CN1562218A - Medication combination of compound tea tree oil for preventing or curing inflammation of human genital tract - Google Patents
Medication combination of compound tea tree oil for preventing or curing inflammation of human genital tract Download PDFInfo
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Abstract
A medicinal tea tree oil composition in the form of spray, aerosol, cream, supporsitory, liniment, ointment, oil etc for preventing and treating the inflammation in reproductive tract is prepared from tea tree oil, the extracted alkaloid of flavescent sophora root, foxtail-like sophora herb, coptis root, phellodendron bark, or tinctorial fibraurea, and pharmacologically acceptable solvent or auxiliary.
Description
Technical field: the pharmaceutical composition that the present invention relates to be applied to prevent or treat human reproduction road inflammation.
Background technology: Camellia sinensis is Myrtaceae (Myrtaceae) paperbark Melaleuca Alternifolia (Melaleucaalternifolia), or loose flower Cortex Melaleucae leucadendrae (Melaleuca dissiliflora) or wheel blade Cortex Melaleucae leucadendrae (Melaleucalinariifolia) or New Zealand Camellia sinensis Manuka (Leptospermum scoparium) or Kanuka (Kunzeaericoides), originate in New South Wales, Australia, local original inhabitants just adopt leaf of tea tree and twig to smash diseases such as back treatment knife injury, mosquito bite, burn and scald to pieces before the centuries.When the silent service Captain Cook arrived Australia seashore in 1770, be subjected to local original inhabitants' influence, boil scented tea with its leaf, thereby, the Camellia sinensis of gaining the name (teatree).The tea tree oil of general indication is the quintessence oil that adopts steam distillation to extract from leaf of tea tree and twig.
Last century the '20s, people just begin to extract, use tea tree ethereal oil (essential oil of teatree) with steam distillation from leaf of tea tree and twig, are called for short tea tree oil (teatree oil or melaleuca oil).To late nineteen nineties, formed a complete tea tree oil industrial chain of producing personal care product, medical supplies or the like from tea tree planting, quintessence oil in Australia, tea tree oil output reaches kiloton, and the product major part exports to North America and Europe, and portioned product has obtained the authentication of FDA.
Data shows that tea tree oil has antibacterium, antifungal, antiviral, immunoregulatory activity widely, and toxicologic study proof tea tree oil has very high safety, and human body skin is not had zest.The tea tree oil product is widely used in Personal hygiene, nursing field as acne, acne, herpes zoster, burn and scald, mosquito bite, oily skin, eczema, tinea corporis, tinea pedis, muscle arthralgia, wound sterilization etc., genitourinary system, as the health care and the respiratory system disease of bacillary, colpitis mycotica, pruritus vulvae etc., as flu, influenza, asthma, tracheitis, sinusitis, tuberculosis, daytime cough, the prevention of chickenpox etc. and pet nursing etc.
The chemical composition of tea tree oil is more clearly now, contains more than 100 kind of chemical compound altogether, and the structure of wherein nearly 80 kinds of chemical compounds is confirmed, thinks that main effective ingredient is (Terpinen-4-ol, CAS No.2438-10-0, MolecularFormula:C
10H
18O).Tea tree oil international standard ISO 4730 (front page 1996-11-15) requires terpinenol-4 content must not be lower than 30%, and cineole (1,8-Cineole, CAS No.470-82-6, Molecular Formula:C
10H
18O) content must not be higher than 15%.
In United States Patent (USP), having many is the patent documentation report of active component with the tea tree oil, main use of flaccid muscles, pain relieving is arranged, hidroschesis, gingivitis, skin pruritus, redness, eczema, sterilization, burn and scald, herbicide, deodorizer, preventing cold, influenza, respiratory tract infection etc., in Chinese patent, there is tea tree oil to be applied to the bibliographical information of aspects such as oral disease, antiseptic, acne.
Radix Sophorae Flavescentis is the dry root of leguminous plant Radix Sophorae Flavescentis (Sophora flavescens Ait.), main chemical compositions contains multiple alkaloid, matrine (Matrine) is arranged, oxymatrine (Oxymatrine), sophor-anol (Sophoranol), N-Methylcytisine (N-Methylcytisine), Anagyrine (Anagyrine), baptifoline (Baptifoline), dehydrogenation matrine (sophocarpine Sophocarpine) etc., has heat clearing and damp drying, parasite killing, the diuresis effect is used for hematodiarrhoea clinically, have blood in stool, the jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, diseases such as trichomonal vaginitis.
