CN1621045A - Externally applied liniment containing propolis - Google Patents
Externally applied liniment containing propolis Download PDFInfo
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- CN1621045A CN1621045A CNA2003101089550A CN200310108955A CN1621045A CN 1621045 A CN1621045 A CN 1621045A CN A2003101089550 A CNA2003101089550 A CN A2003101089550A CN 200310108955 A CN200310108955 A CN 200310108955A CN 1621045 A CN1621045 A CN 1621045A
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- propolis
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Abstract
The present invention relates to propolis-containing liniment and its preparation. The liniment consists of propolis 5-25 weight portions, alcohol 3-30 weight portions, polyhydric fatty alcohol 5-70 weight portions, higher fatty alcohol 1-10 weight portions and dimethyl sulfoxide 5-30 weight portions. The liniment is superior to available propolis preparation, which has irritation on skin and mucous membrane, and has obvious treating effect, especially on herpes genitalis, low cost, high stability and no irritation to skin and wound.
Description
Technical field:
The present invention relates to technical field of medicine, be specifically related to the externally-applied liniment and the preparation method of propolis-containing.
Background technology:
Propolis has another name called propolis, is a kind of resin-like solid matter with aromatic odor that is mixed by resin, Apis mandibular gland secretions and Cera Flava that Apis is gathered from the tender tooth of each kind of plant, is one of major product of Nidus Vespae.The chemical analysis of propolis is extremely complicated, isolated chemical compound reaches kind more than 150 from propolis at present, wherein flavone compound reaches kind more than 40, each kind more than 30 of aromatic ester, fatty acid and ester type compound thereof, each kind more than 20 of trace element such as aminoacid and zinc, aromatic acid and flavanone, each kind more than 10 of terpenoid also have multivitamin, polysaccharose substance etc.
Human understanding and the existing long history of application to propolis.In ancient Egypt, Pharaoh's corpse exactly with propolis and some other medical herbs mix be coated with anticorrosion, all have a large amount of use propolis to cure the record of wounds and burn in ancient Greek, kingdom of ancient Roman, former Soviet Union's patriotic war and World War II.Until 20th century, people just draw attention to the pharmacological action and the chemical constituent of propolis, especially since the seventies, the research of propolis have been obtained major progress, show that it has many-sided pharmacological action and potential applicability in clinical practice widely.
Pharmaceutical research finds that propolis has multiple biological agent, as antibiotic, antiinflammatory, antiviral, pain relieving, anesthesia, promotion tissue regeneration, antitumor, antioxidation, antiulcer, influence metabolism, improve cardiovascular function etc.Find that from clinical observation propolis has dispeiling pathogenic wind and removing dampness, granulation promoting pain relieving, removing toxic substances and promoting subsidence of swelling, warming the meridian and activating blood circulation, moistens effects such as antipruritic.
The external bee glue preparation is mainly used in inhibition, kill bacteria, fungus and antiviral.On the market there be existing external bee glue preparation: tincture, cream, ointment.Tincture since with ethanol as solvent, skin mucosa and wound are stimulated bigger, the patient often is difficult to bear.Used propolis is a water-soluble bee glue liquid in cream and the ointment, because the most of medicinal ingredients in the propolis do not dissolve in water.Therefore the medicinal component content in the relative water-soluble bee glue is also lower; Secondly, perishable, the easy evaporation of water-soluble bee glue, easily precipitate, be difficult for long-term storage; Once more, cream in use pollutes patient's medicated clothing easily, and the patient is pestered beyond endurance.
China and foreign countries' patent of the external preparation that share about propolis and other compositions mainly contains: Chinese patent application 94112075.9,91102224.4, Chinese patent 98807944.5; United States Patent (USP): US 5977176, US 5576005, and US 5561116.
Disclose a kind of propolis cream that is used for the treatment of dermatitis in Chinese patent application 94112075.9, its Main Ingredients and Appearance is Cera Flava and water-soluble bee glue.Be used for the treatment of acne, chap, chilblain and brown patch.Used propolis is got its water-soluble components.Because the main medicinal component flavone compound in the propolis, terpenoid, aromatic acid etc. are all insoluble in water, thereby antibiotic, antiviral effect is not as ethanol extract.
A kind of therapeutic combination that contains phenol composition and propolis is disclosed in Chinese patent application 91102224.4.The weight ratio of its two kinds of compositions is 100/1-650/1.Be used for the treatment of the disease that causes by lipid-coated virus.
