CN101773578A - Vitex oil nanoemulsion and preparation method thereof - Google Patents

Vitex oil nanoemulsion and preparation method thereof Download PDF

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Publication number
CN101773578A
CN101773578A CN201010130295A CN201010130295A CN101773578A CN 101773578 A CN101773578 A CN 101773578A CN 201010130295 A CN201010130295 A CN 201010130295A CN 201010130295 A CN201010130295 A CN 201010130295A CN 101773578 A CN101773578 A CN 101773578A
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China
Prior art keywords
preparation
vitex
oil nanoemulsion
content
prescription
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CN201010130295A
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Chinese (zh)
Inventor
曹庆先
祁小乐
杨南林
徐凌燕
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JIANGSU WUZHONG PHARMACEUTICAL DEVELOPMENT Co Ltd
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JIANGSU WUZHONG PHARMACEUTICAL DEVELOPMENT Co Ltd
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Priority to CN201010130295A priority Critical patent/CN101773578A/en
Publication of CN101773578A publication Critical patent/CN101773578A/en
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Abstract

The invention relates to a vitex oil nanoemulsion and a preparation method and application thereof. The preparation method is characterized in that the advanced nanotechnology is used for the formula and process design of the vitex oil nanoemulsion. The preparation method comprises the steps that: vitex oil, medium chain fatty acid triglyceride, soy lecithin, ethanol and the like are evenly mixed to be used as an oil phase; poloxamer is mixed with water and the like to be used as a water phase; the oil phase is added to the water phase to be mixed and emulsified at a temperature of 40 to 60 DEG C and be treated by a two-step high-pressure homogenizer to obtain the milk-white vitex oil nanoemulsion with the average particle size of less than 100nm. The vitex oil nanoemulsion prepared by the invention has high quality, reliable quality stability and good biocompatibility, and simultaneously has good expectorant, antitussive and antiasthmatic effects.

