CN102652730A - Ointment base, kuh-seng and green tea ointment and preparation method of ointment - Google Patents

Ointment base, kuh-seng and green tea ointment and preparation method of ointment Download PDF

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CN102652730A
CN102652730A CN2012100881490A CN201210088149A CN102652730A CN 102652730 A CN102652730 A CN 102652730A CN 2012100881490 A CN2012100881490 A CN 2012100881490A CN 201210088149 A CN201210088149 A CN 201210088149A CN 102652730 A CN102652730 A CN 102652730A
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radix sophorae
green tea
sophorae flavescentis
ointment
randomly
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CN102652730B (en
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黄璐
牟峰
陈顺钦
张思佳
王俊
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WUHAN HUADA GENE TECHNOLOGY CO LTD
WUHAN HUADA PHARMACEUTICAL CO Ltd
BGI Shenzhen Co Ltd
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WUHAN HUADA GENE TECHNOLOGY CO LTD
WUHAN HUADA PHARMACEUTICAL CO Ltd
BGI Shenzhen Co Ltd
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Abstract

The invention provides an ointment base, kuh-seng and green tea ointment and a preparation method of the ointment. The ointment base contains thixotropic agent which is organic montmorillonite, medicament dispersant, mineral oil, polar solvent, lubricating agent and weak water absorption emulsifier. The ointment base and the kuh-seng and green tea ointment are good in thixotropic property and easy to apply, the application properties of the ointment base and the ointment are affected little by the temperature, and the ointment base and the ointment do not have irritation property.

Description

Ointment base, Radix Sophorae Flavescentis green tea ointment machin its preparation method
Technical field
The present invention relates to the Chinese medicine preparation technical field, relate to ointment base, Radix Sophorae Flavescentis green tea ointment machin its preparation method particularly.More specifically, the invention provides ointment base, Radix Sophorae Flavescentis green tea ointment, the method for preparing Radix Sophorae Flavescentis green tea ointment, Radix Sophorae Flavescentis green tea ointment is infected the Verrucosis that causes, molluscum contagiosum that immunologic hypofunction causes and is infected purposes and the purposes of organo montmorillonite in preparation Radix Sophorae Flavescentis green tea ointment in the medicine of the solar keratosis that causes by HPV in the preparation treatment by HPV.
Background technology
Chinese medicine is processed ointment, pharmaceutical preparation stability better, the drug release effect is strong, the patient is carried out local topical administration after, rapid-action.And ointment base is the important component part of ointment molding and performance drug effect; The composition of substrate and performance can have influence on the physicochemical property of medicine in substrate and the physiological function in skin affected part; Its quality and character are very big to the quality influence of ointment, so choice of base is a very important aspect of ointment research.Yet traditional ointment base thixotropy is poor, and temperature influence is big, and is not enough aspect sticking water, drug release.
CN1239669A discloses the Radix Sophorae Flavescentis green tea compositions ointment of the condyloma acuminatum that a kind of treatment causes because of human nipple virus; This ointment base is a greasing base; Can form closure oil film, lubricated, nonirritant, this has very important protective effect to the very easily oxidized green tea effective ingredient of protection.But this drug ointment water absorption is poor, be difficult for mixing with juice, to discharge penetration poor, has directly influenced the clinical drug effect of medicine.Simultaneously, substrate temperature influences such as the used vaseline of this ointment are bigger, and temperature causes when low that ointment hardness is big, thixotropy is poor.
Therefore, present ointment base still remains to be improved.
Summary of the invention
The present invention is based on inventor's following discovery and accomplishes:
The Chinese medicine Radix Sophorae Flavescentis has heat clearing and damp drying, and the effect of wind dispelling insecticide is used for diseases such as skin ulcer, scabies, tinea disease, main damp-heat dysentery, discharging fresh blood stool, jaundice, dysuria, edema, leukorrhagia, pudendal pruritus, scabies, leprosy, skin pruritus, noxious dampness skin infection more.Green tea has heat-clearing and toxic substances removing, effect such as convergence dehumidifying etc., and proving after deliberation, and green tea also has antiviral, antibiotic, antioxidation, anti-proliferative effect.Chinese medicine Radix Sophorae Flavescentis green tea is prepared into ointment; Can treat by HPV and infect the Verrucosis cause, molluscum contagiosum that immunologic hypofunction causes and infect the solar keratosis that causes by HPV, but present Radix Sophorae Flavescentis green tea ointment water absorption is poor, difficultly mix with juice, to discharge penetration poor, the clinical drug effect of medicine is relatively poor relatively; And; Present Radix Sophorae Flavescentis green tea ointment temperature influence is bigger, and temperature causes when low that ointment hardness is big, thixotropy is poor, is difficult for coating.
The present invention is intended to solve at least one of technical problem that exists in the prior art.For this reason, the invention provides ointment base, Radix Sophorae Flavescentis green tea ointment machin its preparation method.
According to an aspect of the present invention, the invention provides a kind of ointment base.According to embodiments of the invention, this ointment base comprises: thixotropic agent, and it is an organo montmorillonite; The medicine dispersant; Mineral oil; Polar solvent; The weak emulsifying agent of lubricant and suction.Ointment base thixotropy of the present invention is good, be prone to coating, little, the nonirritant of stretchability temperature influence, and medicine is had good release action, better stability of preparation.
According to embodiments of the invention; In ointment base of the present invention; The thixotropic agent organo montmorillonite can be for being selected from least a of dodecyl sodium sulfate modified montmorillonoid, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid, preferred dodecyl sodium sulfate modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid.
Organo montmorillonite is a kind of good thixotropic agent, can be through organically-modified the preparation carried out in montorillonite clay.The basic structural unit of montorillonite clay is to be clipped in the layer structure of leaning on shared oxygen atom between two silicon-oxy tetrahedrons and forming by a slice alumina octahedral.In these sheet surfaces superfluous negative charge is arranged, can adsorb cation, and the end face of montorillonite clay has variable charge, adsorbable again anion under certain condition.Thereby; For example dodecyl sodium sulfate (SDS), cationic surfactant cetyl trimethyl ammonium bromide (CTAB) and hexadecyltrimethylammonium chloride (CTAC) obtain organo montmorillonite as intercalator thereby natural montmorillonite is carried out intercalation modifying can to use anion surfactant.Its interlayer became lipophilic-hydrophobic property by hydrophilic oleophobic property after montorillonite clay was handled through organising, and had strengthened montorillonite clay and the organic compatibility and dispersibility.The dispersibility of montorillonite clay in organic facies through organising after handling significantly improves, and shows good swellability, dispersibility and thixotropy, and temperature influence is little.About can be referring to 1. old sea crowd to the detailed description of organo montmorillonite method for preparing, etc. the preparation of dodecyl sodium sulfate modified montmorillonoid and sign, Chinese Journal of Inorganic Chemistry, 2004,20 (3): 251-256; 2. Wang Yi, etc. the preparation of novel organo montmorillonite, structural characterization and dispersibility thereof, Henan chemical industry, 2006,23 (7): 8-11; 3. Lee's wind rises. and the different surfaces activating agent prepares organo montmorillonite, uses chemical industry, 2008,37 (4): 424-426; 4. Zheng Quan becomes, etc. the research of ultra-dispersed organic montmorillonite, Lanzhou Jiaotong University's journal, 2009,28 (1): 93-96, incorporate it into this paper in full through reference.
According to embodiments of the invention, in ointment base of the present invention, mineral oil can be for being selected from least a of liquid paraffin and soft paraffin, preferred liquid paraffin.The inventor finds, adopts the ointment that contains the oil ointment base preparation of liquid paraffin of the present invention, has the oil sealing effect; The effective ingredient that can solve in the ointment is unstable; Be prone to oxidized problem, and can effectively prolong the resting period of ointment, the effective ingredient that makes ointment is through depositing of long period and not oxidized; Further, ointment base of the present invention has good prospect in the application facet of labile drug.
According to embodiments of the invention, in ointment base of the present invention, polar solvent can be for being selected from glycerol, propylene glycol and alcoholic acid at least a; Preferably glycerine; Adopt the organo montmorillonite of different organic modifiers preparations to receive the polarity alcohols solvent activation influence degree of hydroxyl different, the inventor finds that glycerol, propylene glycol and alcoholic acid adding can promote the viscosity of gel rubber system; Reduce the consumption of organo montmorillonite, obtain more stabilizing gel effect.
The inventor is surprised to find, and the present invention adopts the organo montmorillonite for preparing through the montorillonite clay of ionic surface active agent modified natural, disperses mineral oil and polar solvent; The thixotropic agent mineral oil gel that obtains; Gel rubber system is uniform and stable, has high thixotropic, medicine high dispersive, stretchability temperature influence features of smaller; Thereby; With its main material, can have good release action to medicine, and to have solved with lanoline or vaseline etc. be the defective that traditional ointment base thixotropy is poor, temperature influence is big of main component as ointment base.Further; According to concrete example of the present invention; Adopt the main material of thixotropic agent mineral oil gel, prepare Radix Sophorae Flavescentis green tea ointment, can significantly improve the thixotropy of prepared ointment to replace vaseline and lanoline in traditional ointment base as ointment base; And play thickening power, successfully be incorporated in the ointment thereby can organo montmorillonite be had this character of good thixotropy.
According to embodiments of the invention, in ointment base of the present invention, the medicine dispersant can be for being selected from least a of Polyethylene Glycol-300 and polypropylene glycol-500, and preferably, the medicine dispersant is Polyethylene Glycol-300 or polypropylene glycol-500.Thus, ointment base of the present invention can make medicine disperse effectively.
According to embodiments of the invention; In ointment base of the present invention; Lubricant can be preferably the mixture of isopropyl myristate and Cyclomethicone for being selected from least a of isopropyl myristate, BS, Cyclomethicone, acetyl monoglyceride and 16 octadecanol.The inventor finds that isopropyl myristate is a kind of low-carbon-ester of higher fatty acids, has good lubricity, permeability, can improve the affinity to skin, and it is low that its greasy feeling of while is compared other ointment bases; Cyclomethicone has characteristics such as the coating of being easy to, good, the good permeability of antistatic property, chemical stability are good, and its high volatile volatile and medium solvent characteristics make it become the key component of very ideal topical preparation.This is because its high volatile volatile and medium solvent characteristics can make ointment produce low heat of evaporation at agents area, therefore, use the skin of the special agents area of this ointment can not produce the moist sensation that oil ointment base oil sealing is brought.
The inventor finds; The a large amount of liquid paraffin that exist in the ointment base of the present invention can cause adopting the ointment of ointment base preparation of the present invention to have the insufficient problem of lubricity; Thereby influence the coating of ointment; And the mixture that adopts isopropyl myristate and Cyclomethicone is as lubricant, head it off effectively, and can reduce the moist sensation of the greasy feeling and the agents area of ointment.
