CN101057892B - Medicinal composition for treating vaginal diseases and its preparation method and application - Google Patents
Medicinal composition for treating vaginal diseases and its preparation method and application Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating vaginopathy which comprises the following raw material medicinal materials (by weight proportion): yellow corktree bark 200-600 parts, rheum officinale 200-600 parts, red sage root 200-600 parts, frank incense 60-120 parts, myrrh 60-120g, alkanna tinctoria 200-600 parts, gecko powder 100-300 parts and borneol 10-30 parts.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of the vagina disease and its production and application.
Background technology
Vagina, for example vaginitis, vagina are scratched where it itches, causalgia is common gynecological disease.The pudendal pruritus leukorrhagia is the common sympton of vagina, and " ten woman, nine bands " it serves to show its universality.Vagina is directly endangering vast body of women health.Leukorrhagia, pudendal pruritus are brought inexpressible misery to the women, and severe patient can cause infertile, more give family's Jonah, cause burden to society.Old people's leukorrhagia pudendal pruritus along with long-lived person's sharp increase day by day, also becomes a harm old man's happy life in old age and an able-bodied social problem.
Theory of Chinese medical science is to the explanation of vagina:
It is in the majority that the pudendal pruritus leukorrhagia belongs to damp heat downward flowing type with Chinese medical discrimination, and multifactor body is insufficiency of the spleen, or the overstrain excessive thinking, eating and drinking without temperance and the impairment of the spleen, and insufficiency of the spleen then the mistake in strong fortune, wet turbid damp accumulates to be held back from interior life, for a long time and heat-transformation; Or occupying wetland for a long time, life is experienced damp accidentally; Or through row, in the puerperal vessels of the uterus inanition, the heresy that noxious dampness is foul is taken advantage of a weak point, and directly violates uterus; Or depressed rage impairing the liver, Yu Huare of a specified duration, the Liver Channel heated, following gram spleen soil, damp and hot friendship is vehement.In a word, damp invasion of lower energizer, damage is appointed, is with two arteries and veins, causes dai channel to be failed to keep an appointment, and conception vessel is not solid, and leukorrhagia is more than, and damp and hot heap soil or fertilizer over and around the roots is contained, and coagulation of QI-blood is and infested, and liver follows external genitals event pudendal pruritus endlessly, damp and hot following through taking advantage of in vaginal orifice fought mutually with vim and vigour, and the space between skin and muscles obturation must not be let out more, thereby vaginal orifice swelling.
In addition then, plain body is suffered from a deficiency of the kidney, or exhaustion due to sexual indulgence too, gives up completely to natural impulse; Or old renal failure, so that deficiency of the kidney, the deficiency of YIN is given birth to interior-heat, and the phase heated is contained, and trauma is appointed and is with two arteries and veins, and the network blood trouble is overflow, and dai channel is failed to keep an appointment, so leucorrhea with red and white discharge.Kidney master two the moon, liver follows external genitals, suffers from a deficiency of the kidney, and ailment said due to cold or exposure is taken advantage of, and evil objective space between skin and muscles is let out under the healthy energy, and heresy is just relevant, is skin and has an itch.The hepatic and renal YIN deficiency, the damage of essence insufficiency of blood, wind is given birth in the blood deficiency dryness-transformation, so also have an itch.
At present, the medicine of diseases such as a lot of treatment vaginitiss being arranged, mainly is Western medicine, and Chinese patent medicine seldom.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of vagina, its effective ingredient is Chinese medicine.
Another object of the present invention is to provide the preparation method and the purposes of aforementioned pharmaceutical compositions.
The objective of the invention is to be achieved through the following technical solutions.
A kind of pharmaceutical composition for the treatment of vagina, it comprises raw medicinal materials such as Cortex Phellodendri, Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, Olibanum (system), Myrrha (processed), Radix Arnebiae (Radix Lithospermi), Pulvis concha Mactrae and Borneolum Syntheticum; Preferably include following materials of weight proportions medical material: Cortex Phellodendri 200-600 part, Radix Et Rhizoma Rhei 200-600 part, Radix Salviae Miltiorrhizae 200-600 part, Olibanum (system) 60-120 part, Myrrha (processed) 60-120g, Radix Arnebiae (Radix Lithospermi) 200-600 part, Pulvis concha Mactrae 100-300 part, Borneolum Syntheticum 10-30 part; More preferably comprise: 400 parts of Cortex Phellodendris, 400 parts of Radix Et Rhizoma Rhei, 400 parts of Radix Salviae Miltiorrhizaes, 90 parts of Olibanums (system), 90 parts of Myrrha (processed), 400 parts of Radix Arnebiae (Radix Lithospermi)s, 200 parts of Pulvis concha Mactrae, 20 parts of Borneolum Syntheticums.
Pulvis concha Mactrae be Veneridae animal Conch Meretricis seu Cyclinae the shell drying, pulverize prepared powder.Can directly use Pulvis concha Mactrae among the present invention, also cleaning, dry Concha Meretricis Seu Cyclinae can be pulverized the back and used.
Olibanum (system), Myrrha (processed): be meant Olibanum, Myrrha through concocting, its process of preparing Chinese medicine is according to " process of preparing Chinese medicine general rule in the Chinese pharmacopoeia appendix is carried out, i.e. vinegar system.
Raw materials used medical material among the present invention, for example Cortex Phellodendri, Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, Olibanum (system), Myrrha (processed), Radix Arnebiae (Radix Lithospermi), Pulvis concha Mactrae (or Concha Meretricis Seu Cyclinae) and Borneolum Syntheticum etc. all can be buied from regular pharmacy.
This pharmaceutical composition can be made the exterior-applied formulation of any routine, and exterior-applied formulation is effervescent tablet, lotion (for example washing liquid), suppository etc. for example.
