CN105477554A - Medicine for treating HPV infection and preventing cervical cancer and preparation method of medicine - Google Patents

Medicine for treating HPV infection and preventing cervical cancer and preparation method of medicine Download PDF

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CN105477554A
CN105477554A CN201511012860.8A CN201511012860A CN105477554A CN 105477554 A CN105477554 A CN 105477554A CN 201511012860 A CN201511012860 A CN 201511012860A CN 105477554 A CN105477554 A CN 105477554A
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mixture
following material
medicine
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蒲敬北
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Hubei Green Unbounded Biotechnology Co., Ltd.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8994Coix (Job's tears)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9066Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction

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Abstract

The invention discloses a medicine for treating HPV infection and preventing a cervical cancer. The medicine is prepared from the following components in parts by weight: 5-15 parts of brucea javanica, 0.1-0.5 part of saturated and clarified fresh whitewash, 5-20 parts of coix seeds, 3-10 parts of zedoary oil, 3-10 parts of seabuckthorn seed oil, 5.3-20 parts of a surfactant, 0.5-2 parts of a penetration enhancer, 0.4-5.7 parts of a preservative, 0.2-8 parts of a thickener and 0.66-2.3 parts of a pH modifier. The medicine is low in price, small in toxic or side reaction and excellent in effect, and can be widely promoted.

Description

A kind of medicine and preparation method thereof for the treatment of HPV infection mitigation cervical cancer and occurring
Technical field
The present invention relates to a kind of medicine for the treatment of gynaecopathia and preparation method thereof.
Background technology
Cervical cancer is clinical modal gynecologic malignant tumor.The Germany scientist Chu Erhaosen obtaining Nobel Prize finds, the cervical cancer of 99.9% is caused by high-risk human mammilla papillomavirus (HPV), and high-risk human mammilla papillomavirus (HPV) persistent infection is the Basic disease cause causing the front change of cervical cancer and cervical cancer.The women of persistence (>=2 years) high-risk HPV infection in more than 30 years old is the high-risk group of cervical cancer.Human health screening is learnt, the probability of global women's persistent infection HPV is 17-25%, and therefore, prevention and removing HPV, block and reverse precancerous lesions of uterine cervix CIN, significant for prevention and therapy women cervical cancer.
The effect that modern medicine infects for prevention and therapy HPV also has limitation very much, and preventive means is vaccinate, does not only infect model effectively for 4 kinds at present, expensive, needs multiple injection, can only prevent 4 years.Treatment means is injection of interferon antiviral therapy, treats expensive, and toxicity is large, and limited efficiency, can not popularity.
Chinese medicine has " wart ", " verruca vulgaris ", " condyloma latum ", these sayings, refer now to, with the pathogenic arch-criminal " HPV " of cervical cancer, belong to same pathology category: human papillomavirus--HPV infect.Chinese medicine have accumulated much for treatment side's medicine of " wart ".Wherein most important several plant component is Fructus Bruceae, Semen Coicis, Oleum Curcumae, Fructrs Hippophae seed oil.
Fructus Bruceae is the fruit of Simarubaceae aithullium Fructus Bruceae.Tradition thinks that Fructus Bruceae has heat-clearing and toxic substances removing, the positive dysentery of preventing the attack (or recurrence) of malaria, effect of corrosion warty vegetation and effect.The diseases such as conventional Fructus Bruceae treatment verruca vulgaris, verruca plana, clavus.Drop on wart with Oleum Fructus Bruceae, or Fructus Bruceae is directly rived to rub on wart.
" Records of Tradition Chinese and Western Medicine in Combination " for last rectification and painting, controls wart effect with java brucea seed.
" Records of Tradition Chinese and Western Medicine in Combination ": " removing pathogenic heat from blood and toxic substance from the body, kind controls hot bloody dysentery, and two just because of hot hematochezia ", " control syphilis and flower willow poison drenches.Mash vinegar and dress furunculosis.Be apt to control wart.”
" medicinal herbs among the people of science ": " preventing the attack (or recurrence) of malaria and control amebic dysentery." " make oil, external auditory meatus emulsus tumor can be controlled, papillary tumor, and acuteness condyloma latum.”
