CN102552472B - Chinese medicinal preparation for treating vaginitis and preparation method thereof - Google Patents
Chinese medicinal preparation for treating vaginitis and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a Chinese medicinal preparation for treating vaginitis and a preparation method thereof. According to the Chinese medicinal preparation, hawthorn fruit kernels are used as medicinal raw materials, and after being extracted and purified according to a certain process, the hawthorn fruit kernels are prepared into the Chinese medicinal preparation with a pharmaceutically-acceptable auxiliary material. The Chinese medicinal preparation has the characteristics of simple preparation process, safety, effectiveness and obvious pharmacological and medicinal effects.
Description
Technical field
The present invention relates to a kind of colpitic Chinese medicine preparation and preparation method thereof for the treatment of, belong to the pharmaceutical preparations technology field.
Background technology
Vaginitis is the common frdquently encountered disease in the inflammation of woman genetic system, and cardinal symptom is that leukorrhagia increases, and pudendal pruritus or scorching hot with pudendum belongs to the scope of motherland's medical science leukorrhagia and pudendal pruritus.Get to the bottom of sb.'s illness mostly to be and ignore health, infect cloudy worm, or damp invasion of lower energizer, accumulate strongly fragrant infestedly, or insufficiency of the spleen wet resistance, the turbid damp slime flux part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels injure to appoint and are with two arteries and veins, or the hepatic and renal YIN deficiency, dryness-transformation give birth to wind, or the conscience stagnation of QI, strongly fragrant fire-transformation of a specified duration follow through under disturb and cause.Modern western medicine is thought, vaginitis is the inflammation of connective tissue under vaginal mucosa and the mucosa, common have bacterial vaginitis, trichomonal vaginitis and a colpitis mycotica etc., change with the character of leucorrhea clinically and the pruritus vulvae causalgia is main clinical characters, when urethra is involved in infection, symptoms such as dysurea, urgent micturition can be arranged.
Because vagina has extremely abundant blood capillary, permeability is better than rectum, oral cavity, skin, and vagina does not have clear and definite teleneuron, patient's pain stimulation is little during administration, be effective drug release position for specific disease and medicine, therefore the vagina administration approach is compared with the other treatment system, has following advantage: (1) can self administration, can prolong the holdup time of delivery system; (2) avoid the first pass metabolism of liver; (3) some drugs had higher permeability; (4) in the vagina degraded of enzyme seldom, medicine can be by metabolism and inactivation, disturbs less to the human body normal physiological function.Modern pharmacology studies show that, the absorption of medicine in vagina generally depends on the condition of vagina epithelium, the character of drug-supplying system and the physicochemical property of medicine.Yet Chinese medicine preparation has absolute more excellent curative effect effect on this type for the treatment of of diseases all the time, becomes the focus of the world of medicine's research.
Semen Crataegi is early on the books in the medical classical works of China, as claiming " the relieving dyspepsia mill that gulps down is long-pending, controls insane hernia " in the Compendium of Material Medica, claims in " Bencao Congxin " " to control hernia, expedite the emergence of." the research report of relevant Semen Crataegi is less in the present existing technical information, especially about the technical scheme of Semen Crataegi single medical material extraction process report not almost.We find in the process of experimental of reality; the vaginitis disease that Semen Crataegi single medical material causes for a variety of causes; has beyond thought therapeutic effect; between this; we have applied for that on June 26th, 2003 application number is 03139655.0 patent of invention; after this and obtained mandate; this patent document mainly is to protect from aspects such as prescription proportioning and lotions; yet; because existing, vaginal lotion dosage form itself use inconvenience, medicinal liquid to lose shortcomings such as big, thereby cause it to influence the curative effect of medicine itself to a certain extent.Therefore the present invention carries out a large amount of experimentatioies on this basis, and the method for extraction and purification of Semen Crataegi and preparations shaping method in the side of finding out of novelty, be purpose to improve medicine stability and curative effect of medication, and creationary succeed in developing a kind of treat colpitic Chinese medicine preparation.
Summary of the invention
The object of the invention is to provide a kind of steady quality, and curative effect is reliable, the colpitic Chinese medicine preparation of the treatment that bioavailability is high.Subjective symptoms, curative effect that said preparation can improve the patient rapidly are lasting, do not destroy the sour environment of vagina after the use, so be conducive to recover vagina normal antimicrobial protection effect.
Another object of the present invention is to provide this to treat the preparation method of colpitic Chinese medicine preparation, the technology of this method is easy, stable, and the Chinese medicine preparation that makes is through corresponding clinical trial research, and the result shows this Chinese medicine preparation stable curative effect, effective, reliable.
