopoeia version in 2010).
Cape jasmine content assaying method:
Measure according to high performance liquid chromatography (annex VID of Chinese Pharmacopoeia version in 2010);
Chromatographic condition and system suitability: taking octadecylsilane chemically bonded silica as filling agent; Detection wavelength is 238nm; Acetonitrile-water=7: 93 is mobile phase; Theoretical cam curve is calculated and should be not less than 2000 by Gardenoside peak; The preparation of reference substance solution: it is appropriate that precision takes Gardenoside reference substance, adds methyl alcohol and makes the solution containing 30 μ g in every 1ml, to obtain final product.
The preparation of need testing solution: get this product and remove cap, to cooling placement in the environment of 5 DEG C 30 minutes, on aluminium lid, bore an aperture, after gas discharges, collect liquid to tool plug triangular flask, the ultrasonic 1-2 hour of tool plug, leave standstill 5 hours, precision measures this product 20ml, put in 100ml measuring bottle, add ethanol to scale, shake up, precision measures 20ml again, add zeyssatite 3g, mix, evaporate to dryness, the residue 40ml that adds water, 20 minutes (power 250W of ultrasonic processing, frequency 33KHz), filter, with about 10ml water washing residue, filtrate and cleansing solution merge, put in separating funnel.The 20ml that adds diethyl ether, jolting is extracted, and emits water layer, adds about 10ml water washing ether layer, discards ether solution, merges aqueous solution evaporate to dryness, and residue adds methyl alcohol to be made to dissolve in right amount, is transferred in 50ml measuring bottle, and is diluted to scale, mixes, and to obtain final product.
Determination method: precision measures reference substance solution and the each 10 μ l of need testing solution respectively, injection liquid chromatography respectively, measures, and to obtain final product.The every 1ml liquid of this product contains cape jasmine in Gardenoside (C17H24010), must not be lower than 0.40mg.
Beneficial effect of the present invention: this quality standard detecting method is to formulate for the grieved aerosol of the ice Cape jasmine that has changed propellant, on existing quality standard basis, improve, concrete improvement is that the earlier stage processing method of aerosol is revised, increased the quantitative detection of amount of alcohol inspection and cape jasmine simultaneously, make drug test result more accurate, improve the control to drug quality, and then the security that has improved medicine.
Embodiment
The grieved aerosol quality standard of ice Cape jasmine
[prescription] rheum officinale 80g, cape jasmine 50g, Glabrous Sarcandra Herb 100g, dried rhizome of rehmannia 40g, dalbergia wood 30g, fragrant-flowered garlic root 60g, Semen Strychni 40g, peach kernel 30g, turpentine 30g, rhizoma zingiberis 30g, Chinese prickly ash 30g, bush 50g, camphortree root 30g, masson pine branchlet-tip 40g, camphor 40g, borneol 30g;
[preparation method] above ten Six-element medicines, except camphor, borneol, the 12 taste medicines such as rheum officinale, vomiting nut and all the other Glabrous Sarcandra Herbs are dry at 60 DEG C respectively, be ground into meal, be solvent with 90% ethanol respectively, rheum officinale medicinal powder is collected percolate 80ml, and vomiting nut medicinal powder is collected percolate 120ml, and the 12 taste medicines such as Glabrous Sarcandra Herb are collected percolate 600ml.Merge above-mentioned three kinds of percolates, camphorate, borneol, after dissolving, then add ethyl cellulose 36g, azone 10ml, propylene glycol 3.5ml, mix, add 90% ethanol to 1000ml, packing, is pressed into propellant HFA-134a, and sealing, to obtain final product.
[proterties] this product is non-quantitation valve aerosol, and content is yellowish-brown liquid, and liquid is yellowish-brown liquid in pressure vessel; There is special fragrance, can film forming.
Detection method:
[discriminating] got this product and removed cap, to cooling placement in the environment of 5 DEG C 30 minutes, bores an aperture on aluminium lid, after gas discharges, collects liquid, and ultrasonic 1-2 hour, leaves standstill 5 hours, carries out following discrimination test:
(1) thin-layered chromatography (annex VIB of Chinese Pharmacopoeia version in 2010) is differentiated cape jasmine.
(2) thin-layered chromatography (annex VIB of Chinese Pharmacopoeia version in 2010) is differentiated borneol.
(3) thin-layered chromatography (annex VIB of Chinese Pharmacopoeia version in 2010) is differentiated vomiting nut.
(4) thin-layered chromatography (annex VIB of Chinese Pharmacopoeia version in 2010) is differentiated rheum officinale.