The compatibility foundation of pharmaceutical composition of the present invention:
Cortex Phellodendri, Radix Et Rhizoma Rhei heat clearing and damp drying in the side, eliminating fire and detoxication is a monarch drug to remove the damp and hot of the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels; Be aided with Radix Salviae Miltiorrhizae, Olibanum, Myrrha, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, removing heat from blood eliminating carbuncle, antipruritic effect and promoting granulation are ministerial drug; Radix Arnebiae (Radix Lithospermi), Pulvis concha Mactrae heat-clearing and toxic substances removing, dampness removing, to hold back skin ulcer be adjuvant drug; Borneolum Syntheticum clearing away heat to alleviate pain, anticorrosion antipruritic, granulation promoting are messenger drug, and all medicine compatibilities have heat-clearing and toxic substances removing, the dampness leukorrhagia stopping, killing parasites for relieving itching, the effect of detumescence and promoting granulation, full side sees from the integral body of the traditional Chinese medical science, consider local application, dialectically execute it, cooperate rigorously, the medical material medicine source of being adopted is abundant, cheap, the demand of suitable China present town and country medical market extensive patients.
For exterior-applied formulation, mainly can use following excipient in its preparation process: sodium bicarbonate, adipic acid, sodium carboxymethyl cellulose, tween 80, low-substituted hydroxypropyl cellulose, Polyethylene Glycol-6000, sodium lauryl sulphate, micropowder silica gel, Pulvis Talci and IV acrylic resin etc., preferred weight proportion is: sodium bicarbonate 150-250 part, adipic acid 150-300 part, sodium carboxymethyl cellulose 15-45 part, tween 80 5-20 part, low-substituted hydroxypropyl cellulose 30-60 part, Polyethylene Glycol-6000 5-20 part, sodium lauryl sulphate 10-30 part, micropowder silica gel 10-40 part, Pulvis Talci is an amount of, IV acrylic resin 5-15 part; More preferably 192 parts of sodium bicarbonate, 264 parts of adipic acids, 30 parts of sodium carboxymethyl cellulose, 10 parts of tween 80s, 46 parts of low-substituted hydroxypropyl celluloses, Polyethylene Glycol-600010 part, 18 parts of sodium lauryl sulphates, 25 parts of micropowder silica gels, Pulvis Talci are an amount of, 7.5 parts of IV acrylic resins.
The present invention also provides preparation aforementioned pharmaceutical compositions method, and this method may further comprise the steps:
A. the extraction of Cortex Phellodendri, Radix Et Rhizoma Rhei: take by weighing Cortex Phellodendri, the Radix Et Rhizoma Rhei of described weight, use ethanol extraction, get extracting solution;
B. the extraction of Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae: take by weighing Radix Arnebiae (Radix Lithospermi), the Radix Salviae Miltiorrhizae of described weight, use ethanol extraction, get extracting solution;
C. the extraction of volatile oil in Olibanum, the Myrrha: take by weighing Olibanum, Myrrha after the process of preparing Chinese medicine of described weight, extracting in water volatile oil, the volatile oil dehydrate gets light yellow oil, standby, medical filtration after the distillation, medicinal residues with water extraction after gained extracting solution and a gained extracting solution merge, merge extractive liquid;
D. the preparation of Pulvis concha Mactrae: can use the Pulvis concha Mactrae directly buied or Concha Meretricis Seu Cyclinae pulverized and use;
E. the preparation of dried cream powder: gained extracting solution among b, the c is merged, and concentrating under reduced pressure adds Pulvis concha Mactrae, and the drying that is mixed is pulverized the powder that gets dry extract;
F. the preparation of volatile oil beta-CD inclusion complex: take by weighing beta-schardinger dextrin-, behind the adding dissolved in distilled water, volatile oil is added in β-CD aqueous solution, stir, filter, drying, porphyrize gets volatile oil beta-CD inclusion complex;
G. the preparation of Borneolum Syntheticum β-CD inclusion complex: take by weighing β-CD and use dissolved in distilled water, take by weighing Borneolum Syntheticum and use dissolve with ethanol, the alcoholic solution of Borneolum Syntheticum is added in the aqueous solution of β-CD, stir, filtration, drying, porphyrize gets Borneolum Syntheticum β-CD inclusion complex;
H. with medicine dried cream powder and β-CD inclusion complex mixing, be equally divided into two parts, a copy of it medicated powder and adipic acid and sodium carboxymethyl cellulose, tween 80, low-substituted hydroxypropyl cellulose, Polyethylene Glycol-6000, sodium lauryl sulphate, micropowder silica gel and Pulvis Talci are even, the mixed soft material of ethanol liquid that adds the IV acrylic resin of 3～10wt%, drying gets acid particles; Another part medicated powder and sodium bicarbonate and sodium carboxymethyl cellulose, tween 80, low-substituted hydroxypropyl cellulose, Polyethylene Glycol-6000, sodium lauryl sulphate, micropowder silica gel and Pulvis Talci mixing, the mixed soft material of ethanol liquid that adds the IV acrylic resin of 3～10wt%, dry, obtain alkali grain, above acid particles and alkali grain is dry respectively, mixing, tabletting promptly get the tablet of pharmaceutical composition of the present invention.
The present invention also provides the another kind of method of preparation aforementioned pharmaceutical compositions, and this method may further comprise the steps:
A. the extraction of Cortex Phellodendri, Radix Et Rhizoma Rhei: take by weighing Cortex Phellodendri, the Radix Et Rhizoma Rhei of described weight, use ethanol extraction, get extracting solution;
B. the extraction of Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae: take by weighing Radix Arnebiae (Radix Lithospermi), the Radix Salviae Miltiorrhizae of described weight, use ethanol extraction, get extracting solution;
C. the preparation of Pulvis concha Mactrae: can use the Pulvis concha Mactrae directly buied or Concha Meretricis Seu Cyclinae pulverized and use;
D. the extraction of Olibanum, Myrrha, Concha Meretricis Seu Cyclinae: take by weighing Olibanum, Myrrha and Pulvis concha Mactrae after the process of preparing Chinese medicine of described weight, decoct with water extraction, extracting solution and a gained extracting solution merge, merge extractive liquid;
E. with above b, the merging of d gained extracting solution, filter, add the dissolve with ethanol liquid of Borneolum Syntheticum before the fill, stir, sterilization, fill get washing liquid in dispensing bottle.
Pharmaceutical composition of the present invention has the effect of heat clearing and damp drying, killing parasites for relieving itching, detumescence and promoting granulation, for various vagina, especially vaginitis, particularly mycotic, trichomonal vaginitis have good efficacy, and symptoms such as damp and hot pudendal pruritus, pudendal pruritus, profuse leukorrhea and Se Bai or Huang, bitter taste xerostomia, red tongue with yellowish and greasy fur, wiry and frequent pulse or sliding number are significantly improved.