According to embodiments of the invention, in ointment base of the present invention, the weak emulsifying agent of suction can be for being selected from least a of stearyl alcohol and glyceryl monostearate, preferred stearyl alcohol.Thus, ointment base of the present invention can be regulated the water absorption and the drug release rate of the ointment that adopts its preparation effectively.The inventor finds; In ointment base, add the weak emulsifying agent of suction; Can significantly improve the sticking outlet capacity of the ointment that adopts this ointment base preparation, make ointment under the situation that agents area has a small amount of juice to ooze out, can in time absorb mixing, can also significantly improve the water permeability of ointment simultaneously; Make its can be when promoting the skin hydration effect contained hydrophilic polyglycol or polypropylene glycol absorption portion water in the binding matrix; Accelerate release rate of drugs greatly, efficiently solved the problem of common oil ointment base release property difference, and increased the washability of medicine.
According to embodiments of the invention, each components in proportions does not receive special restriction in the ointment base.According to concrete example of the present invention, ointment base can comprise the mineral oil of 100-200 medicaments in part by weight dispersant, 400-600 weight portion, the thixotropic agent of 20-60 weight portion, the polar solvent of 10-30 weight portion, the lubricant of 200-300 weight portion and the weak emulsifying agent of suction of 50-100 weight portion.
According to concrete examples more of the present invention, ointment base of the present invention has certain yield value for the pseudoplastic fluid of suitable denseness, and is thinning when shearing or rub, and coats easily, and shears the viscosity that recovers it when stopping rapidly.In addition; The inventor is surprised to find; Ointment base of the present invention has high thixotropic, medicine high dispersive, stretchability temperature influence features of smaller, under 0 ℃, 25 ℃, 40 ℃ conditions, all can keep semi-fluid condition, and ointment situation really up to the mark or rare excessively not occur.Thus; Ointment base of the present invention has improved the defective that general ointment base thixotropy is poor, temperature influence is big; Play medicine had good release action in; Reduced the sensitivity of ointment to temperature, strengthened the thixotropy of ointment, the while also has good prospect to the application of aqueous solution labile drug.
According to another aspect of the present invention, the invention provides a kind of Radix Sophorae Flavescentis green tea ointment.According to embodiments of the invention, this Radix Sophorae Flavescentis green tea ointment comprises: Radix Sophorae Flavescentis or Radix Sophorae Flavescentis extract, this Radix Sophorae Flavescentis extract are the water extract of Radix Sophorae Flavescentis; Green tea or green tea extract, this green tea extract are the alcohol extracts of green tea; And ointment base of the present invention.The inventor is surprised to find, and Radix Sophorae Flavescentis green tea ointment of the present invention can treat or prevent to infect the Verrucosis that causes, the molluscum contagiosum that immunologic hypofunction causes and the solar keratosis that is caused by the HPV infection by HPV effectively.Wherein, solar keratosis is a kind of skin precancerous lesion.According to concrete example of the present invention; Radix Sophorae Flavescentis green tea ointment of the present invention; Quality uniform and smooth, thixotropy be good, be prone to coating, color and luster uniformity, denseness suit, nonirritant, use do not have greasy feeling and moist sensation; The drug release effect is strong, but the better stability of preparation resting period is long, and can be easily through the commercial production preparation.
According to embodiments of the invention, Radix Sophorae Flavescentis extract prepares through the following step: Radix Sophorae Flavescentis is carried out extracting in water, so that obtain Radix Sophorae Flavescentis extractive liquid; Radix Sophorae Flavescentis extractive liquid is concentrated, so that obtain the Radix Sophorae Flavescentis concentrated solution; The Radix Sophorae Flavescentis concentrated solution is carried out pH regulator; And the Radix Sophorae Flavescentis concentrated solution that will pass through pH regulator carries out purification, so that obtain Radix Sophorae Flavescentis extract.According to some embodiments of the present invention, Radix Sophorae Flavescentis is carried out extracting in water, may further include: Radix Sophorae Flavescentis is carried out decocting in water 2-4 time with the water of 6-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain Radix Sophorae Flavescentis extractive liquid.According to embodiments of the invention, the relative density of Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees centigrade is 1.06～1.08.According to some embodiments of the present invention, can utilize hydrochloric acid that the Radix Sophorae Flavescentis concentrated solution is carried out pH regulator, wherein, the pH of the Radix Sophorae Flavescentis concentrated solution of process pH regulator is 2-5.According to embodiments of the invention, can utilize cation exchange resin that the Radix Sophorae Flavescentis concentrated solution is carried out purification.
According to embodiments of the invention, green tea extract prepares through the following step: green tea is added alcohol extraction, so that obtain green tea extractive liquor; And green tea extractive liquor carried out purification, so that obtain green tea extract.According to some embodiments of the present invention, green tea is added alcohol extraction may further include: green tea is carried out heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain green tea extractive liquor.According to concrete example of the present invention, green tea extractive liquor is carried out purification may further include: green tea extractive liquor is carried out reduced pressure treatment, so that remove ethanol; Green tea extractive liquor is carried out macroporous resin column handle, so that obtain purified green tea extractive liquor.
Particularly, according to one embodiment of present invention, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent of Radix Sophorae Flavescentis, green tea, medicine dispersant, mineral oil, thixotropic agent, polar solvent, lubricant and suction.According to another embodiment of the invention, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent of Radix Sophorae Flavescentis extract, green tea extract, medicine dispersant, mineral oil, thixotropic agent, polar solvent, lubricant and suction.
In addition; According to embodiments of the invention; In Radix Sophorae Flavescentis green tea ointment of the present invention; The thixotropic agent organo montmorillonite can be for being selected from least a of dodecyl sodium sulfate modified montmorillonoid, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid, preferred dodecyl sodium sulfate modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid.Thus, Radix Sophorae Flavescentis green tea ointment thixotropy of the present invention is good, and temperature influence is little.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, mineral oil can be for being selected from least a of liquid paraffin and soft paraffin, preferred liquid paraffin.Thus, Radix Sophorae Flavescentis green tea ointment of the present invention has the oil sealing effect, can make the stable effective ingredients in the ointment, is difficult for oxidizedly, and then can effectively prolong resting period of ointment.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, polar solvent can be for being selected from glycerol, propylene glycol and alcoholic acid at least a, preferably glycerine.Thus, can promote the viscosity of gel rubber system, reduce the consumption of organo montmorillonite, obtain more stabilizing gel effect.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, the medicine dispersant can be for being selected from least a of Polyethylene Glycol-300 and polypropylene glycol-500, and preferably, the medicine dispersant is Polyethylene Glycol-300 or polypropylene glycol-500.Thus, Radix Sophorae Flavescentis green tea ointment of the present invention can make medicine disperse effectively.
According to embodiments of the invention; In Radix Sophorae Flavescentis green tea ointment of the present invention; Lubricant can be preferably the mixture of isopropyl myristate and Cyclomethicone for being selected from least a of isopropyl myristate, BS, Cyclomethicone, acetyl monoglyceride and 16 octadecanol.Thus, Radix Sophorae Flavescentis green tea soft grease lubrication property of the present invention is good, is easy to coating, and can effectively reduce the moist sensation of the greasy feeling and the agents area of ointment.
According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment of the present invention, the weak emulsifying agent of suction can be for being selected from least a of stearyl alcohol and glyceryl monostearate, preferred stearyl alcohol.Thus, Radix Sophorae Flavescentis green tea ointment water absorption of the present invention and drug release rate are good, and washability is good.
According to embodiments of the invention; According to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis extract 42-84 weight portion, green tea extract 50-100 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and suction.According to embodiments of the invention, in Radix Sophorae Flavescentis green tea ointment, can use Radix Sophorae Flavescentis and green tea to substitute Radix Sophorae Flavescentis green tea extract and green tea extract respectively.Thus; According to a concrete example of the present invention, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis 1500-3000 weight portion, green tea 500-1000 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and suction.
According to a concrete example of the present invention; According to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 76 weight portions, green tea extract 90 weight portions, polypropylene glycol-500 180 weight portion, liquid paraffin 500 weight portions, dodecyl sodium sulfate modified montmorillonoid 40 weight portions, glycerol 20 weight portions, isopropyl myristate 180 weight portions, Cyclomethicone 50 weight portions, stearyl alcohol 70 weight portions.
According to a concrete example of the present invention; According to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 70 weight portions, green tea extract 86 weight portions, Polyethylene Glycol-300 140 weight portion, liquid paraffin 450 weight portions, dodecyl sodium sulfate modified montmorillonoid 50 weight portions, glycerol 25 weight portions, isopropyl myristate 200 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 55 weight portions.
According to a concrete example of the present invention; According to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 75 weight portions, green tea extract 95 weight portions, Polyethylene Glycol-300 200 weight portion, liquid paraffin 400 weight portions, hexadecyltrimethylammonium chloride modified montmorillonoid 60 weight portions, ethanol 30 weight portions, BS 270 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 50 weight portions
According to a concrete example of the present invention; According to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 42 weight portions, green tea extract 50 weight portions, polypropylene glycol-500 100 weight portion, liquid paraffin 600 weight portions, dodecyl sodium sulfate modified montmorillonoid 30 weight portions, glycerol 10 weight portions, isopropyl myristate 170 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 100 weight portions.
According to a concrete example of the present invention; According to parts by weight, Radix Sophorae Flavescentis green tea ointment of the present invention can comprise: Radix Sophorae Flavescentis extract 84 weight portions, green tea extract 100 weight portions, Polyethylene Glycol-300 150 weight portion, liquid paraffin 480 weight portions, dodecyl sodium sulfate modified montmorillonoid 20 weight portions, glycerol 15 weight portions, isopropyl myristate 240 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 80 weight portions.
According to embodiments of the invention, the inventor utilizes ointment base of the present invention and Radix Sophorae Flavescentis green tea ointment to carry out the skin hypersensitivity experiment, and experimental result shows that ointment base of the present invention and the Radix Sophorae Flavescentis green tea ointment for preparing with this substrate do not have sensitization to guinea pig skin.
According to another aspect of the invention, the invention provides a kind of method for preparing Radix Sophorae Flavescentis green tea ointment.According to embodiments of the invention, this method comprises: the preparation Radix Sophorae Flavescentis extract, and this Radix Sophorae Flavescentis extract is a water extract; The preparation green tea extract, this green tea extract is an alcohol extract; And use ointment base of the present invention, Radix Sophorae Flavescentis extract and green tea extract are processed Radix Sophorae Flavescentis green tea ointment.The inventor finds; Utilize the method for preparing Radix Sophorae Flavescentis green tea of the present invention; Can prepare Radix Sophorae Flavescentis green tea ointment easily and effectively, and this method is simple, efficient is high, can be applied to large-scale industrialization production, the ointment quality uniform and smooth of acquisition, thixotropy be good, be easy to coating, color and luster uniformity, denseness are suitable, nonirritant, use do not have greasy feeling and moist sensation; The drug release effect is strong, but the better stability of preparation resting period is long.