In Chinese patent 98807944.5, disclose the compositions that contains propolis and at least a essential oil, be used for virus, antibacterial and fungal infection.
In U.S. Pat 5576005, disclose a kind of propolis and salicylic compositions of containing, be used for the treatment of wart.It consists of: 60-70% propolis alcoholic solution; The 15-20% salicylic acid, with 15-20%Aquaphor as carrier.
Disclose a kind of propolis and salicylic acid of containing in U.S. Pat 5977176, perhaps the compositions of propolis and 17-hydroxy-11-dehydrocorticosterone is used for the treatment of wart and herpesvirus.
Disclose a kind of water dispersible solid that contains propolis in U.S. Pat 5561116, its preparation method is that the propolis composition with water soluble organic solvent extraction mixes with at least a anhydrousugar and cyclodextrin and sloughs moisture content, obtains solid mixture.
Still lack at present and both preserved the whole active component of propolis, again the external preparation that can be used for the treatment of genitals bleb disease that skin is had no stimulation.
Summary of the invention:
Technical problem to be solved by this invention is to overcome existing bee glue preparation to Mucocutaneous stimulation problem, provide a kind of with low cost, therapeutic effect is remarkable, preparation stabilization, and to skin with wound has no stimulation and the external propolis liniment of sense of discomfort.
The externally-applied liniment weight portion of propolis-containing disclosed by the invention consists of:
Propolis cream 5---25 parts
Ethanol 3---30 parts
Multi-alcohol 5---70 parts
High fatty alcohol 1---10 parts
Dimethyl sulfoxine 5---30 parts
Wherein propolis cream is that propolis is fine ground, extracts with alcohol heating reflux, filter, and merging filtrate, centrifugal, concentrate the back and obtain.
Ethanol is the solvent of dissolving propolis in the present invention's prescription; Multi-alcohol is a wetting agent, can select one or more ethylene glycol, propylene glycol, glycerol, sorbitol, Polyethylene Glycol for use; High fatty alcohol is a synergist, can select one or more C for use
22-C
28The monobasic high fatty alcohol; Dimethyl sulfoxine is a transdermal agent.
Used ethanol, multi-alcohol, dimethyl sulfoxine in the present invention's prescription when they use with high concentration separately, all has stimulation to skin, but when they use with low concentration, then skin had no stimulation.Pharmacological testing also confirms when these compositions mix use with certain proportion, skin is not had stimulation.Because the dissolubility of propolis cream in ethanol be bigger, do not use ethanol can't make preparation form the mixture of homogeneous, but the concentration of alcohol increase will cause the stimulation of preparation to skin, so alcoholic acid content must be controlled at below 30% in the preparation of the present invention.Use simultaneously dimethyl sulfoxine as transdermal agent in the preparation, high fatty alcohol is as synergist, and antibiotic, antivirus action is significantly increased.
Another technical problem to be solved by this invention is to disclose the preparation method of the externally-applied liniment of above-mentioned propolis-containing.
The preparation of the externally-applied liniment of propolis-containing disclosed by the invention comprises the steps:
(1) propolis cream preparation
Propolis is fine ground, extract secondary with alcohol heating reflux, filter, merging filtrate, centrifugal, centrifugal liquid is concentrated into the thick paste shape;
(2) liniment preparation
Measure propolis cream by prescription, add dissolve with ethanol, add multi-alcohol, high fatty alcohol and dimethyl sulfoxine then, stir promptly.
With propolis-containing liniment of the present invention, carry out skin irritation test and hypersensitive test, result's demonstration has no stimulation and anaphylaxis to skin.Concrete test is as follows:
1. skin irritation test
(1). test material
A. animal: the adult healthy rabbit, about body weight 2kg, tried preceding 24 hours of thing tame rabbit back spinal column diamond wool is taken off with giving, the depilation area is about body surface area 10% (about 50 square centimeters of every side).
