CN104587165A - Preparation process of compound fenticonazole nitrate preparation - Google Patents
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Abstract
The invention relates to a preparation process of a compound fenticonazole nitrate preparation. The compound fenticonazole nitrate preparation is a traditional Chinese and western medicine compound preparation and is prepared from the following raw materials in parts by weight: 10g of fenticonazole nitrate, 10g of traditional Chinese medicine effective components, 30g of poloxamer 407, 15g of poloxamer 188, 5g of carbomer, 250g of propylene glycol, 150g of glycerol, 5g of sodium benzoate, 0.3g of ethylene diamine tetraacetic acid and 475g of distilled water. The compound preparation prepared by using a method disclosed by the invention can be used for treating both symptoms and root causes of vaginitis, cannot cause toxicity and harms to a human body, does not have side effects, is low in cost and simple and convenient to prepare, and has wide application prospects.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of preparation technology of compound recipe fenticonazole nitrate preparation.
Background technology
Vaginitis be a kind of with the change of leucorrhea character, pruritus vulvae, pudendum causalgia, sexual anhedonia for main clinical manifestation, the diseases associated with inflammation that women is common, frequent micturition, urgent micturition, dysurea can be levied with bladder irritation, severe patient can occur that vagina is hemorrhage on a small quantity, course of disease elder can be occurred together anemia, the symptoms such as appearance headache, dizzy, asthenia is unable, insomnia Yi Xing are a kind of gynecological common diseases of puzzlement women's health.From dissection, the pudendum of women is in the state of a Natural closure, and vaginal wall is also closed state at front and rear wall at ordinary times, and it is a route of transmission of colpitis mycotica that mediate contact infects.Contact, by the toilet seat in the common lavatory of mycete patient infection, bathtub, bathing pool seat, towel, uses unclean toilet paper, can cause propagation, when the vulvoaginal candidiasis of infected person reaches some, mycotic vulvovaginitis can occur.
At present, doctor trained in Western medicine for colpitic treatment adopt more local and whole body application antibiotic with or triazole antifungal agent, fenticonazole nitrate is common drug,
Fenticonazole nitrate
English language Chemical name: 1-[2-(2,4-dichlorophenyl)-2-[[4-(phenylthio) phenyl] methoxy] ethyl-1H-imidazole mononitrate
Chinesization formal name used at school: 1-[2-(2,4-Dichlorobenzene base)-2-[[4-(benzene sulfo-) phenyl] methoxyl group] ethyl-1H-imidazole nitrate.
Structural formula:
Molecular formula: C24H20Cl2N2OSHNO3
Fenticonazole nitrate is imidazoles broad-spectrum antifungal medicine, is used for the treatment of superficial mycosis and vaginal Candida infection.This medicine went through to go on the market in 1986 in Italy, and dosage form has ointment, spray and vaginal suppository.Its mechanism of action makes the phospholipid of its cell wall present labile state by the hydroxylation of the cytochrome P-450 of Antifungi cell, and then fungal cell is broken and necrosis, but, the balance of nature of vagina easily broken by this medicine, change the microenvironment of vagina, drug withdrawal easily repeatedly, easily causes the generation of other vagina simultaneously owing to breaking colony balance, the time for the treatment of and rehabilitation is long.With regard to recent, the late result acquired by it, result is also unsatisfactory.And certain toxic and side effects can be caused, as nephrotoxicity, liver toxicity etc., also can bring out generation drug resistance.
Motherland's medical science thinks that vaginitis belongs to TCM Gynecology miscellaneous diseases pudendal pruritus and leukorrhagia category, and both normal companions mutually see.Pudendal pruritus and leukorrhagia have two reasons: on the one hand and endogenous cause of ill: liver,kidney,spleen malfunction closes, and the liver pulse is around external genitals, and main store blood is again viscus attriguted to wind and wood; Kidney controlling essence storage, main reproduction, have one's ideas straightened out Yu Eryin; The spleen has the function to transport and transform nutrients, and water wets.If dampness-heat of the liver or the life of stagnation of liver-QI with deficiency of the spleen fire-transformation are wet, damp and hot heresy, with through bet, pents up external genitals so pudendal pruritus; Or deficiency of the liver and kindey, blood and essence asthenia, raw air slaking are not dry, pudendum failure of skin and muscle to be nourished, flourish and itch; Infect the sick worm of damp in addition on the one hand with exopathogenic factor relevant, careless because taking the photograph body, cause the sick worm of damp and invade, worm disturbs pudendum, sends out as pudendal pruritus." Yizong Jinjian gynecological heart method gist " said " married woman's pudendal pruritus, how because of parasite caused by accumulation of damp-heat in the body " is namely this meaning.