The modern study of Fructus Bruceae:
The chemical composition of Fructus Bruceae: this product mainly contains kusulactone and glycoside thereof, as brucein A.B, C, E.F, C.H, I, brucealin A, B etc.: class quassinoids is as Brusatol, brucein, bruceolide; Alkaloids is as brucamarine, yatanine, glucoside brucealin; Flavonoid has Quercetin-3-0-β-D-galactoside, luteolin-7-O-β-D-Glucose glycoside; Java brucea seed fatty oil (Oleum Fructus Bruceae) has volatile oil, oleic acid, linoleic acid, stearic acid, Palmic acid etc.In addition, Fructus Bruceae is also containing vanillic acid, Fructus Bruceae A prime, brucenol, bruceolic acid etc.
The pharmacological action of Fructus Bruceae:
1, Fructus Bruceae water decoction and chloroform extract have parasite killing to control dysentery and the effect of In Vitro Anti plasmodium;
2, Fructus Bruceae has antitumor action, and it is downright bad that its paste and water preparation topical application can make mouse skin cancer and papillomatous oncocyte change in quality.Extract has anti-cancer effect in vitro, human nasopharyngeal carcinoma KB cell can be suppressed, also inhibitory action is had to ehrlich carcinoma, W256 carcinosarcoma, P388 Lymphocytic leukemia etc., main anti-tumor composition is brucealin, brucealin B, Brusatol, bruceine D, brucealin O, dehydrogenation Fructus Bruceae alcohol, bruceen, quassinoids etc.Its antitumor action is anticancer protein synthesis, affects cell generation cycle, improves caused by animal cAMP content.
3, deoil Fructus Bruceae preserved material and other crude extracts can make dog blood pressure temporarily decline, and is inhibitory action in place and isolated heart.Java brucea seed extractum can excited isolated uterine, in place and rat small intestine in vitro.
4, in addition, Fructus Bruceae has certain treatment gonorrhea and antiviral effect, but concrete effect is indefinite.
The modern usage of Fructus Bruceae: even can not survey consequence because its water soluble ingredient easily causes allergy, existing its refined oil multiplex.Common as oleum fructus bruceae soft capsule, oleum fructus bruceae injection liquid (oral liquid) etc., but existing goods dosage form, oil capsule and oil preparation, have intense stimulus to oral cavity, esophagus, gastrointestinal and skin mucosa, range of application critical constraints.
Semen Coicis, slightly sweet flavor, cool in nature, kind in dampness, return spleen, stomach, lung meridian.Dampness removing spleen invigorating; Arthralgia relieving by relaxing muscles and tendons; Clearing away heat and discharging pus.Main edema; Foot gas; Dribbling urination; Damp-warm diseases; To have loose bowels leukorrhagia; Rheumatic arthralgia; The contracture of muscle arteries and veins; Lung abscess; Intestinal carbuncle; Verruca plana.
The modern study of Semen Coicis
Semen Coicis main component is protein, vitamin B1, B2, and have the effect making skin smooth, reduce wrinkle, eliminate pigment spot, long-term drink, can treat edema leucorrhea, brown patch, freckle, pimples, and speckle is disappeared and Glycerin.Prove through modern pharmacological research, Semen Coicis has certain antibacterial, antiviral efficacy.Among the peoplely treat with it the effective percentage that verruca plana has 70.8%; Treat the effective percentage that common wart also has 30.6%.Usage gets 100 grams of Semen Coiciss every day, cooks congee or boil soup to eat.Initial several days, wart district can increase and reddens, and after continuing to take a wheat harvesting period, wart just can dry desquamation gradually, so that disappears.Long-term taking, can make skin smooth fine and smooth, fair and clear glossy.Antitumor: " in recent years; a large amount of scientific researches and clinical practice prove; Semen Coicis or a kind of cancer therapy drug; Preliminary Identification; its anticancer effective ingredient comprises selenium element; can the propagation of effective anticancer, can be used for the auxiliary treatment of gastric cancer, cervical cancer, it can reach more than 35% to the suppression ratio of cancer.Especially wet pulmonary carcinoma is held under the arm with the digestive tract tumor of insufficiency of the spleen leading to overabundance of dampness and expectorant heat more suitable.Semen Coicis oil energy enhancing immunity and antiinflammatory action, Semen Coicis oil has facilitation to cellular immunization, humoral immunization.The modern usage of Semen Coicis is based on oral, and the mainly whitening of its oil of external, had not had the application of topical antiviral.
The modern study of Compound Zedoary Turmeric Oil Suppositories:
Compound Zedoary Turmeric Oil Suppositories treatment cervicitis merges HPV infection and has certain curative effect.HPV negative conversion rate is about 37%.