Herba Sophorae alopecuroidis (Sophora alopecuraides L.) is a cassia leguminous plant, has another name called Radix Sophorae Alopecuroidis, Herba Astragali Melilotoidis, Sophora Alopecuroides L..Medicinal, rhizome, herb and seed, bitter in the mouth is cold in nature, and heat-clearing and toxic substances removing is arranged, wind dispelling dampness, effects such as pain relieving parasite killing.Discovering in recent years, the Herba Sophorae alopecuroidis main chemical compositions is an alkaloid, as sophocarpine (Sophocarpine), matrine (Matrine), oxymatrine (Oxymatrine), sophoridine (sophoridine), sophoramine (sophoramine), aloperine (aloperine), eulexine (cytisine), N-Methylcytisine (N-Methylcytisine) etc.
Rhizoma Coptidis is the dry rhizome of ranunculaceae plant Rhizoma Coptidis (Coptis chinensis Franch), Coptis deltoidea C.Y.Cheng et Hsiao (Coptis deltoideaC.Y.Cheng et Hsiao) or Coptis Teeta Wall (Coptis teeta Wall.), and the three is commonly called as " flavor connects ", " refined company ", " Coptis Teeta Wall " respectively.Its main chemical compositions is multiple alkaloid, comprise berberine (berberine), coptisine (coptisine), 13-methyl-.psi.-coptisine. (worenine), fibrauretin ((palmatine), jateorhizine (jatrorrhizine) and epiberberine (epiberberine) etc., main pharmacological research report is a research emphasis with the berberine, have antibiotic widely, anti-inflammatory activity, be applied to treat aspects such as dysentery, acute gastroenteritis, chronic diarrhea, respiratory tract infection, the wet disease of baby clinically.
Cortex Phellodendri is the bark of wampee (Phellodendron chinense Schneid.), or the dry bark of rutaceae Cortex Phellodendri (Phellodendron amurense Rupr.), the former practises title " Cortex Phellodendri ", the latter practises title " Cortex Phellodendri ", main contain little Pi's alkali, and contain fibrauretin (palmatine), jateorhizine (jatrorrhizine), phellodendrine (phellodendrine), Caulis menispermi and appoint alkali (menisperine), white bridge alkali (candicine), Cortex Phellodendri paulownia (obacunone) etc.The Cortex Phellodendri antibiotic effective ingredient is a berberine, thus its pharmacological action and Rhizoma Coptidis broadly similar, cure mainly damp and hot due to disease such as dysentery, jaundice.
Caulis Fibraureae is the dry rattan of Menispermaceae (Menispermaceae) plant Herba Aristolochiae (Fibraurea recisa Pierre), fibrauretin (palmatine) is its main effective ingredient, have antipyretic and antidote functions, clinical practice is in diseases such as gynecological inflammation, bacillary dysentery, enteritis, respiratory tract, urinary tract and surgical infections.
Summary of the invention: it is the like product of main active that the present invention obviously is different from the chemosynthesis disinfectant, it is antibacterial to have broad-spectrum, bactericidal activity, safety and low toxicity, main pathogenic bacterium are had no drug resistance, to human body appearance skin and tract mucosa nonirritant and sensitization, pathogenic bacterium to relevant disease have long suppression ratio and higher sterilizing rate, can put into practice according to clinical medicine, make medically acceptable several formulations form, washing liquid for example, liniment, spray, aerosol, cream, suppository, foam, disposable wet tissue or the like, both can be used for the prevention or the treatment of diseases such as urogenital tract infection, can be applicable to the cleaning-nursing of adult daily external genitalia official of men and women or sexual behaviour front and back again.
The compound recipe tea tree oil pharmaceutical composition that the present invention proposes, weight percent meter by volume, per unit dosage contains tea tree oil 0.10～5.0% (v/v), Radix Sophorae Flavescentis or Sophora alopecuroides alkaline extraction thing (in matrine) 0.05～2.0%, and surplus is medically acceptable solvent or adjuvant.Perhaps
Weight percent meter by volume, per unit dosage contains tea tree oil 0.10～5.0% (v/v), Rhizoma Coptidis or Cortex Phellodendri extract (in berberine) 0.05～2.0%, surplus is medically acceptable solvent or adjuvant.Perhaps
Weight percent meter by volume, per unit dosage contains tea tree oil 0.10～5.0% (v/v), Caulis Fibraureae alkaloid extract (in fibrauretin) 0.05～2.0%, surplus is medically acceptable solvent or adjuvant.
Above-mentioned tea tree oil adopts Myrtaceae paperbark Melaleuca Alternifolia, or the quintessence oil of the leaves of loose flower Cortex Melaleucae leucadendrae or wheel blade Cortex Melaleucae leucadendrae or New Zealand's Camellia sinensis and twig extraction.
The above tea tree oil can be that conventional steam distillation extracts, or the extraction of solvent soaking method, as: soak with ethanol extraction method, or carbon dioxide supercritical extraction method.
Above-mentioned Radix Sophorae Flavescentis alkaloid extract is total alkaloids or the purification matrine that leguminous plant Radix Sophorae Flavescentis dry root extracts, or the total alkaloids or the purification matrine of the extraction of leguminous plant Herba Sophorae alopecuroidis rhizome.