Pudendal pruritus caused by the sick worm of infection damp, leukorrhagia person show as dampness-heat of the liver more, and thus treatment should with removing damp-heat, killing parasites for relieving itching for principle.Primary disease is mainly because of damp-heat accumulation, and in worm-eaten the moon, caused damp and hot heresy has inside and outside dividing.Cause outside damp invade as occupied wetland etc. for a long time, strongly fragrant and heat-transformation, or menstrual period, puerperal, toxic dampness and heat is taken advantage of a weak point, and this is that diseases caused by exogenous pathogenic factor are damp and hot.If ferritic deficiency-weakness of spleen-QI, or depression of liver-QI, wood gram spleen soil, dysfunction of the spleen in transportation, stay in water is wet, stopping pouring down Jiao, accumulate and heat-transformation, is then that interior life is damp and hot.Damp-heat accumulation, ligament is not solid, then leukorrhagia increases, yellow skin.Damp-heat in lower-JIAO, the excellent then concurrent stranguria of failing to keep an appointment of wing; With the passing of time damp contamination becomes poison, or infects pyretic toxicity pathogen, the absurd row of intenseness of heat forcing blood, or noxious dampness corrosion skin, then visible band defecation with blood and pus, or sees " erosion of the vulva ", " erosion of vulva ".Web rot is infested, or health preserving is careless, and worm heresy directly violates external genitals, then pudendal pruritus in worm-eaten the moon, though causalgia primary disease disease is at external genitals in the moon, often relevant with the internal organs such as liver spleen.
Acid fenticonazole dosage form of abroad going on the market has cream, lotion, aerosol and soft gelatin vaginal suppository, wherein lotion and aerosol short in the lesions position holdup time; In ointment, ointment, effective agent mostly is dispersity, not easily gives full play to drug effect, and is difficult to cleaning after using; Suppository is suitable for cavity/canal drug administration, but fully can not contact with Lesional epidermal or mucosa, is not easy to giving full play to of drug effect, and in recent years, gel applied research is more and more subject to the attention of Chinese scholars.Gel has good bioadhesive and biocompatibility, can with the epidermis of medicine-feeding part or mucosa tight adhesion, make drug delivery system be fixed on specific part, extend the holdup time.Especially situ-gel, with solution state administration, fully contacts with Lesional epidermal or mucosa, at agents area generation phase in version after administration, long in the lesions position holdup time, the object that medicament slow release is long-acting can be reached, become the focus that pharmaceutics and biological technical field are studied.
Motherland's therapeutic treatment vaginitis has had long history, and large quantity research finds in recent years, some Chinese medicine and effective ingredient thereof have significant therapeutic effect to vaginitis, achieve the achievement that some are gratifying, clinical report all obtains good curative effect, therefore seek a kind of dosing techniques easy, the medicament valid density of medicine-feeding part can be maintained, and the compound gel that effectively medicament can be administered into administration difficulty place is the technical barrier of pendulum in face of medical circle.
Summary of the invention
The object of this invention is to provide a kind of dosing techniques easy, the medicament valid density of medicine-feeding part can be maintained, and effectively medicament can be administered into the local compound recipe fenticonazole nitrate preparation of administration difficulty and application thereof.Its objective is to solve treatment vaginitis, etc, overcoming single fenticonazole nitrate onset slow, drug withdrawal easily waits obviously not enough repeatedly, and the problem such as administration is inconvenient, reaches the object for the treatment of both the principal and secondary aspects of a disease.
