CN102048768A - Preparation method of Naoqing nasal spray emulsion for treating ischemic stroke - Google Patents
Preparation method of Naoqing nasal spray emulsion for treating ischemic stroke Download PDFInfo
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- CN102048768A CN102048768A CN2010106110755A CN201010611075A CN102048768A CN 102048768 A CN102048768 A CN 102048768A CN 2010106110755 A CN2010106110755 A CN 2010106110755A CN 201010611075 A CN201010611075 A CN 201010611075A CN 102048768 A CN102048768 A CN 102048768A
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Abstract
The invention relates to a preparation method of a Naoqing nasal spray emulsion for treating ischemic stroke. The Naoqing nasal spray emulsion is a Chinese medical compound preparation containing fine extracts of Moschus, Borneolum, Radix Notoginseng, Rhizoma Chuanxiong, Rhizoma Acori Tatarinowii and Herba Menthae as the main components, and other auxiliary materials containing emulsifying agent, soybean oil, osmosis regulator, stabilizer, antioxidant, preservative, water and so on. The preparation method comprises uniformly mixing soybean oil, Rhizoma Acori Tatarinowii oil, Herba Menthae oil, osmosis regulator, stabilizer, antioxidant, preservative and emulsifying agent at 50 to 70 DEG C; stirring, and slowly adding the extracts of the Chinese medical materials at 50 to 70 DEG C into the above mixture dropwise to obtain primary emulsion; cooling to the room temperature; adding the ethanol extract of Moschus, in which Borneolum is dissolved; adding water to a sufficient amount; and cycling in a high pressure homogenizer for 5 times under 1 000 to 1 500 bar to obtain the final product. The method can improve the contents of water-soluble and fat-soluble effective components, and facilitates the nasal administration to increase the drug concentration in the brain.
Description
Technical field
The present invention relates to a kind of herbal mixture effective ingredient Emulsion, be specifically related to the Emulsion of effective ingredient such as Moschus, Rhizoma Chuanxiong, Rhizoma Acori Graminei, and the preparation method of this Emulsion.
Background technology
The sick mortality rate of cerebral infarction (AIS), disability rate remain high, so far still lack ideal treatment means, one of its major reason is that medicine must just can enter focus by blood brain barrier (BBB), causes a lot of medicines can't bring into play drug effect because of being difficult to enter brain.
Nasal-cavity administration bioavailability and infiltration rate approach intravenous injection.Its characteristics comprise: administration is easy to use, good to the basic not damaged of body, patient's compliance, be specially adapted to because a variety of causes and patient that can't be oral.Nasal-cavity administration absorbs rapidly, and is rapid-action, is very suitable for first aid, saves oneself, and can walk around BBB and enter central nervous system (CNS) and wait these characteristics, makes it become the new route of administration of present treatment AIS.
At present, external nasal cavity administrated preparation listing dosage form mostly is nasal drop, spray and powder spray.At home, via intranasal application administration treatment AIS has tcm characteristic and advantage, and therefore, research has the pure Chinese medicinal preparation of effects such as promoting flow of QI and blood, dispelling pathogenic wind and eliminating phlegm, consciousness-restoring and orifice-opening and treats AIS, an existing value for clinical application is opened up the apoplexy emergency case again and is ground the problem of controlling new approaches beyond doubt.Domestic existing research is at present adopted modern preparation technique to combine with the Chinese medicine compound recipe and is made nasal drop treatment cerebral infarction.
The main component of a kind of Chinese medicine compound spray nose Emulsion of this patent development is a Six-element Chinese medicine, with Moschus, Borneolum Syntheticum causing resuscitation with aromatic drugs is monarch, compatibility Rhizoma Acori Graminei, Rhizoma Chuanxiong, Radix Notoginseng are minister, to strengthen the have one's ideas straightened out effect of refreshment of Moschus, Borneolum Syntheticum, and promoting flow of QI and blood arranged, the merit of eliminating phlegm and calming wind, Herba Menthae fragrance is walked to scurry, and the behavior assistant makes on the medicine carrying.This Chinese medicinal formulae for many years in clinical use, clinical use prove its to the treatment AIS have good curative effect.The present invention has improved water solublity and the concentration of fat-soluble effective ingredient in preparation in the Chinese medicine by being made into stable Emulsion, has improved the absorption of medicine.