The specific embodiment
The tablet of getting pharmaceutical composition of the present invention carries out following test, obtains as drawing a conclusion:
One, The pharmacological results:
1, antifungal experiment: the bacteriostatic test result shows to the Candida albicans inside and outside, the tablet of pharmaceutical composition of the present invention (to call the cloudy sheet that relaxes of woman in the following text) has stronger inhibitory action to Candida albicans, its Mlc is 1: 16, the abscess that obviously suppresses the caused local organization of white beads mattress, inflammatory such as adhesion, subcutaneous hyperemia changes, to clinical isolating Candida albicans MIC
50, MIC
90Be 12.25mg/ml.
2, external anti-trichomonal test shows: the cloudy sheet that relaxes of woman has the obvious suppression effect to trichomonal vaginitis, and its Mlc is 1: 8.
3, bacteriostasis: the cloudy sheet that relaxes of woman is external to anaerobe such as bacteroides fragilis, Wei Rong Shi coccus, peptostreptococcus, gonococcuss; To staphylococcus aureus, owe aerobe such as enterobacteria, bacillus pyocyaneus, group B streptococcus, Staphylococcus albus and clinical typical vaginitis patient vaginal secretions in various degree bacteriostasis all arranged, but the bacillus acidophilus does not have inhibitory or killing effect to vagina, to safeguard the self purification of vagina.
4, antiinflammatory action: the cloudy sheet that relaxes of woman shows that by the swollen method of mouse ear, the swollen method of rat foot and the swollen test of rat granuloma this product has tangible antagonism to acute inflammation.
5, analgesic activity: the cloudy sheet that relaxes of woman can obviously prolong glacial acetic acid induced mice pain sensation incubation period, reduces to turn round the body number of times and bring into play significant analgesia role.
6, itching-relieving action: the cloudy sheet that relaxes of woman can obviously improve Cavia porcellus and cause the Fujian of itching, and stronger itching-relieving action is arranged.
7, microcirculation improvement effect: the cloudy sheet that relaxes of woman has the effect that to a certain degree improves the caused mesentery microcirculation disturbance of local instillation epinephrine.Help the reparation and the regeneration of inflammation part tissue.
Two, toxicologic study
1, acute toxicity test: when relaxing sheet 1.2g/Kg, do not cause tangible toxic reaction and death, be equivalent to 60 times of people's consumption per day to rabbit vagina placement woman the moon.
2, repeat mucomembranous irritant test: a continuous week is only placed the cloudy sheet 1.0g/ of relaxing of woman to rabbit vagina, and not observing has tangible zest to vaginal mucosa.
3, skin anaphylactic test: only give the cloudy sheet 0.2g/ of relaxing of Cavia porcellus sensitization woman, find no tangible skin allergy.
Three, long term toxicity test
Placed cloudy sheet 1.2g/Kg, the 0.4g/Kg of relaxing of woman in continuous 22 days for rabbit, be equivalent to 60 times, 20 times of clinical 60Kg people's consumption per day respectively, do not observe animal general situation, hematology, urine, blood is biochemical and important organ body ratio and histopathologic change.All do not find the toxic and side effects of tangible irreversibility, clinical medicine dose and administration time safety that this medicine is drafted are described, low toxicity.
Four, clinical test results:
Pharmaceutical composition of the present invention has carried out the research of II clinical trial phase in January, 1998 to July, 440 routine patients have been observed altogether, with pharmaceutical composition effervescent tablet of the present invention (calling " the cloudy sheet that relaxes of woman " in the following text) treatment damp heat downward flowing type pudendal pruritus (colpitis mycotica, trichomonal vaginitis) 320 examples, with JIEERYIN PAOTENGPIAN treatment 120 example contrasts, to observe its clinical efficacy and safety.
One, physical data
By the diagnosis standard, include standard in and get rid of the case standard, filter out qualified case 440 examples, outpatient service 427 examples wherein, 13 examples of being in hospital, treating 320 examples with the cloudy easypro sheet of woman is the treatment group, treating 120 examples with JIEERYIN PAOTENGPIAN is matched group, and its NATURAL DISTRIBUTION situation sees Table 1 (A), 1 (B), 1 (C).
Table 1 (A) 440 routine clinical data NATURAL DISTRIBUTION situations relatively
Statistical result shows: treatment group and matched group patient there are no significant on age, the state of an illness, the course of disease distribute difference (P＞0.05).
The sick NATURAL DISTRIBUTION situation of planting of table 1 (B)
The sick distribution situation of planting is identical between two groups.
Table 1 (C) severity extent NATURAL DISTRIBUTION situation
Through X
2Check, treatment group and matched group conditions of patients degree distribution there was no significant difference.
Two, case choice criteria
(1) diagnostic criteria
1, tcm diagnosis standard
Pudendal pruritus is meant that pudendum and pruritus of vagina can't bear, and the pain of very then itching increases unbearably or with leukorrhagia etc.
2, differential diagnosis in tcm
Damp heat downward flowing type
Primary symptom:
(1) pudendal pruritus, the pain of very then itching
(2) profuse leukorrhea, Se Bai or Huang are the bean dregs sample or are foam water from washing rice sample.
Inferior disease:
(1) vexedly sleeps less
(2) bitter taste and being bored with
(3) discomfort uncomfortable in chest
(4) poor appetite
The tongue arteries and veins:
Red tongue, yellow and greasy fur, wiry and frequent pulse or sliding number.
Diagnosis: the primary symptom indispensability, inferior disease tool can be diagnosed as damp heat downward flowing type pudendal pruritus with reference to the tongue arteries and veins more than 2.
3, Western medicine diagnose standard:
(1) symptom: pudendum, pruritus of vagina, causalgia or with urethral stimulant symptoms such as frequent micturition, urgent micturition, dysureas, or with the local excitation symptom.
(2) gynecologial examination: vaginal secretions increases and has unusually, and colpitis mycotica secretions is the bean dregs sample; Trichomonal vaginitis secretions is yellow foam water from washing rice sample, and vaginal mucosa is congested or the petechia is arranged, and is apparent in view with posterior fornix.