Present inventor is according to forefathers' experience and oneself medical practice for many years, by the research to Chinese medicine, and in conjunction with dialectical demonstration, in many ways collect the length of many families, seek therapeutic regimen, from motherland's medical treasure-house, filter out the natural Chinese medicine of removing damp-heat, dispelling wind for relieving itching, by theory of Chinese medical science prescription, be meticulously mixed with compound recipe fenticonazole nitrate preparation of the present invention in conjunction with Traditional Chinese Medicine technology, it has the effect of taking stopgap measures and effecting a permanent cure to vaginitis.
For achieving the above object, the technical solution used in the present invention is as follows:
A preparation technology for compound recipe fenticonazole nitrate preparation, described preparation is prepared by following raw material and obtains,
Fenticonazole nitrate 10g, Effective Component of Chinese Medicine 10g, poloxamer188 30g, PLURONICS F87 15g, carbomer 5g, propylene glycol 250g, glycerol 150g, sodium benzoate 5g, disodiumedetate 0.3g, distilled water 475g.
Described Effective Component of Chinese Medicine is prepared by the raw material of following weight proportioning and obtains::
Herba Leonuri 35 parts, Herba Polygoni cymosi 35 parts, Herba Taraxaci 30 parts, Semen Plantaginis 30 parts, Cortex Phellodendri 25 parts,
Caulis Spatholobi 25 parts, Rhizoma Dioscoreae Hypoglaucae 25 parts, the Cortex Eucommiae 22 parts, Radix Notoginseng 20 parts, Rhizoma Chuanxiong 20 parts,
Radix Puerariae 15 parts, Pollen Typhae 15 parts, the Radix Angelicae Dahuricae 10 parts, the Radix Astragali 10 parts, Bulbus Lilii 10 parts, Rhizoma Cyperi 10 parts,
10 parts, Flos Carthami, Herba Artemisiae Anomalae 5 parts, 5 parts, Radix Rubiae, Oletum Trogopterori 5 parts.
The preparation method of described Effective Component of Chinese Medicine is:
(1) raw material is taken according to proportioning;
(2) get Herba Polygoni cymosi, Herba Taraxaci, Semen Plantaginis, Cortex Phellodendri, Caulis Spatholobi, Rhizoma Dioscoreae Hypoglaucae, the Cortex Eucommiae, Radix Puerariae, Pollen Typhae, the Radix Angelicae Dahuricae, the Radix Astragali, Herba Artemisiae Anomalae add 2 times of weight 90% alcohol dipping 24 hours; reflux, extract, twice; each 1 hour; merge extractive liquid; be condensed into the extractum that density is 1.1 ~ 1.2 g/ml, crushed after being dried obtains A;
(3) get residual components water boiling and extraction 2 times, first time extracts the water adding 5 times of weight, and extraction time is 1 hour; Second time extracts the water adding 2 times of weight, and extraction time is 1 hour; Filter, merging filtrate, be concentrated into the thick paste that density is 1.1 ~ 1.2 g/ml, crushed after being dried obtains complex B;
Namely mixed complex A and complex B obtains Effective Component of Chinese Medicine.
The preparation method of described compound recipe fenticonazole nitrate preparation is:
Conventionally prepare gel;
Preferably: fenticonazole nitrate, Effective Component of Chinese Medicine, poloxamer188, PLURONICS F87, glycerol are made to dissolve completely and mix homogeneously in 65 DEG C of heating; Sodium benzoate and disodiumedetate are dissolved in distilled water, carbomer and propylene glycol are joined in above-mentioned solution and make abundant dissolving/or swelling and mix homogeneously; By above-mentioned solution mix homogeneously, to obtain final product.
The polymer selected in the present invention, there is good bioadhesive and biocompatibility, fully contact with medicine-feeding part skin or mucosa upon administration, and be detained the long period in medicine-feeding part, make effective agent be in the ad-hoc location of medicine-feeding part, make drug delivery system be positioned specific medicine-feeding part, effective prolong drug is in the holdup time of medicine-feeding part, the slow release effect making medicine reach good, is conducive to improving bioavailability, gives full play to drug effect.