Technical solution of the present invention is realized by following step:
(1) get 1170 parts of Semen Crataegis, pulverize, add alcohol heating reflux and extract, filter, ethanol liquid is continued to employ; After soaking in the medicinal residues, heating decocts extracts, and filters, and water liquid is continued to employ;
(2) the water liquid in above-mentioned (1) is added ethanol, cold preservation filters, and after the ethanol liquid merging in filtrate and above-mentioned (1), decompression recycling ethanol and concentrate drying, is ground into dried cream powder, and is standby;
(3) select suppository medicinal substrate and additives thereof commonly used on the pharmaceutics for use, after gained dried cream powder in above-mentioned (2) mixes, pour in the suppository mould, cooling, namely.
Technical solution of the present invention is specifically realized by following steps:
(1) get 1170 parts of Semen Crataegis, be ground into coarse granule, adding with the medical material weight ratio is that 8～12 times of amounts, concentration are that 60%～90% alcohol heating reflux extracts 1～3 time, and each 1～2h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 6～10 times of amounts, and heating decocts extracts 1～3 time, and each 1～2h filters, merging filtrate, and water liquid is continued to employ;
(2) the water liquid in above-mentioned (1) is added ethanol and make and contain the alcohol amount and reach 60%-80%, behind the cold preservation 12-36h, filter, after filtrate merges with ethanol liquid in (1), decompression recycling ethanol and concentrate drying, be ground into dried cream powder, standby;
(3) select suppository medicinal substrate and additives thereof commonly used on the pharmaceutics for use, after gained dried cream powder in above-mentioned (2) mixes, pour in the suppository mould, cooling, namely.
The final optimized technical scheme of preparation of the present invention is as follows:
(1) get 1170 parts of Semen Crataegis, be ground into coarse granule, adding with the medical material weight ratio is that 10 times of amounts, 70% alcohol heating reflux extract 2 times, and each 1.5h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 8 times of amounts, and heating decocts extracts 2 times, and each 1h filters, merging filtrate, and water liquid is continued to employ;
(2) the water liquid in above-mentioned (1) is added ethanol and make and contain the alcohol amount and reach 70%, behind the cold preservation 24h, filter, after filtrate merges with ethanol liquid in (1), decompression recycling ethanol and concentrate drying, be ground into dried cream powder, standby;
(3) select suppository medicinal substrate and additives thereof commonly used on the pharmaceutics for use, after gained dried cream powder in above-mentioned (2) mixes, pour in the suppository mould, cooling, namely.
Above-mentioned Chinese medicine preparation suppository medicinal substrate is one or several the mixture in cocoa butter, semi-synthetic cocos nucifera oil fat, semi-synthetic palm oil grease, glycerin gelatine, polyethylene glycols, Myrj 45, poloxamer and the carbomer; Suppository additives in the preparation are one or several in absorption enhancer, plasticizer, antioxidant and the antiseptic, and wherein absorption enhancer is selected for use is one or several mixture of tween 80, azone, dimethyl sulfoxide, propylene glycol and Polyethylene Glycol apoplexy due to endogenous wind; Plasticizer is selected for use is one or several mixture in tween 80, fatty glyceride, glycerol and the propylene glycol; Antioxidant is selected for use is one or several mixture in gallic acid, tannic acid and the ascorbic acid; What antiseptic was selected for use is parabens.
In the technical scheme (3) of above-mentioned Chinese medicine preparation, preferred medicinal substrate is glycerin gelatine, and its concrete step is as follows:
Get 30～50 parts of adding distil waters of gelatin and soak 0.5～1.5h, after treating the gelatin complete expansion, add in 30～50 parts of water-baths of glycerol after the heat fused, add in above-mentioned (2) gained medicinal liquid and suppository additives azone thereof, ethyl hydroxybenzoate is an amount of, after fully stirring evenly, pour in the suppository mould, take out the cooling back, namely.
Its optimized technical scheme (3) is as follows:
Get 40 parts of adding distil waters of gelatin and soak 1h, treat the gelatin complete expansion after, add in 40 parts of water-baths of glycerol after the heat fused, add in above-mentioned (2) gained medicinal liquid and suppository additives azone thereof, ethyl hydroxybenzoate is an amount of, after fully stirring evenly, pour in the suppository mould, take out the cooling back, namely.
Chinese medicine preparation of the present invention has detoxifying, removing dampness, the effect of killing parasites for relieving itching.Be used for pudendal pruritus, leukorrhagia that noxious dampness is made a bet, colpitis mycotica and nonspecific vaginitis are seen above-mentioned card marquis person.We are in the middle of the research process of reality, than the patent 03139655.0 in first to file, extraction purification, the moulding process of medical material all have huge difference, belong to and have taked different technological means, to bring the brand-new technology effect thus, concrete beneficial effect is as follows.