The modern study of compound seabuckthorn fruit oil suppository
According to document " compound seabuckthorn fruit oil suppository treatment high-risk HPV infectious effect is observed " Liu Yong, Huang Huirong, Fan Xiangling, prunus mume (sieb.) sieb.et zucc. is (Beijing Municipal No. 2 Hospital smoothly, Beijing 100031) report, compound seabuckthorn fruit oil suppository treatment high-risk human papillomavirus (HPV) infects certain curative effect.Treatment group 32 example gives compound seabuckthorn fruit oil suppository treatment, and matched group 27 example gives Recombinant human interferon α-2b gel treatment.Treat 3 months all continuously for 2 groups, HPV high-risk-type DNA detection is checked in drug withdrawal after 3 months.Result treatment group and the total negative conversion rate of matched group are respectively 72% and 63%, and seabuckthorn fruit oil suppository vaginal adhesion is bad, and effective percentage is still not high enough.
Summary of the invention
The technical problem to be solved in the present invention is: overcome that existing treatment of human cervical cancer is expensive, toxicity be large, limited efficiency, can not the defect of popularity, a kind of medicine and preparation method thereof for the treatment of HPV infection mitigation cervical cancer and occurring is proposed, cheap, toxicity is little, excellent effect, can popularity.
In order to solve the problems of the technologies described above, the present invention proposes following technical proposal: a kind of medicine for the treatment of HPV infection mitigation cervical cancer and occurring, it is made up of following component that counting by weight: fresh lime water 0.1-0.5 part of Fructus Bruceae 5-15 part, saturated clarification, Semen Coicis 5-20 part, Oleum Curcumae 3-10 part, Fructrs Hippophae seed oil 3-10 part, surfactant 5.3-20 part, penetration enhancer 0.5-2 part, antiseptic 0.4-5.7 part, thickening agent 0.2-8 part, Ph regulator 0.66-2.3 part.
The further restriction of technique scheme is, described surfactant is one or more the mixture in following material: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether; Anionic surfactant agent; Cationic surfactant;
Described penetration enhancer is one or more the mixture in following material: natural Broneolum Syntheticum, Mentholum, aromatic oil, azone, thiophene ketone;
Described antiseptic is one or more the mixture in following material: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate, Nipagin ester and sodium salt thereof, potassium sorbate, sodium benzoate, triclosan, triclocarban;
Described thickening agent is one or more the mixture in following material: natural polysaccharide, poloxamer, carbomer, xanthan gum, modified cellulose, polymer viscosifier;
Described PH regulator is one or more the mixture in following material: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid, hydrochloric acid, citric acid, phosphoric acid.
The further restriction of technique scheme is, described surfactant is one or more the mixture in following material: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether.
The further restriction of technique scheme is, described surfactant is poloxamer;
Described penetration enhancer is one or more the mixture in following material: natural Broneolum Syntheticum, Mentholum;
Described antiseptic is one or more the mixture in following material: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate;
Described thickening agent is sodium alginate;
Described PH regulator is one or more the mixture in following material: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid.In order to solve the problems of the technologies described above, the present invention proposes following technical proposal: a kind of manufacture method for the treatment of the medicine that HPV infection mitigation cervical cancer occurs, it comprises the following steps:
Step 1: frying fragrant by the peeling of raw Fructus Bruceae 5-15 part is degree, adds lime water 0.1-0.5 part while hot, continues little fire and dry;
Step 2: upper ball mill wet grinding more than 5 hours after the 200-800 part that adds water, Semen Coicis 5-20 part, Oleum Curcumae 3-10 part, Fructrs Hippophae seed oil 3-10 part, surfactant 5.3-20 part, the mixing of antiseptic 0.4-5.7 part, temperature is no more than 70 degree, levigate, allow its particle diameter be not more than 2um;
Step 3: upper cryogenic high pressure homogenizer homogenizing is not more than 200 nanometers to particle diameter, is no more than 60 DEG C, 120-180bar;
Step 4: middle temperature 55-70 degree vacuum-0.09MPa evaporation or rotary evaporation removing excessive moisture, remaining heavy 100 parts;
Step 5: add thickening agent 0.2-8 part, penetration enhancer 0.5-2 part, swelling evenly after add ph regulator 0.16-0.8 part and be neutralized to alkalescence ph=7.0-8.0, stir, thickening becomes colloid;
Step 6: stir colloid again, slowly drips ph regulator 0.5-1.5 part, returns acid to ph4.0-6.5;
Step 7: detect antibacterial index, as qualified, is dispensed into administrator.