Above-mentioned Rhizoma Coptidis alkaloid extract is biology total alkali or the purifying biological alkali from the dry rhizome extraction of cohosh Rhizoma Coptidis or Coptis deltoidea C.Y.Cheng et Hsiao or Coptis Teeta Wall, or the biology total alkali or the purifying biological alkali of the dry bark extraction of rutaceae wampee or Cortex Phellodendri.
Above-mentioned Caulis Fibraureae alkaloid extract is biology total alkali or the purification fibrauretin from the dry rattan extraction of menispermaceous plants Herba Aristolochiae.
Aforementioned pharmaceutical compositions is made pharmaceutically acceptable dosage form, as: spray, aerosol, cream, suppository, liniment, unguentum, oil preparation, disposable wet tissue.
Following length just the present invention elaborates
Microorganism fungus kind is used in test: escherichia coli (Escherichia coli ATCC 8099), staphylococcus aureus (Staphylococcus aureus ATCC 6538), Candida albicans (Candida albicans ATCC 10231), Pseudomonas aeruginosa (Pseudomonas aeruginosa ATCC 15442).
Test method:
(1) minimal inhibitory concentration is measured--MIC:(nutrient broth dilution method)
In culture medium, by bacterial growth whether inoculated bacteria then, determines that sample suppresses to be tried the Cmin (MIC) of bacteria growing with variable concentrations disinfecting liquid mixed dissolution.
Test procedure:
1) preparation bacterial suspension;
2) sample is done the test solution that is subjected to that times serial dilution is become variable concentrations with distilled water, respectively get 2.5ml and added in the culture medium test tube of the double concentration of 2.5ml by test solution;
3) add in the culture medium test tube of the double concentration of 2.5ml (solvent control) with the solvent 2.5ml that does not contain sample;
4) get 0.1ml and contain 10
8The bacterial suspension of cfu/ml is inoculated in the above test tube, as the test group sample;
5) get 0.1ml and contain 10
8The bacterial suspension of cfu/ml is inoculated in the test tube that does not contain disinfecting liquid, as positive control;
6) get 0.1ml and contain 10
8The bacterial suspension of cfu/ml is inoculated in the solvent control test tube, as solvent control;
7) get 2 culture medium as negative control;
8) sample sets, matched group are positioned over 37 ℃ of cultivations, observed result after 48 hours.
Pass judgment on rule:
The positive control bacterial growth, the negative control antibacterial does not grow, test group does not have the pairing disinfecting liquid concentration of high dilution of bacterial growth, for this sample to being tried the MIC of bacterium.
(2) immersion test
Sample and control fabric are put into the triangle culture bottle respectively, be inoculated on sample and the control fabric with the test organisms liquid that contains culture medium, through cultivating, the antibacterial before and after will cultivating respectively on the sample washes, measure bacterial number, can calculate the percentage rate that antibacterial reduces on the sample.This method is used in the fabric of leachability.
The preparation of sample:
The circular specimen and the control fabric of cutting diameter 5cm are some, get some parts of samples and control fabric and are loaded on triangular flask respectively, build bottleneck, and 121 ℃ of 15min sterilizations are standby.Fabric is selected non-woven fabrics for use.
Mix with double culture medium and equal-volume sample solution, get 1ml and be added drop-wise on the aseptic fabric, dry back is available.
Test procedure:
1) get respectively on the fabric that the 1ml bacteria suspension is added in 3 triangular flasks, uniform distribution, and do not stay residual liquid, seal vaporization prevention;
2) in the triangular flask of 1 sample and control fabric, add 50ml 0.03M PBS respectively, acutely rock 1 minute washing antibacterial, get 1ml and do 10 times of serial dilutions, and the inoculated and cultured ware, as the bacterial population on " 0 " sample time of contact and the control fabric;
3) the negative control sample is not inoculated bacteria suspension, and add 50ml PBS " 0 " time of contact, acutely rocks the inoculated and cultured ware 1 minute;
4) positive control is got the triangular flask that fabric is housed, and inoculation 1ml bacteria suspension was cultivated 20 ± 2 hours for 37 ℃, added 50ml PBS, acutely rocked 1 minute, got 1ml and did 10 times of serial dilutions, inoculated and cultured ware;
5) test group is got the triangular flask that sample and fabric are housed, and inoculation 1ml bacteria suspension was cultivated 20 ± 2 hours for 37 ℃, added 50ml PBS, acutely rocked 1 minute, got 1ml and did 10 times of serial dilutions, inoculated and cultured ware;
6) each group culture dish is put into 37 ℃ of incubators, cultivate counting after 48 hours;
7) the parallel repetition of test is 3 times.