(3) lab testing: vaginal secretions can find mycete or infusorian at microscopically.Vagina cleanness degree is more than II °.
4, standards of grading
(1) found mycete in the leucorrhea 10 minutes
(2) found infusorian in the leucorrhea 10 minutes
(3) pruritus vulvae causalgia: violent 5 minutes obvious 3 minutes slight 1 minute
(4) leucorrhoea grow in quantity: many 3 minutes more 2 minutes not a lot of 1 minute of amount
(5) 1 fen Io of 2 fens IIo of vagina cleanness degree: IIIo 0 minute
(6) vaginal mucosa has the petechia: extensively accompany ulcer 2 to be dispersed in 1 fen
(7) sexual anhedonia is 1 minute
(8) frequent micturition, urgent micturition, dysurea are 1 minute
5, mark
Severe: iterated integral is more than 20 minutes
Moderate: iterated integral was at 16～19 minutes
Slightly: iterated integral was at 13～15 minutes
(2) include the case standard in
1, pudendal pruritus patient differential diagnosis in tcm belongs to the warm card person that makes a bet
2, Western medicine diagnose is colpitis mycotica or trichomonal vaginitis
3, married, 20～60 years old age
(3) get rid of the case standard
1, the pudendal pruritus patient differential diagnosis in tcm person that do not belong to the syndrome of dampness-heat diffusing downward
2, Western medicine diagnose does not belong to colpitis mycotica and trichomonal vaginitis person
3, merge gestation, suffer from beyond the pudendal pruritus that disease need be used Drug therapy person such as antibiotics, hormone or this medicine allergy sufferers
4, merge moderate and severe cervical person
5, with primary diseases such as serious cardiovascular, liver, kidney, psychotic
6, do not meet the standard of including in, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment and safety judgement person
Three, test method:
(1) grouping
Abide by the principle that contrasts blind method at random, to meeting diagnostic criteria, include standard in and through the qualified study subject of exclusion standard screening, be assigned to treatment group and matched group by the lot method, 320 examples are organized in treatment, matched group 120 examples.Two groups of disease degree requirements are basic identical, and should strict its variable factor of control.
(2) medication
Adopt single blind method, the treatment group is with the cloudy sheet that relaxes of woman, and the matched group JIEERYIN PAOTENGPIAN is produced by Chinese-foreign joint Chengdu En Wei pharmaceutical Co. Ltd, as if the southern western pharmaceutical factory of effluent provides.
Expose vagina with vaginal speculum, get a little secretions microscopy.Wipe the examination vagina with the sterilization dry cotton ball, remove secretions, get cloudy 1 of the effervescent tablet (1.2g/ sheet) that relaxes of woman, put into posterior fornix portion with alligator pliers, once a day, logotype seven days.The administration by the same method of contrast medicine (JIEERYIN PAOTENGPIAN 0.3g/ sheet).Or advise the patient to wear fingerstall medication voluntarily.Forbid sexual life during the medication.
(3) course of treatment
7 days is a course of treatment, begins administration from menstruation after clean 5 days, and finish back 3～5 days the course of treatment, carries out efficacy evaluation.
(4) observational technique
1, above-mentioned each observation item part need be observed when going to a doctor (first visit and further consultation) and mark.
2, recording method: in the observation item part, the symptom before and after the treatment, projects such as sign and secretions inspection are given a mark according to state of an illness weight, or have and then beat "+", do not have and then beat "-".Give overall score according to standards of grading.Every laboratory examination result's laboratory test report should conscientiously be filled in after all need sticking on the observation table, fills out entirely inaccurate null term.
3, should must not add with any other medicine or means in strict accordance with the plan requirement in the observation process.
4, occur any untoward reaction in the observation process, record faithfully.
5, after the end course of treatment, need make last evaluation with regard to curative effect and safety.
6, fully recover in the recent period in the case, three menstrual cycle further consultations of drug withdrawal are to judge its late result.
Four, result of the test
(1) curative effect determinate standard
1, total effects criterion
(1) recovery from illness: the primary symptom of tcm syndrome (pudendal pruritus, leukorrhagia unusual) disappears, and inferior disease is most of to be disappeared, and doctor trained in Western medicine checks that secretions is normal, and mycete and infusorian are not found in chemical examination.Scoring is 0 minute, and three menstrual cycle do not have recurrence after the drug withdrawal, and multiple inspection is all normal.
(2) produce effects: the primary symptom of tcm syndrome (pudendal pruritus, leukorrhagia unusual) disappears, and inferior disease partly disappears, and the laboratory is checked normal, and treatment back integration reduces more than 2/3 before than treatment.
(3) effective: the laboratory is checked normal and other symptom exists, or other transference cure or alleviate, and that the laboratory is checked is unusual.Treatment back integration reduces more than 1/3 than treatment is preceding.
(4) invalid: treatment back symptom and inspection are with before treating.
2, primary symptom curative effect determinate standard
(1) pudendal pruritus and leukorrhagia exception level decline one-level are onset (effectively).
(2) decline two-stage is produce effects.
(3) drop to 0 and be divided into recovery from illness.
(2) efficacy analysis
1, total effects:
According to curative effect determinate standard, with symptom, sign and the lab testing comprehensive analysis and judgement of pudendal pruritus.(seeing Table 2)
Table 2 treatment group and matched group curative effect are relatively
Statistical result: two groups of cure rates compare: X
2=53.06 P＜0.01
Two groups of cure-remarkable-effectiveness rates compare: X
2=60.17 P＜0.01
The Ridit of two groups of total effective rates analyzes:
Treatment group R=0.44 matched group R=0.67 P＜0.05
Statistics shows: two groups cure rate, cure-remarkable-effectiveness rate and total effective rate all have significant difference (P＜0.01, P＜0.01, P＜0.05)
2, mark between two groups relatively before and after the treatment: (seeing Table 3)
Mark relatively between two groups before and after table 3 treatment
Statistical result:
Compare before and after the treatment of treatment group: t=51.81 P＜0.01
Compare before and after the treatment of control group: t=18.69 P＜0.01
Compare two groups of treatment backs: t=5.76 P＜0.01
Statistics shows: treatment group treatment front and back, treatment of control group front and back and two groups of treatment back scorings more all have significant difference.