According to embodiments of the invention, the preparation Radix Sophorae Flavescentis extract may further include the following step: Radix Sophorae Flavescentis is carried out extracting in water, so that obtain Radix Sophorae Flavescentis extractive liquid; Radix Sophorae Flavescentis extractive liquid is concentrated, so that obtain the Radix Sophorae Flavescentis concentrated solution; The Radix Sophorae Flavescentis concentrated solution is carried out pH regulator; And the Radix Sophorae Flavescentis concentrated solution that will pass through pH regulator carries out purification, so that obtain Radix Sophorae Flavescentis extract.According to some embodiments of the present invention, Radix Sophorae Flavescentis is carried out extracting in water, may further include: Radix Sophorae Flavescentis is carried out decocting in water 2-4 time with the water of 6-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain Radix Sophorae Flavescentis extractive liquid.According to embodiments of the invention, the relative density of Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees centigrade is 1.06～1.08.According to some embodiments of the present invention, can utilize hydrochloric acid that the Radix Sophorae Flavescentis concentrated solution is carried out pH regulator, wherein, the pH of the Radix Sophorae Flavescentis concentrated solution of process pH regulator is 2-5.According to embodiments of the invention, can utilize cation exchange resin that the Radix Sophorae Flavescentis concentrated solution is carried out purification.
According to embodiments of the invention, the preparation green tea extract may further include the following step: green tea is added alcohol extraction, so that obtain green tea extractive liquor; And green tea extractive liquor carried out purification, so that obtain green tea extract.According to some embodiments of the present invention, green tea is added alcohol extraction may further include: green tea is carried out heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain green tea extractive liquor.According to concrete example of the present invention, green tea extractive liquor is carried out purification may further include: green tea extractive liquor is carried out reduced pressure treatment, so that remove ethanol; Green tea extractive liquor is carried out macroporous resin column handle, so that obtain purified green tea extractive liquor.
According to embodiments of the invention; Radix Sophorae Flavescentis extract and said green tea extract are processed ointment may further include: with Radix Sophorae Flavescentis extract and green tea extract respectively with the medicine dispersant so that obtain Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid; Thixotropic agent is dissolved in mineral oil and carries out first dispersion treatment, so that obtain the thixotropic agent mineral oil mixture; In the thixotropic agent mineral oil mixture that obtains, add polar solvent and carry out second dispersion treatment, so that obtain the thixotropic agent mineral oil gel; In the thixotropic agent mineral oil gel of gained, add emulsifying agent a little less than Radix Sophorae Flavescentis extract medicine dispersion liquid, green tea extract medicine dispersion liquid, lubricant and the suction successively, mix homogeneously is so that obtain Radix Sophorae Flavescentis green tea ointment.
Wherein, according to concrete example of the present invention, first and second dispersion treatment one of at least be in colloid mill, to carry out wet grinding to disperse, preferably, first and second dispersion treatment all are in colloid mill, to carry out wet grinding to disperse.Thus, each component is disperseed effectively, and gel rubber system evenly, stable.Its concrete principle is: organo montmorillonite is an agglomerant thin layer heap, add organic solvent after, solvent infiltrates the capillary slit and moistening and then make the depolymerization of thin layer heap, causes the viscosity of system to increase.And the dispersibility of raising organo montmorillonite in organic solvent; Can significantly improve gel strength, thixotropy and the heat stability performance of organo montmorillonite, further can improve the thixotropy of the thixotropic agent mineral oil gel, ointment base and the ointment that adopt this organo montmorillonite.In addition, the dispersion of organo montmorillonite in organic solvent generally adopted stirring or in than large space, utilized mechanical rotation formation high speed shear to carry out.This method has only simple shearing force, only be reinforced dispersed with stirring, and viscous shear space is bigger, can't obtain higher, the stabilizing gel system more of dispersion.According to concrete examples more of the present invention, the inventor is surprised to find, and adopts colloid milling, in colloid mill, carries out the thixotropic agent mineral oil gel that the wet grinding dispersion prepares, and gel rubber system is even, stable, and effect is very good.This be because; When organo montmorillonite and organic solvent are disperseed in colloid mill; Be to be cooperatively interacted by the rotor of colloid mill and stator to accomplish material dispersed, emulsifying and even matter, what organo montmorillonite and organic solvent were suffered is not the effect of single shearing force, but the combined effect of various physical force such as powerful shearing force, frictional force, dither, high speed whirlpool; Therefore resulting dispersion not only has the dispersed with stirring effect; Grind dispersion effect simultaneously in addition, resulting thus gel rubber system is more even, more stable.
According to embodiments of the invention, in the thixotropic agent mineral oil gel, before the interpolation Radix Sophorae Flavescentis extract medicine dispersion liquid, may further include the thixotropic agent mineral oil gel is heated.According to concrete example of the present invention, Radix Sophorae Flavescentis extract and green tea extract are processed ointment may further include the step that the weak emulsifying agent of lubricant and suction is carried out preheating.
Particularly; According to embodiments of the invention; Radix Sophorae Flavescentis extract and green tea extract are processed Radix Sophorae Flavescentis green tea ointment may further include: Radix Sophorae Flavescentis extract, green tea extract is even with the medicine dispersant respectively, Radix Sophorae Flavescentis extract medicine dispersion liquid, green tea extract medicine dispersion liquid; Thixotropic agent is dissolved in mineral oil, places the colloid mill wet grinding to disperse 5-10 minute, after fully disperseing, so that obtain the thixotropic agent mineral oil mixture; In the thixotropic agent mineral oil mixture, add polar solvent, continue to disperse 3-5 minute, so that obtain the thixotropic agent mineral oil gel; The thixotropic agent mineral oil gel is heated to 60-70 degree centigrade,, stirs while adding then to wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively; Add the lubricant and the weak emulsifying agent of suction that are preheated to 55-65 degree centigrade then; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, so that obtain Radix Sophorae Flavescentis green tea ointment.
Particularly, according to some embodiments of the present invention, the method for preparing Radix Sophorae Flavescentis green tea ointment of the present invention can may further comprise the steps:
A. take by weighing the Radix Sophorae Flavescentis of recipe quantity, add the water of 6-12 times of volume at every turn, decoct 2-4 time, each 0.5-2 hour, merge extractive liquid, filtered, and being concentrated into relative density is the concentrated solution of 1.06～1.08 (50 ℃).Add the hydrochloric acid adjust pH to 2-5; Filter, supernatant is crossed 732 type cation exchange resin columns, with the 15-40% ethanol remove impurity of the water and the 4-8 times of resin volume of 8-12 times of resin volume; Reuse 1-3 times of resin volume strong aqua ammonia alkalization resin is with 4-10 times of resin volume 15-40% ethanol elution.Eluent is through concentrating under reduced pressure, and drying under reduced pressure is pulverized, and gets the Radix Sophorae Flavescentis extract fine powder.
B. take by weighing the green tea of recipe quantity, 50-60 ℃ of heating and refluxing extraction of 40-80% ethanol that adding 8-12 doubly measures 1-3 time, each 0.5-2h, merge extractive liquid; Filter, filtrate decompression concentrates and removes ethanol, adds medical material weight 1-3 water dissolution doubly and extracts extractum, and is centrifugal; Discard residue, D101 type macroporous resin column on the supernatant, elder generation is with the water elution remove impurity of 4-8 column volume; The 10-30% ethanol elution remove impurity of a reuse 4-8 column volume is at last with the ethanol elution of the 60-95% of 6-12 times of resin volume, with the eluent concentrating under reduced pressure; Drying under reduced pressure is pulverized, and gets the green tea extract fine powder.
C. Radix Sophorae Flavescentis extract fine powder and medicine dispersant were at room temperature ground 5 minutes,, get Radix Sophorae Flavescentis extract medicine dispersion liquid up to grinding evenly; Green tea extract fine powder and medicine dispersant were at room temperature ground 5 minutes,, get green tea extract medicine dispersion liquid up to grinding evenly.Then, the thixotropic agent that takes by weighing recipe quantity is dissolved in the mineral oil, places the colloid mill wet grinding to disperse 5-10 minute; After abundant the dispersion, add polar solvent and continue to disperse 3-5 minute, get the thixotropic agent mineral oil gel; Be heated and remain 60-70 degree centigrade,, stir while adding then to wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively; Add the lubricant and the weak emulsifying agent of suction be preheated to 55-65 degree centigrade then, the limit edged stirs, to be mixed evenly after; Stop heating, continue to be stirred to room temperature, so that obtain Radix Sophorae Flavescentis green tea ointment.
According to embodiments of the invention; According to parts by weight, the method for preparing Radix Sophorae Flavescentis green tea ointment of the present invention can adopt: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis 1500-3000 weight portion, green tea 500-1000 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and suction.According to embodiments of the invention; Also can directly use Radix Sophorae Flavescentis extract or green tea extract; Thus; According to embodiments of the invention, the method for preparing Radix Sophorae Flavescentis green tea ointment of the present invention can adopt: the weak emulsifying agent 50-100 weight portion of Radix Sophorae Flavescentis extract 42-84 weight portion, green tea extract 50-100 weight portion, medicine dispersant 100-200 weight portion, mineral oil 400-600 weight portion, thixotropic agent 20-60 weight portion, polar solvent 10-30 weight portion, lubricant 200-300 weight portion and suction.
According to a concrete example of the present invention; This method can adopt Polyethylene Glycol-300 as the medicine dispersant; Adopt liquid paraffin as mineral oil; Adopt the dodecyl sodium sulfate modified montmorillonoid as thixotropic agent; Adopt glycerol as polar solvent, the mixture that adopts isopropyl myristate and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is: Radix Sophorae Flavescentis 2700 weight portions, green tea 900 weight portions, Polyethylene Glycol-300150 weight portion, liquid paraffin 450 weight portions, dodecyl sodium sulfate modified montmorillonoid 40 weight portions, glycerol 20 weight portions, isopropyl myristate 230 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 70 weight portions.
According to a concrete example of the present invention; This method can adopt polypropylene glycol-500 as the medicine dispersant; Adopt liquid paraffin as mineral oil; Adopt the dodecyl sodium sulfate modified montmorillonoid as thixotropic agent; Adopt glycerol as polar solvent, the mixture that adopts isopropyl myristate and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is: Radix Sophorae Flavescentis 2450 weight portions, green tea 860 weight portions, polypropylene glycol-500130 weight portion, liquid paraffin 480 weight portions, dodecyl sodium sulfate modified montmorillonoid 50 weight portions, glycerol 25 weight portions, isopropyl myristate 200 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 55 weight portions.