Technical solutions according to the invention are on the colpitic clinical experience basis of Chinese traditional treatment, in conjunction with modern pharmacy achievement develop with the compound preparation of Integrated TCM.Chinese medicine and Western medicine are combined effectively, symptom can be improved rapidly, effectively control inflammation, stop disease, vaginitis is had to effect of healing, overcome the slow and drug withdrawal of the prior art drug effect easily side effect such as repeatedly, reach the object for the treatment of both the principal and secondary aspects of a disease, recommend medication: vagina administration, start medication in clean period after 2 one 3 days, smear appropriate, (menstrual phase forbids medication) 7 days is a course for the treatment of.
Compound recipe fenticonazole nitrate preparation of the present invention obtains following effect:
1 comprehensively suits vaginitis pathogenesis, and compound recipe composition reduces antibiotic dosage greatly, and prescription is in order reasonable, and drug effect is deeply lasting, medicine letter and power is special;
2 the present invention, by the choose reasonable to medicine components, proportioning, achieve desirable therapeutic effect, have both met state-promulgated pharmacopoeia to the requirement about drug dose, can ensure good therapeutic effect again, non-evident effect.
Detailed description of the invention
Embodiment 1
A preparation technology for compound recipe fenticonazole nitrate preparation, described preparation is prepared by following raw material and obtains,
Fenticonazole nitrate 10g, Effective Component of Chinese Medicine 10g, poloxamer188 30g, PLURONICS F87 15g, carbomer 5g, propylene glycol 250g, glycerol 150g, sodium benzoate 5g, disodiumedetate 0.3g, distilled water 475g.
Described Effective Component of Chinese Medicine is prepared by the raw material of following weight proportioning and obtains::
Herba Leonuri 35 parts, Herba Polygoni cymosi 35 parts, Herba Taraxaci 30 parts, Semen Plantaginis 30 parts, Cortex Phellodendri 25 parts,
Caulis Spatholobi 25 parts, Rhizoma Dioscoreae Hypoglaucae 25 parts, the Cortex Eucommiae 22 parts, Radix Notoginseng 20 parts, Rhizoma Chuanxiong 20 parts,
Radix Puerariae 15 parts, Pollen Typhae 15 parts, the Radix Angelicae Dahuricae 10 parts, the Radix Astragali 10 parts, Bulbus Lilii 10 parts, Rhizoma Cyperi 10 parts,
10 parts, Flos Carthami, Herba Artemisiae Anomalae 5 parts, 5 parts, Radix Rubiae, Oletum Trogopterori 5 parts.
The preparation method of described Effective Component of Chinese Medicine is:
(1) raw material is taken according to proportioning;
(2) get Herba Polygoni cymosi, Herba Taraxaci, Semen Plantaginis, Cortex Phellodendri, Caulis Spatholobi, Rhizoma Dioscoreae Hypoglaucae, the Cortex Eucommiae, Radix Puerariae, Pollen Typhae, the Radix Angelicae Dahuricae, the Radix Astragali, Herba Artemisiae Anomalae add 2 times of weight 90% alcohol dipping 24 hours; reflux, extract, twice; each 1 hour; merge extractive liquid; be condensed into the extractum that density is 1.2 g/ml, crushed after being dried obtains A;
(3) get residual components water boiling and extraction 2 times, first time extracts the water adding 5 times of weight, and extraction time is 1 hour; Second time extracts the water adding 2 times of weight, and extraction time is 1 hour; Filter, merging filtrate, be concentrated into the thick paste that density is 1.2 g/ml, crushed after being dried obtains complex B;
Namely mixed complex A and complex B obtains Effective Component of Chinese Medicine.
The preparation method of described compound recipe fenticonazole nitrate preparation is:
Fenticonazole nitrate, Effective Component of Chinese Medicine, poloxamer188, PLURONICS F87, glycerol are made to dissolve completely and mix homogeneously in 65 DEG C of heating; Sodium benzoate and disodiumedetate are dissolved in distilled water, carbomer and propylene glycol are joined in above-mentioned solution and make abundant dissolving/or swelling and mix homogeneously; By above-mentioned solution mix homogeneously, to obtain final product.