3, the course of disease and curative effect are relatively: (seeing Table 4)
Table 4 course of disease and curative effect be (treatment group) relatively
Statistical result:
The Ridit of total effective rate analyzes: (A) R=0.49 (B) R=0.53 (C) R=0.52P＞0.05
Prompting: curative effect and course of disease length there was no significant difference (P＞0.05)
4, the disease curative effect relatively: two groups symptoms, sign and auxiliary examination are carried out the individual event curative effect relatively: (seeing Table 5)
Table 5 disease curative effect relatively
Statistics shows: pudendal pruritus, leukorrhagia are unusual, vaginal mucosa has petechia, sexual anhedonia, vagina cleanness degree to reach the unusual curative effect of leukorrhagia microscopy unusually, and the treatment group obviously is better than matched group (P＜0.01); The curative effect of urine short number causalgia, the treatment group is higher than matched group (86.92%, 76.60%), but statistics there was no significant difference (P＞0.05).
5, Western medicine diagnose and curative effect are relatively.(seeing Table 6)
Table 6 Western medicine diagnose and curative effect relatively see Table 6
Statistical result:
1. the Ridit of total effective rate analyzes between two groups of colpitis mycoticas:
Treatment group: R=0.44 matched group: R=0.66 P＜0.05
Prompting: total effective rate has significant difference (P＜0.05) between two groups of colpitis mycoticas, and the treatment group is apparently higher than matched group.
2. the Ridit of total effective rate analyzes between two groups of trichomonal vaginitis:
Treatment group: R=0.44 matched group: R=0.67 P＜0.05
Prompting: total effective rate has significant difference (P＜0.05) between two groups of trichomonal vaginitis, and the treatment group is apparently higher than matched group.
3. the Ridit of total effective rate analyzes between colpitis mycotica and trichomonal vaginitis treatment group:
Colpitis mycotica: R=0.49
Trichomonal vaginitis: R=0.50 P＞0.05
Prompting: total effective rate compares there was no significant difference (P＞0.05) between colpitis mycotica and trichomonal vaginitis treatment group
4. cure-remarkable-effectiveness rate compares between colpitis mycotica and trichomonal vaginitis treatment group:
X2＝0.07 P＞0.05
Prompting: cure-remarkable-effectiveness rate compares there was no significant difference (P＞0.05) between two kinds of vaginitis treatment groups
6, more show the case primary symptom and lapse to time ratio: (seeing Table 7)
Table 7 more shows the case primary symptom and lapses to time ratio
The result shows: the first effect time, effective time and the cure time treatment group that more show the case primary symptom are significantly shorter than matched group (P＜0.01)
7, disease compares recovery time: (seeing Table 8)
Table 8 disease compares recovery time
Statistics prompting: pudendal pruritus, leukorrhagia are unusual, the red and swollen petechia of vaginal mucosa, vagina cleanness degree reach unusually the leukorrhagia microscopy between unusual recovery time the treatment group also be significantly shorter than matched group (P＜0.01), there was no significant difference (P＞0.05) between two groups of recovery times of sexual anhedonia and urethral stimulant symptom
8, laboratory detection result: (see Table 9, table 10, table 11, table 12, table 13, table 14)
Hemocyte relatively before and after table 9 treatment
Prompting: the relatively more equal no change of Hb and WBC before and after the treatment of treatment group
Routine urinalysis changes relatively before and after table 10 treatment
Statistical result: X2=55.46 P＜0.01
Prompting: routine urinalysis relatively has significant difference (P＜0.01) before and after the treatment of treatment group
Stool routine examination changes relatively (treatment group) before and after table 11 treatment
Changes of liver function compares (treatment group) before and after table 12 treatment
Renal function changes relatively (treatment group) before and after table 13 treatment
Electrograph changes relatively (treatment group) before and after table 14 treatment
9, late result
According to the requirement of curative effect determinate standard, the recovery from illness case is all carried out the further consultation inspection at three menstrual cycle of drug withdrawal, its review result is as follows: (seeing Table 15)
Table 15 treatment group and matched group relapse rate compare:
Statistical result shows: the relapse rate of recovery from illness case has significant difference (P＜0.01) between two groups.
(3) toxic and side effects and untoward reaction:
The treatment group is by 320 routine clinical observations and patient reaction, has 2 routine patients pudendum when first time medication that slight causalgia discomfort is arranged, and continues the medication symptom and dies away, and surplusly do not find toxic and side effects and untoward reaction.
(4) withdraw from, reject the case situation:
In the treatment group observation process, withdrawing from case 11 examples, all is that a variety of causes is failed continuous use, stops automatically to examine, so withdrawed from.Reject case 10 examples, all tie up to when using woman's the moon to relax effervescent tablet, use other medicine that affects the treatment and judge again, wherein 4 examples add norfloxacin, and 2 examples add cephalexin number, and 2 examples are used JIEERYIN XIYE voluntarily, 1 example adds voluntarily with skin health lotion washout, and 1 example adds uses metronidazole, so rejected.
Conclusion:
1. clinical efficacy is remarkable
On curative effect, treatment group total effective rate is 94.73%, and cure rate is 64.69%, and the matched group total effective rate is 77.50%, and cure rate is 25.83%, and the treatment group obviously is better than matched group (P＜0.05, P＜0.01); The treatment group is compared with matched group except that the curative effect of urine short number causalgia the there was no significant difference (P＜0.05), and pudendal pruritus, leukorrhagia are unusually, vaginal mucosa has petechia, sexual anhedonia, vagina cleanness degree to reach the unusual individual event curative effect of leukorrhagia microscopy unusually all obviously to be better than matched group (P＜0.01); The cloudy sheet that relaxes of woman all has the obvious treatment effect to colpitis mycotica and trichomonal vaginitis, and total effective rate compares there was no significant difference (P＞0.05) between two kinds of vaginitis treatment groups; The cloudy easypro sheet of woman unusually also has the obvious treatment effect to routine urinalysis, and significant difference (P＜0.01) is relatively arranged before and after the treatment, and the treatment back points out this medicine that the urethral stimulant symptom is had therapeutical effect preferably significantly better than before treating.