The result calculates:
Bacteriostasis rate (%)=[(B or C or (B+C/2))-A]/(B or C or (B+C/2)) * 100
A: test group bacterial population B: " 0 " sample time of contact bacterial population
C: " 0 " control fabric time of contact bacterial population
Annotate: B, C difference are bigger, get big; B, C are more or less the same, and are averaged.
Pass judgment on rule: 1) bacterium colony of " 0 " matched group time of contact should be at 1000～5000cfu/ml; 2) negative control should not have bacterial growth, and positive control should be obviously more than " 0 " clump count time of contact; 3) bacteriostasis rate of each time test all 〉=50% can confirm that this print has bacteriostasis.
(3) antibacterial ring test
Disinfecting liquid forms Concentraton gradient through agar diffusion, to show its bacteriostasis.This method is applicable to soluble products.
Test procedure:
1) preparation of bacteria inhibition tablet: the filter paper of getting aseptic, dry diameter 5mm * 5mm.Every drips actual working concentration disinfecting liquid 20ul, lies against then in the sterile petri dish, and 37 ℃ or drying at room temperature are standby.
2) negative control sheet preparation: operate the samely, dropping sterile distilled water 20ul lies against in the sterile petri dish then, and 37 ℃ or drying at room temperature are standby.
3) solvent control sheet preparation: operate the samely, drip aseptic solvent 20ul, lie against then in the sterile petri dish, 37 ℃ or drying at room temperature are standby.
4) inoculation: dip in 5 * 10 with aseptic cotton swab
5Cfu/ml～5 * 10
6Cfu/ml bacterium liquid is smeared 3 times on the agar culture medium surface, changes 60 degree at every turn, smears a week around plate edge at last, and drying at room temperature is 5 minutes then;
5) print pastes and puts: each flat board is put 4 test films, 1 negative control sheet.Each sheet center is at a distance of 25mm, with the edge at a distance of 15mm, gently press print, make it to be adjacent to, 37 ℃, cultivated 16～18 hours, with the diameter of vernier caliper measurement ring.
Pass judgment on rule:
1) negative control does not have antibacterial ring, otherwise invalid;
2) inhibition zone diameter is greater than 7mm, for effectively;
3) 3 repeated trials all have the bacteriostasis result, for qualified.
(4) carrier soaks quantitative disinfecting test
Test procedure:
1) make bacteria suspension, concentration is 1 * 10
8～5 * 10
8Cfu/ml;
2) make the bacterium sheet, the clean aseptic filter paper sheet of 10mm*10mm, every drips 10ul new system bacteria suspension, standby after 30 minutes in 37 ℃ of placements;
3) carrier soaks quantitative disinfecting test:
Get aseptic plate,, add disinfectant solution by the amount of every bacterium sheet 5ml;
Under 20 ± 1 ℃, place 5min, put into 3 bacterium sheets that prepare respectively;
The bacterium sheet moves on to respectively in the nertralizer (culture medium) that contains 5.0ml during respectively with liquid effects 10min, 20min and 30min, fully vibrates and places more than the 5min, gets 200ul inoculation plate; Replace disinfectant solution with culture medium in addition, repeat above step as positive control;
Above plate was all cultivated 48 hours in 37 ℃ of incubators.
4) logarithm value is killed in calculating.
Kill logarithm value=matched group viable count (cfu/ sheet) logarithm value-test group viable count logarithm value.
Decision rule as a result:
1. in minimum activity of product and minimum action time, repeat 3 times, what carrier soaked quantitative disinfecting test kills logarithm value all 〉=3.00;
2. when minimum activity of product and minimum action time 1.5 times, what carrier soaked quantitative disinfecting test kills logarithm value all 〉=3.00;
3. when minimum activity of product and minimum action time 0.5 times, carrier soaks the quantitative disinfecting test tolerable to occurring defective result in different bacterium or the part repeated trials;
4. kill logarithm value greater than 5.00 o'clock, be expressed as 〉=5.00; Less than 5.00 o'clock, should list concrete numeral.
Specific embodiment:
Embodiment 1: contain 0.25% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 2.8 gram 90% Radix Sophorae Flavescentis total alkaloidss (in matrine), two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 1.25 milliliters of tea tree oil, 1.25 milliliter Tween 80, two merging, the concussion mix homogeneously, the Radix Sophorae Flavescentis total alkaloids solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain faint yellow emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 0.25% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray sample preparation.
Embodiment 2: contain 0.5% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 2.8 gram 90% Radix Sophorae Flavescentis total alkaloidss (in matrine), two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with acetic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 2.5 milliliters of tea tree oil, 2.5 milliliter Tween 80, two merging, the concussion mix homogeneously, the Radix Sophorae Flavescentis total alkaloids solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain faint yellow emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 0.5% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray sample preparation.