Summary of the invention
One of purpose of the present invention provides the preparation method of treatment cerebral infarction NAOQING spray nose Emulsion, is a kind of effective component extracting of herbal mixture for the treatment of ischemia apoplexy and a kind of nasal-cavity administration Emulsion of pharmaceutic adjuvant composition.
Another purpose of the present invention is the preparation method of treatment cerebral infarction NAOQING nose Emulsion.
Emulsion component of the present invention and mass percent thereof are:
Wherein, described Rhizoma Acori Graminei oil is the volatile oil of Rhizoma Acori Graminei.
Described accent penetration enhancer is one or both in propylene glycol and the glycerol.
Described stabilizing agent is one or more in oleic acid, enuatrol, cholic acid, cholate, deoxycholic acid, Polyethylene Glycol, polyvidone, the poloxamer.
Described antioxidant is one or both in vitamin C, the vitamin E.
Described antiseptic is a kind of in Wei Jiechun, the benzalkonium chloride.
Described emulsifying agent is one or more in soybean phospholipid, polyoxyethylene ether (40) castor oil hydrogenated, the poloxamer.
Described Chinese medicine extraction liquid is the Radix Notoginseng of equal proportion and the water extract of Rhizoma Chuanxiong medical material, and the concentration of water extract is 1/10th of medical material amount.
The dehydrated alcohol extraction liquid that described 3-methylcyclopentadecanol extract is 10 times of amounts.
More than Emulsion component of the present invention and percentage by weight thereof be:
The preparation method of above-mentioned Emulsion of the present invention: with soybean oil, Rhizoma Acori Graminei oil, Oleum menthae, accent penetration enhancer, stabilizing agent, antioxidant, antiseptic, emulsifying agent in 50～70 ° of C mix homogeneously; Then, under condition of stirring, the Chinese medicine extraction liquid of heat to 50～70 ° C is slowly dropped in the above-mentioned mixed liquor, make colostrum, be cooled to add after the room temperature and be dissolved with the 3-methylcyclopentadecanol extract of Borneolum Syntheticum, and add water to capacity; At last, circulation is 5 times in high pressure homogenizer, and pressure 1000～1500bar promptly gets a kind of Chinese medicine compound spray nose Emulsion.
The character of this preparation is pale yellow, uniform emulsion.In 4000rpm, centrifugal under the condition of 15min, not stratified.
Prescription of the present invention is to belong to original creation, and the soybean oil in Emulsion, stabilizing agent, emulsifying agent, the many optimums that obtain through long-time research of Chinese medicine extraction liquid are not if just can't be prepared into stable Emulsion in this scope.
Compared with the prior art the present invention has following beneficial effect: Emulsion of the present invention has improved water solublity and the concentration of fat-soluble effective ingredient in preparation in the Chinese medicine, and stability is good.And utilize the characteristics of Emulsion and nasal-cavity administration, increase the concentration of medicine, bring into play the effect of this herbal mixture treatment ischemia apoplexy better at brain.
The specific embodiment
Embodiment 1: with soybean oil 5g, Rhizoma Acori Graminei oil 0.6g, Oleum menthae 0.09g, glycerol 2.25g, oleic acid 0.4g, the pure 0.05g of vitamin E 0.04g, Wei Jie, soybean phospholipid 1.2g, polyoxyethylene ether (40) castor oil hydrogenated 2g in 50～70 ° of C mix homogeneously; Then, under condition of stirring, the Chinese medicine extraction liquid 50g of heat to 50～70 ° C is slowly dropped in the above-mentioned mixed liquor, makes colostrum, be cooled to room temperature after.Get 3-methylcyclopentadecanol extract 3g, dissolve in the 0.3g Borneolum Syntheticum, add above-mentioned colostrum again, and add water to capacity; At last, circulation is 5 times in high pressure homogenizer, and pressure 1000～1500bar promptly gets a kind of Chinese medicine compound spray nose Emulsion.