2. drug effect is rapid
Clinical test results shows that treatment group and matched group more show first effect time, effective time and the cure time of case primary symptom, and two groups relatively have significant difference (P＜0.01), and the treatment group is significantly shorter than matched group.
3. safety
Check that through the laboratory hemoglobin and the equal no change of leukocyte before and after the medication of treatment group point out this medicine that blood is had no adverse reaction; Routine urinalysis changes before and after the treatment of treatment group relatively significant difference (P＜0.01), significantly better than before the treatment, illustrates that this medicine has no side effect to urinary system, and the obvious treatment effect is arranged after the treatment; The stool routine examination inspection does not also have change before and after the treatment of treatment group, points out this medicine that digestive system is had no side effect; By treatment being organized liver function, kidney merit and the electrocardiogram detection that 40 routine patients carry out, all there is not change before and after its treatment, point out this medicine to liver, kidney, the harmless effect of cardiac function; Examine reflection by clinical observation and patient to 320 routine patients, all find no serious toxic and side effects and untoward reaction and occur, therefore, it is more safe and reliable using this medicine.
Above result shows, pharmaceutical composition of the present invention has tangible heat-clearing and toxic substances removing, the dampness leukorrhagia stopping, killing parasites for relieving itching, the effect of detumescence and promoting granulation, it is antipruritic, the leukorrhagia stopping effect is rather good, has stronger antibacterial insecticidal action,, sexual anhedonia unusual to inflammatory vaginal mucosa, vagina cleanness degree and urethral stimulant symptom all have tangible effect, are to treat the comparatively ideal medicine of women's damp heat downward flowing type pudendal pruritus at present.
The preparation of embodiment 1 pharmaceutical composition effervescent tablet of the present invention:
1, the extraction of Cortex Phellodendri, Radix Et Rhizoma Rhei: take by weighing Cortex Phellodendri 400g, Radix Et Rhizoma Rhei 400g, add 60～85% ethanol of 4800-8000g, heating and refluxing extraction 2～4 hours is filtered, and collects filtrate; 60～85% ethanol that in the gained medicinal residues, add 3200-6400g, reflux 1～3 hour is filtered, and collects filtrate; 60～85% ethanol that in the gained medicinal residues, add 3200-6400g, reflux 0.5～2 hour is filtered, and collects filtrate; Merge three times gained filtrate, filtrate decompression is concentrated into every 1ml is equivalent to 1g crude drug amount (relative density is about 1.12-1.15,50 ℃ of surveys) 1. as standby medicinal liquid.
2, the extraction of Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae: take by weighing Radix Arnebiae (Radix Lithospermi) 400g, Radix Salviae Miltiorrhizae 400g, add 80～95% ethanol of 6400-11200g, get to soak under the temperature at 40 ℃-70 ℃ and extracted 2～4 days, filter, collect filtrate; 80～95% ethanol that in the gained medicinal residues, add 6400-9600g, 40 ℃-70 ℃ soak under the temperature and extracted 1～3 day, filter, collect filtrate; 80～95% ethanol that in the gained medicinal residues, add 6400-9600g, 40 ℃-70 ℃ soak under the temperature and extracted 1～3 day, filter, collect filtrate.Merge 3 times gained filtrate, be evaporated to 1ml under 50 ℃ the temperature and be equivalent to 1g crude drug (the about 1.12-1.15 of relative density, 40 ℃ of surveys) being lower than, for standby medicinal liquid 2..
3, the extraction of volatile oil in Olibanum, the Myrrha: take by weighing the Olibanum after 90g concocts, the Myrrha after the 90g process of preparing Chinese medicine, pulverize, add the water of 720-1440g, be heated to little boiling, extract the about 6h of volatile oil, must about 4.5ml light yellow oil with gained volatile oil dehydrate, for standby sample 3..With the medical filtration after the above-mentioned distillation, collect filtrate, medicinal residues add the water of 720-1440g, decoct 1～2 hour, filter and collect filtrate, and 1. 2 gained filtrates are merged with medicinal liquid, concentrated after as standby medicinal liquid 4..
4, the preparation of Pulvis concha Mactrae: Concha Meretricis Seu Cyclinae is cleaned, sterilizing-drying, pulverizings of milling, mistake sieve for No. nine fine powder, it is standby to take by weighing the 200g Pulvis concha Mactrae.
5, the preparation of the mixing of condensed cream and xeraphium: 4. and 2. above standby medicinal liquid is merged, be evaporated to relative density 1.30-1.35 (50 ℃ of surveys), the Pulvis concha Mactrae that adds 4 gained, mix homogeneously, bake drying below 60 ℃ was pulverized sieve No. 5, and fine powder gets dry extract, place dry place, for standby sample 5..
6, the preparation of volatile oil beta-CD inclusion complex: take by weighing 22.5～67.5g beta-schardinger dextrin-, in β-CD: the ratio of water=1: 10～40 adds distilled water 225～2700ml, slight fever makes its dissolving, under electromagnetic agitation with 3 in gained volatile oil slowly splash into β-CD aqueous solution, drip off the back and continue to stir 2.5h, after placing room temperature, under 0-4 ℃ temperature, leave standstill 24h, sucking filtration, 40～60 ℃ of dryings, porphyrize is put drying and is located standby.
7, the preparation of Borneolum Syntheticum β-CD inclusion complex: take by weighing β-CD of 100～200g, add 2500～5000ml distilled water slight fever and make its dissolving, obtain the aqueous solution of β-CD, other takes by weighing the 20g Borneolum Syntheticum, obtain the alcoholic solution of Borneolum Syntheticum with 50～60ml95% dissolve with ethanol, under electromagnetic agitation, slowly the alcoholic solution of Borneolum Syntheticum is splashed in the aqueous solution of β-CD, drip off the back and continue to stir 2.5 hours, put cold, under 0-4 ℃ temperature, leave standstill 24h, sucking filtration, 40～60 ℃ of dryings, porphyrize is put drying and is located standby.