Chinese medicine preparation of the present invention is only made by Semen Crataegi single medical material, and its prescription simplifies, efficiently; Since ancient times, Fructus Crataegi can be used as medicine, and has the effect of promoting digestion and invigorating the stomach, circulation of qi promoting dissipating blood stasis, invigorating the spleen and benefiting QI, yet less about the research report of Semen Crataegi.We have at first carried out a large amount of exploratory studys to its effect and preparation; in previous application documents 03139655.0; Semen Crataegi is collected dry distillation liquid and empyreumatic oil by the high-temperature retorting technology; and the two is made according to certain composition proportioning a kind ofly treats vaginitis, dermopathic medicine has carried out open report, and be protected thus.But we find that this technical scheme production cost is higher in long-term application practice, and medication operation inconvenience, liquid waste are big, are necessary to change medicine basis and preparation technology, expand the clinical application scope and reduce production costs.Then be with after being ground into coarse grained Semen Crataegi and carrying out alcohol extraction for the technical scheme of the present patent application, medicinal residues carry out water extract-alcohol precipitation again, merge ethanol liquid then and reclaim ethanol, be dried and crushed into dried cream powder, again in conjunction with the physicochemical property of extracting solution and the clinical practice characteristics of vaginitis class disease thereof, our creationary suppository formulations that finally is made into the direct administration of vagina.With the patent scheme of correlation technique 03139655.0 and technology contents of the present invention more as can be known, the former is a kind of technology that macromolecular substances is cracked into small-molecule substance by chemical method, the gained chemical constituent is single, main component is furfural, guaiaci lignum phenols material, be fit to topical, owing to be the cracking gained, therefore the material base of its pharmaceutical preparation onset of finally making is the chemical substance that does not originally have in the Semen Crataegi, and material and performance to production equipment all have higher requirement, thereby can cause that lysis efficiency is wayward.In addition, furfural, this small molecule material of guaiacol cause curative effect of medication to be difficult to guarantee at the easy oxidation deterioration of storage process.And in the technology of the present invention brand-new thinking theory is taked in the drug utilization of Semen Crataegi, the solvent method of employing physics extracts the active chemical in the Semen Crataegi, and carries out certain refining pure metallization processes, finally is made into Chinese medicine suppository evident in efficacy.Thus, we can significantly draw the diversity that the two technical scheme and technical thought have matter, and the pharmaceutical preparation of making therefrom not only has different moulding process, and having a diverse curative effect effect basis, this point is one of the outstanding substantive distinguishing features of the present patent application just.
In addition, we are also in the research of the extraction and purification process of medicine of the present invention, for the active constituent content of other the prepared preparation of extracting method, the kind of chemical constituent such as only take that alcohol extraction, decocting boil, stability of formulation and homogeneity etc. quality evaluation parameter is studied, the above-mentioned evaluation index of finding its result and the prepared medicine of technical scheme of the present invention has the kind of bigger diversity, particularly active substance and content, and difference is huge especially; And we also carry out the curative effect comparison by following " pharmacodynamic study " experiment, find results such as its bacteriostasis antibiosis, antiinflammatory and clinical efficacy, all with technical scheme of the present invention significant difference are arranged, and its efficacy result obviously is worse than technology contents of the present invention.
In a word, the technical scheme of extraction purification of the present invention, molding is that we are in the research process of reality, by unremitting groping and accidental discovery, and the clinical practice demand of the said preparation of comprehensively having investigated, reasonably plan as a whole, comparison and the process route that draws, thereby guaranteed science, the high efficiency of the Chinese medicine preparation finally made.
Below be the pharmacodynamics test research detailed to content of the present invention, consider zooperal operability, therefore we will fully verify the drug effect of the middle product medicine of the present invention group in pharmacodynamic experiment, below only provide with the best-of-breed technology scheme is the result of study of representative, helping those skilled in the art to the understanding of the technology of the present invention effect, however the technology of the present invention content never be limited to this scope.
1 test material and result processing method:
1.1 the preparation of trial drug group of the present invention:
(1) get Semen Crataegi 1170g, be ground into coarse granule, adding with the medical material weight ratio is that 10 times of amounts, 70% alcohol heating reflux extract 2 times, and each 1.5h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 8 times of amounts, and heating decocts extracts 2 times, and each 1h filters, merging filtrate, and water liquid is continued to employ;
(2) the water liquid in above-mentioned (1) is added ethanol and make and contain the alcohol amount and reach 70%, behind the cold preservation 24h, filter, after filtrate merges with ethanol liquid in (1), decompression recycling ethanol and concentrate drying, be ground into dried cream powder, standby; Face with before adding water and be made into certain density medicinal liquid, namely get product group in the middle of the medicine of the present invention;
(3) get gelatin 40g adding distil water and soak 1h, after treating the gelatin complete expansion, add in the glycerol 40g water-bath after the heat fused, add in above-mentioned (2) gained dried cream powder and suppository additives azone thereof, ethyl hydroxybenzoate is an amount of, after fully stirring evenly, pour in the suppository mould, take out the cooling back, namely gets final drug group of the present invention.