Embodiment 2: with soybean oil 6g, Rhizoma Acori Graminei oil 0.6g, Oleum menthae 0.09g, glycerol 2.5g, oleic acid 0.6g, the pure 0.1g of vitamin E 0.1g, Wei Jie, soybean phospholipid 1.5g, polyoxyethylene ether (40) castor oil hydrogenated 2g in 50～70 ° of C mix homogeneously; Then, under condition of stirring, the Chinese medicine extraction liquid 50g of heat to 50～70 ° C is slowly dropped in the above-mentioned mixed liquor, makes colostrum, be cooled to room temperature after.Get 3-methylcyclopentadecanol extract 3g, dissolve in the 0.3g Borneolum Syntheticum, add above-mentioned colostrum again, and add water to capacity; At last, circulation is 5 times in high pressure homogenizer, and pressure 1000～1500bar promptly gets a kind of Chinese medicine compound spray nose Emulsion.
Embodiment 3: with soybean oil 4g, Rhizoma Acori Graminei oil 0.2g, Oleum menthae 0.03g, glycerol 2g, oleic acid 0.2g, the pure 0.05g of vitamin E 0.01g, Wei Jie, soybean phospholipid 1.2g, polyoxyethylene ether (40) castor oil hydrogenated 2g in 50～70 ° of C mix homogeneously; Then, under condition of stirring, the Chinese medicine extraction liquid 17g of heat to 50～70 ° C is slowly dropped in the above-mentioned mixed liquor, makes colostrum, be cooled to room temperature after.Get 3-methylcyclopentadecanol extract 1g, dissolve in the 0.1g Borneolum Syntheticum, add above-mentioned colostrum again, and add water to capacity; At last, circulation is 5 times in high pressure homogenizer, and pressure 1000～1500bar promptly gets a kind of Chinese medicine compound spray nose Emulsion.
Embodiment 4: with soybean oil 5g, Rhizoma Acori Graminei oil 0.2g, Oleum menthae 0.03g, glycerol 2.25g, oleic acid 0.4g, the pure 0.05g of vitamin E 0.04g, Wei Jie, soybean phospholipid 1.2g, polyoxyethylene ether (40) castor oil hydrogenated 2g in 50～70 ° of C mix homogeneously; Then, under condition of stirring, the Chinese medicine extraction liquid 17g of heat to 50～70 ° C is slowly dropped in the above-mentioned mixed liquor, makes colostrum, be cooled to room temperature after.Get 3-methylcyclopentadecanol extract 1g, dissolve in the 0.1g Borneolum Syntheticum, add above-mentioned colostrum again, and add water to capacity; At last, circulation is 5 times in high pressure homogenizer, and pressure 1000～1500bar promptly gets a kind of Chinese medicine compound spray nose Emulsion.
Embodiment 5: with soybean oil 5.375g, Rhizoma Acori Graminei oil 0.4g, Oleum menthae 0.06g, glycerol 2.25g, oleic acid 0.4g, the pure 0.075g of vitamin E 0.04g, Wei Jie, soybean phospholipid 1.2g, polyoxyethylene ether (40) castor oil hydrogenated 2.35g in 50～70 ° of C mix homogeneously; Then, under condition of stirring, the Chinese medicine extraction liquid 34g of heat to 50～70 ° C is slowly dropped in the above-mentioned mixed liquor, makes colostrum, be cooled to room temperature after.Get 3-methylcyclopentadecanol extract 2g, dissolve in the 0.2g Borneolum Syntheticum, add above-mentioned colostrum again, and add water to capacity; At last, circulation is 5 times in high pressure homogenizer, and pressure 1000～1500bar promptly gets a kind of herbal mixture spray nose Emulsion.
Claims (3)
1. treat the preparation method of cerebral infarction NAOQING spray nose Emulsion, it is characterized in that its Emulsion component and percentage by weight thereof:
Described Rhizoma Acori Graminei oil is the volatile oil of Rhizoma Acori Graminei;
Described accent penetration enhancer is one or both in propylene glycol and the glycerol;
Described stabilizing agent is one or more in oleic acid, enuatrol, cholic acid, cholate, deoxycholic acid, Polyethylene Glycol, polyvidone, the poloxamer;
Described antioxidant is one or both in vitamin C, the vitamin E;
Described antiseptic is a kind of in Wei Jiechun, the benzalkonium chloride;
Described emulsifying agent is one or more in soybean phospholipid, polyoxyethylene ether (40) castor oil hydrogenated, the poloxamer;
Described Chinese medicine extraction liquid is the Radix Notoginseng of equal proportion and the water extract of Rhizoma Chuanxiong medical material, and the concentration of water extract is 1/10th of medical material amount;
The dehydrated alcohol extraction liquid that described 3-methylcyclopentadecanol extract is 10 times of amounts.