Embodiment 3: contain 1.0% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 2.8 gram 90% Radix Sophorae Flavescentis total alkaloidss (in matrine), two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with boric acid regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the Radix Sophorae Flavescentis total alkaloids solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain faint yellow emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 1.0% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray sample preparation.
Embodiment 4: contain 1.0% tea tree oil, 0.5% matrine compound recipe tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 2.5 gram matrines, two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the matrine solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 1.0% tea tree oil, 0.5% matrine compound recipe tea tree oil spray sample preparation.
Embodiment 5: contain 2.0% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 2.8 gram 90% Radix Sophorae Flavescentis total alkaloidss (in matrine), two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with citric acid regulating solution pH value to 5.0～6.0, stand-by; Measure 10 milliliters of tea tree oil, 10 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the Radix Sophorae Flavescentis total alkaloids solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain milky emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 2.0% tea tree oil, 0.5% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray sample preparation.
Embodiment 6: contain 5.0% tea tree oil, 0.1% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 0.6 gram 90% Radix Sophorae Flavescentis total alkaloids (in matrine), two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with citric acid regulating solution pH value to 5.0～6.0, stand-by; Measure 25 milliliters of tea tree oil, 15 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the Radix Sophorae Flavescentis total alkaloids solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain milky emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 5.0% tea tree oil, 0.1% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray sample preparation.
Embodiment 7: contain 1.0% tea tree oil, 0.25% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 1.4 gram 90% Radix Sophorae Flavescentis total alkaloidss (in matrine), two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, 0.5 the milliliter Oleum menthae, three merging, concussion mix homogeneously, the Radix Sophorae Flavescentis total alkaloids solution that slow adding has prepared, stirring and emulsifying is added pure water to 500 milliliter, obtains faint yellow emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 1.0% tea tree oil, 0.25% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil spray sample preparation.
Embodiment 8: contain 1.0% tea tree oil, 1.0% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil washing liquid
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 5.6 gram 90% Radix Sophorae Flavescentis total alkaloidss (in matrine), two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the Radix Sophorae Flavescentis total alkaloids solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain faint yellow emulsion, divide to install in 10 50 milliliters of screw socket bottle for handling liquid toilet or cosmetic substance, finish 10 50 milliliters of dresses and contain 1.0% tea tree oil, 0.25% Radix Sophorae Flavescentis total alkaloids compound extract tea tree oil washing liquid sample preparation.
Embodiment 9: contain 1.0% tea tree oil, 0.5% Rhizoma Coptidis total alkaloids compound extract tea tree oil washing liquid
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 2.8 grams, 90% Rhizoma Coptidis total alkaloids extract (in berberine), two merging add 400 milliliters of pure water, stirring and dissolving, obtain clear solution, with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the Rhizoma Coptidis total alkaloids extract solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain yellow emulsion, divide to install in 10 50 milliliters of screw socket bottle for handling liquid toilet or cosmetic substance, finish 10 50 milliliters of dresses and contain 1.0% tea tree oil, 0.5% Rhizoma Coptidis total alkaloids compound extract tea tree oil washing liquid sample preparation.
Embodiment 10: contain 2.0% tea tree oil, 0.5% Rhizoma Coptidis total alkaloids compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 2.8 grams, 90% Rhizoma Coptidis total alkaloids extract, two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 10 milliliters of tea tree oil, 10 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the Rhizoma Coptidis total alkaloids extract solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain yellow emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 2.0% tea tree oil, 0.5% Rhizoma Coptidis total alkaloids compound extract tea tree oil spray sample preparation.
Embodiment 11: contain 2.0% tea tree oil, 0.5% Cortex Phellodendri total flavones compound extract tea tree oil spray
At sterile working's laboratory, measure 50 milliliters of glycerol, take by weighing 2.8 grams, 90% Cortex Phellodendri total flavones extract, two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 10 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the Cortex Phellodendri total flavones extract solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain yellow emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 2.0% tea tree oil, 0.5% Cortex Phellodendri total flavones compound extract tea tree oil spray sample preparation.
Embodiment 12: contain 1.0% tea tree oil, 0.5% Caulis Fibraureae total alkali compound extract tea tree oil spray
At sterile working's laboratory, measure 50 milliliters of glycerol, take by weighing 2.8 grams, 90% Caulis Fibraureae total alkali extract (in fibrauretin), two merging add 400 milliliters of pure water, stirring and dissolving, obtain clear solution, with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 3 milliliters of Tween 80s, take by weighing Borneolum Syntheticum 0.5 gram, three merging, concussion mix homogeneously, the Caulis Fibraureae total alkali extract solution that slow adding has prepared, stirring and emulsifying is added pure water to 500 milliliter, obtains yellow emulsion, divide to install in 10 50 milliliters of screw socket spray bottles, finish 10 50 milliliters of dresses and contain 1.0% tea tree oil, 0.5% Caulis Fibraureae total alkali compound extract tea tree oil spray sample preparation.