1.2 laboratory animal: Cavia porcellus, Kunming kind white mice is provided by The Fourth Military Medical University's Experimental Animal Center.
1.3 bacterial strain, infusorian and culture medium: Hemophilus vaginalis(Hemophilus vaginalis), escherichia coli ATCC25922 strain, staphylococcus aureus ATCC25925 strain, blue pus organism ATCC27853 strain, Candida albicans ATCC10231; Trichomonas vaginitis; The CPLM culture medium, improvement Sabourad culture medium, nutrient broth medium.
1.4 statistical procedures: experimental result with
Expression adopts the t check to measure the significance of group difference.
2 test methods and result:
2.1 vitro antibacterial activity:
(1) preparation of medicinal liquid: pipette the middle product medicine of the present invention group, each 20ml of positive control metronidazole solution (0.01mg/ml), behind 80ml meat soup mixing, with aperture 0.22 μ m ultra micro filter filtration sterilization, sterile liquid medicine is put 4 ℃ of refrigerators and is preserved standby.
(2) bacterium liquid preparation: the experimental bacteria of cultivation in 37 ℃, 24 hours is inoculated in meat soup, puts 37 ℃ of common incubators, cultivated in 24 hours, turbidimetry is carried out count of bacteria, is deployed into 10 with meat soup
6CFU/ml bacterium liquid is standby.
(3) MIC, MBC measure: medicinal liquid is carried out continuous two times gradient dilutions by 10% for starting point with meat soup, be added to successively on the 96 porocyte culture plates, adding concentration again is 10
6The experimental bacteria liquid of CFU/ml is set up the contrast of antibacterial and culture medium simultaneously, puts 4 ℃ of effects 12 hours, in 37 ℃ of common incubators, cultivation in 48 hours, observed result.The little drug level of no bacterial growth Kongzui is minimal inhibitory concentration (MIC) (unit: g crude drug/ml).Again successively with the culture in each no bacterial growth hole with 10 times of sterile distilled water dilutions, draw the 0.01ml dibbling in the plain agar flat board, put 37 ℃ of incubators, cultivated in 48 hours, the corresponding medicine Cmin in no bacterial growth dibbling zone is minimal bactericidal concentration (MBC) (unit: g crude drug/ml), the results are shown in Table 1,2.
The mensuration of the MIC of table 1 pair bacterial strain (
N=20)
Annotate: compare with metronidazole medicine group,
*P＜0.05.
As known from Table 1, product medicine group and metronidazole medicine group are in the test of in-vitro antibacterial MIC in the middle of the present invention, the two all has significant bacteriostasis to Hemophilus vaginalis(Hemophilus vaginalis), escherichia coli, blue pus organism, staphylococcus aureus, Candida albicans strain, and compare with metronidazole medicine group, product medicine group has all reached the difference effect of significance in the middle of the present invention to the measurement result of the MIC of above bacterial strain.
The mensuration of the MBC of table 2 pair bacterial strain (
N=20)
Annotate: compare with metronidazole medicine group,
*P＜0.05,
*P＜0.01.
As known from Table 2: product medicine group and metronidazole medicine group are in the test of the minimal bactericidal concentration of in-vitro antibacterial in the middle of the present invention, no matter the two all has significant bactericidal action to Hemophilus vaginalis(Hemophilus vaginalis), escherichia coli, blue pus organism, staphylococcus aureus, Candida albicans strain, especially more outstanding to the bactericidal action of Candida albicans and Hemophilus vaginalis(Hemophilus vaginalis).Compare with metronidazole medicine group, product medicine group has significant difference to above-mentioned bacterial strains MBC measurement result in the middle of the present invention.
By studies show that of above in-vitro antibacterial test, product medicine group all has significantly antibacterial and bactericidal action to the various bacteria bacterial strain in the middle of the present invention, and with the apparent in view difference effect that has reached significance of low concentration metronidazole medicine, the result of study prompting: medicine group of the present invention has good antiinflammatory action, and the vaginitis disease in clinical is had the good curing effect.