Bioadhesive (bioadhesion in vitro test)
Test method: the fresh vagina tissue two sections getting rabbit, be individually fixed in bottom glass ampule, testing sample to be coated on two sections of vagina tissues and to make it reach required temperature, after two sections of vagina tissues are connected by testing sample, measure the peeling force that two sections of two sections of vagina tissues sticked by gel are separated just, and calculate Bioadhesive force (peeling force of unit are).Result is as follows: N/cm
25 DEG C of adhesive force (m N/cm
2) 30.15;
33 DEG C of adhesive force (m N/cm
2) 38.73;
Embodiment 2
Toxicological study
1 acute toxicity test:
30 rabbit are divided into 3 groups at random, often organize 10, male and female half and half, with 10% sodium sulfide to family's rabbit back depilation, unhairing area is about 150cm
2.The making of damaged skin adopts sterilization ferrum file to scratch (with oozing of blood degree of being), invention formulation 0.2 is applied respectively after unhairing, 0.5 and 0.7ml in depilation district being fixed with nonirritant adhesive plaster, every animal sub-cage rearing, administration after 24 hours 1,24,48,72 little of the 7th day, observe every day and record the change of the body weight of animal, fur, gloss, diet, eye and mucosa, the activity of respiratory center, nervous system, extremity and death condition, and put to death rabbit after Yu Qi, the change of the internal organs such as its heart of anatomic observation, liver, spleen, lung, kidney.
Result: gel prepared by the present invention is to the behavior of damaged skin rabbit, activity, diet, fur gloss, respiratory center, nervous system and body weight without any harmful effect, and none rabbit is dead.Rabbit is put to death, the main organs no abnormality seens such as its heart of anatomic observation, liver, spleen, lung, kidney after seven days.Therefore compound medicine of the present invention does not all cause acute toxic reaction to rabbit on damaged skin.
2 long term toxicities carry out the chronic toxicity test of 6 months by a definite date to rat and Canis familiaris L. oral administration, and overall test results shows that toleration is good.
3 irritation test results of study displays: normal and damaged skin is showed no zest to this product to rabbit; This product dermal topical application has no has sensitization to Cavia porcellus.
4 reproductive toxicity tests can not disturb the gonad function of masculinity and femininity, can not change the reproductive function of first stage.Reproductive toxicology research display, the same with other imidazole derivatives, there is fetology effect (> 20mg/kg), without sensitization, phototoxicity and photoallergy in high dose group.
Mouse model is studied
The impact of medicine dialogue beads vaginitis model mouse vagina of the present invention
Laboratory animal: ICR mice, all female, body weight 18g-22g.
Trial drug: gel prepared by embodiment 1; Contrast 1 group: JIEERYIN XIYE, commercially available; Contrast 2 groups (CN103349755, fenticonazole nitrate suppositories prepared by embodiment 1)
Modeling: get healthy mice 50, female, body weight 18-22g, wherein 10 mices are as Normal group, all the other 40 equal subcutaneous injection estradiol benzoate 5mg/kg, every other day once, totally 3 times, the 6th day mouse vagina inoculation Candida albicans, the liquid-tight degree of bacterium of inoculation is 9 × 10
8individual/ml, every only 20 μ L, once a day, totally three times, modeling, after 10 days, observes modeling result on the 11st day, method rinses mouse vagina with aseptic PBS (phosphate buffer), collect irrigating solution, smear, dyeing, microscopy, main pseudohypha of looking for Candida albicans under the microscope, because the pseudohypha of Candida albicans just has the ability of settling down vaginal mucosa, thus causes colpitis.In 40 modeling mices, select the more mice of 30 pseudohyphas carry out test grouping administration: Normal group, deionized water;
Get 30 successful mices of modeling and be divided into 3 groups at random, often organize 10,
First group of medicine group of the present invention, gives gel prepared by embodiment 1,0.5ml/kg;
Second group of JIEERYIN XIYE group, every daily washing liquid rinses mouse vagina 22.5mg/kg;
3rd group of CN103349755 group, fills in mouse vagina 3.0g/kg suppository respectively every day;