Compared with prior art, the present invention has following beneficial effect: modern medicine has confirmed that Oleum Fructus Bruceae has antitumor action, preparation way is oral capsule or injection emulsifiable concentrate, but its antiviral ingredients and sphere of action are all indefinite, untapped antiviral related preparations.The present inventor confirms through a large amount of clinical case, Fructus Bruceae water soluble ingredient and liposoluble constituent all have the anti-skin infection HPV of good specificity, also have the effect of the anti-cervical HPV virus of specificity, especially water soluble ingredient removing cervical HPV infection effect is more better than liposoluble constituent.The anti-cervical HPV that it is nucleus compatibility Oleum Curcumae Fructrs Hippophae seed oil that the present invention has formulated with the water solublity of compound collecting Fructus Bruceae, Semen Coicis and liposoluble constituent, blocks and reverses the vagina external-use gel formula of cervix uteri CIN. through the clinical verification of ten several years, and excellent effect.The present invention also has excellent effect to the condyloma acuminatum that vaginal infection HPV causes.
The attenuation concocting method of Fructus Bruceae
The toxicity of Fructus Bruceae can not be ignored, Fructus Bruceae water-soluble phenolic, acrylic component are poisonous, bibliographical information, do not concoct or concoct composition and cause having between the case of severe allergy generation improperly because using, modern Application its oil multiplex, dare not use the water soluble ingredient that its antiviral effect is more outstanding.According to the experience in the present inventor's handed down from the older generations of the family several generation, toxic component and the effective ingredient of Fructus Bruceae have plyability, and correct concocting method is the key of Fructus Bruceae attenuation synergistic.The present invention is the toxicity deducting Fructus Bruceae, both the ancient method of honor employed fire and fried the process of preparing Chinese medicine, create " yardstick "-" with perfume (or spice) the degree of being " that the duration and degree of heating is affectedly bashful, the excessive process of preparing Chinese medicine then effect reduces, and innovatively employs again the method that lime water is concocted, and part neutralizes its acid toxic component, reach the effect subtracting toxicity reduction, " yardstick " concocted, amount and " little fire dries " of lime water are also the indexs needing accurate assurance, thus substantially increase the effectiveness and safety that use Fructus Bruceae water soluble ingredient.
Two Liquid Phases extraction is carried out to Fructus Bruceae, other plant oil and PLURONICS F87 is added when wet grinding Fructus Bruceae, this is to allow water and oil form Two Liquid Phases, surface agent poloxamer 188 is allowed to play its Action of Surfactant, interactive between two-phase interface, thus its liposoluble constituent of compound collecting while of in the process extracting water soluble ingredient.
Compatibility Semen Coicis, reinforced effects: the present inventor is from observation on Clinical Application, and face flat wart patient, oral have good result, and be coated with by Semen Coicis serosity and be used for face flat wart place, the effect removing verruca plana is more better than oral.Further research finds, Semen Coicis composition is used for separately condyloma acuminata of vagina and cervical HPV infection, its, the effect that blocking-up HPV copied, removed HPV is also very outstanding, by the course for the treatment of of half a year, folk prescription uses Semen Coicis composition, and hpv persistent infection person the moon of 70% can be allowed to turn, through following up a case by regular visits to 2 years without recurrent infection.The present inventor thinks, Semen Coicis composition has the feature of obvious targeting HPV infection cell-" wart body ", and it perhaps by removing wart somatic cell, reaches the object removing hpv indirectly.On the other hand, it can strengthen immunocompetence again, the rapid generation of enhancing antibody.
Compatibility Oleum Curcumae, compatibility Fructrs Hippophae seed oil, reinforced effects.Alone Oleum Curcumae bolt, HPV negative conversion rate is undesirable, about only 30%, alone compound seabuckthorn fruit oil suppository also only has an appointment 60%, still undesirable, if the present invention only uses Fructus Bruceae and Semen Coicis oil two kinds of nucleuses, HPV and CIN negative conversion rate can reach 90%, coordinate Oleum Curcumae and Fructrs Hippophae seed oil, HPV negative conversion rate is more up to more than 95%.
Fructus Bruceae, through concocting and two-phase extraction, although allergen greatly reduces, but still may have a small amount of residual, be ensure being perfectly safe of user, present invention employs Atrigel, to promote safety, and effectiveness, abirritate.Sustained-release gel administration of the present invention, reduces prominent release amount, extends simultaneously and reaches desensitization effect by the medicine time, avoids high quick individuality to occur anaphylactoid probability, ensures the safety of medication person.Sustained-release gel adhesiveness is good simultaneously, and administration is steadily long-acting, significantly can reduce the zest of Fructus Bruceae oil components to skin mucosa.Successively be applied to thousands of sufferers through the clinical more than two decades of inventor, the slight stimulation rubescent micro-reaction of itching in local of an example only occurs.Can tolerance range.