2.2 the vitro inhibition effect to trichomonas vaginitis:
With clinical separation and through transferred species well-grown infusorian in the CPLM culture medium repeatedly, with this culture medium dilution into about 6 * 10
5Bar/mL (with the blood cell counting plate counting).Adopt doubling dilution, use the CPLM culture medium, product drug matching in the middle of the present invention is made series concentration, each concentration 2 pipe is inoculated the outstanding 0.3ml of above-mentioned infusorian respectively and (is contained 1.8 * 10 approximately
5Bar) put 37 ℃ and cultivate 48h, ask with the blood cell counting plate counting and press down the worm rate, in addition we to kill lowest drug concentration 95% or more serve as minimum but worm concentration (MIC) the results are shown in Table 3.
The vitro inhibition effect result of study of table 3 pair trichomonas vaginitis
As shown in Table 3: product medicine group has the obvious suppression effect to trichomonas vaginitis in the middle of the present invention, when drug level is 585g crude drug amount/L, all have 100% but the worm rate.When drug level is 73g crude drug amount/L, in the middle of the present invention product medicine group just reached minimum but worm concentration, namely killing rate is more than 95%; Above-mentioned result of study prompting: product medicine group is to the therapeutic effect highly significant of trichomonas vaginitis in the middle of the present invention.
2.3 the influence to histamine phosphate's itch-threshold value:
40 of Cavia porcelluss are divided into 4 groups at random, are respectively blank group, metronidazole positive controls, the middle product medicine of the present invention group.Tested preceding 1 day, each organizes the depilation of the right back instep of Cavia porcellus and coating 1 time.Experiment is worked as daily coarse sandpaper and is abraded right back instep depilation place epidermis 1cm
2, repasting medicine 1 time, behind the 20min, 0.01% 0.05mL/ of histamine phosphate Mus is dripped in the district in the scratch depilation, after this, every 3min successively with 0.02,0.03,0.04,0.05% ... the concentration that increases progressively drips that later to lick right back histamine's total amount when sufficient to Cavia porcellus be the itch-threshold value, the results are shown in Table 4.
Due to the table 4 pair histamine phosphate Cavia porcellus itch threshold value influence (
N=10)
Annotate: compare with the normal saline matched group,
* *P＜0.001; Compare with metronidazole medicine group,
△P＜0.05.
No matter as shown in Table 4, compare with the normal saline group, be product group in the middle of the present invention, or metronidazole medicine group, and all the Cavia porcellus itch-threshold value that histamine phosphate is caused reaches extremely significant diversity effect, shows that the two all has good itching-relieving action; Compare with metronidazole medicine group, product medicine group obviously has the Cavia porcellus itch-threshold value of raising and has also reached significant diversity effect in the middle of the present invention, point out technical scheme of the present invention to have good antipruritic ability, this is the unusual therapeutical effect of produce effects for the vaginitis disease.
2.4 antiinflammatory action:
(1) to the influence of mice ear: get 40 of mices, be divided into 4 groups at random, be administered once every day, gastric infusion 7d, behind last administration 1h, be coated with dimethylbenzene 0.05ml in the mouse right ear positive and negative, to 2h behind the dimethylbenzene, put to death animal, cut ear, sweep away auricle in corresponding site with the 8mm steel drift, weigh, difference with left and right sides ear weight is the swelling degree, the results are shown in Table 5.
Table 5 xylol causes the influence of mice ear
Annotate: compare with the normal saline group,
* *P＜0.001.
(2) to the influence of mouse skin capillary permeability: get 40 of mices, be divided into 4 groups at random, be administered once every day, gastric infusion 7d, behind last administration 1h, tail vein injection 1% Azo-Blue normal saline 0.1ml/10g body weight, and inject histamine 5 μ g (0.1ml) in abdominal part depilation place Intradermal immediately.Behind the 20min, put to death animal, cut indigo plant and dye skin graft, be soaked in acetone normal saline (7: the 3) mixed liquor, behind the 24min, the centrifuging and taking supernatant the results are shown in Table 6 in 721 type spectrophotometer wavelength 610nm colorimetrics.
The influence of table 6 pair mouse skin capillary permeability
Annotate: compare with the normal saline group,
* *P＜0.001; Compare with metronidazole medicine group,
△P＜0.05.
(3) to the influence of mice granuloma induced by implantation of cotton pellets: implant each 1 of 5mg sterilized cotton ball in oxter, the mice left and right sides, the grouping administration, every day 1 time, 7d puts to death animal behind last administration 1h altogether, gets granuloma induced by implantation of cotton pellets, and weigh (weight in wet base) the results are shown in Table 7.
The table 7 pair granulomatous influence of mice cotton balls number (
Mg)
Annotate: compare with the normal saline group,
*P＜0.01,
* *P＜0.001; Compare with metronidazole medicine group,
△P＜0.05.