2. the preparation method of treatment cerebral infarction NAOQING spray nose Emulsion according to claim 1 is characterized in that its Emulsion component and mass percent thereof:
。
3. the preparation method of treatment cerebral infarction NAOQING spray nose Emulsion according to claim 1 is to carry out successively according to the following steps:
Will be by described Emulsion component and percentage by weight thereof, to soybean oil, Rhizoma Acori Graminei oil, Oleum menthae, accent penetration enhancer, stabilizing agent, antioxidant, antiseptic, emulsifying agent in 50～70 ° of C mix homogeneously; Then, under condition of stirring, the Chinese medicine extraction liquid of heat to 50～70 ° C is slowly dropped in the above-mentioned mixed liquor, make colostrum, be cooled to add after the room temperature and be dissolved with the 3-methylcyclopentadecanol extract of Borneolum Syntheticum, and add water to capacity; At last, circulation is 5 times in high pressure homogenizer, and pressure 1000～1500bar promptly gets a kind of Chinese medicine compound spray nose Emulsion.
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| CN2010106110755A CN102048768B (en) | 2010-12-29 | 2010-12-29 | Preparation method of Naoqing nasal spray emulsion for treating ischemic stroke |
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| CN102048768B CN102048768B (en) | 2012-08-15 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102698001A (en) * | 2012-06-06 | 2012-10-03 | 蔚小平 | Health-care product for recovering hemiplegia |
| CN103182033A (en) * | 2011-12-28 | 2013-07-03 | 安徽中医学院 | Traditional Chinese medicinal composite effective ingredient preparation for treating ischemic stroke and preparation method thereof |
| CN107998078A (en) * | 2017-12-27 | 2018-05-08 | 山东宏济堂制药集团股份有限公司 | A kind of muskone nasal spray microemulsion and its application |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474319A (en) * | 2009-01-19 | 2009-07-08 | 广东药学院 | Nasal spray microemulsion preparation for clearing brain, preparation method and application thereof |
-
2010
- 2010-12-29 CN CN2010106110755A patent/CN102048768B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101474319A (en) * | 2009-01-19 | 2009-07-08 | 广东药学院 | Nasal spray microemulsion preparation for clearing brain, preparation method and application thereof |
Non-Patent Citations (2)
| Title |
|---|
| 《山东中医杂志》 19990228 邵念方 等 脑通滴鼻液治疗缺血性脑卒中的临床研究 58-61页 1-3 第18卷, 第2期 2 * |
| 《海峡药学》 20101115 王欣然 等 脑清喷鼻乳剂的指标性成分TLC分析 75页"2 脑清喷鼻乳剂的制备"部分 1-3 第22卷, 第11期 2 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103182033A (en) * | 2011-12-28 | 2013-07-03 | 安徽中医学院 | Traditional Chinese medicinal composite effective ingredient preparation for treating ischemic stroke and preparation method thereof |
| CN103182033B (en) * | 2011-12-28 | 2017-07-04 | 安徽中医药大学 | One kind treats ishemic stroke Chinese medicine compound prescription preparation of active ingredient and preparation method thereof |
| CN102698001A (en) * | 2012-06-06 | 2012-10-03 | 蔚小平 | Health-care product for recovering hemiplegia |
| CN107998078A (en) * | 2017-12-27 | 2018-05-08 | 山东宏济堂制药集团股份有限公司 | A kind of muskone nasal spray microemulsion and its application |
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| CN102048768B (en) | 2012-08-15 |
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Address after: 510220 40 Haizhuqu District, Guangdong, Guangzhou. Patentee after: Guangdong Pharmaceutical University Address before: 510006 No. 280 East Ring Road, Guangzhou City University, Guangdong Patentee before: Guangdong Pharmaceutical University |
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Effective date of registration: 20220126 Address after: 510000 No. 16, Zhuji Road, Guangzhou, Guangdong Patentee after: Affiliated Hospital of traditional Chinese medicine of Guangzhou Medical University Address before: 510220 40 Haizhuqu District, Guangdong, Guangzhou. Patentee before: GUANGDONG PHARMACEUTICAL University |