According to a concrete example of the present invention; This method can adopt Polyethylene Glycol-300 as the medicine dispersant; Adopt liquid paraffin as mineral oil; Adopt the hexadecyltrimethylammonium chloride modified montmorillonoid as thixotropic agent; Adopt ethanol as polar solvent, the mixture that adopts BS and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is: Radix Sophorae Flavescentis 2500 weight portions, green tea 1000 weight portions, Polyethylene Glycol-300200 weight portion, liquid paraffin 400 weight portions, hexadecyltrimethylammonium chloride modified montmorillonoid 60 weight portions, ethanol 30 weight portions, BS 270 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 50 weight portions
According to a concrete example of the present invention; This method can adopt polypropylene glycol-500 as the medicine dispersant; Adopt liquid paraffin as mineral oil; Adopt the hexadecyltrimethylammonium chloride modified montmorillonoid as thixotropic agent; Adopt ethanol as polar solvent, the mixture that adopts BS and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is: Radix Sophorae Flavescentis 1500 weight portions, green tea 500 weight portions, polypropylene glycol-500100 weight portion, liquid paraffin 600 weight portions, dodecyl sodium sulfate modified montmorillonoid 30 weight portions, glycerol 10 weight portions, isopropyl myristate 170 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 100 weight portions.
According to a concrete example of the present invention; This method can adopt Polyethylene Glycol-300 as the medicine dispersant; Adopt liquid paraffin as mineral oil; Adopt the dodecyl sodium sulfate modified montmorillonoid as thixotropic agent; Adopt glycerol as polar solvent, the mixture that adopts isopropyl myristate and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is: Radix Sophorae Flavescentis 3000 weight portions, green tea 1000 weight portions, Polyethylene Glycol-300160 weight portion, liquid paraffin 450 weight portions, dodecyl sodium sulfate modified montmorillonoid 20 weight portions, glycerol 15 weight portions, isopropyl myristate 240 weight portions, Cyclomethicone 30 weight portions, stearyl alcohol 80 weight portions.
According to another aspect of the invention, the invention provides according to the prepared Radix Sophorae Flavescentis green tea ointment of the method for preparing Radix Sophorae Flavescentis green tea ointment of the front embodiment of the invention.
In accordance with a further aspect of the present invention, the invention provides according to the Radix Sophorae Flavescentis green tea ointment of the embodiment of the invention and infect the Verrucosis that causes, molluscum contagiosum that immunologic hypofunction causes by HPV and infect the purposes in the medicine of the solar keratosis that causes by HPV in preparation prevention and treatment.
According to a further aspect in the invention, the invention provides the purposes of organo montmorillonite in preparation Radix Sophorae Flavescentis green tea ointment.According to embodiments of the invention, this Radix Sophorae Flavescentis green tea ointment is used to prevent and treat by HPV and infect the Verrucosis that causes, the molluscum contagiosum that immunologic hypofunction causes and the solar keratosis that is caused by the HPV infection.According to concrete example of the present invention; Organo montmorillonite can be for being selected from least a of dodecyl sodium sulfate modified montmorillonoid, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid, preferred dodecyl sodium sulfate modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid.According to embodiments of the invention; The purposes of organo montmorillonite noted earlier in preparation Radix Sophorae Flavescentis green tea ointment shows as: organo montmorillonite can be as the thixotropic agent of the ointment base that is used to prepare Radix Sophorae Flavescentis green tea ointment; Thus, the Radix Sophorae Flavescentis green tea ointment thixotropy for preparing is good, medicine high dispersive, stretchability temperature influence are little.
Need to prove, be according to the ointment base of the embodiment of the invention, the advantage of Radix Sophorae Flavescentis green tea ointment machin its preparation method:
1, ointment base of the present invention; The organo montmorillonite that employing prepares through the montorillonite clay of ionic surface active agent modified natural; Therefore the thixotropic agent mineral oil gel that disperse to form has high thixotropic, medicine high dispersive, stretchability temperature influence features of smaller as the main material of ointment base, and having solved with lanoline or vaseline etc. is that traditional ointment base thixotropy of main component is poor; The defective that temperature influence is big; And adopt the ointment medicament release action of this ointment base preparation strong, little to the sensitivity of temperature, thixotropy is good.
2, ointment base of the present invention is owing to added water absorption and the drug release rate that absorbs water weak emulsifying agent and can regulate the ointment that adopts this ointment base preparation effectively.The interpolation of the weak emulsifying agent of suction; Can significantly improve the sticking outlet capacity and the water permeability of the ointment that adopts this ointment base preparation; Accelerate release rate of drugs, efficiently solved the problem of common oil ointment base release property difference, and increased the washability of medicine.
3, ointment base of the present invention; Since with the mixture of isopropyl myristate and Cyclomethicone as lubricant; Solve the insufficient problem of lubricity that has a large amount of liquid paraffin in the ointment that adopts this ointment base preparation and cause, and reduced the moist sensation of the greasy feeling and the agents area of ointment.
4, adopt the ointment that contains the oil ointment base preparation of liquid paraffin of the present invention; Have the oil sealing effect, the effective ingredient that can solve in the ointment is unstable, is prone to oxidized problem; And can effectively prolong resting period of ointment; And not oxidized, further, ointment base of the present invention has good prospect in the application facet of labile drug to the effective ingredient that makes ointment through depositing of long period.
5, Radix Sophorae Flavescentis green tea ointment of the present invention, quality uniform and smooth, thixotropy be good, be prone to coating, color and luster uniformity, denseness suit, nonirritant, drug release effect are strong, better stability of preparation.
6, in the method for preparing of Radix Sophorae Flavescentis green tea ointment of the present invention, adopt colloid milling, in colloid mill, carry out the thixotropic agent mineral oil gel that the wet grinding dispersion prepares, gel rubber system is even, stable; With Radix Sophorae Flavescentis extract and green tea extract fine powder respectively with the medicine dispersant; After being prepared into two kinds of abundant dispersive medicine dispersion liquids, again with other drug adjuvant stirring and evenly mixing, thus; Can prevent effectively that effective ingredient in Radix Sophorae Flavescentis and the green tea is because of directly contacting the stability that influences pharmaceutical preparation; And technology is simple, and is workable, is fit to industrialized great production.
Additional aspect of the present invention and advantage part in the following description provide, and part will become obviously from the following description, or recognize through practice of the present invention.
The specific embodiment
Describe embodiments of the invention below in detail.The embodiment that describes below is exemplary, only is used to explain the present invention, and can not be interpreted as limitation of the present invention.
The preparation and the quality evaluation of embodiment 1, three kind of prescription Radix Sophorae Flavescentis green tea ointment
According to the Radix Sophorae Flavescentis green tea ointment prescription of listing in the table 1, and the corresponding preparation technology of each prescription, prepare three kinds of Radix Sophorae Flavescentis green tea ointment respectively.
Table 1, Radix Sophorae Flavescentis green tea ointment prescription are formed
Particularly, according to three kinds of Radix Sophorae Flavescentis green tea ointment of following steps preparation:
Prepare Radix Sophorae Flavescentis extract and green tea extract at first, respectively.
Wherein, Radix Sophorae Flavescentis extract prepares according to following steps:
Radix Sophorae Flavescentis 10800 gram, with the decocting in water of 8 times of amounts 3 times, each 1 hour, so that the acquisition Radix Sophorae Flavescentis extractive liquid, merge extractive liquid, and with its filtration was concentrated into the concentrated solution that relative density is 1.06～1.08 (50 ℃) with filtrating then.Add hydrochloric acid adjust pH to 3～4 then, filter, and supernatant is crossed 732 type cation exchange resin columns; With 30% ethanol flush away partial impurities of 10 times of resinite hydrops and 6 times of resin volumes, 1 times of resin volume of reuse strong aqua ammonia alkalization resin is used 6 times of resin volume 30% ethanol elutions then; And with eluent through concentrating under reduced pressure, drying is pulverized; Get Radix Sophorae Flavescentis extract fine powder 300 grams, subsequent use.
Green tea extract prepares according to following steps are rapid:
Green tea 2000 grams, 60% alcohol heating reflux that adds 10 times of amounts extracts twice, and each 1.5 hours, so that obtain green tea extractive liquor; Merge extractive liquid, and with its filtration then reclaims filtrate decompression and removes ethanol, carries out centrifugally then, discards residue; D101 type macroporous resin column on the filtrating, water are eluted to does not have the alcohol flavor, then, and with the water elution of 6 column volumes; 70% ethanol elution of 5 column volumes is used in 15% ethanol elution remove impurity of 5 column volumes of reuse at last, and will be partially recycled through ethanol elution; Drying gets green tea extract fine powder 200 grams, and is subsequent use.
Then, according to Radix Sophorae Flavescentis green tea ointment prescription in the table 1,, the Radix Sophorae Flavescentis extract and the green tea extract of above-mentioned acquisition is prepared as three kinds of Radix Sophorae Flavescentis green tea ointment respectively according to following preparation technology:
The preparation technology of Comparative Examples: the Radix Sophorae Flavescentis green tea ointment method for preparing referring to described in the CN1239669A prepares Comparative Examples Radix Sophorae Flavescentis green tea ointment, incorporates it into this paper in full through reference.
The preparation technology of experimental example 1 and experimental example 2: the Polyethylene Glycol-300 of Radix Sophorae Flavescentis extract fine powder and half recipe quantity was at room temperature ground 5 minutes,, get Radix Sophorae Flavescentis extract medicine dispersion liquid up to grinding evenly; The Polyethylene Glycol-300 of green tea extract fine powder and half recipe quantity was at room temperature ground 5 minutes,, get green tea extract medicine dispersion liquid up to grinding evenly.Then, the dodecyl sodium sulfate modified montmorillonoid is dissolved in the liquid paraffin, places the colloid mill wet grinding to disperse 5 minutes; After abundant the dispersion, adding glycerol continues to disperse 5 minutes, gets the liquid paraffin gel that the dodecyl sodium sulfate modified montmorillonoid disperses formation; Be heated to 65 degrees centigrade,, stir while adding then to wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively; Add again and be preheated to 65 degrees centigrade isopropyl myristate, Cyclomethicone and stearyl alcohol; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, so that obtain Radix Sophorae Flavescentis green tea ointment (prescription B or C Radix Sophorae Flavescentis green tea ointment).
Thus, obtain the Radix Sophorae Flavescentis green tea ointment of Comparative Examples, experimental example 1 and experimental example 2.
The Radix Sophorae Flavescentis green tea ointment of three kinds of prescriptions obtaining is carried out outward appearance observe, the result shows that three kinds of prescriptions all can obtain uniform and smooth, the Radix Sophorae Flavescentis green tea ointment that color and luster is bright, and ointment denseness and viscosity at normal temperatures all meets the requirements.