B. tried thing: the propolis liniment.
C. other materials: shears, depilatory cream, pan paper, gauze, knife blade (all disinfecting).
(2). test method
A. single-dose: select 4 rabbit for use, tried thing district and check plot (depilation back), the disposable thing 1ml that will be tried is applied to and is tried the thing district, and blank solvent then is applied to the check plot, and pan paper and gauze are fixed with sterilizing.Remove residual thing and the blank solvent tried with warm water after 24 hours.Removal is tried behind the thing to observe in 1,24,48 and 72 hour smears the position and has or not situations such as erythema and edema, and the recovery situation of above-mentioned variation and time.The irritation test of damaged skin: other gets 4 rabbit, after the depilation, after both sides skin carried out disinfection, makes the well word with the knife blade of sterilizing and cuts off skin, long 3～the 5cm of the edge of a knife, the edge of a knife is 1.0～1.7cm at interval, the degree of being with the oozing of blood, one side coating, in addition side in contrast, criterion is the same.
B. multiple dosing: repeatedly give and tried the thing test and smear once then general every day, a continuous week, all the other all with once give the method for being tried thing consistent with requirement.
(3). the result judges and estimates
Grouping score value skin irritation intensity evaluation
The single intact skin is tried thing group 0 nonirritant
Single intact skin blank group 0 nonirritant
The single damaged skin is tried thing group 0 nonirritant
Single damaged skin blank group 0 nonirritant
Repeatedly intact skin is tried thing group 0 nonirritant
Intact skin blank group 0.25 nonirritant repeatedly
Repeatedly damaged skin is tried thing group 0.25 nonirritant
Damaged skin blank group 0.25 nonirritant repeatedly
(4). conclusion
Animal skin irritation test result shows that this product do not have skin irritation.
2. skin anaphylactic test
(1). test material
A. animal: select Cavia porcellus male and female half and half, body weight is at 250～300g, tried preceding 24 hours of thing the guinea pig back diamond wool is taken off about 3 * 3 square centimeters of the unhairing district every side of scope with giving.
B. tried thing: the propolis liniment.
C. positive sensitizer: 2,1% the sensitization concentration that 4-dinitro fluorobenzene is made and 0.1% excite concentration.
D. other materials: shears, depilatory cream
(2). test method
A. test grouping: Cavia porcellus is divided into three groups at random by the body weight sex, and 10 every group (male and female half and half) are given for first group and are tried thing, second group of blank (giving blank solvent), the 3rd group of positive thing contrast (giving positive sensitizer).
B. sensitization contact: get and tried thing 0.1ml and be coated in depilation district, animal left side, continue 6 hours, use warm water cleaning after 6 hours.The 7th day and the 14th day, repeat once with same method.Blank group and positive thing matched group method are the same.
C. excite contact: in last give tried thing sensitization after 14 days, to be tried thing 0.1ml and be applied to depilation district, guinea pig back right side, remove after 6 hours and tried thing, at once observe, observed the skin allergy situation then once more in 24,48,72 hours, blank and positive control method are all with being tried the thing group.
(3). the result judges and estimates
Divide group reaction meansigma methods sensitization rate sensitization intensity
Tried thing group 00 weak sensitizations
Blank group 30 weak sensitizations
Positive controls 0 100 is sensitization extremely
(4). conclusion
The result of skin anaphylactic test shows that this product do not have sensitization of skin.
The propolis liniment that the present invention makes has carried out 30 routine small sample clinical trials by the Shanghai hospitals of traditional Chinese and western medicine, is used for the treatment of genital herpes.Test confirms that this propolis liniment has significant therapeutical effect to genital herpes, and curative effect reaches 100%.Concrete test is as follows:
1. physical data:
30 routine genital herpes patients all are effective case.Male's 24 examples, women's 6 examples; 20～71 years old age, average 37.5 ± 11.2 years old; The course of disease 1 hour～48 hours, average 20.1 ± 14.1 hours; 20～29 years old 7 example (23.3%) wherein, 30～39 years old 11 example (36.7%), 40～49 years old 7 example (23.3%), 50～59 years old 4 example (13.3%),＞60 years old 1 example (3.3%).
First morbidity example 18 examples (60.0%), recurrent cases 12 examples (40.0%); Betide 4 examples of foreskin, glans penis 5 examples, coronary sulcus 7 examples, body of penis 8 examples, big nympha 5 examples, groin 1 example.
2 treatment and observational techniques
2.1 drug application and medication:
Medicine for treatment propolis liniment is provided by Shanghai Xinya Pharmaceutical Industry Minhang Co., Ltd..Medication: clean affected part with warm water earlier before using, partial points is coated with medicinal liquid then, treats that it absorbs naturally.Use every day 2 times, continuous 7 days was 1 course of treatment.