Successive administration 7 days.Detect: last administration, after 8 hours, starts to rinse mouse vagina with aseptic PBS liquid, every only 20 μ L, collect irrigating solution, wherein 10 μ L smears, dyeing, microscopy, observation spore, pseudohypha, pseudohypha are rolled into a ball formational situation and carry out classification to its amount, to judge to infect the order of severity.The criteria for classifying is: whole smear has no pseudohypha and be designated as 0, and pseudohypha amount < 10 is designated as 1, between 10-30, be designated as 2, and have a pseudohypha group to be designated as 3, pseudohypha group > 1 is designated as 4; Remain 10 μ L to add in the aseptic PBS liquid of 1ml and dilute, then in diluent, get 50 μ L, be inoculated in the culture medium of husky fort, cultivate 48 hours, carry out CFU counting (i.e. colony-forming units, with bacterium colony number/L) for 30 DEG C.After every mouse vagina irrigating solution is got, put to death, get mice monilial infection vagina tissue, fix, draw materials through 10% formalin, routine paraffin wax embeds, serial section, thickness 5 μm, and HE dyes, and observes with LEICA biological microscope.First group of sterilizing rate is 99.72%, second group of sterilizing rate is 89.60%, 3rd group of sterilizing rate is 92.75%, embodiment 1 medicine and JIEERYIN group, and CN103349755 group can make the pseudohypha in mouse vagina irrigating solution significantly reduce, and of the present invention group of sterilizing rate significantly strengthens (P < 0.01, P < 0.05) than other group
Embodiment 3
Select connect voluntarily subject vaginitis patient 131 example, inclusion criteria: the age more than 18 years old, non-menopause; Clinical diagnosis vaginitis, non-pregnancy, non-diabetic, tumor and other kinds genitals infect, and do not apply local or whole body antifungal drug before medical in January.Be divided into two groups at random, treatment group and matched group, wherein treatment group 66 example, matched group 65 example, two groups of patient age symptoms are formed without significant difference.There is comparability (P>0.05).
Therapeutic Method
Each group of Primary Care is consistent, and treatment group gives compound recipe fenticonazole preparation prepared by embodiment 1, smears 1 every day;
Matched group gives the CN103349755 suppository prepared, vagina administration, each 1 piece.
Below respectively organizing menstrual phase and forbid medication, 7 days is a course for the treatment of.
Clinical diagnosis: pudendum convulsion is itched/causalgia, mucous hyperemia and leucorrhoea grow in quantity; Microscopy: adopt disinfecting silk or cotton swab, obtain specimen from vaginal sidewall, cotton swab is put normal saline in vitro censorship.(getting a little curdy secretions is placed on microscope slide to adopt saline humidity strip method direct examination, add the potassium hydroxide of one 10% or isotonic sodium chloride solution, be covered with coverslip, under being placed in microscope, having seen oval blastogenesis, to embrace son or pseudohypha be that candidiasis is positive).Cloudy suitable secretions is gathered to all candidiasis positive patients simultaneously and does candidiasis cultivation.Employing section code praises Candida chromogenic medium, cultivates 24 ~ 48 h in 37 DEG C, cultivates and is the positive to candidiasis.Adopt the API Candi-da reagent that French Mei Liai biotech firm develops, qualification is separated candidiasis bacterial strain.
Efficacy assessment standard: judge curative effect according to clinical symptoms, sign and Mycology examination three indexs.
Cure: subjective symptoms and sign disappear, microscopy and cultivation are all turned out cloudy;
Effective: subjective symptoms and sign are clearly better, microscopy and cultivation are turned out cloudy or symptom, sign disappear, microscopy and cultivate be still once the positive;
Invalid: symptom, sign are more unchanged with before treatment or increase the weight of, microscopy and cultivation are for positive.
Cure and effective add up to effective.
Shown by above clinical study results
| Group | Number of cases | Cure | Effectively | Invalid | Effective percentage |
| Treatment group | 66 | 60 | 5 | 1 | 98.5％ |
| Matched group | 65 | 55 | 6 | 4 | 93.8% |
Treatment group is matched group significant difference comparatively, and medicine group of the present invention is obviously better than matched group.