Then, through following experiment the Radix Sophorae Flavescentis green tea ointment of Comparative Examples, experimental example 1 and experimental example 2 is carried out quality evaluation and comparison:
1. stability test
(1) cold-resistant heat resistant test
Cold-resistant experiment: three kinds of prescription Radix Sophorae Flavescentis green tea ointment of above-mentioned acquisition are respectively charged into airtight sealing in the bottle; Requirement will be sealed bottle and filled up; To seal bottle then and place constant incubator (40 ℃ ± 1 ℃); Observe behind the 10d and the color and luster of record ointment, become sour, character such as foreign odor, layering and quality, the result sees the following form 2.
Heat resistant test: three kinds of prescription Radix Sophorae Flavescentis green tea ointment of above-mentioned acquisition are respectively charged into airtight sealing in the bottle; Requirement will be sealed bottle and filled up; To seal bottle then and place refrigerator (18 ℃ ± 1 ℃); Observe behind the 10d and the color and luster of record ointment, become sour, character such as foreign odor, layering and quality, the result sees the following form 2.
Table 2, the character comparative result of three kinds of prescription Radix Sophorae Flavescentis green tea ointment behind high temperature and low temperature held 10d
Figure BDA0000148489820000121
Can find out by table 2; Behind the K cryogenic treatment 10d; Becoming sour does not all appear in 3 kinds of prescription Radix Sophorae Flavescentis green tea ointment, foreign odor and the stratified phenomenon of drug matrices, but the color and luster and the quality of Comparative Examples Radix Sophorae Flavescentis green tea ointment (being also referred to as Comparative Examples ointment in this article sometimes) and experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment (being also referred to as experimental example 1 and 2 ointment in this article sometimes) show difference, the color and luster and the fine texture of experimental example 1 and 2 ointment; And the glossiness of Comparative Examples ointment has reduction slightly; And the quality phenomenon of hardening slightly occurred, this maybe be at low temperatures can hardening relevant with vaseline in the Comparative Examples ointment and lanoline, and experimental example 1 and 2 ointment adopt liquid paraffin gel that organo montmorillonite disperses to form as ointment base; Temperature influence is less, still can keep at low temperatures and the following consistent character of room temperature.Behind the high-temperature process 10d, all characteristic indexs of experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment are all no abnormal, though and becoming sour does not appear in Comparative Examples Radix Sophorae Flavescentis green tea ointment, foreign odor and the stratified phenomenon of drug matrices, its glossiness descends, and quality becomes soft partially rare partially character.Thus, explain that cold-resistant thermostability is superior to Comparative Examples Radix Sophorae Flavescentis green tea ointment according to the experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment of method preparation of the present invention.
(2) centrifugal test
Three kinds of above-mentioned acquisition prescription Radix Sophorae Flavescentis green tea ointment are placed different centrifuge tubes respectively, and equal centrifugal 20min under different rotating speeds takes out the lamination of observing ointment more then, and the result sees table 3.Wherein, the amount of the Radix Sophorae Flavescentis green tea ointment in each centrifuge tube is 10g.
The centrifugal test result of table 3, three kinds of prescription Radix Sophorae Flavescentis green tea ointment
Figure BDA0000148489820000122
Can know that by table 3 three kinds of prescription Radix Sophorae Flavescentis green tea ointment is at≤4000rmin -1Rotating speed under behind the centrifugal 20min, the stratified phenomenon of medicine and substrate does not all take place, in stable condition; And at 5000rmin -1Rotating speed under behind the centrifugal 20min, prescription B, C Radix Sophorae Flavescentis green tea ointment are in stable condition, the drug matrices lamination do not occur, but obvious layering take place prescription A Radix Sophorae Flavescentis green tea ointment.Thus, explain that stability is superior to Comparative Examples Radix Sophorae Flavescentis green tea ointment according to the experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment of method preparation of the present invention.
2. rheology test
(1) utilizes the rotary viscosimeter (rotating cylinder of the rotating cylinder factor * 10; 25 ℃ ± 1 ℃ constant temperature); Measure and be recorded in the viscosity behind the initial viscosity of three kinds of prescription Radix Sophorae Flavescentis green tea ointment (front prepares) in the viscometer test barrel and the rotation 30s behind the condition of different temperatures held 3h; The ratio of viscosity after calculating the initial viscosity of each ointment then respectively and rotating 30s, note is made the thixotroping value, and the result sees the following form 4.
The rheological property of table 4, three kinds of prescription Radix Sophorae Flavescentis green tea ointment is measured the result
Figure BDA0000148489820000131
Can know that by table 4 after (25 ℃) were placed 3h under normal temperature condition, the initial viscosity of three kinds of prescription Radix Sophorae Flavescentis green tea ointment was more approaching; When with ointment behind viscometer test barrel internal rotation 30s; Promptly receive after the shear action 30s, the viscosity of three kinds of prescription Radix Sophorae Flavescentis green tea ointment all has decline in various degree, compared to Comparative Examples ointment; The viscosity degradation of experimental example 1 and 2 ointment is remarkable; Demonstrate stronger thixotropy, coating also has good improvement, and this adopts the ointment of Radix Sophorae Flavescentis green tea ointment prescription of the present invention preparation to adopt the gain effect that main material brought of the dispersive liquid paraffin gel of organo montmorillonite as ointment base just because of these two kinds.Behind 0 ℃ of held 3h; With compare under the normal temperature condition, the initial viscosity of experimental example 1 and 2 ointment receives Influence of Temperature little than Comparative Examples ointment, the viscosity number after viscosity number after shearing through 30s and the experimental example under the normal temperature condition 1 and 2 ointment are sheared is approaching; And Comparative Examples ointment is after depositing under 0 ℃; Viscosity increases greatly, and surrender property is little after shearing, and still shows bigger viscosity number.Equally, the ointment behind 40 ℃ of held 3h, viscosity temperature influence degree aspect, experimental example 1 and 2 ointment are superior to Comparative Examples ointment, and it is rare excessively to be embodied in Comparative Examples ointment, is unfavorable for local the use.Thus, explain that thixotropy and stability are superior to Comparative Examples Radix Sophorae Flavescentis green tea ointment according to the experimental example 1 and the 2 Radix Sophorae Flavescentis green tea ointment of method preparation of the present invention.
(2) adopt the single-point rapid test method, the rheology stability of Comparative Examples, experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment is detected.In brief, it is an amount of to get three kinds of prescription Radix Sophorae Flavescentis green tea ointment, places viscometer, measures its viscosity under 0 ℃, 25 ℃, 30 ℃, 35 ℃, 40 ℃, 45 ℃ respectively, then according to the Arrhenius chemical kinetics equation
Figure BDA0000148489820000132
Calculate the rheological parameters E of each ointment under the different temperatures respectively ηValue, the result sees the following form 5, and wherein η is a viscosity, and R is a molar gas constant, and T is a thermodynamic temperature, A is a pre-exponential factor, can obtain slope (E by log η to the relation of 1/T η/ 2.303R), can calculate the rheological parameters E of each ointment under the different temperatures by slope ηValue.Wherein, in the Arrhenius chemical kinetics equation, E ηBe flow-activation energy, it can reflect fluidic stability, E ηBe worth greatly more, fluid is stable more, thus; When the Arrhenius chemical kinetics equation is applied to Researches on Fluids; Can explain approx fluidic viscosity and temperature interdependence (can be referring to Ma Xing, etc. the Research on The Rheology of emulsion-type liniment substrate. pharmacy circular, 1988; 23 (4): 207-208., incorporate it into this paper in full through reference).In addition, adopting the single-point rapid test method to carry out the rheology stability study of ointment, is that mastic viscosity is bigger, causes bigger operate miss easily, is difficult for recording accurate rheological curve because in rheological property research.
The rheology stability of table 5, three kinds of prescription Radix Sophorae Flavescentis green tea ointment is measured the result
Radix Sophorae Flavescentis green tea ointment prescription E η(KJ)
Comparative Examples 3.46
Experimental example 1 4.98
Experimental example 2 4.54
E by three kinds of prescription Radix Sophorae Flavescentis green tea ointment in the table 5 ηValue can find out that the flow-activation energy of experimental example 1 and 2 ointment is higher than Comparative Examples ointment in intuitive analysis, because E ηBe worth big more; Fluid is stable more; Then the result shows that experimental example 1 and 2 ointment are higher than the stability of Comparative Examples ointment, and the result that cold-resistant heat resistant test is obtained in this and the test of aforementioned stable property is consistent, and promptly to be embodied in the heat resistant test that resists cold be that the character temperature influence is less for experimental example 1 and the higher flow-activation energy of 2 ointment; It is high that stability is wanted, thereby also proved from fluidic its stability of flow-activation energy supposition to have reasonability.Thus, further specify experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment according to method preparation of the present invention, stability is superior to Comparative Examples Radix Sophorae Flavescentis green tea ointment.
3. ductility test
The ductility of ointment can directly reflect ointment whether the quality uniform and smooth, be prone to coating etc., be one of important indicator of ointment quality evaluation.Thus, three kinds of acquisition noted earlier prescription Radix Sophorae Flavescentis green tea ointment are carried out ductility research, concrete grammar is following: get the big or small clean glass plate of 2 20cm * 25cm; On glass plate, finish grid with marking pen, and 2 glass plates are stacked, and make and be positioned at the heavy 125g (deficiency adds counterweight and supplies weight) of upper glass plate; Take by weighing three kinds of each 1g of prescription Radix Sophorae Flavescentis green tea ointment behind 0 ℃, 25 ℃, 40 ℃ held 24h then respectively, place between 2 glass plates that stack, behind the 1min; Measure and write down the diameter of each ointment after extending with ruler; Get maximum and minima and calculate the two meansigma methods (can be referring to Tu Xide, etc. pharmaceutics. Beijing: the People's Press, 2001:378.; Incorporate it into this paper in full through reference), the result sees the following form 6.
The ductility experimental result of table 6, three kinds of prescription Radix Sophorae Flavescentis green tea ointment
Figure BDA0000148489820000141
Figure BDA0000148489820000151
Can know that by table 6 under 25 ℃ of conditions, the extension diameter range of Comparative Examples, experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment is all between 40-70mm; The stretchability of ointment is better; Steady quality is explained under normal temperature condition, and 3 kinds of ointment all can provide good physical effect for the use of medicine.Wherein, The ointment of extension diameter≤50mm is called half steel body (Semi-stiff) ointment; The ointment of extension diameter in the 50-70mm scope is called semifluid (Semi-fluid) ointment; Wherein semifluid ointment is considered to comparatively ideal external ointment preparation, and the Comparative Examples under the normal temperature condition, experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment basically all are in this scope.But through after 0 ℃ and the 40 ℃ of processing, difference appears in the ductility of 3 kinds of prescription Radix Sophorae Flavescentis green tea ointment.Comparative Examples ointment is after low temperature (0 ℃) is handled, and viscosity increases, and it is bigger that the extension diameter receives Influence of Temperature; Become half steel body ointment, thereby influenced the stretchability of ointment, and after high temperature (40 ℃) is handled; Rare character occurs, also be unfavorable for the exhibition that is coated with of ointment.And experimental example 1 and 2 ointment after treatment of different temperature, still remain viscid physical state, and the extension diameter is about 60mm, and stretchability is good especially.Thus, further specify experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment according to method preparation of the present invention, ductility is superior to Comparative Examples Radix Sophorae Flavescentis green tea ointment.