Embodiment 13: contain 1.0% tea tree oil, 0.5% Caulis Fibraureae total alkali compound extract tea tree oil wet tissue
At sterile working's laboratory, measure 50 milliliters of glycerol, take by weighing 2.8 grams, 90% Caulis Fibraureae total alkali extract (in fibrauretin), two merging add 400 milliliters of pure water, stirring and dissolving, obtain clear solution, with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s take by weighing Borneolum Syntheticum 0.5 gram, three merging, the concussion mix homogeneously, the slow Caulis Fibraureae total alkali extract solution that prepared of adding, stirring and emulsifying is added pure water to 500 milliliter, obtain yellow emulsion, according to the technology that routine is produced wet sanitary napkins, 20 milliliters of emulsions that configure of each sheet filling are finished 25 mmic packages and are contained 1.0% tea tree oil, 0.5% Caulis Fibraureae total alkali compound extract tea tree oil wet tissue sample preparation.
Embodiment 14: contain 1.0% tea tree oil, 0.25% Radix Sophorae Flavescentis total alkaloids, 0.25% fibrauretin compound recipe tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 1.4 grams, 90% Radix Sophorae Flavescentis total alkaloids, take by weighing 1.25 gram fibrauretin, three merging add 400 milliliters of pure water, stirring and dissolving, obtain clear solution, with boric acid solution regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the alkaloid solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain yellow emulsion, divide to install in 5 100 milliliters of screw socket spray bottles, finish 5 100 milliliters of dresses and contain 1.0% tea tree oil, 0.25% Radix Sophorae Flavescentis total alkaloids, 0.25% fibrauretin compound recipe tea tree oil spray sample preparation.
Embodiment 15: contain 1.0% tea tree oil, 0.25% Radix Sophorae Flavescentis total alkaloids, 0.25% berberine compound recipe tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 1.4 grams, 90% Radix Sophorae Flavescentis total alkaloids, take by weighing 1.25 gram berberines, three merging add 400 milliliters of pure water, stirring and dissolving, obtain clear solution, with boric acid solution regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the alkaloid solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain yellow emulsion, divide to install in 5 100 milliliters of screw socket spray bottles, finish 5 100 milliliters of dresses and contain 1.0% tea tree oil, 0.25% Radix Sophorae Flavescentis total alkaloids, 0.25% berberine compound recipe tea tree oil spray sample preparation.
Embodiment 16: contain 1.0% tea tree oil, 0.25% fibrauretin, 0.25% berberine compound recipe tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 1.25 grams, 90% fibrauretin, take by weighing 1.25 gram berberines, three merging add 400 milliliters of pure water, stirring and dissolving, obtain clear solution, with boric acid solution regulator solution pH value to 5.0～6.0, stand-by; Measure 5 milliliters of tea tree oil, 5 milliliters of Tween 80s, two merging, the concussion mix homogeneously, the alkaloid solution that slow adding has prepared, stirring and emulsifying, add pure water to 500 milliliter, obtain yellow emulsion, divide to install in 5 100 milliliters of screw socket wash bottles, finish 5 100 milliliters of dresses and contain 1.0% tea tree oil, 0.25% fibrauretin, 0.25% berberine compound recipe tea tree oil washing liquid sample preparation.
Embodiment 17: contain 2.5% tea tree oil, 0.5% Sophora alopecuroides alkaline extraction thing compound recipe tea tree oil foam aerosol
At sterile working's laboratory, take by weighing 1.4 gram 90% Radix Sophorae Flavescentis or Sophora alopecuroides alkaline extraction things (in matrine), with the water of preparing in advance-1,2-propylene glycol-ethylene glycol (75: 10: 15) solution (lactic acid is regulated pH value to 4.5) dissolving, obtain clear solution, stand-by; Measure 25 milliliters of tea tree oil, use Tween 80-Arlacel-80 composite emulsifying, press oil phase-water-1: 3: 0.25 preparating liquid of emulsifying agent, with F12 is propellant (dichlorodifluoromethane), adopt pressure filling to fill propellant, finish 2.5% tea tree oil, 0.5% Sophora alopecuroides alkaline extraction thing compound recipe tea tree oil foam aerosol sample preparation.