(4) to the influence of inflammation exudate PGE content: get 40 of mices, be divided into 4 groups at random, be administered once every day, gavage medicine 7d, behind last administration 1h, injection 1% carrageenin 0.1ml/ only under the foot plantar aponeurosis of a left side, behind the 3h, cut swollen foot from Mus left hind joint, weigh, peeling shreds, steep 40min in the 5ml normal saline, get supernatant 0.5ml, add 2ml 10.5N KOH methanol solution, isomerization 20min in 50 ℃ of water-baths, add methanol again and be diluted to 20ml, survey its optical density with 751 type spectrophotometer wavelength 278nm, try to achieve the PGE total content, see Table 8.
The influence of table 8 pair inflammation exudate PGE content
Annotate: compare with the normal saline group,
* *P＜0.001; Compare with metronidazole medicine group,
△P＜0.05.
Experimental result by table 5-8 shows that product medicine group and metronidazole medicine group all have good antiinflammatory action in the middle of the present invention in above-mentioned antiinflammatory experiment, compare with the normal saline group, and the two has all reached the difference of significance; Compare with metronidazole medicine group, medicine group of the present invention all has the effect of the significance difference opposite sex in to the experiment of antiinflammatories such as mice, capillary permeability, granuloma induced by implantation of cotton pellets, inflammation exudate PGE content; Above result of the test prompting: product medicine group has good antiinflammatory action in the middle of the present invention.
Product medicine group had better curative effect aspect the treatment colpitis in the middle of above pharmacological evaluation had confirmed the present invention, and in order comprehensively to verify the curative effect of final drug of the present invention, we have also carried out corresponding clinical experimental study, now the result are reported as follows.
(1) object of study: vaginitis patient 190 examples of in February, 2008～2011 step-length hospital in year February, make a definite diagnosis according to " new drug (Chinese medicine) clinical research guideline vaginitis diagnosis and treatment standard " transvaginal secretions inspection, trichomonal vaginitis 70 examples wherein, colpitis mycotica 74 examples, bacterial vaginitis 42 examples, infusorian mycete concurrent infection 4 examples.
(2) method: according to making the clinical trial medicine in above-mentioned 1.1 the method, carry out clinical administration according to following method then: the patient cleans pudendum with warm water, cleans both hands, gets 1 piece of suppository then, puts people's vagina deep gently, and every day twice, 7d is 1 course for the treatment of; Infusorian property, colpitis mycotica should be in menstruation medications in the 4th day later, and respectively are used in conjunction 7d again in second and third menstrual cycle, and respectively check 1 time through after date every month, and other vaginitiss are except passing through, but sexual life is prohibited in all medications during the treatment.
(3) efficacy assessment standard: consult and carry out " new drug (Chinese medicine) clinical research guideline vaginitis diagnosis and treatment standard ".Recovery from illness: infusorian property, colpitis mycotica need to observe 3 menstrual cycle by after the medication course for the treatment of of above regulation, and symptom all disappears, through after three vaginal smear examination infusorian all negative.Other vaginitis symptoms disappear, and the vaginal secretions inspection is turned out cloudy.Produce effects: symptom disappears substantially or is clearly better, and vaginal smear examination infusorian or mycete are turned out cloudy.Effectively: sx, vaginal secretions check negative or show weak positive.Invalid: though through treatment, symptom and vaginal secretions all do not have change.
(4) result: by above clinical research result as can be known: 114 examples of wherein fully recovering account for 60%; Produce effects 20 examples account for 10.5%; Effective 46 examples account for 24.2%; Invalid 10 examples account for 5.3%; Total effective rate is 94.7%.
Above-mentioned clinical research result shows that final drug group of the present invention has obviously good action effect on the vaginitis treatment of diseases that various pathogenic bacterias cause.
Show according to above research contents, Chinese medicine preparation of the present invention has characteristics such as preparation technology is efficiently feasible, drug effect is clear and definite, stable curative effect is reliable, its curative effect effect not only is better than the positive controls metronidazole, no matter its beneficial effect is from the extraction and purification process of medicine, or the forming technique of finished product preparation, all effectively guaranteed the excellent results of preparation of the present invention, this will bring great potential and development space for the clinical practice of this Chinese medicine preparation.
The specific embodiment
Below be the specific embodiment of content of the present invention, be used for setting forth the technical scheme that present specification is wanted the technical solution problem, help those skilled in the art to understand content of the present invention.But the realization of technical solution of the present invention is not limited to these embodiment.