4. medicine releasability test
Radix Sophorae Flavescentis green tea ointment will produce therapeutical effect as the medication to skin, and at first its effective ingredient must be discharged into skin or mucomembranous surface from ointment base, and therefore, the medicine releasability of ointment also is one of important indicator of ointment quality evaluation.
Utilize diffusion cell, three kinds of prescription Radix Sophorae Flavescentis green tea ointment to acquisition noted earlier carry out the drug release Journal of Sex Research respectively, and concrete grammar is following:
At first, get the microporous filter membrane of 1 μ m, be fixed in the supply pool of diffusion cell and accept between the pond; Recirculated water is remained 37 ℃ ± 0.5 ℃; Accept the pond with 15% ethanol as accepting medium, add stirrer and stir with the speed of 200r/min, drain bubble; In Supply House, add 0.5g Radix Sophorae Flavescentis green tea ointment then, then experiment beginning.
Then, carry out 1,2,4,6 respectively at experiment, and taking-up 1ml acceptable solution during 8h (15% ethanol, subsequent use, and in reception tank, replenish the acceptable solution (i.e. 15% ethanol) of equivalent equality of temperature immediately.
Then; Utilize high performance liquid chromatograph; Measure in the acceptable solution of each collected time point the content of the effective ingredient EGCG, matrine and the oxymatrine that discharge from Radix Sophorae Flavescentis green tea ointment respectively, and calculate the cumulative release amount of various effective ingredients, the result sees the following form 7.
The cumulative release amount of the effective ingredient of table 7, three kinds of prescriptions of each time point Radix Sophorae Flavescentis green tea ointment
Figure BDA0000148489820000152
Figure BDA0000148489820000161
Wherein, select 15% alcoholic solution, so that guarantee that release medium is eligible as release medium.Can know by table 7, after handling through permeable membrane, all can detect corresponding effective ingredient in the acceptable solution of 3 kinds of Radix Sophorae Flavescentis green tea ointment, and along with the prolongation of experimental period, the cumulative release amount of various effective ingredients also increases in the acceptable solution thereupon.From table, can find out; When 8h is carried out in experiment; The EGCG cumulative release amount of experimental example 1 and 2 ointment is respectively 1.85,1.94 times of Comparative Examples ointment; Matrine cumulative release amount is respectively 1.98,1.91 times of Comparative Examples ointment, and oxymatrine cumulative release amount is respectively 1.49,1.35 times of Comparative Examples ointment.Thus, further specify experimental example 1 and 2 Radix Sophorae Flavescentis green tea ointment according to method preparation of the present invention, medicine releasability is superior to Comparative Examples Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 2, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 2700g, green tea 900g, Polyethylene Glycol-300 150g, liquid paraffin 450g, dodecyl sodium sulfate modified montmorillonoid 40g, glycerol 20g, isopropyl myristate 230g, Cyclomethicone 30g, stearyl alcohol 70g.
(2) method for making:
A. take by weighing Radix Sophorae Flavescentis 2700g, with the decocting in water of 8 times of amounts 3 times, each 1 hour.Merge extractive liquid,, being concentrated into relative density is the concentrated solution of 1.06～1.08 (50 ℃).Add hydrochloric acid adjust pH to 3～4; Filter, supernatant is crossed 732 type cation exchange resin columns, with 30% ethanol flush away partial impurities of 10 times of resinite hydrops and 6 times of resin volumes; 1 times of resin volume of reuse strong aqua ammonia alkalization resin is with 6 times of resin volume 30% ethanol elutions.Eluent is through concentrating under reduced pressure, and drying is pulverized, and gets the Radix Sophorae Flavescentis extract fine powder, and is subsequent use.
B. take by weighing green tea 900g, 60% alcohol heating reflux that adds 10 times of amounts extracts twice, and each 1.5 hours, merge extractive liquid.The extracting solution reclaim under reduced pressure is removed ethanol, and extracting solution is centrifugal, discards residue, D101 type macroporous resin column on the filtrating; Water is eluted to does not have the alcohol flavor, with the water elution of 6 column volumes, and 15% ethanol elution of 5 column volumes of reuse; Use 70% ethanol elution of 5 column volumes at last, will be partially recycled through ethanol elution, drying; Pulverize, get the green tea extract fine powder, subsequent use.
C. above-mentioned Radix Sophorae Flavescentis extract fine powder and 75g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 75g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 40g and be dissolved in liquid paraffin 450g, place the colloid mill wet grinding to disperse 8 minutes, after fully disperseing; Add glycerol 20g and continue to disperse 5 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 60 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 60 degrees centigrade isopropyl myristate 230g, Cyclomethicone 30g and stearyl alcohol 70g again while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 3, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 2450g, green tea 860g, polypropylene glycol-500 130g, liquid paraffin 480g, dodecyl sodium sulfate modified montmorillonoid 50g, glycerol 25g, isopropyl myristate 200g, Cyclomethicone 30g, stearyl alcohol 55g.
(2) method for making:
A. according to recipe quantity,, prepare Radix Sophorae Flavescentis extract and green tea extract respectively according to embodiment 2 described methods, subsequent use.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 65g polypropylene glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 65g polypropylene glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 50g and be dissolved in liquid paraffin 480g, place the colloid mill wet grinding to disperse 5 minutes, after fully disperseing; Add glycerol 25g and continue to disperse 5 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 70 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 55 degrees centigrade isopropyl myristate 200g, Cyclomethicone 30g, stearyl alcohol 55g then while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 4, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 2500g, green tea 1000g, Polyethylene Glycol-300 200g, liquid paraffin 400g, hexadecyltrimethylammonium chloride modified montmorillonoid 60g, ethanol 30g, BS 270g, Cyclomethicone 30g, stearyl alcohol 50g.
(2) method for making:
A. according to recipe quantity,, prepare Radix Sophorae Flavescentis extract and green tea extract respectively according to embodiment 2 described methods, subsequent use.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 100g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 100g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing hexadecyltrimethylammonium chloride modified montmorillonoid 60g and be dissolved in liquid paraffin 400g, place the colloid mill wet grinding to disperse 8 minutes, after fully disperseing; Add ethanol 30g and continue to disperse 3 minutes, get the liquid paraffin gel that the dispersion of hexadecyltrimethylammonium chloride modified montmorillonoid forms, be heated to 65 degrees centigrade; Then to wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively; Stir while adding, add being preheated to 65 degrees centigrade BS 270g, Cyclomethicone 30g, stearyl alcohol 50g then, the limit edged stirs; To be mixed evenly after; Stop heating, continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 5, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 1500g, green tea 500g, polypropylene glycol-500 100g, liquid paraffin 600g, dodecyl sodium sulfate modified montmorillonoid 30g, glycerol 10g, isopropyl myristate 170g, Cyclomethicone 30g, stearyl alcohol 100g.
(2) method for making:
A. according to recipe quantity,, prepare Radix Sophorae Flavescentis extract and green tea extract respectively according to embodiment 2 described methods, subsequent use.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 50g polypropylene glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 50g polypropylene glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 30g and be dissolved in liquid paraffin 600g, place the colloid mill wet grinding to disperse 10 minutes, after fully disperseing; Add glycerol 10g and continue to disperse 5 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 63 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 58 degrees centigrade isopropyl myristate 170g, Cyclomethicone 30g, stearyl alcohol 100g then while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 6, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis 3000g, green tea 1000g, Polyethylene Glycol-300 160g, liquid paraffin 450g, dodecyl sodium sulfate modified montmorillonoid 20g, glycerol 15g, isopropyl myristate 240g, Cyclomethicone 30g, stearyl alcohol 80g.
(2) method for making:
A. according to recipe quantity,, prepare Radix Sophorae Flavescentis extract and green tea extract respectively according to embodiment 2 described methods, subsequent use.
B. above-mentioned Radix Sophorae Flavescentis extract fine powder and 80g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; Above-mentioned green tea extract fine powder and 80g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 20g and be dissolved in liquid paraffin 450g, place the colloid mill wet grinding to disperse 6 minutes, after fully disperseing; Add glycerol 15g and continue to disperse 4 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 66 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 60 degrees centigrade isopropyl myristate 240g, Cyclomethicone 30g, stearyl alcohol 80g then while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 7, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 76g (according to the embodiment 2 described method preparations that prepare Radix Sophorae Flavescentis extract), green tea extract 90g (according to the embodiment 2 described method preparations that prepare green tea extract), polypropylene glycol-500 180g, liquid paraffin 500g, dodecyl sodium sulfate modified montmorillonoid 40g, glycerol 20g, isopropyl myristate 180g, Cyclomethicone 50g, stearyl alcohol 70g.
(2) method for making:
76g Radix Sophorae Flavescentis extract and 90g polypropylene glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; 90g green tea extract and 90g polypropylene glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 40g and be dissolved in liquid paraffin 500g, place the colloid mill wet grinding to disperse 10 minutes, after fully disperseing; Add glycerol 20g and continue to disperse 5 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 65 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 65 degrees centigrade isopropyl myristate 180g, Cyclomethicone 50g, stearyl alcohol 70g then while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 8, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 70g (according to the embodiment 2 described method preparations that prepare Radix Sophorae Flavescentis extract), green tea extract 86g (according to the embodiment 2 described method preparations that prepare green tea extract), Polyethylene Glycol-300 140g, liquid paraffin 450g, dodecyl sodium sulfate modified montmorillonoid 50g, glycerol 25g, isopropyl myristate 200g, Cyclomethicone 30g, stearyl alcohol 55g.
(2) method for making:
70g Radix Sophorae Flavescentis extract and 70g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; 86g green tea extract and 70g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 50g and be dissolved in liquid paraffin 450g, place the colloid mill wet grinding to disperse 10 minutes, after fully disperseing; Add glycerol 25g and continue to disperse 5 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 65 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 60 degrees centigrade isopropyl myristate 200g, Cyclomethicone 30g, stearyl alcohol 55g then while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 9, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 75g (according to the embodiment 2 described method preparations that prepare Radix Sophorae Flavescentis extract), green tea extract 95g (according to the embodiment 2 described method preparations that prepare green tea extract), Polyethylene Glycol-300 200g, liquid paraffin 400g, hexadecyltrimethylammonium chloride modified montmorillonoid 60g, ethanol 30g, BS 270g, Cyclomethicone 30g, stearyl alcohol 50g.