Embodiment 18: contain 2.0% tea tree oil, 0.1% Sophora alopecuroides alkaline extraction thing compound recipe tea tree oil spray
At sterile working's laboratory, measure 50 milliliters of glycerol, take by weighing 0.56 gram, 90% Sophora alopecuroides alkaline extraction thing (in matrine), two merging add 400 milliliters of pure water, stirring and dissolving, obtain clear solution, with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 10 milliliters of tea tree oil, 5 milliliters of Tween 80s, 0.5 the milliliter Oleum menthae, three merging, concussion mix homogeneously, the Sophora alopecuroides alkaline extraction thing solution that slow adding has prepared, stirring and emulsifying is added pure water to 500 milliliter, obtains faint yellow emulsion, divide to install in 5 100 milliliters of screw socket spray bottles, finish 5 100 milliliters of dresses and contain 2.0% tea tree oil, 0.1% Sophora alopecuroides alkaline extraction thing compound recipe tea tree oil spray sample preparation.
Embodiment 19: contain 2.0% tea tree oil, 0.25% berberine compound extract tea tree oil spray
At sterile working's laboratory, measure 25 milliliters of glycerol, take by weighing 1.3 gram berberine hydrochloride, two merging add 400 milliliters of pure water, and stirring and dissolving obtains clear solution, and is with lactic acid regulator solution pH value to 5.0～6.0, stand-by; Measure 10 milliliters of tea tree oil, 5 milliliters of Tween 80s, 0.5 the milliliter Oleum menthae, three merging, concussion mix homogeneously, the berberine solution that slow adding has prepared, stirring and emulsifying is added pure water to 500 milliliter, obtains faint yellow emulsion, divide to install in 5 100 milliliters of screw socket spray bottles, finish 5 100 milliliters of dresses and contain 2.0% tea tree oil, 0.25% berberine compound recipe tea tree oil spray sample preparation.
Result of the test:
One. bacteriostatic test
More than 19 embodiment as for test agent, according to " disinfection technology standard (version in 2002) " (Ministry of Health of the People's Republic of China, in November, 200 2) require to estimate result of the test: escherichia coli (Escherichiacoli ATCC 8099), staphylococcus aureus (Staphylococcus aureus ATCC 6538), Candida albicans (Candida albicans ATCC 10231), Pseudomonas aeruginosa (Pseudomonas aeruginosa ATCC 15442) are all had significant fungistatic effect for test agent.
Two. bactericidal assay
More than 19 embodiment as for test agent, according to " disinfection technology standard (version in 2002) " (Ministry of Health of the People's Republic of China of country, in November, 200 2) require to estimate, result of the test: supply test agent to escherichia coli (Escherichia coli ATCC 8099), staphylococcus aureus (Staphylococcus aureus ATCC6538), Candida albicans (Candida albicans ATCC 10231), Pseudomonas aeruginosa 4 bacterial strains such as (Pseudomonasaeruginosa ATCC 15442) were at 10 minutes, 20 fens kinds, clump count is 0 in the test group of 30 minute three action time, so can't calculate its logarithm value, serve as that value is calculated with 0.The logarithm value minimum of killing in each action time is 3.76.Draw a conclusion according to decision rule: above 19 embodiment have obvious sterilizing effect for test agent.
The present invention describes in detail by above-mentioned 19 embodiment, and feature of the present invention clearly has been described, listed examples just set forth content of the present invention for further concrete, but protection scope of the present invention is not limited to embodiment.
Claims (9)
1, a kind of is the compound recipe tea tree oil pharmaceutical composition that main active ingredient is used to prevent or treat human reproduction road inflammation with the tea tree oil extract, it is characterized in that: weight percent meter by volume, per unit dosage contains tea tree oil 0.10～5.0% (v/v), Radix Sophorae Flavescentis or Sophora alopecuroides alkaline extraction thing (in matrine) 0.05～2.0%, surplus are medically acceptable solvent or adjuvant.
2, a kind of is the compound recipe tea tree oil pharmaceutical composition that main active ingredient is used to prevent or treat human reproduction road inflammation with the tea tree oil extract, it is characterized in that: weight percent meter by volume, per unit dosage contains tea tree oil 0.10～5.0% (v/v), Rhizoma Coptidis or Cortex Phellodendri extract (in berberine) 0.05～2.0%, surplus are medically acceptable solvent or adjuvant.
3, a kind of is the compound recipe tea tree oil pharmaceutical composition that main active ingredient is used to prevent or treat human reproduction road inflammation with the tea tree oil extract, it is characterized in that: weight percent meter by volume, per unit dosage contains tea tree oil 0.10～5.0% (v/v), Caulis Fibraureae alkaloid extract (in fibrauretin) 0.05～2.0%, surplus are medically acceptable solvent or adjuvant.
4, according to claim 1,2 and 3 described pharmaceutical compositions, it is characterized in that: tea tree oil adopts Myrtaceae (Myrtaceae) paperbark Melaleuca Alternifolia (Melaleuca alternifolia), or the quintessence oil of the leaves of loose flower Cortex Melaleucae leucadendrae (Melaleuca dissiliflora) or wheel blade Cortex Melaleucae leucadendrae (Melaleuca linariifolia) or New Zealand Camellia sinensis Manuka (Leptospermum scoparium) or Kanuka (Kunzea ericoides) and twig extraction.