Embodiment 1
(1) get Semen Crataegi 1170g, be ground into coarse granule, adding with the medical material weight ratio is that 10 times of amounts, 70% alcohol heating reflux extract 2 times, and each 1.5h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 8 times of amounts, and heating decocts extracts 2 times, and each 1h filters, merging filtrate, and water liquid is continued to employ;
(2) the water liquid in above-mentioned (1) is added ethanol and make and contain the alcohol amount and reach 70%, behind the cold preservation 24h, filter, after filtrate merges with ethanol liquid in (1), decompression recycling ethanol and concentrate drying, be ground into dried cream powder, standby;
(3) get gelatin 40g adding distil water and soak 1h, treat the gelatin complete expansion after, add in the glycerol 40g water-bath after the heat fused, add in above-mentioned (2) gained dried cream powder and suppository additives azone thereof, ethyl hydroxybenzoate is an amount of, after fully stirring evenly, pour in the suppository mould, take out the cooling back, namely.
Embodiment 2
(1) get Semen Crataegi 1170g, be ground into coarse granule, adding with the medical material weight ratio is that 8 times of amounts, 60% alcohol heating reflux extract 3 times, and each 1h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 10 times of amounts, and heating decocts extracts 1 time, and each 2h filters, merging filtrate, and water liquid is continued to employ;
(2) the water liquid in above-mentioned (1) is added ethanol and make and contain the alcohol amount and reach 80%, behind the cold preservation 36h, filter, after filtrate merges with ethanol liquid in (1), decompression recycling ethanol and concentrate drying, be ground into dried cream powder, standby;
(3) get gelatin 30g adding distil water and soak 0.5h, treat the gelatin complete expansion after, add in the glycerol 30g water-bath after the heat fused, add in above-mentioned (2) gained dried cream powder and suppository additives azone thereof, ethyl hydroxybenzoate is an amount of, after fully stirring evenly, pour in the suppository mould, take out the cooling back, namely.
Embodiment 3
(1) get Semen Crataegi 1170g, be ground into coarse granule, adding with the medical material weight ratio is that 12 times of amounts, 90% alcohol heating reflux extract 1 time, and each 2h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 6 times of amounts, and heating decocts extracts 3 times, and each 1.5h filters, merging filtrate, and water liquid is continued to employ;
(2) the water liquid in above-mentioned (1) is added ethanol and make and contain the alcohol amount and reach 60%, behind the cold preservation 12h, filter, after filtrate merges with ethanol liquid in (1), decompression recycling ethanol and concentrate drying, be ground into dried cream powder, standby;
(3) get gelatin 50g adding distil water and soak 1.5h, treat the gelatin complete expansion after, add in the glycerol 50g water-bath after the heat fused, add in above-mentioned (2) gained dried cream powder and suppository additives azone thereof, ethyl hydroxybenzoate is an amount of, after fully stirring evenly, pour in the suppository mould, take out the cooling back, namely.
In specific implementation process, the medicinal substrate glycerin gelatine can select for use one or several the mixture in cocoa butter, semi-synthetic cocos nucifera oil fat, semi-synthetic palm oil grease, glycerin gelatine, polyethylene glycols, Myrj 45, poloxamer and the carbomer to replace; The suppository additives can be one or several in absorption enhancer, plasticizer, antioxidant and the antiseptic, and wherein absorption enhancer can be selected one or several mixture of tween 80, azone, dimethyl sulfoxide, propylene glycol and Polyethylene Glycol apoplexy due to endogenous wind for use; Plasticizer can be selected one or several the mixture in tween 80, fatty glyceride, glycerol and the propylene glycol for use; Antioxidant can be selected one or several the mixture in gallic acid, tannic acid and the ascorbic acid for use; Antiseptic can be selected parabens for use.
Claims (8)
1. treat colpitic Chinese medicine preparation for one kind, it is characterized in that it is to be prepared from by following technology:
⑴ get 1170 parts of Semen Crataegis, is ground into coarse granule, and adding with the medical material weight ratio is that 8～12 times of amounts, concentration are that 60%～90% alcohol heating reflux extracts 1～3 time, and each 1～2h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 6～10 times of amounts, and heating decocts extracts 1～3 time, and each 1～2h filters, merging filtrate, and water liquid is continued to employ;
⑵ add ethanol with the water liquid among the above-mentioned ⑴ makes and contains the alcohol amount and reach 60%-80%, behind the cold preservation 12-36h, filters, and after the ethanol liquid merging among filtrate and the ⑴, decompression recycling ethanol and concentrate drying, is ground into dried cream powder, standby;
⑶ select suppository medicinal substrate and additives thereof commonly used on the pharmaceutics for use, after the gained dried cream powder mixes among the above-mentioned ⑵, pour in the suppository mould, and cooling, namely.