2.2 observation item and evaluation index: each participant specifies specialist respectively to observe the patient 1 time in the 3rd day, 5 days, 7 days and 10 days before medication and after the medication, and content comprises dermoreaction, subjective symptoms and untoward reaction etc.The situation of change of skin lesion scope after the record patient medication, vesicle quantity, erosion, redness, incrustation, decrustation situation, local pruritus, scorching hot, pain etc. and untoward reaction etc. have time of origin, persistent period, processing method and result etc. after untoward reaction person answers recording medicine.
The symptom score standard:
(1) subjective symptom: divide pain, scorching hot, pruritus, with 4 grades of point system scorings.0=is asymptomatic; The symptom of the indistinct sensation of 1=; The feeling symptom of 2=idol, but do not influence work, sleep; The symptom that 3=feels often influences work, sleep.
(2) nbjective symptom: divide vesicle number of clusters, erosion, redness, with 4 grades of point system scorings.1. vesicle a small bundle of straw, etc. for silkworms to spin cocoons on number: 0=does not have vesicle; 1=1 bunch; 2=2 bunch; 3=3 bunch.2. rotten to the corn: 0=does not have erosion; 1=is light, accounts for skin lesion area≤25%; Among the 2=, account for skin lesion area 26%～74%; 3=is heavy, accounts for skin lesion area 〉=75%.3. red and swollen: 0=does not have redness; 1=is light, the little red pneumonedema of color; Among the 2=, color is redder, and is little swollen; 3=is heavy, and color is scarlet, obviously swelling.
(3) the recording start incrustation time (my god) and the decrustation time (my god).
2.3 therapeutic evaluation standard: according to the total mark of subjective symptom before the medication and nbjective symptom, respectively with medication after the 3rd, 5,7,10 day total mark compare respectively, calculate therapeutic index.
Total mark * 100% before therapeutic index=(total mark before the treatment-treatment back total mark)/treatment.
2.4 curative effect judging standard:
With recovery from illness, produce effects, effective, invalid 4 grades of evaluations.Recovery from illness: therapeutic index 〉=90%; Produce effects: therapeutic index 60～89%; Effectively: therapeutic index 21～59%; Invalid: therapeutic index≤20%.
The two adds up to recovery from illness and produce effects effectively, calculates effective percentage in view of the above.
2.5 data analysis and statistical disposition: this paper does not establish matched group.Because the data of observing is ranked data, so adopt RIDIT to analyze.
3 results
3.1 clinical efficacy: treat genital herpes 30 examples altogether, general comment is divided into 13.0 ± 3.8 before the treatment.The medication natural law is the shortest 5 days, and is the longest 10 days, average 7.6 ± 1.3 days.Its clinical evaluation sees following table for details.The 3rd day effective percentage is that 53.3%, the 5 day effective percentage is that 96.7%, the 7 day effective percentage promptly reaches 100%.In table: analyzed through RIDIT with the 5th day result with the 3rd day, the 7th day in the 5th day, P all＜0.01, difference all has highly significant; And compared with the 7th day in the 10th day, P＞0.05, difference does not have significance.
Table 1 propolis liniment treated genital herpes clinical efficacy
The 3rd day (a) the 5th day (b) the 7th day (c) the 10th day (d)
Be almost recovered 0/30 (0%) 6/30 (20%) 23/30 (76.7%) 28/30 (93.3%)
Produce effects 16/30 (53.3%) 23/30 (76.7%) 7/30 (23.3%) 2/30 (6.7%)
Take a turn for the better 13/30 (43.3%) 1/30 (3.3%) 0/30 (0%) 0/30 (0%)
Invalid 1/30 (3.3%) 0/30 (0%) 0/30 (0%) 0/30 (0%)
(ab)u＝3.75，P＜0.01；(bc)u＝3.98，P＜0.01；(cd)u＝1.15，P＞0.05
3.2 incrustation and decrustation situation: the incrustation time is the shortest 2 days, and is the longest 5 days, and average 3.3 ± 1.0 days, the decrustation time was the shortest 3 days, and is the longest 9 days, average 5.6 ± 1.3 days.
3.3 untoward reaction and safety: do not have 1 example the 30 routine genital herpes patients that observe and whole body and local untoward reaction occur, promptly adverse reaction rate is 0.Safety reflects good 11 examples (36.7%), good 19 examples (63.3%).
Above-mentioned clinical test results proves preparation safety of the present invention, does not have any stimulation, is particularly useful for making the medicine of treatment genital herpes.