5, according to claim 1,2 or 3 described pharmaceutical compositions, it is characterized in that: tea tree oil can be that conventional steam distillation extracts, or the extraction of solvent soaking method, as: soak with ethanol extraction method, or carbon dioxide supercritical extraction method.
6, pharmaceutical composition according to claim 1, it is characterized in that: the Radix Sophorae Flavescentis alkaloid extract is total alkaloids or the purification matrine that leguminous plant Radix Sophorae Flavescentis (Sophora Flavescens Ait) dry root extracts, or the total alkaloids or the purification matrine of the extraction of leguminous plant Herba Sophorae alopecuroidis (Sophora al Opecuroides L.) rhizome.
7, pharmaceutical composition according to claim 2, it is characterized in that: the Rhizoma Coptidis alkaloid extract is biology total alkali or the purifying biological alkali from the dry rhizome extraction of cohosh Rhizoma Coptidis (Coptis chinensis Franch.) or Coptis deltoidea C.Y.Cheng et Hsiao (Coptis deltoidea C.Y.Cheng et Hsiao) or Coptis Teeta Wall (Coptis teeta Wall.), or the biology total alkali or the purifying biological alkali of the dry bark extraction of rutaceae wampee (Phellodendron chinense Schneid.) or Cortex Phellodendri (Phellodendron amurense Rupr.).
8, pharmaceutical composition according to claim 3 is characterized in that: the Caulis Fibraureae alkaloid extract is dry rattan biology total alkali or the purification fibrauretin from Menispermaceae (Menispermaceae) plant Herba Aristolochiae (Fibraurea recisa Pierre).
9, according to the application of claim 1,2 or 3 described pharmaceutical compositions, it is characterized in that: it is an acceptable dosage form pharmaceutically, as: spray, aerosol, cream, suppository, liniment, unguentum, oil preparation, disposable wet tissue.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410022317 CN1562218A (en) | 2004-04-13 | 2004-04-13 | Medication combination of compound tea tree oil for preventing or curing inflammation of human genital tract |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410022317 CN1562218A (en) | 2004-04-13 | 2004-04-13 | Medication combination of compound tea tree oil for preventing or curing inflammation of human genital tract |
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| CN1562218A true CN1562218A (en) | 2005-01-12 |
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| CN 200410022317 Pending CN1562218A (en) | 2004-04-13 | 2004-04-13 | Medication combination of compound tea tree oil for preventing or curing inflammation of human genital tract |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101829074A (en) * | 2010-05-18 | 2010-09-15 | 南宁辰康生物科技有限公司 | Standardized recombinant tea tree oil and preparing method thereof |
| WO2010125408A3 (en) * | 2009-05-01 | 2011-03-03 | Giorgi Gogbaidze | Prostata-norm rectal suppositories for the treatment of prostatitis |
| CN102268328A (en) * | 2011-07-08 | 2011-12-07 | 中国热带农业科学院农产品加工研究所 | Method for extracting tea tree oil by microwave radiation |
| CN102949460A (en) * | 2012-06-29 | 2013-03-06 | 上海莱博生物科技有限公司 | Application of melaleuca alternifolia oil and preparation thereof |
| CN103520031A (en) * | 2013-09-29 | 2014-01-22 | 上海莱博生物科技有限公司 | Plant formula used as natural preservative |
| WO2017101790A1 (en) * | 2015-12-16 | 2017-06-22 | 成都昊健生物科技有限责任公司 | Pharmaceutical composition for treating cutaneous pruritus and use thereof |
-
2004
- 2004-04-13 CN CN 200410022317 patent/CN1562218A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010125408A3 (en) * | 2009-05-01 | 2011-03-03 | Giorgi Gogbaidze | Prostata-norm rectal suppositories for the treatment of prostatitis |
| CN101829074A (en) * | 2010-05-18 | 2010-09-15 | 南宁辰康生物科技有限公司 | Standardized recombinant tea tree oil and preparing method thereof |
| CN102268328A (en) * | 2011-07-08 | 2011-12-07 | 中国热带农业科学院农产品加工研究所 | Method for extracting tea tree oil by microwave radiation |
| CN102949460A (en) * | 2012-06-29 | 2013-03-06 | 上海莱博生物科技有限公司 | Application of melaleuca alternifolia oil and preparation thereof |
| CN103520031A (en) * | 2013-09-29 | 2014-01-22 | 上海莱博生物科技有限公司 | Plant formula used as natural preservative |
| WO2017101790A1 (en) * | 2015-12-16 | 2017-06-22 | 成都昊健生物科技有限责任公司 | Pharmaceutical composition for treating cutaneous pruritus and use thereof |
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