Description

A kind of vitex oil nanoemulsion and preparation method thereof
Technical field
The present invention relates to a kind of vitex oil nanoemulsion and its production and application, belong to medical technical field.
Background technology
Chinese medicine is the rarity of Chinese traditional culture, in China long history in several thousand is arranged, and its unique drug effect is very important at world medical circle.Traditional Chinese medicine preparation dosage form mostly is decoction, pill, electuary, powder etc.Traditional heating means make its bioactive ingredients destroyed easily, and mouthfeel is not good and dosage is big, and body absorption rate is low, is difficult to give full play to its usefulness.Especially liquid oiliness Chinese medicine comprises Chinese medicine unsaturated fatty acids oil and volatile oil, has stronger physiologically active usually, but relatively more responsive to air, light and temperature, easily oxidation Decomposition is rotten.Therefore, the development of Chinese medicine preparation presses for modern formulation and combines.Nanotechnology is a kind of effective ways that change medicine existence in preparation.The suitable dosage form of applying nano technology preparation makes oiliness Chinese medicine nanometer emulsified, and then makes injection, oral agents or transdermal agent, can overcome himself shortcoming, significantly improves its physicochemical property, prolongs to store the time limit, enlarges range of application.At present, nano-emulsion has shown comparatively remarkable advantages in the intravenously administrable carrier as traditional medicine volatile oil and poorly water soluble drugs, cause vast medical worker's concern.
Oleum Viticis Negundo is the fresh leaf of Verenaceae plant Herba Viticis Cannabifoliae, the volatile oil that obtains through vapor distillation.Oleum Viticis Negundo eliminates the phlegm, antitussive action is stronger, and more weak antiasthmatic effect is also arranged.Viticis Negundo Oil Emulsion is the oral latex emulsion that is come through form improvement by pharmacopeia kind viticis negundo oil capsules.Viticis Negundo Oil Emulsion is to adopt Oleum Viticis Negundo that emulsifying technology will have a drug effect to be dispersed in the water Emulsion for preparing with the form of droplet.Compare with viticis negundo oil capsules, Viticis Negundo Oil Emulsion is taken medicine conveniently, and the patient of the pill that is particularly useful for being bad at swallowing takes, and is the ideal medicament of chronic pneumatic tube inflammation of treatment.
Summary of the invention
The objective of the invention is advanced person's nanotechnology is used for the prescription and the technological design of Oleum Viticis Negundo Emulsion, best in quality, quality stability is reliable, good biocompatibility thereby prepare, and have simultaneously good eliminate the phlegm, the vitex oil nanoemulsion of cough-relieving, the effect of relievining asthma.
The technical solution adopted in the present invention is: a kind of vitex oil nanoemulsion and preparation method thereof is characterized in that this vitex oil nanoemulsion contains following component:
Oleum Viticis Negundo 1%-15%
Medium chain length fatty acid triglyceride 15%-30%
Soybean phospholipid 1%-4%
Vitamin E 0.1%-0.2%
Oleic acid 0.25%-0.5%
Sorbic acid 0.05%-0.20%
Mentholum 0.1%-1%
Ethanol 10%-20%
Poloxamer 1%-6%
Polyvidone 0.1%-0.5%
Water 40%-60%
Its preparation methods steps is as follows in the vitex oil nanoemulsion of the present invention:
(1) with 1%-15% Oleum Viticis Negundo, 15%-30% MCT Oil, 1%-4% soybean phospholipid, 0.25%-0.5% oleic acid, 0.1%-0.2% vitamin E, 0.05%-0.2% sorbic acid, 0.1%-1% Mentholum and 10%-20% ethanol mixed dissolution, 40 ℃-60 ℃ insulation 30min, preparation obtains oil phase.
(2) 0.1%-0.5% polyvidone and 1%-6% poloxamer are dissolved in the part pure water (account for Emulsion final volume 40%), 40 ℃-60 ℃ insulation 30min, preparation obtains water.
(3) with the oil phase of above acquisition while hot, under stirring, slowly add aqueous phase, obtain colostrum.
(4) colostrum for preparing more than the general after two circulations of high pressure homogenize (500bar-1000bar), is added pure water, adopts sodium hydroxide solution to regulate pH to 7.5, standardize solution.With the above emulsion that obtains, four circulations of high pressure homogenize (500bar-1000bar) obtain outward appearance and are milky white shape, and mean diameter is less than 100nm, stay-in-grade vitex oil nanoemulsion.
Vitex oil nanoemulsion of the present invention can adopt 100 ℃ of flowing steam 30min, sterilizes.Vitex oil nanoemulsion of the present invention has effectively solved the stability problem of Oleum Viticis Negundo Emulsion in long-term the placement.In the long term store process, can keep the emulsified state of homogeneous, meet in the Chinese Pharmacopoeia rules of preparations requirement to Emulsion: the centrifugal 15min of 4000rpm, Emulsion is not stratified.Thereby a kind of good biocompatibility is provided, and have simultaneously good eliminate the phlegm, the vitex oil nanoemulsion of cough-relieving, the effect of relievining asthma, improved compliance of patients.
The specific embodiment
Example 1:
Oleum Viticis Negundo 20g
MCT Oil 200g
Soybean phospholipid PRS95 10g
Poloxamer 188 40g
Vitamin E 2g
Oleic acid 2.5g
Sorbic acid 1g
Ethanol 100g
Mentholum 5g
30 POVIDONE K 30 BP/USP 30 1g
Add purified water to 1000ml
Example 2:
Oleum Viticis Negundo 20g
MCT Oil 200g
Soybean phospholipid PRS95 10g
Poloxamer 188 40g
Vitamin E 2g
Oleic acid 2.5g
Sorbic acid 1g
Ethanol 100g
Mentholum 5g
30 POVIDONE K 30 BP/USP 30 5g
Add purified water to 1000ml
Example 3:
Oleum Viticis Negundo 20g
Medium chain length fatty acid triglyceride 200g
Soybean phospholipid PRS95 10g
Poloxamer 188 40g
Vitamin E 2g
Oleic acid 2.5g
Sorbic acid 1g
Ethanol 150g
Mentholum 5g
30 POVIDONE K 30 BP/USP 30 1g
Add purified water to 1000ml
Example 4:
Oleum Viticis Negundo 20g
Medium chain length fatty acid triglyceride 200g
Soybean phospholipid PRS95 20g
Poloxamer 188 40g
Vitamin E 2g
Oleic acid 2.5g
Sorbic acid 1g
Ethanol 100g
Mentholum 5g
30 POVIDONE K 30 BP/USP 30 1g
Add purified water to 1000ml
With phospholipid, oleic acid, vitamin E, Mentholum, Oleum Viticis Negundo, medium chain length fatty acid triglyceride, sorbic acid and the ethanol mixed dissolution of recipe quantity, 40 ℃-60 ℃ insulation 30min, preparation obtains oil phase.The polyvinylpyrrolidone of recipe quantity and poloxamer are dissolved in the part pure water (account for Emulsion final volume 40%), 40 ℃-60 ℃ insulation 30min, preparation obtains water.With the oil phase of above acquisition while hot, under stirring, slowly add aqueous phase, obtain colostrum.
With the above colostrum for preparing, after two circulations of high pressure homogenize (500bar-1000bar), add pure water, adopt sodium hydroxide solution to regulate pH to 7.5, standardize solution.With the above emulsion that obtains, four circulations of high pressure homogenize (500bar-1000bar) obtain final Emulsion.Fill the nitrogen packing, 100 ℃ of flowing steams, sterilization 30min, promptly.