The specific embodiment:
Embodiment 1: propolis is fine ground, extract secondary with alcohol heating reflux, and filter, merging filtrate, centrifugal, centrifugal liquid is concentrated into the thick paste shape, gets propolis cream.Take by weighing 10 parts of propolis cream by weight percentage with 15 parts of dissolve with ethanols, add 35 parts of propylene glycol, 25 parts of PEG400s, 5 parts of docosanols, 10 parts of dimethyl sulfoxines, stir, make liniment.
Embodiment 2: operational approach is pressed column weight amount share and is taken by weighing each component with embodiment 1:
30 parts of 25 parts of ethanol of propolis cream
20 parts of 24 parts of dimethyl sulfoxines of glycerol
1 part of octacosanol
Embodiment 3: operational approach is pressed column weight amount share and is taken by weighing each component with embodiment 1:
3 parts of 5 parts of ethanol of propolis cream
10 parts of 35 parts of docosanols of ethylene glycol
12 parts of 35 parts of dimethyl sulfoxines of PEG400
Embodiment 4: operational approach is pressed column weight amount share and is taken by weighing each component with embodiment 1:
25 parts of 18 parts of ethanol of propolis cream
9 parts of 30 parts of hexacosyl alcohols of ethylene glycol
5 parts of 13 parts of dimethyl sulfoxines of sorbitol
Claims (6)
1, a kind of externally-applied liniment of propolis-containing is characterized in that the weight portion of said preparation consists of: propolis cream 5-25 part, ethanol 3-30 part, multi-alcohol 5-70 part, high fatty alcohol 1-10 part, dimethyl sulfoxine 5-30 part.
2, externally-applied liniment according to claim 1 is characterized in that wherein said propolis cream is that propolis is fine ground, extracts with alcohol heating reflux, filter, and merging filtrate, centrifugal, concentrate the back and obtain.
3, externally-applied liniment according to claim 1 is characterized in that wherein said multi-alcohol is selected from one or more ethylene glycol, propylene glycol, glycerol, sorbitol, Polyethylene Glycol.
4, externally-applied liniment according to claim 1 is characterized in that wherein said high fatty alcohol is selected from one or more C
22-C
28The monobasic high fatty alcohol.
5, the preparation method of externally-applied liniment according to claim 1 is characterized in that said preparation comprises the steps:
(1) propolis cream preparation
Propolis is fine ground, extract secondary with alcohol heating reflux, filter, merging filtrate, centrifugal, centrifugal liquid is concentrated into the thick paste shape;
(2) liniment preparation
Measure propolis cream by prescription, add dissolve with ethanol, add multi-alcohol, high fatty alcohol and dimethyl sulfoxine then, stir promptly.
6, the application of propolis-containing externally-applied liniment according to claim 1 in preparation treatment genital herpes medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2003101089550A CN1621045A (en) | 2003-11-28 | 2003-11-28 | Externally applied liniment containing propolis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2003101089550A CN1621045A (en) | 2003-11-28 | 2003-11-28 | Externally applied liniment containing propolis |
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| Publication Number | Publication Date |
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| CN1621045A true CN1621045A (en) | 2005-06-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2003101089550A Pending CN1621045A (en) | 2003-11-28 | 2003-11-28 | Externally applied liniment containing propolis |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101095895B (en) * | 2007-07-06 | 2010-06-30 | 韦建学 | Externally-used medicament for the sanitation and health-care of female vagina and for treating gynecology vagina diseases and method for making the same |
| CN102366426A (en) * | 2011-10-26 | 2012-03-07 | 江苏江大源生态生物科技有限公司 | Propolis tincture for external use and preparation method thereof |
| GB2518826A (en) * | 2013-09-27 | 2015-04-08 | Thanasis Athanasiou | Composition |
-
2003
- 2003-11-28 CN CNA2003101089550A patent/CN1621045A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101095895B (en) * | 2007-07-06 | 2010-06-30 | 韦建学 | Externally-used medicament for the sanitation and health-care of female vagina and for treating gynecology vagina diseases and method for making the same |
| CN102366426A (en) * | 2011-10-26 | 2012-03-07 | 江苏江大源生态生物科技有限公司 | Propolis tincture for external use and preparation method thereof |
| GB2518826A (en) * | 2013-09-27 | 2015-04-08 | Thanasis Athanasiou | Composition |
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