8, adopt acid, alkali granulation respectively, with the medicine dried cream powder 5. and β-abundant mixing of CD inclusion complex, be equally divided into two parts, a copy of it medicated powder and 264g adipic acid, 15g sodium carboxymethyl cellulose, 5g tween 80,23g low-substituted hydroxypropyl cellulose, 5g Polyethylene Glycol-6000,9g sodium lauryl sulphate, 12.5g micropowder silica gel and an amount of Pulvis Talci mix homogeneously, the ethanol liquid that adds 3.75g 3～10wt%IV acrylic resin, mixed soft material, granulate with 16 mesh sieves, in dry below 60 ℃, granulate gets acid particles; Another part medicated powder and 192g sodium bicarbonate, 15g sodium carboxymethyl cellulose, 5g tween 80,23g low-substituted hydroxypropyl cellulose, 5g Polyethylene Glycol-6000,9g sodium lauryl sulphate, 12.5g micropowder silica gel and an amount of Pulvis Talci mix homogeneously, the ethanol liquid that adds 3.75g 3～10wt%IV acrylic resin, mixed soft material, granulate with 16 mesh sieves, in dry below 60 ℃, granulate gets alkali grain.With above acid particles and alkali grain cold drying respectively, and abundant mixing behind the granulate, be pressed into 1000, every heavily about 1.5g, packing, sealing gets final product.
Usage and consumption:
Clean hands and external genital, with the finger of putting on plastic fingertip this product is filled in the vagina depths, disintegrate rapidly makes active ingredient be uniformly distributed in intravaginal.Every day a slice, seven is a course of treatment; Use an amount of eliminating cold for resuscitation water with 1～2 rinsing vulva portion of this productization in case of necessity.
The preparation of embodiment 2 pharmaceutical composition washing liquids of the present invention:
1, the extraction of Cortex Phellodendri, Radix Et Rhizoma Rhei: take by weighing 200g Cortex Phellodendri, 600g Radix Et Rhizoma Rhei, add 60～85% ethanol of 4800-8000g, heating and refluxing extraction 2～4 hours is filtered, and collects filtrate; Add 3200-6400g60～85% ethanol in filtering residue (medicinal residues), reflux 1～3 hour is filtered, and collects filtrate; Add 3200-6400g 60～85% ethanol in filtering residue (medicinal residues), reflux 0.5～2 hour is filtered, and collects filtrate; Merge three times filtrate, be evaporated to every 1ml and be equivalent to 1g crude drug amount (relative density is about 1.12-1.15,50 ℃ of surveys) 1. as standby medicinal liquid.
2, the extraction of Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae: take by weighing 200g Radix Arnebiae (Radix Lithospermi), 600g Radix Salviae Miltiorrhizae, soak under 40 ℃-70 ℃ temperature with 6400-11200g 80～95% ethanol and extracted 2～4 days, filter, collect filtrate; In filtering residue (medicinal residues), add 6400-9600g 80～95% ethanol, under 40 ℃-70 ℃ temperature, soak and extracted 1～3 day, filter, collect filtrate; In filtering residue (medicinal residues), add 6400-9600g 80～95% ethanol, under 40 ℃-70 ℃ temperature, soak and extracted 1～3 day, filter, collect filtrate.Merge 3 times filtrate, be evaporated to 1ml under 50 ℃ the temperature and be equivalent to 1g crude drug (the about 1.12-1.15 of relative density, 40 ℃ of surveys) being lower than, for standby medicinal liquid 2..
3, the preparation of Pulvis concha Mactrae: Concha Meretricis Seu Cyclinae is cleaned, sterilizing-drying, and the pulverizing of milling is crossed No. nine and is sieved to such an extent that fine powder is standby.
4, the extraction of Olibanum, Myrrha, Pulvis concha Mactrae: take by weighing 120g Olibanum (processed), 60g Myrrha (processed) and 300g Pulvis concha Mactrae, suitably pulverize, add the water of 2000-4000g, decocted medical filtration 2～3 hours, filtrate for later use, in medicinal residues, add the water of 2000-4000g, decocted again 1～2 hour, filter and collect filtrate, 2 gained filtrates and medicinal liquid are merged in 1., concentrate 3. as standby medicinal liquid.
5,3., 2. above medicinal liquid is merged, be evaporated to amount of formulation 20000ml, filter, leave standstill cooling.The 10g Borneolum Syntheticum is dissolved in the 30ml95% ethanol, adds the ethanol liquid of Borneolum Syntheticum before the fill, stir, sterilization, fill get 200 bottles of washing liquids in dispensing bottle, and every bottle of washing liquid contains medicinal liquid 100ml.
Usage and consumption:
Clean hands and external genital, with washing the device flushing, each 20ml.
The preparation of embodiment 3 pharmaceutical composition washing liquids of the present invention:
Use the method identical with embodiment 2 to prepare washing liquid, its difference only is that raw materials used weight is respectively: Cortex Phellodendri 600g, Radix Et Rhizoma Rhei 200g, Radix Arnebiae (Radix Lithospermi) 600g, Radix Salviae Miltiorrhizae 200g, Olibanum (processed) 60g, Myrrha (processed) 120g, Pulvis concha Mactrae 100g, Borneolum Syntheticum 30g.
Claims (8)
1. pharmaceutical composition for the treatment of vagina, it is to be made by following materials of weight proportions medical material: Cortex Phellodendri 200-600 part, Radix Et Rhizoma Rhei 200-600 part, Radix Salviae Miltiorrhizae 200-600 part, Olibanum (processed with vinegar) 60-120 part, Myrrha (processed with vinegar) 60-120g, Radix Arnebiae (Radix Lithospermi) 200-600 part, Pulvis concha Mactrae 100-300 part, Borneolum Syntheticum 10-30 part.
2. pharmaceutical composition as claimed in claim 1 is characterized in that, this pharmaceutical composition is to be made by following materials of weight proportions medical material: 400 parts of Cortex Phellodendris, 400 parts of Radix Et Rhizoma Rhei, 400 parts of Radix Salviae Miltiorrhizaes, 90 parts of Olibanum (processed with vinegar), 90 parts of Myrrha (processed with vinegar), 400 parts of Radix Arnebiae (Radix Lithospermi)s, 200 parts of Pulvis concha Mactrae, 20 parts of Borneolum Syntheticums.
3. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that, the dosage form of this pharmaceutical composition is an exterior-applied formulation, and described exterior-applied formulation is effervescent tablet, lotion or suppository.
4. the method for preparing the described pharmaceutical composition of claim 1, this method comprises:
A. the extraction of Cortex Phellodendri, Radix Et Rhizoma Rhei: take by weighing Cortex Phellodendri, the Radix Et Rhizoma Rhei of described weight, use ethanol extraction, get extracting solution;
B. the extraction of Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae: take by weighing Radix Arnebiae (Radix Lithospermi), the Radix Salviae Miltiorrhizae of described weight, use ethanol extraction, get extracting solution;
C. the extraction of volatile oil in Olibanum, the Myrrha: take by weighing Olibanum, Myrrha after the process of preparing Chinese medicine of described weight, extracting in water volatile oil, the volatile oil dehydrate gets light yellow oil, standby, medical filtration after the distillation, medicinal residues with water extraction after gained extracting solution and a gained extracting solution merge, merge extractive liquid;
D. the preparation of Pulvis concha Mactrae: use the Pulvis concha Mactrae directly buy or Concha Meretricis Seu Cyclinae pulverized and use;
E. the preparation of dried cream powder: gained extracting solution among b, the c is merged, and concentrating under reduced pressure adds Pulvis concha Mactrae, and the drying that is mixed is pulverized the powder that gets dry extract;
F. the preparation of volatile oil beta-CD inclusion complex: take by weighing beta-schardinger dextrin-, behind the adding dissolved in distilled water, gained volatile oil among the b is added in β-CD aqueous solution, stir, filter, drying, porphyrize gets volatile oil beta-CD inclusion complex;
G. the preparation of Borneolum Syntheticum β-CD inclusion complex: take by weighing β-CD and use dissolved in distilled water, take by weighing Borneolum Syntheticum and use dissolve with ethanol, the alcoholic solution of Borneolum Syntheticum is joined in the aqueous solution of β-CD, stir, filtration, drying, porphyrize gets Borneolum Syntheticum β-CD inclusion complex;
H. with medicine dried cream powder and β-CD inclusion complex mixing, be equally divided into two parts, a copy of it medicated powder and adipic acid and sodium carboxymethyl cellulose, tween 80, low-substituted hydroxypropyl cellulose, Polyethylene Glycol-6000, sodium lauryl sulphate, micropowder silica gel and Pulvis Talci mix homogeneously, the mixed soft material of ethanol liquid that adds the IV acrylic resin of 3～10wt%, drying gets acid particles; Another part medicated powder and sodium bicarbonate and sodium carboxymethyl cellulose, tween 80, low-substituted hydroxypropyl cellulose, Polyethylene Glycol-6000, sodium lauryl sulphate, micropowder silica gel and Pulvis Talci mixing, the mixed soft material of ethanol liquid that adds the IV acrylic resin of 3～10wt%, dry, obtain alkali grain, above acid particles and alkali grain is dry respectively, mixing, tabletting obtains the tablet of the described pharmaceutical composition of claim 1.
5. the method for preparing the described pharmaceutical composition of claim 1, this method comprises:
A. the extraction of Cortex Phellodendri, Radix Et Rhizoma Rhei: take by weighing Cortex Phellodendri, the Radix Et Rhizoma Rhei of described weight, use ethanol extraction, get extracting solution;
B. the extraction of Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae: take by weighing Radix Arnebiae (Radix Lithospermi), the Radix Salviae Miltiorrhizae of described weight, use ethanol extraction, get extracting solution;
C. the preparation of Pulvis concha Mactrae: use the Pulvis concha Mactrae directly buy or Concha Meretricis Seu Cyclinae pulverized and use;
D. the extraction of Olibanum, Myrrha, Pulvis concha Mactrae: take by weighing Olibanum, Myrrha and Pulvis concha Mactrae after the process of preparing Chinese medicine of described weight, decoct with water extraction, extracting solution and a gained extracting solution merge, merge extractive liquid;
E. with above b, the merging of d gained extracting solution, filter, add the dissolve with ethanol liquid of Borneolum Syntheticum before the fill, stir, sterilization, fill get washing liquid in dispensing bottle.
6. the application of pharmaceutical composition as claimed in claim 1 or 2 in preparation treatment vagina medicine.
7. application as claimed in claim 6 is characterized in that, described vagina is a vaginitis.
8. application as claimed in claim 7 is characterized in that, described vaginitis is colpitis mycotica or trichomonal vaginitis.
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| CN102018761B (en) * | 2010-11-26 | 2012-02-01 | 田海平 | Drug for treating vagina pruritus and preparation method thereof |
| US8287924B2 (en) | 2011-03-17 | 2012-10-16 | Sonia Pharma Gmbh | Treatment of menopausal symptoms as novel indication for myrrh |
| ES2440649T3 (en) * | 2011-03-17 | 2014-01-29 | Sonia Pharma Gmbh | Treatment of menopausal symptoms with new indication for myrrh |
| BR112013023092A2 (en) * | 2011-03-17 | 2016-12-06 | Sonia Pharma Gmbh | myrrh in a vaginal dosage form |
| CN107184828A (en) * | 2017-05-22 | 2017-09-22 | 李亚庆 | A kind of lotion for treating gynaecologic vaginal infection and preparation method thereof |
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| CN1742859A (en) * | 2004-09-02 | 2006-03-08 | 周长居 | Medicinal ointment for regenerating-repairing burn and scald |
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| CN1742859A (en) * | 2004-09-02 | 2006-03-08 | 周长居 | Medicinal ointment for regenerating-repairing burn and scald |
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| Title |
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| 廖爱民.宫颈炎外治法研究近况.安徽中医学院学报11 1.1992,11(1),59-63. |
| 廖爱民.宫颈炎外治法研究近况.安徽中医学院学报11 1.1992,11(1),59-63. * |
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Address after: 474500 No. 168 Zhongjing Road, Xixia County, Henan Province Patentee after: ZHONGJING WANXI PHARMACEUTICAL CO., LTD. Address before: 474550 No. 168 Zhongjing Road, Xixia County, Henan Province Patentee before: Wanxi Pharmaceutical Co., Ltd., Henan Prov. |