Clinical effectiveness of the present invention
The present invention uses the total composition of Fructus Bruceae and the total composition of Semen Coicis as the compound preparation of the main component of prevention and therapy vagina cervical HPV infection innovatively, healthy women uses the course for the treatment of through one (3 months), without a routine new infeetioa cervical HPV occurs, infect cervical HPV person, use to make cervical HPV and cervix uteri CIN negative conversion rate reach more than 95% one to three course for the treatment of (3-9 month), through the long term follow-up of 1-5 without recurrence.During medication and between follow-up period, the normal ripple disable of patient's hepatic and renal function, all are normal for the heart, brain, bone marrow, spleen, pancreas, blood, reproductive system function etc.Conclusion, safe and efficient, the simple and easy to do Chinese medicine for outer use of invention formulation to be one with pure natural plant ingredients be completely effective ingredient, its prevention and therapy cervical HPV infection, reverse cervix uteri CIN, there is very outstanding effect, be prevent even to block the outstanding preparation that precancerous lesions of uterine cervix progress is cervical cancer, will bring glad tidings for the good health and a long life of numerous female friends.
Detailed description of the invention
The present invention proposes a kind of medicine for the treatment of HPV infection mitigation cervical cancer and occurring, and it is made up of following component that counting by weight: fresh lime water 0.1-0.5 part of Fructus Bruceae 5-15 part, saturated clarification, Semen Coicis 5-20 part, Oleum Curcumae 3-10 part, Fructrs Hippophae seed oil 3-10 part, surfactant 5.3-20 part, penetration enhancer 0.5-2 part, antiseptic 0.4-5.7 part, thickening agent 0.2-8 part, Ph regulator 0.66-2.3 part.
Described surfactant is one or more the mixture in following material: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether; Anionic surfactant agent; Cationic surfactant.
One or more mixture in the preferred following material of described surfactant: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether.
Described surfactant is preferred poloxamer further.
Described penetration enhancer is one or more the mixture in following material: natural Broneolum Syntheticum, Mentholum, aromatic oil, azone, thiophene ketone.
One or more mixture in the preferred following material of described penetration enhancer: natural Broneolum Syntheticum, Mentholum.
Described antiseptic is one or more the mixture in following material: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate, Nipagin ester and sodium salt thereof, potassium sorbate, sodium benzoate, triclosan, triclocarban.
One or more mixture in the preferred following material of described antiseptic: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate.
Described thickening agent is one or more the mixture in following material: natural polysaccharide, poloxamer, carbomer, xanthan gum, modified cellulose, polymer viscosifier.
The preferred sodium alginate of described thickening agent.
Described PH regulator is one or more the mixture in following material: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid, hydrochloric acid, citric acid, phosphoric acid.
One or more mixture in the preferred following material of described PH regulator: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid.The present invention also proposes the manufacture method of the medicine that above-mentioned treatment HPV infection mitigation cervical cancer occurs, and comprises the following steps:
Step 1: frying fragrant by the peeling of raw Fructus Bruceae 5-15 part is degree, adds lime water 0.1-0.5 part while hot, continues little fire and dry;
Step 2: upper ball mill (temperature is no more than 70 degree) wet grinding more than 5 hours after the 200-800 part that adds water, Semen Coicis 5-20 part, Oleum Curcumae 3-10 part, Fructrs Hippophae seed oil 3-10 part, surfactant 5.3-20 part, the mixing of antiseptic 0.4-5.7 part, levigate, allow its particle diameter be not more than 2um;
Step 3: upper cryogenic high pressure homogenizer (being no more than 60 DEG C, 120-180bar) homogenizing is not more than 200 nanometers to particle diameter;
Step 4: middle temperature 55-70 degree vacuum-0.09MPa evaporation or rotary evaporation removing excessive moisture, remaining heavy 100 parts;
Step 5: add penetration enhancer 0.5-2 part and stir evenly, add thickening agent 0.2-8 part, swelling evenly after add ph regulator 0.16-0.8 part and be neutralized to alkalescence ph=7.0-8.0, stir, thickening becomes colloid;
Step 6: stir colloid again, slowly drips ph regulator 0.5-1.5 part, returns acid to ph4.0-6.5;
Step 7: detect antibacterial index, as qualified, is dispensed into administrator.