(5) thin-layered chromatography (annex VIB of Chinese Pharmacopoeia version in 2010) is differentiated Glabrous Sarcandra Herb.
Above-mentioned (1)-(5) are differentiated identical with existing quality standard method.
[inspection] ethanol measures this product and removes cap, to cooling placement in the environment of 5 DEG C 30 minutes, on aluminium lid, bore an aperture, after gas discharges, collect liquid to tool plug triangular flask, the ultrasonic 1-2 hour of tool plug, leaves standstill 5 hours, then sampling should be not less than 60% (annex IXM of Chinese Pharmacopoeia version in 2010); Injection rate should be not less than 0.80g/s (annex IZ of Chinese Pharmacopoeia version in 2010);
Other should meet regulation relevant under aerosol item (annex IZ of Chinese Pharmacopoeia version in 2010).
[assay]
Vomiting nut is according to measuring by high performance liquid chromatography (annex VID of Chinese Pharmacopoeia version in 2010), and its detection method is identical with the method in existing quality standard.
Cape jasmine is measured according to high performance liquid chromatography (annex VID of Chinese Pharmacopoeia version in 2010).
Chromatographic condition and system suitability are taking octadecylsilane chemically bonded silica as filling agent; Detection wavelength is 238nm; Acetonitrile-water (7: 93) is mobile phase; Theoretical cam curve is calculated and should be not less than 2000 by Gardenoside peak.It is appropriate that the preparation precision of reference substance solution takes Gardenoside reference substance, adds methyl alcohol and make the solution containing 30 μ g in every 1ml, to obtain final product.
The preparation of need testing solution is got this product and is removed cap, to cooling placement in the environment of 5 DEG C 30 minutes, on aluminium lid, bore an aperture, after gas discharges, collect liquid to tool plug triangular flask, the ultrasonic 1-2 hour of tool plug, leave standstill 5 hours, precision measures this product 20ml, put in 100ml measuring bottle, add ethanol to scale, shake up, precision measures 20ml again, add zeyssatite 3g, mix, evaporate to dryness, the residue 40ml that adds water, 20 minutes (power 250W of ultrasonic processing, frequency 33KHz), filter, with about 10ml water washing residue, filtrate and cleansing solution merge, put in separating funnel.The 20ml that adds diethyl ether, jolting is extracted, and emits water layer, adds about 10ml water washing ether layer, discards ether solution, merges aqueous solution evaporate to dryness, and residue adds methyl alcohol to be made to dissolve in right amount, is transferred in 50ml measuring bottle, and is diluted to scale, mixes, and to obtain final product.
Determination method respectively precision measures reference substance solution and the each 10 μ l of need testing solution, and injection liquid chromatography respectively, measures, and to obtain final product.
The every 1ml liquid of this product contains cape jasmine in Gardenoside (C17H24010), must not be lower than 0.40mg.
Embodiment 1
Lot number 20131003
Detect by above-mentioned testing process, recording ethanol content is 70%, injection rate 0.80g/s, Determination of Gardenoside 0.53mg/ml.
Embodiment 2
Lot number 20131006
Detect by above-mentioned testing process, recording ethanol content is 75%, injection rate 0.85g/s, Determination of Gardenoside 0.50mg/ml.
Embodiment 3
Lot number 20131011
Detect by above-mentioned testing process, recording ethanol content is 65%, injection rate 0.85g/s, Determination of Gardenoside 0.48mg/ml.
Claims (4)
1. the grieved aerosol quality standard detecting method of ice Cape jasmine, comprises
Prescription: rheum officinale 80g, cape jasmine 50g, Glabrous Sarcandra Herb 100g, dried rhizome of rehmannia 40g, dalbergia wood 30g, fragrant-flowered garlic root 60g, Semen Strychni 40g, peach kernel 30g, turpentine 30g, rhizoma zingiberis 30g, Chinese prickly ash 30g, bush 50g, camphortree root 30g, masson pine branchlet-tip 40g, camphor 40g, borneol 30g;
Preparation method: above ten Six-element medicines, except camphor, borneol, the 12 taste medicines such as rheum officinale, vomiting nut and all the other Glabrous Sarcandra Herbs are dry at 60 DEG C respectively, be ground into meal, be solvent with 90% ethanol respectively, rheum officinale medicinal powder is collected percolate 80ml, and vomiting nut medicinal powder is collected percolate 120ml, and the 12 taste medicines such as Glabrous Sarcandra Herb are collected percolate 600ml.Merge above-mentioned three kinds of percolates, camphorate, borneol, after dissolving, add again ethyl cellulose 36g, azone 10ml, propylene glycol 3.5ml, mix, add 90% ethanol to 1000ml, packing, be pressed into propellant HFA-134a, sealing, to obtain final product, and it is characterized in that: the pre-treating method that quality assurance of drug is differentiated is revised, and increase amount of alcohol check item and utilize the detection of HPLC to cape jasmine content detection, medical liquid spraying speed.