Above-mentioned each Chinese medicine and western medicine that the present invention adopts makes compatibility mutually, its collaborative effect of curing the disease can be played, there is between each composition of raw material of Chinese medicine used drug effect and be interweaved and mutually promote and coordinate usefulness, not only greatly reduce the side effect that antibiotic brings, and lasting medicine, through clinical verification, there is good therapeutic effect to vaginitis, in the applicant's medical practice for many years, the case Numerous of curing, all obtain good effect, and with low cost, alleviate the burden of patient.
Claims (3)
1. a preparation technology for compound recipe fenticonazole nitrate preparation, is characterized in that, described technique comprises the steps:
Get fenticonazole nitrate 10g, Effective Component of Chinese Medicine 10g, poloxamer188 30g, PLURONICS F87 15g, carbomer 5g, propylene glycol 250g, glycerol 150g, sodium benzoate 5g, disodiumedetate 0.3g, distilled water 475g, be prepared into gel, obtain final product;
The preparation method of described Effective Component of Chinese Medicine comprises the steps:
Get by weight Herba Leonuri 35 parts, Herba Polygoni cymosi 35 parts, Herba Taraxaci 30 parts, Semen Plantaginis 30 parts, Cortex Phellodendri 25 parts,
Caulis Spatholobi 25 parts, Rhizoma Dioscoreae Hypoglaucae 25 parts, the Cortex Eucommiae 22 parts, Radix Notoginseng 20 parts, Rhizoma Chuanxiong 20 parts,
Radix Puerariae 15 parts, Pollen Typhae 15 parts, the Radix Angelicae Dahuricae 10 parts, the Radix Astragali 10 parts, Bulbus Lilii 10 parts, Rhizoma Cyperi 10 parts,
10 parts, Flos Carthami, Herba Artemisiae Anomalae 5 parts, 5 parts, Radix Rubiae, Oletum Trogopterori 5 parts;
By Herba Polygoni cymosi, Herba Taraxaci, Semen Plantaginis, Cortex Phellodendri, Caulis Spatholobi, Rhizoma Dioscoreae Hypoglaucae, the Cortex Eucommiae, Radix Puerariae, Pollen Typhae, the Radix Angelicae Dahuricae, the Radix Astragali, Herba Artemisiae Anomalae mixing, add 2 times of weight 90% alcohol dipping 24 hours, reflux, extract, twice, each 1 hour, merge extractive liquid, be condensed into the extractum that density is 1.1 ~ 1.2 g/ml, crushed after being dried obtains A;
Residual components mixed, by water boiling and extraction 2 times, first time extracts the water adding 5 times of weight, and extraction time is 1 hour; Second time extracts the water adding 2 times of weight, and extraction time is 1 hour; Filter, merging filtrate, be concentrated into the thick paste that density is 1.1 ~ 1.2 g/ml, crushed after being dried obtains complex B;
Namely mixed complex A and complex B obtains Effective Component of Chinese Medicine.
2. preparation technology according to claim 1, is characterized in that, described technique comprises the steps:
(1) fenticonazole nitrate, Effective Component of Chinese Medicine, poloxamer188, PLURONICS F87, glycerol are made to dissolve completely and mix homogeneously in 65 DEG C of heating;
(2) sodium benzoate and disodiumedetate are dissolved in distilled water, then add carbomer and propylene glycol and make fully to dissolve and mix homogeneously;
Solution prepared by blend step (1) and (2) and get final product.
3. the pharmacy application of technique described in claim 1-2.
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| CN108066460A (en) * | 2018-02-08 | 2018-05-25 | 翔宇药业股份有限公司 | A kind of preparation for treating dermatomycosis |
| CN108066460B (en) * | 2018-02-08 | 2020-12-22 | 翔宇药业股份有限公司 | A preparation for treating dermatomycosis |
| CN108079098A (en) * | 2018-02-28 | 2018-05-29 | 翔宇药业股份有限公司 | Pharmaceutical preparation of anti-fungal infection and preparation method thereof |
| CN109078069A (en) * | 2018-11-08 | 2018-12-25 | 黑龙江省中医药科学院 | Vaginal mucosa antibacterial gel and preparation method thereof |
| CN109078069B (en) * | 2018-11-08 | 2021-05-25 | 黑龙江省中医药科学院 | Vaginal mucosa antibacterial gel and preparation method thereof |
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