The using method of the medicine that above-mentioned treatment HPV infection mitigation cervical cancer occurs is: administration near vagina cervix uteri mouth, oneself injects administration, every two days once, each one, (menstrual period, product, pregnant, drug withdrawal age of sucking) continuous 3 months, HPV can turn out cloudy, continuous 6 months, CIN reversible.
Preparation embodiment 1
Step 1: removed the peel by raw Fructus Bruceae 5 parts and fry perfume for degree, adds the little fire of lime water 0.3 part continuation while hot and dries;
Step 2: add Semen Coicis 5 parts, 500 parts, water, 20 parts, surfactant (being made up of PLURONICS F87 20 parts), Oleum Curcumae 8 parts, Fructrs Hippophae seed oil 3 parts, rear upper ball mill (temperature the is no more than 70 degree) wet grinding more than 5 hours of antiseptic 3 parts (being made up of Capmul MCM C8 3 parts) mixing, levigate, allow its particle diameter be not more than 2um;
Step 3: upper cryogenic high pressure homogenizer (being no more than 60 DEG C, 120-180bar) homogenizing is not more than 200 nanometers to particle diameter;
Step 4: middle temperature 55-70 degree vacuum-0.09MPa evaporation or rotary evaporation removing excessive moisture, remaining heavy 100 parts;
Step 5: add penetration enhancer 0.5 part and stir evenly, add thickening agent carbomer 8 parts, swelling evenly after add ph regulator sodium hydroxide solution 0.16 part and be neutralized to alkalescence ph=7.0-8.0, stir, thickening becomes colloid;
Step 6: stir colloid again, slowly drips ph regulator lactic acid 0.5 part, returns acid to ph4.0-6.5;
Step 7: detect antibacterial index, as qualified, is dispensed into administrator.
Preparation embodiment 2
Step 1: removed the peel by 10 parts raw, Fructus Bruceae seed and fry perfume for degree, adds the little fire of lime water 0.1 part continuation while hot and dries;
Step 2: add Semen Coicis 12 parts, 200 parts, water, 5.3 parts, surfactant (being made up of PLURONICS F87 5.3 parts), Oleum Curcumae 10 parts, Fructrs Hippophae seed oil 6 parts, rear upper ball mill (temperature the is no more than 70 degree) wet grinding more than 5 hours of antiseptic 0.4 part (being made up of Capmul MCM C8 0.4 part) mixing, levigate, allow its particle diameter be not more than 2um;
Step 3: upper cryogenic high pressure homogenizer (being no more than 60 DEG C, 120-180bar) homogenizing is not more than 200 nanometers to particle diameter;
Step 4: middle temperature 55-70 degree vacuum-0.09MPa evaporation or rotary evaporation removing excessive moisture, remaining heavy 100 parts;
Step 5: add penetration enhancer 2 parts and stir evenly, add thickening agent carbomer 0.2 part, swelling evenly after add ph regulator sodium hydroxide solution 0.5 part and be neutralized to alkalescence ph=7.0-8.0, stir, thickening becomes colloid;
Step 6: stir colloid again, slowly drips ph regulator lactic acid 1 part, returns acid to ph4.0-6.5;
Step 7: detect antibacterial index, as qualified, is dispensed into administrator.
Preparation embodiment 3
Step 1: removed the peel by raw Fructus Bruceae 15 parts and fry perfume for degree, adds the little fire of lime water 0.5 part continuation while hot and dries;
Step 2: add Semen Coicis 20 parts, 800 parts, water, 12 parts, surfactant (being made up of PLURONICS F87 12 parts), Oleum Curcumae 3 parts, Fructrs Hippophae seed oil 10 parts, rear upper ball mill (temperature the is no more than 70 degree) wet grinding more than 5 hours of antiseptic 5.7 parts (being made up of Capmul MCM C8 5.7 parts) mixing, levigate, allow its particle diameter be not more than 2um;
Step 3: upper cryogenic high pressure homogenizer (being no more than 60 DEG C, 120-180bar) homogenizing is not more than 200 nanometers to particle diameter;
Step 4: middle temperature 55-70 degree vacuum-0.09MPa evaporation or rotary evaporation removing excessive moisture, remaining heavy 100 parts;
Step 5: add penetration enhancer 1 part and stir evenly, add thickening agent carbomer 4 parts, swelling evenly after add ph regulator sodium hydroxide solution 0.8 part and be neutralized to alkalescence ph=7.0-8.0, stir, thickening becomes colloid;
Step 6: stir colloid again, slowly drips ph regulator lactic acid 1.5 parts, returns acid to ph4.0-6.5;
Step 7: detect antibacterial index, as qualified, is dispensed into administrator.