Claims (13)

1. vitex oil nanoemulsion and preparation method thereof, the particle mean size that it is characterized in that this vitex oil nanoemulsion is less than 100mm.
2. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that principal agent is an Oleum Viticis Negundo, and its content is 1%-15%.
3. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing MCT Oil as oil phase in the prescription, and its content is 15%-30%.
4. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing soybean phospholipid as emulsifying agent in the prescription, and its content is 1%-4%.
5. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing vitamin E as antioxidant in the prescription, and its content is 0.1%-0.2%.
6. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing oleic acid as stabilizing agent in the prescription, and its content is 0.25%-0.5%.
7. vitex oil nanoemulsion according to claim 1 and preparation method thereof contains the dispersion aids of ethanol as emulsifying agent in it is characterized in that writing out a prescription, and its content is 10%-20%.
8. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing poloxamer as emulsifying agent in the prescription, and its content is 1%-6%.
9. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing polyvidone as coemulsifier in the prescription, and its content is 0.1%-0.5%.
10. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that aqueous phase content is 40%-60% in the prescription.
11. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing antiseptic sorbic acid or benzoic acid in the prescription, its content is 0.05%-0.2%.
12. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that containing correctives in the prescription, comprises sweeting agent or aromatic, as Mentholum, its content is 0.1%-1%.
13. vitex oil nanoemulsion according to claim 1 and preparation method thereof is characterized in that this method step is as follows:
(1) with Oleum Viticis Negundo, MCT Oil, soybean phospholipid, oleic acid, vitamin E, sorbic acid, Mentholum and ethanol mixed dissolution, 40 ℃-60 ℃ insulation 30min, preparation obtains oil phase.
(2) polyvidone and poloxamer are dissolved in the part water (account for Emulsion final volume 40%), 40 ℃-60 ℃ insulation 30min, preparation obtains water.
(3) with the oil phase of above acquisition while hot, under stirring, slowly add aqueous phase, obtain colostrum.(4) colostrum for preparing more than the general after two circulations of high pressure homogenize (500bar-1000bar), is added water, adopts the NaOH solution of 0.2mol/L to regulate pH to 7.5, standardize solution.With the above emulsion that obtains, continue four circulations of high pressure homogenize (500bar-1000bar), obtain outward appearance and be creamy white, particle mean size is less than 100nm, stay-in-grade vitex oil nanoemulsion.
CN201010130295A 2010-03-23 2010-03-23 Vitex oil nanoemulsion and preparation method thereof Pending CN101773578A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104042568A (en) * 2014-06-23 2014-09-17 青岛优度生物工程有限公司 Astaxanthin nanoemulsion preparation and preparation method thereof
CN104524012A (en) * 2014-11-27 2015-04-22 江苏吴中医药集团有限公司 Vitex oil self-emulsifying preparation and preparing method thereof
CN110522824A (en) * 2018-05-23 2019-12-03 北京盈科瑞创新药物研究有限公司 A kind of sucking oil of negundo chastetree pharmaceutical solutions and preparation method thereof
CN111803445A (en) * 2020-07-10 2020-10-23 贵州大学 Preparation method of high-stability nano emulsion and nano emulsion gel
CN113318232A (en) * 2021-05-25 2021-08-31 广州白云山星群(药业)股份有限公司 Preparation method of oleum Viticis negundo preparation
CN113332242A (en) * 2020-12-30 2021-09-03 杭州隽和生物医药有限公司 Permeation-promoting biological factor nano-emulsion

Citations (1)

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Publication number Priority date Publication date Assignee Title
CN1785315A (en) * 2005-11-07 2006-06-14 苏州长征-欣凯制药有限公司 Hemp-leaved ritet emulsion used for phlegm dispelling cough suppressing and panting calming, and preparing process thereof

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CN1785315A (en) * 2005-11-07 2006-06-14 苏州长征-欣凯制药有限公司 Hemp-leaved ritet emulsion used for phlegm dispelling cough suppressing and panting calming, and preparing process thereof

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Title
《江西中医学院学报》 20020430 黄敬耀,徐彭,等 牡荆子平喘作用的药理实验研究 13-14 1-13 第14卷, 第4期 2 *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104042568A (en) * 2014-06-23 2014-09-17 青岛优度生物工程有限公司 Astaxanthin nanoemulsion preparation and preparation method thereof
CN104042568B (en) * 2014-06-23 2016-06-29 青岛优度生物工程有限公司 A kind of astaxanthin nano-emulsion preparation and preparation method thereof
CN104524012A (en) * 2014-11-27 2015-04-22 江苏吴中医药集团有限公司 Vitex oil self-emulsifying preparation and preparing method thereof
CN104524012B (en) * 2014-11-27 2019-01-08 江苏吴中医药集团有限公司 A kind of oil of negundo chastetree self-emulsifiable preparation and preparation method thereof
CN110522824A (en) * 2018-05-23 2019-12-03 北京盈科瑞创新药物研究有限公司 A kind of sucking oil of negundo chastetree pharmaceutical solutions and preparation method thereof
CN111803445A (en) * 2020-07-10 2020-10-23 贵州大学 Preparation method of high-stability nano emulsion and nano emulsion gel
CN113332242A (en) * 2020-12-30 2021-09-03 杭州隽和生物医药有限公司 Permeation-promoting biological factor nano-emulsion
CN113318232A (en) * 2021-05-25 2021-08-31 广州白云山星群(药业)股份有限公司 Preparation method of oleum Viticis negundo preparation
CN113318232B (en) * 2021-05-25 2021-12-14 广州白云山星群(药业)股份有限公司 Preparation method of oleum Viticis negundo preparation

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Open date: 20100714