2. the colpitic Chinese medicine preparation for the treatment of as claimed in claim 1 is characterized in that it is to be prepared from by following technology:
⑴ get 1170 parts of Semen Crataegis, is ground into coarse granule, and adding with the medical material weight ratio is that 10 times of amounts, 70% alcohol heating reflux extract 2 times, and each 1.5h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 8 times of amounts, and heating decocts extracts 2 times, and each 1h filters, merging filtrate, and water liquid is continued to employ;
⑵ add ethanol with the water liquid among the above-mentioned ⑴ makes and contains the alcohol amount and reach 70%, behind the cold preservation 24h, filters, and after the ethanol liquid merging among filtrate and the ⑴, decompression recycling ethanol and concentrate drying, is ground into dried cream powder, standby;
⑶ select suppository medicinal substrate and additives thereof commonly used on the pharmaceutics for use, after the gained dried cream powder mixes among the above-mentioned ⑵, pour in the suppository mould, and cooling, namely.
3. the preparation method of the colpitic Chinese medicine preparation for the treatment of as claimed in claim 1 is characterized in that:
⑴ get 1170 parts of Semen Crataegis, is ground into coarse granule, and adding with the medical material weight ratio is that 8～12 times of amounts, concentration are that 60%～90% alcohol heating reflux extracts 1～3 time, and each 1～2h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 6～10 times of amounts, and heating decocts extracts 1～3 time, and each 1～2h filters, merging filtrate, and water liquid is continued to employ;
⑵ add ethanol with the water liquid among the above-mentioned ⑴ makes and contains the alcohol amount and reach 60%-80%, behind the cold preservation 12-36h, filters, and after the ethanol liquid merging among filtrate and the ⑴, decompression recycling ethanol and concentrate drying, is ground into dried cream powder, standby;
⑶ select suppository medicinal substrate and additives thereof commonly used on the pharmaceutics for use, after the gained dried cream powder mixes among the above-mentioned ⑵, pour in the suppository mould, and cooling, namely.
4. the preparation method of the colpitic Chinese medicine preparation for the treatment of as claimed in claim 3 is characterized in that:
⑴ get 1170 parts of Semen Crataegis, is ground into coarse granule, and adding with the medical material weight ratio is that 10 times of amounts, 70% alcohol heating reflux extract 2 times, and each 1.5h filters, merging filtrate, and medicinal liquid is continued to employ; Adding with the medical material weight ratio in the medicinal residues is the water of 8 times of amounts, and heating decocts extracts 2 times, and each 1h filters, merging filtrate, and water liquid is continued to employ;
⑵ add ethanol with the water liquid among the above-mentioned ⑴ makes and contains the alcohol amount and reach 70%, behind the cold preservation 24h, filters, and after the ethanol liquid merging among filtrate and the ⑴, decompression recycling ethanol and concentrate drying, is ground into dried cream powder, standby;
⑶ get 30～50 parts of adding distil waters of gelatin and soak 0.5～1.5h, treat the gelatin complete expansion after, add 30～50 parts of glycerol, after the heat fused, add gained dried cream powder and suppository additives thereof among the above-mentioned ⑵, after fully stirring evenly in the water-bath, pour in the suppository mould, take out the cooling back, namely.
5. the preparation method of the colpitic Chinese medicine preparation for the treatment of as claimed in claim 3 is characterized in that described suppository medicinal substrate is one or several the mixture in cocoa butter, semi-synthetic cocos nucifera oil fat, semi-synthetic palm oil grease, glycerin gelatine, polyethylene glycols, Myrj 45, poloxamer and the carbomer.
6. the preparation method of the colpitic Chinese medicine preparation for the treatment of as claimed in claim 4 is characterized in that described step ⑶ is:
Get 40 parts of adding distil waters of gelatin and soak 1h, treat the gelatin complete expansion after, add in 40 parts of water-baths of glycerol after the heat fused, add among the above-mentioned ⑵ gained dried cream powder and suppository additives azone thereof, ethyl hydroxybenzoate is an amount of, after fully stirring evenly, pour in the suppository mould, take out the cooling back, namely.
7. as the preparation method of claim 3 or the colpitic Chinese medicine preparation of 4 described treatments, it is characterized in that described suppository additives are one or several in absorption enhancer, plasticizer, antioxidant and the antiseptic.
8. the preparation method of the colpitic Chinese medicine preparation for the treatment of as claimed in claim 7, what it is characterized in that described absorption enhancer selects for use is one or several mixture of tween 80, azone, dimethyl sulfoxide, propylene glycol and Polyethylene Glycol apoplexy due to endogenous wind; Plasticizer is selected for use is one or several mixture in tween 80, fatty glyceride, glycerol and the propylene glycol; Antioxidant is selected for use is one or several mixture in gallic acid, tannic acid and the ascorbic acid; Antiseptic is selected parabens for use.
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