Enumerate the clinical treatment example that several the present invention treats the medicine that HPV infection mitigation cervical cancer occurs below:
Case one, thanks certain, Sichuan Nanchong people, 37 years old, suffer from cervical erosion, be with the blood several years in band, on JIUYUE 8th, 2011, because sexual partner's reason recent infection condyloma acuminata of vagina is examined, cervical secretions look into see hpv11,18,33,58 type virus-positives, TCT looks into and sees CINI.By Drug therapy of the present invention, every day one, except menstrual period, after a course for the treatment of (3 months), condyloma acuminatum disappears completely, and after continuing the next course for the treatment of, 4 kinds of model hpv all turn out cloudy, and CIN is negative, cervical erosion returns to one's perfect health, and rear check every half a year once, is followed up a case by regular visits to 3 years, do not had recurrence.
Case two, Zhang, people from Ji'an, Jiangxi, 46 years old, HPV33 was shown in in May, 2010 HPV examination, and 59 is positive, do not give treatment, in December, 2010, and check is still positive, and after a course for the treatment of of this Drug therapy, 33.59 all turn negative, and follow up a case by regular visits to and do not recur for 3 years.
Case three, Chen, people from Guangzhou, 55 years old, in March, 2009 health check-up found cervical erosion III, HPV11,16 positives, CINII, does not give treatment, check in 2010 June, cervical erosion III, HPV11,16 are still positive, CINIII, through 3 courses for the treatment of of Drug therapy of the present invention, in April, 2011 checks, and cervical erosion returns to one's perfect health, HPV11,16 feminine genders, CIN turns negative.Follow up a case by regular visits to and do not recur for 3 years.
Case four, suddenly certain, normal person is opened in Guangdong, 24 years old, because unclean sexual life infects HPV6, 16, 18, 59, suffer from cervical erosion, condyloma acuminatum 4 years, though through local laser, the means such as basilar part injection of interferon are repeatedly treated, suffer untold misery, right HPVDNA index all the time seniority top digit is hovered about 4.0E05, vagina and crissum condyloma acuminatum recurrent exerbation, start in February, 2012 after 1 course for the treatment of of Drug therapy of the present invention, condyloma acuminatum disappears, after 2 courses for the treatment of, hpv tetra-turns out cloudy entirely, after 3 courses for the treatment of, cervical erosion returns to one's perfect health, follow up a case by regular visits to 3 years, nothing repeatedly, without new infeetioa HPV hypotype.
Case five, grandson, people from Nanchang, 46 years old, suffer from cervical erosion III, be with blood in band for many years, have no result through multi-treatment, in February, 2009 to Grade A hospital detects the HPV18 positive, CINII, Grade A hospital suggestion row conization of cervix, because fear operation is examined, treats a course for the treatment of (three months) through invention formulation, the rehabilitation of cervical erosion III degree is to I degree, after second course for the treatment of, cervical erosion returns to one's perfect health, and HPV18 turns out cloudy, after three courses for the treatment of, CIN the moon turns, drug withdrawal after 1 course for the treatment of of continuing to strengthen property medication, follows up a case by regular visits to 5 years without recurrence.
Case six, week certain, Nanyang, henan people, 29 years old, because unclean sexual behaviour infects HPV6,33 types virus 3 years, vagina and condyloma acuminatum of anus recurrent exerbation, rose and use after 2 courses for the treatment of through invention formulation in March, 2009, and HPVDNA the moon turns, and symptom is again without recurring.Follow up a case by regular visits to 5 years, HPV continues negative.

Claims (8)

1. the medicine for the treatment of HPV infection mitigation cervical cancer and occurring, it is characterized in that, it is made up of following component that counting by weight: Fructus Bruceae 5-15 part, fresh lime water 0.1-0.5 part of saturated clarification, Semen Coicis 5-20 part, Oleum Curcumae 3-10 part, Fructrs Hippophae seed oil 3-10 part, surfactant 5.3-20 part, penetration enhancer 0.5-2 part, antiseptic 0.4-5.7 part, thickening agent 0.2-8 part, Ph regulator 0.66-2.3 part.