2. the grieved aerosol quality standard detecting method of ice Cape jasmine as described in claim 1, it is characterized in that: the pre-treating method that quality assurance of drug is differentiated: get this product and remove cap, to cooling placement in the environment of 5 DEG C 30 minutes, on aluminium lid, bore an aperture, after gas discharges, collect liquid, ultrasonic 1-2 hour, leaves standstill 5 hours.
3. the grieved aerosol quality standard detecting method of ice Cape jasmine as described in claim 1, it is characterized in that: amount of alcohol inspection method, get this product and remove cap, to cooling placement in the environment of 5 DEG C 30 minutes, on aluminium lid, bore an aperture, after gas discharges, collect liquid to tool plug triangular flask, the ultrasonic 1-2 hour of tool plug, leave standstill 5 hours, sample, should be not less than 60%, medical liquid spraying speed is not less than 0.80g/s.
4. the grieved aerosol quality standard detecting method of ice Cape jasmine as described in claim 1, is characterized in that: cape jasmine content assaying method:
According to high effective liquid chromatography for measuring;
Chromatographic condition and system suitability: taking octadecylsilane chemically bonded silica as filling agent; Detection wavelength is 238nm; Acetonitrile-water=7: 93 is mobile phase; Theoretical cam curve is calculated and should be not less than 2000 by Gardenoside peak; The preparation of reference substance solution: it is appropriate that precision takes Gardenoside reference substance, adds methyl alcohol and makes the solution containing 30 μ g in every 1ml, to obtain final product;
The preparation of need testing solution: get this product and remove cap, to cooling placement in the environment of 5 DEG C 30 minutes, bore an aperture on aluminium lid, after gas discharges, collect liquid to tool plug triangular flask, the ultrasonic 1-2 hour of tool plug, leaves standstill 5 hours, precision measures this product 20ml, put in 100ml measuring bottle, add ethanol to scale, shake up, precision measures 20ml again, add zeyssatite 3g, mix, evaporate to dryness, the residue 40ml that adds water, ultrasonic processing 20 minutes, filters, with about 10ml water washing residue, filtrate and cleansing solution merge, and put in separating funnel.The 20ml that adds diethyl ether, jolting is extracted, and emits water layer, adds about 10ml water washing ether layer, discards ether solution, merges aqueous solution evaporate to dryness, and residue adds methyl alcohol to be made to dissolve in right amount, is transferred in 50ml measuring bottle, and is diluted to scale, mixes, and to obtain final product;
Determination method: precision measures reference substance solution and the each 10 μ l of need testing solution respectively, injection liquid chromatography respectively, measures, and to obtain final product; The every 1ml liquid of this product contains cape jasmine in Gardenoside (C17H24010), must not be lower than 0.40mg.
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CN108303491A (en) * | 2018-04-18 | 2018-07-20 | 贵州景诚制药有限公司 | A kind of camphortree root drug quality detection method |
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CN1418655A (en) * | 2002-11-28 | 2003-05-21 | 贵州安泰药业有限公司 | Aerosol for treating burn and scald, and its prepn-process |
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Patent Citations (3)
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CN1418655A (en) * | 2002-11-28 | 2003-05-21 | 贵州安泰药业有限公司 | Aerosol for treating burn and scald, and its prepn-process |
RU2324915C2 (en) * | 2006-03-20 | 2008-05-20 | ГОУ ВПО Иркутский государственный университет | Method of producing synthetic standard specimens of atmospheric aerosols loaded on filter |
CN102580038A (en) * | 2012-03-19 | 2012-07-18 | 贵州安泰药业有限公司 | Borneol cape jasmine pain releasing aerosol |
Non-Patent Citations (2)
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN108303491A (en) * | 2018-04-18 | 2018-07-20 | 贵州景诚制药有限公司 | A kind of camphortree root drug quality detection method |
CN108303491B (en) * | 2018-04-18 | 2020-05-08 | 贵州景诚制药有限公司 | Method for detecting quality of camphor root medicine |
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