(2) method for making:
75g Radix Sophorae Flavescentis extract and 100g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; 95g green tea extract and 100g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing hexadecyltrimethylammonium chloride modified montmorillonoid 60g and be dissolved in liquid paraffin 400g, place the colloid mill wet grinding to disperse 6 minutes, after fully disperseing; Add ethanol 30g and continue to disperse 3 minutes, get the liquid paraffin gel that the dispersion of hexadecyltrimethylammonium chloride modified montmorillonoid forms, be heated to 65 degrees centigrade; Then to wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively; Stir while adding, add being preheated to 60 degrees centigrade BS 270g, Cyclomethicone 30g, stearyl alcohol 50g then, the limit edged stirs; To be mixed evenly after; Stop heating, continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 10, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 42g (according to the embodiment 2 described method preparations that prepare Radix Sophorae Flavescentis extract), green tea extract 50g (according to the embodiment 2 described method preparations that prepare green tea extract), polypropylene glycol-500 100g, liquid paraffin 600g, dodecyl sodium sulfate modified montmorillonoid 30g, glycerol 10g, isopropyl myristate 170g, Cyclomethicone 30g, stearyl alcohol 100g.
(2) method for making:
42g Radix Sophorae Flavescentis extract and 50g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; 50g green tea extract and 50g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 30g and be dissolved in liquid paraffin 600g, place the colloid mill wet grinding to disperse 7 minutes, after fully disperseing; Add glycerol 10g and continue to disperse 5 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 70 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 60 degrees centigrade isopropyl myristate 170g, Cyclomethicone 30g, stearyl alcohol 100g then while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The preparation of embodiment 11, Radix Sophorae Flavescentis green tea ointment
(1) prescription:
Radix Sophorae Flavescentis extract 84g (according to the embodiment 2 described method preparations that prepare Radix Sophorae Flavescentis extract), green tea extract 100g (according to the embodiment 2 described method preparations that prepare green tea extract), Polyethylene Glycol-300 150g, liquid paraffin 480g, dodecyl sodium sulfate modified montmorillonoid 20g, glycerol 15g, isopropyl myristate 240g, Cyclomethicone 30g, stearyl alcohol 80g.
(2) method for making:
84g Radix Sophorae Flavescentis extract and 75g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get Radix Sophorae Flavescentis extract medicine dispersion liquid; 100g green tea extract and 75g Polyethylene Glycol-300 were at room temperature ground 5 minutes, get green tea extract medicine dispersion liquid.
Take by weighing dodecyl sodium sulfate modified montmorillonoid 20g and be dissolved in liquid paraffin 480g, place the colloid mill wet grinding to disperse 7 minutes, after fully disperseing; Add glycerol 15g and continue to disperse 5 minutes, get the liquid paraffin gel that the dispersion of dodecyl sodium sulfate modified montmorillonoid forms, be heated to 70 degrees centigrade; To wherein slowly adding Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid successively, stir then, add being preheated to 60 degrees centigrade isopropyl myristate 240g, Cyclomethicone 30g, stearyl alcohol 80g then while adding; The limit edged stirs, to be mixed evenly after, stop heating; Continue to be stirred to room temperature, promptly get Radix Sophorae Flavescentis green tea ointment.
In addition, the discrimination test result shows: in the test sample chromatograph of the Radix Sophorae Flavescentis green tea ointment of acquisition, occur the speckle of same color on its position identical with the reference substance chromatograph.Show the effective ingredient matrine, oxymatrine, the epigallocatechin gallate (EGCG) that contain Radix Sophorae Flavescentis green tea in the prepared Radix Sophorae Flavescentis green tea ointment.
The discriminating of embodiment 12, Radix Sophorae Flavescentis green tea ointment
The identification result of the Radix Sophorae Flavescentis green tea ointment of the foregoing description 2-11 preparation obtains through the following step:
Get each 1g of Radix Sophorae Flavescentis green tea ointment of embodiment 2-11 preparation, place 10 tool plug conical flasks respectively, add 3 of dehydrated alcohol 20ml, strong aqua ammonia (concentration is 25-28%) then respectively; Then tool plug conical flask is carried out heating in water bath to ointment and melt, carried out supersound extraction then 45 minutes, put to room temperature; Filter; The filtrating evaporate to dryness adds chloroform 2ml dissolving, as need testing solution.Other gets matrine, oxymatrine reference substance, adds methanol respectively and processes the solution that every 1ml contains 0.1mg, as reference substance solution.Utilize thin layer chromatography to make an experiment: to draw each 20 μ l point of above-mentioned solution in the silica gel g thin-layer plate of same 0.4%NaOH; With volume ratio is that lower floor's solution of chloroform-methanol-strong ammonia solution of 5: 0.6: 0.3 is developing solvent; Launch; Take out, dry, spray successively then with bismuth potassium iodide test solution and sodium nitrite ethanol test solution.In the test sample chromatograph, on its position identical with the reference substance chromatograph, the speckle of same color should appear.
Get each 1g of Radix Sophorae Flavescentis green tea ointment of embodiment 2-11 preparation, place 10 tool plug conical flasks respectively, carry out heating in water bath to ointment behind the interpolation dehydrated alcohol 20ml and melt; Carried out supersound extraction then 45 minutes, and filtered, the filtrating evaporate to dryness; Add chloroform 2ml dissolving, as need testing solution.Other gets the epigallocatechin gallate (EGCG) reference substance and adds methanol and process the solution that every 1ml contains 0.1mg, as reference substance solution.Utilize thin layer chromatography to make an experiment: drawing each 20 μ l point of above-mentioned solution on same silica gel G plate, is that chloroform-methanol-acetic acid of 13: 4: 2.5 is developing solvent with volume ratio, launches; Take out; Dry, spray sulphuric acid ethanol test solution then, be heated to clear spot at 105 ℃ with 10%.In the test sample chromatograph, on its position identical with the reference substance chromatograph, the speckle of same color should appear.
Embodiment 13, the test of Radix Sophorae Flavescentis green tea ointment sensitization of skin property
1, animal and material
30 of healthy albino guinea-pigs, male and female half and half, body weight 250～300g is provided by the Wuhan University Experimental Animal Center.
Radix Sophorae Flavescentis green tea ointment (according to the foregoing description 2 preparation), not the blank substrate of drug (according to the method for preparing of the foregoing description 2, difference with the blank substrate of drug not in do not add Radix Sophorae Flavescentis green tea medicine), the 2.4-dinitrochlorobenzene of 1% concentration.
2, test method
Utilize 6% sodium sulfide with the depilation of the spinal column both sides, back of 30 healthy albino guinea-pigs, every lateral area is 9 square centimeters, observes after 24 hours no skin irritation react; Cavia porcellus is divided into three groups at random; Every group 10, male and female are given Radix Sophorae Flavescentis green tea ointment 0.2g for half and half, the first group; Second group of blank group given the not blank substrate 0.2g of drug; The 3rd group of positive controls given the 2.4-dinitrochlorobenzene 0.2ml of 1% concentration, and every group all only to the administration of guinea pig back right side, and the left side is coated with normal saline as negative control.Every animal sub-cage rearing, and make medicine keep 6h in administration place.Then, when the 7d of the administration first time and 14d, in kind respectively repeat once, amount to administration 3 times.14d after the last administration excites contact; Depilation district, right side, back to all Cavia porcelluss carries out administration, and first group is coated with Radix Sophorae Flavescentis green tea ointment 0.2g, and the blank group is coated with the blank substrate of 0.2g; Positive controls is coated with the 2.4-dinitrochlorobenzene 0.2ml of 1% concentration; Remove the medicine or the blank substrate of administration place behind the administration 6h, observe administration place at once and have or not skin allergy, then respectively at observing the skin allergy situation behind administration 24h, 48h, the 72h once more; And calculate the sensitization incidence rate, and carry out the sensitization evaluation.
Wherein anaphylaxis is divided into erythema, edema, systemic anaphylaxis.The sensitization incidence rate calculates according to following method: the number of animals of skin erythema, edema or systemic anaphylaxis will occur, and divided by the animal subject sum, promptly get the sensitization incidence rate of each treated animal.The sensitization evaluation criterion is: 1～10% is no sensitization; 11～30% slight sensitizations; 31～60% severe sensitizations; 61～80% height sensitizations; 81～100% extreme sensitizations.
3, result of the test
The sensitization incidence rate and the sensitization evaluation result of each treated animal see the following form 9.
Each treated animal sensitization of table 8 is estimated
Group Sensitization incidence rate (%) The evaluation of sensitization of skin property
Radix Sophorae Flavescentis green tea ointment group 0 No sensitization
Blank matrix group 0 No sensitization
Positive controls 100 The extreme sensitization
After the administration; Phenomenons such as redness all appear in the animal skin of positive controls; The sensitization rate is 100%; And the animal of Radix Sophorae Flavescentis green tea ointment group and blank matrix group does not all have the red swelling of the skin appearance, and the sensitization rate is 0, shows that ointment base of the present invention and the Radix Sophorae Flavescentis green tea ointment for preparing with this substrate do not have sensitization to guinea pig skin.
In the description of this description, the description of reference term " embodiment ", " some embodiment ", " example ", " concrete example " or " some examples " etc. means the concrete characteristic, structure, material or the characteristics that combine this embodiment or example to describe and is contained at least one embodiment of the present invention or the example.In this manual, the schematic statement to above-mentioned term not necessarily refers to identical embodiment or example.And concrete characteristic, structure, material or the characteristics of description can combine with suitable manner in any one or more embodiment or example.
Although illustrated and described embodiments of the invention; Those having ordinary skill in the art will appreciate that: under the situation that does not break away from principle of the present invention and aim, can carry out multiple variation, modification, replacement and modification to these embodiment, scope of the present invention is limited claim and equivalent thereof.