2. the medicine for the treatment of HPV infection mitigation cervical cancer according to claim 1 generation, is characterized in that,
Described surfactant is one or more the mixture in following material: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether; Anionic surfactant agent; Cationic surfactant;
Described penetration enhancer is one or more the mixture in following material: natural Broneolum Syntheticum, Mentholum, aromatic oil, azone, thiophene ketone;
Described antiseptic is one or more the mixture in following material: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate, Nipagin ester and sodium salt thereof, potassium sorbate, sodium benzoate, triclosan, triclocarban;
Described thickening agent is one or more the mixture in following material: natural polysaccharide, poloxamer, carbomer, xanthan gum, modified cellulose, polymer viscosifier;
Described PH regulator is one or more the mixture in following material: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid, hydrochloric acid, citric acid, phosphoric acid.
3. the medicine for the treatment of HPV infection mitigation cervical cancer according to claim 1 generation, it is characterized in that, described surfactant is one or more the mixture in following material: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether.
4. the medicine for the treatment of HPV infection mitigation cervical cancer according to claim 1 generation, it is characterized in that, described surfactant is poloxamer;
Described penetration enhancer is one or more the mixture in following material: natural Broneolum Syntheticum, Mentholum;
Described antiseptic is one or more the mixture in following material: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate;
Described thickening agent is sodium alginate;
Described PH regulator is one or more the mixture in following material: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid.
5. a manufacture method for the medicine for the treatment of HPV infection mitigation cervical cancer as claimed in claim 1 generation, it is characterized in that, it comprises the following steps:
Step 1: frying fragrant by the peeling of raw Fructus Bruceae 5-15 part is degree, adds lime water 0.1-0.5 part while hot, continues little fire and dry;
Step 2: upper ball mill wet grinding more than 5 hours after the 200-800 part that adds water, Semen Coicis 5-20 part, Oleum Curcumae 3-10 part, Fructrs Hippophae seed oil 3-10 part, surfactant 5.3-20 part, the mixing of antiseptic 0.4-5.7 part, temperature is no more than 70 degree, levigate, allow its particle diameter be not more than 2um;
Step 3: upper cryogenic high pressure homogenizer homogenizing is not more than 200 nanometers to particle diameter, is no more than 60 DEG C, 120-180bar;
Step 4: middle temperature 55-70 degree vacuum-0.09MPa evaporation or rotary evaporation removing excessive moisture, remaining heavy 100 parts;
Step 5: add thickening agent 0.2-8 part, add penetration enhancer 0.5-2 part, swelling evenly after add ph regulator 0.16-0.8 part and be neutralized to alkalescence ph=7.0-8.0, stir, thickening becomes colloid;
Step 6: stir colloid again, slowly drips ph regulator 0.5-1.5 part, returns acid to ph4.0-6.5;
Step 7: detect antibacterial index, as qualified, is dispensed into administrator.
6. the manufacture method of the medicine for the treatment of HPV infection mitigation cervical cancer according to claim 5 generation, is characterized in that,
Described surfactant is one or more the mixture in following material: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether; Anionic surfactant agent; Cationic surfactant;
Described penetration enhancer is one or more the mixture in following material: natural Broneolum Syntheticum, Mentholum, aromatic oil, azone, thiophene ketone;
Described antiseptic is one or more the mixture in following material: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate, Nipagin ester and sodium salt thereof, potassium sorbate, sodium benzoate, triclosan, triclocarban;
Described thickening agent is one or more the mixture in following material: natural polysaccharide, poloxamer, carbomer, xanthan gum, modified cellulose, polymer viscosifier;
Described PH regulator is one or more the mixture in following material: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid, hydrochloric acid, citric acid, phosphoric acid.
7. the manufacture method of the medicine for the treatment of HPV infection mitigation cervical cancer according to claim 6 generation, is characterized in that,
Described surfactant is one or more the mixture in following material: non-particle surface agent poloxamer, fatty acid ester, spans, Tweens, polyoxyethylene castor oil class, alkyl polyglucoside class, polyglycereol esters, fatty alcohol-polyoxyethylene ether.
8. the manufacture method of the medicine for the treatment of HPV infection mitigation cervical cancer according to claim 6 generation, is characterized in that,
Described surfactant is poloxamer;
Described penetration enhancer is one or more the mixture in following material: natural Broneolum Syntheticum, Mentholum;
Described antiseptic is one or more the mixture in following material: Capmul MCM C8, thymol, Folium Baeckeae oil, sodium diacetate, dehydro sodium acetate;
Described thickening agent is sodium alginate;
Described PH regulator is one or more the mixture in following material: sodium hydroxide, potassium hydroxide, triethanolamine acetic acid, lactic acid.
CN201511012860.8A 2015-12-31 2015-12-31 Medicine for treating HPV infection and preventing cervical cancer and preparation method of medicine Pending CN105477554A (en)

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