Claims (9)

1. an ointment base is characterized in that, comprises:
Thixotropic agent, said thixotropic agent are organo montmorillonite;
The medicine dispersant, randomly, said medicine dispersant is be selected from Polyethylene Glycol-300 and polypropylene glycol-500 at least a;
Mineral oil, randomly, said mineral oil is be selected from liquid paraffin and soft paraffin at least a;
Polar solvent, randomly, said polar solvent is for being selected from glycerol, propylene glycol and alcoholic acid at least a;
Lubricant, randomly, said lubricant is be selected from isopropyl myristate, BS, Cyclomethicone, acetyl monoglyceride and 16 octadecanol at least a; And
The weak emulsifying agent of suction, randomly, the weak emulsifying agent of said suction is be selected from stearyl alcohol and glyceryl monostearate at least a,
Randomly; Said organo montmorillonite is be selected from dodecyl sodium sulfate modified montmorillonoid, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid at least a; Preferred dodecyl sodium sulfate modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid
Randomly, said medicine dispersant is Polyethylene Glycol-300 or polypropylene glycol-500,
Randomly, said mineral oil is liquid paraffin,
Randomly, said polar solvent is a glycerol,
Randomly, said lubricant is the mixture of isopropyl myristate and Cyclomethicone,
Randomly, the weak emulsifying agent of said suction is a stearyl alcohol,
Randomly, said ointment base comprises the mineral oil of 100-200 medicaments in part by weight dispersant, 400-600 weight portion, the thixotropic agent of 20-60 weight portion, the polar solvent of 10-30 weight portion, the lubricant of 200-300 weight portion and the weak emulsifying agent of suction of 50-100 weight portion.
2. a Radix Sophorae Flavescentis green tea ointment is characterized in that, comprises:
Radix Sophorae Flavescentis or Radix Sophorae Flavescentis extract, said Radix Sophorae Flavescentis extract are the water extract of Radix Sophorae Flavescentis;
Green tea or green tea extract, said green tea extract are the alcohol extracts of green tea; And
The described ointment base of claim 1,
Randomly, said Radix Sophorae Flavescentis extract prepares through the following step:
Radix Sophorae Flavescentis is carried out extracting in water, so that obtain Radix Sophorae Flavescentis extractive liquid;
Said Radix Sophorae Flavescentis extractive liquid is concentrated, so that obtain the Radix Sophorae Flavescentis concentrated solution;
Said Radix Sophorae Flavescentis concentrated solution is carried out pH regulator; And
Said Radix Sophorae Flavescentis concentrated solution through pH regulator is carried out purification, so that obtain said Radix Sophorae Flavescentis extract,
Randomly, said Radix Sophorae Flavescentis is carried out extracting in water, further comprises:
Said Radix Sophorae Flavescentis is carried out decocting in water 2-4 time with the water of 6-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain said Radix Sophorae Flavescentis extractive liquid,
Randomly, the relative density of said Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees centigrade is 1.06～1.08,
Randomly, utilize hydrochloric acid that said Radix Sophorae Flavescentis concentrated solution is carried out pH regulator, wherein, the pH of the Radix Sophorae Flavescentis concentrated solution of said process pH regulator is 2-5,
Randomly, utilize cation exchange resin that said Radix Sophorae Flavescentis concentrated solution is carried out purification,
Randomly, said green tea extract prepares through the following step:
Green tea is added alcohol extraction, so that obtain green tea extractive liquor; And
Said green tea extractive liquor is carried out purification, so that obtain said green tea extract,
Randomly, green tea being added alcohol extraction further comprises:
Said green tea is carried out heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain said green tea extractive liquor,
Randomly, said green tea extractive liquor being carried out purification further comprises:
Said green tea extractive liquor is carried out reduced pressure treatment, so that remove ethanol;
Said green tea extractive liquor is carried out macroporous resin column handle, so that obtain purified green tea extractive liquor.
3. Radix Sophorae Flavescentis green tea ointment according to claim 2 is characterized in that, according to parts by weight, said Radix Sophorae Flavescentis green tea ointment comprises:
Figure FDA0000148489810000021
Randomly, according to parts by weight, said Radix Sophorae Flavescentis green tea ointment comprises:
Randomly, according to parts by weight, said Radix Sophorae Flavescentis green tea ointment comprises:
Figure FDA0000148489810000023
Figure FDA0000148489810000031
Randomly, according to parts by weight, said Radix Sophorae Flavescentis green tea ointment comprises:
Figure FDA0000148489810000032
Randomly, according to parts by weight, said Radix Sophorae Flavescentis green tea ointment comprises:
Figure FDA0000148489810000033
Randomly, according to parts by weight, said Radix Sophorae Flavescentis green tea ointment comprises:
Figure FDA0000148489810000034
4. a method for preparing Radix Sophorae Flavescentis green tea ointment is characterized in that, comprising:
The preparation Radix Sophorae Flavescentis extract, said Radix Sophorae Flavescentis extract is a water extract;
The preparation green tea extract, said green tea extract is an alcohol extract; And
Use the described ointment base of claim 1, said Radix Sophorae Flavescentis extract and said green tea extract processed said Radix Sophorae Flavescentis green tea ointment,
Wherein,
Randomly, said preparation Radix Sophorae Flavescentis extract further comprises the following steps:
Radix Sophorae Flavescentis is carried out extracting in water, so that obtain Radix Sophorae Flavescentis extractive liquid;
Said Radix Sophorae Flavescentis extractive liquid is concentrated, so that obtain the Radix Sophorae Flavescentis concentrated solution;
Said Radix Sophorae Flavescentis concentrated solution is carried out pH regulator; And
Said Radix Sophorae Flavescentis concentrated solution through pH regulator is carried out purification, so that obtain said Radix Sophorae Flavescentis extract,
Randomly, said Radix Sophorae Flavescentis is carried out extracting in water, further comprises:
Said Radix Sophorae Flavescentis is carried out decocting in water 2-4 time with the water of 6-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain said Radix Sophorae Flavescentis extractive liquid,
Randomly, the relative density of said Radix Sophorae Flavescentis concentrated solution in the time of 50 degrees centigrade is 1.06～1.08,
Randomly, utilize hydrochloric acid that said Radix Sophorae Flavescentis concentrated solution is carried out pH regulator, wherein, the pH of the Radix Sophorae Flavescentis concentrated solution of said process pH regulator is 2-5,
Randomly, utilize cation exchange resin that said Radix Sophorae Flavescentis concentrated solution is carried out purification,
Randomly, said preparation green tea extract further comprises the following steps:
Green tea is added alcohol extraction, so that obtain green tea extractive liquor; And
Said green tea extractive liquor is carried out purification, so that obtain said green tea extract,
Randomly, green tea being added alcohol extraction further comprises:
Said green tea is carried out heating and refluxing extraction 1-3 time with the 40-80% ethanol of 8-12 times of weight, each 0.5-2 hour, and merge extractive liquid,, so that obtain said green tea extractive liquor,
Randomly, said green tea extractive liquor being carried out purification further comprises:
Said green tea extractive liquor is carried out reduced pressure treatment, so that remove ethanol;
Said green tea extractive liquor is carried out macroporous resin column handle, so that obtain purified green tea extractive liquor,
Randomly, said Radix Sophorae Flavescentis extract and said green tea extract being processed ointment further comprises:
With said Radix Sophorae Flavescentis extract and said green tea extract respectively with the medicine dispersant so that obtain Radix Sophorae Flavescentis extract medicine dispersion liquid and green tea extract medicine dispersion liquid;
Thixotropic agent is dissolved in mineral oil and carries out first dispersion treatment, so that obtain the thixotropic agent mineral oil mixture;
In said thixotropic agent mineral oil mixture, add polar solvent and carry out second dispersion treatment, so that obtain the thixotropic agent mineral oil gel;
In said thixotropic agent mineral oil gel, add emulsifying agent a little less than said Radix Sophorae Flavescentis extract medicine dispersion liquid, said green tea extract medicine dispersion liquid, lubricant and the suction successively, mix homogeneously, so that obtain Radix Sophorae Flavescentis green tea ointment,
Randomly, said first and second dispersion treatment one of at least be in colloid mill, to carry out wet grinding to disperse,
Randomly, in said thixotropic agent mineral oil gel, before the said Radix Sophorae Flavescentis extract medicine dispersion liquid of interpolation, further comprise said thixotropic agent mineral oil gel heated,
Randomly, further comprise the step that the weak emulsifying agent of said lubricant and suction is carried out preheating.
5. method according to claim 4 is characterized in that, according to parts by weight, said method adopts:
Figure FDA0000148489810000051
Randomly, adopt Polyethylene Glycol-300, adopt liquid paraffin as mineral oil as the medicine dispersant; Adopt the dodecyl sodium sulfate modified montmorillonoid as thixotropic agent; Adopt glycerol as polar solvent, the mixture that adopts isopropyl myristate and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is:
Figure FDA0000148489810000052
Randomly, adopt polypropylene glycol-500, adopt liquid paraffin as mineral oil as the medicine dispersant; Adopt the dodecyl sodium sulfate modified montmorillonoid as thixotropic agent; Adopt glycerol as polar solvent, the mixture that adopts isopropyl myristate and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is:
Figure FDA0000148489810000053
Figure FDA0000148489810000061
Randomly, adopt Polyethylene Glycol-300, adopt liquid paraffin as mineral oil as the medicine dispersant; Adopt the hexadecyltrimethylammonium chloride modified montmorillonoid as thixotropic agent; Adopt ethanol as polar solvent, the mixture that adopts BS and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is:
Figure FDA0000148489810000062
Randomly, adopt polypropylene glycol-500, adopt liquid paraffin as mineral oil as the medicine dispersant; Adopt the dodecyl sodium sulfate modified montmorillonoid as thixotropic agent; Adopt glycerol as polar solvent, the mixture that adopts isopropyl myristate and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is:
Figure FDA0000148489810000063
Randomly, adopt Polyethylene Glycol-300, adopt liquid paraffin as mineral oil as the medicine dispersant; Adopt the dodecyl sodium sulfate modified montmorillonoid as thixotropic agent; Adopt glycerol as polar solvent, the mixture that adopts isopropyl myristate and Cyclomethicone adopts stearyl alcohol as the weak emulsifying agent of suction as lubricant; And according to parts by weight, the ratio of said raw material is:
Figure FDA0000148489810000064
Figure FDA0000148489810000071
6. a Radix Sophorae Flavescentis green tea ointment is characterized in that, said Radix Sophorae Flavescentis green tea ointment is by claim 4 or 5 described method preparations.
7. ointment base according to claim 1 or infect the Verrucosis that causes, molluscum contagiosum that immunologic hypofunction causes by HPV and infect the purposes in the medicine of the solar keratosis that causes by HPV in the preparation treatment according to claim 2,3 or 6 described Radix Sophorae Flavescentis green tea ointment.
8. the purposes of organo montmorillonite in preparation Radix Sophorae Flavescentis green tea ointment, randomly, said Radix Sophorae Flavescentis green tea ointment is used to prevent and treats by HPV and infect the Verrucosis that causes, molluscum contagiosum that immunologic hypofunction causes and infected the solar keratosis that causes by HPV.
9. purposes according to claim 8; It is characterized in that; Said organo montmorillonite is be selected from dodecyl sodium sulfate modified montmorillonoid, cetyl trimethyl ammonium bromide modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid at least a, preferred dodecyl sodium sulfate modified montmorillonoid and hexadecyltrimethylammonium chloride modified montmorillonoid.
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