CN1951445A - Itching relieving lotion and preparation method thereof - Google Patents
Itching relieving lotion and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a lotion against itching, wherein each 1000ml of the lotion comprises flavescent sophora root 50-70g, yellow corktree bark 50-70g, Chinese prickly ash 15-25g, borneol 0.5-2g, cnidium fruit 25-35g, dittany bark 25-35g, menthol 0.5-2g, domiphen bromide 0.5-2g. The preparing process of the lotion comprises steps of immersing cnidium fruit and pricklyash peel with 20 times by weight of water, distilling and collecting volatile oil, charging 5ml of Tween-80, grinding into slag, gathering distilled aqueous solution, merging raw materials and charging 12 times by weight of water for immersion, grilling and filtering, charging 10 times by weight of water into drug dross, grilling twice, filtering the decoction liquid, merging the filter liquor, filtering and merging the filter liquor with distilled aqueous solution, obtaining extract through decompression and concentration, charging ethanol to content of 60%, homogenizing, stewing, extracting supernatant fluid, reclaiming ethanol till no alcohol smell is present, and diluting to 1000ml with water.
Description
Technical field
The present invention relates to that a kind of medicine for the treatment of common gynecological disease---itching relieving lotion and preparation method thereof belongs to the field of Chinese medicines.
Background technology
Common gynecological disease has vaginitis and pruritus vulvae etc.In recent years, because influence of various factors, this disease has multiple trend clinically, and the numerous women's physical and mental health of serious harm influences its life, working and learning.
Though the treatment onset of Western medicine is very fast, life-time service is bigger to the zest of vaginal mucosa, and most of women patient be difficult for to accept, and just can't adhere to after often using a period of time, causes medicine can't reach expected effect.Behind the oral chemical drugs, it is lower that medicine arrives the partial concentration of vagina, need to use bigger oral dose just can play the effect of kill bacteria and infusorian, but heavy dose of oral this type of medicine can cause bigger systemic adverse reactions, and patient also can't accept.
The present medicine of Chinese medicine has JIEERYIN, FUYINJIE etc.The main composition medicine of JIEERYIN has Chinese medicines such as Folium Artemisiae Argyi, Fructus Cnidii, Radix Angelicae Pubescentis, and the main composition medicine of FUYINJIE has the Fructus Kochiae, Herba Senecionis Scandentis, Cortex Phellodendri, Folium Baeckeae oil, Folium Eucalypti Robustae oil, Oleum sesami all over the mountain, Fructus Cnidii oil.These medicines are commonly used, and antipruritic effect is not obvious, and what have also can cause verrucous hyperplasia, because the medicinal liquid color is darker, also can pollute underwear.
Summary of the invention
The problem to be solved in the present invention provides good and little also safe and reliable itching relieving lotion of side effect of a kind of therapeutic effect and preparation method thereof.
In order to address the above problem, the technical scheme of itching relieving lotion of the present invention is:
Contain in per 1000 milliliters of washing liquids:
Radix Sophorae Flavescentis 50g～70g, Cortex Phellodendri 50g～70g, Pericarpium Zanthoxyli 15g～25g, Borneolum Syntheticum 0.5g～2g, Fructus Cnidii 25g～35g, Cortex Dictamni 25g～35g, Mentholum 0.5g～2g, domiphen bromide 0.5g～2g.
Preferably, contain in per 1000 milliliters of washing liquids:
Radix Sophorae Flavescentis 60g, Cortex Phellodendri 60g, Pericarpium Zanthoxyli 20g, Borneolum Syntheticum 1g, Fructus Cnidii 30g, Cortex Dictamni 30g, Mentholum 1g, domiphen bromide 1g.
Correspondingly, a kind of preparation method of itching relieving lotion comprises the steps:
1) Pericarpium Zanthoxyli of the Fructus Cnidii of 25g～35g and 15g～25g is added the water logging bubble 1 hour of 20 times of amounts of its weight, redistillation was collected volatile oil after 5 hours, added the 5ml tween 80 and ground to form medicinal residues, and the aqueous solution after the distillation is collected in addition;
2) Radix Sophorae Flavescentis of medicinal residues and 50g～70g, the Cortex Phellodendri of 50g～70g and the Cortex Dictamni of 25g～35g are merged, put in the multi-function extractor, add 12 times of weight parts waters and soaked 1 hour, decoct again after 1 hour decocting liquid is filtered with 100 eye mesh screens;
3) with step 2) medicinal residues after decocting boils add 10 times of weight parts waters respectively again and decoct 2 times, each 1 hour, after decocting liquid filters with 100 eye mesh screens, merging filtrate, the reuse filter press filters, and the aqueous solution after the described distillation of filtrate and step 1 merges, being evaporated to relative density is the extractum of 1.04-1.06 (80 ℃), add 95% ethanol and make and contain the alcohol amount and reach 60%, stir evenly, left standstill 48 hours;
4) get supernatant, reclaim ethanol to there not being the alcohol flavor;
5) left standstill below 10 ℃ 48 hours, filter;
6) get the Mentholum of Borneolum Syntheticum, 0.5g～2g of 0.5g～2g and the domiphen bromide of 0.5g～2g and add ethanol 50ml dissolving, merge, stir evenly the back and add in the above-mentioned filtrate, be diluted with water to 1000ml, stir evenly and get final product with aforementioned volatile oil.
Preferably, the preparation method of itching relieving lotion of the present invention comprises the steps:
1) Pericarpium Zanthoxyli of the Fructus Cnidii of 30g and 20g is added the water logging bubble 1 hour of 20 times of amounts of its weight, redistillation was collected volatile oil after 5 hours, added the 5ml tween 80 and ground to form medicinal residues, and the aqueous solution after the distillation is collected in addition;
2) Radix Sophorae Flavescentis of medicinal residues and 60g, the Cortex Phellodendri of 60g and the Cortex Dictamni of 30g are merged, put in the multi-function extractor, add 12 times of weight parts waters and soaked 1 hour, decoct again after 1 hour decocting liquid is filtered with 100 eye mesh screens;
3) with step 2) medicinal residues after decocting boils add 10 times of weight parts waters respectively again and decoct 2 times, each 1 hour, after decocting liquid filters with 100 eye mesh screens, merging filtrate, the reuse filter press filters, and the aqueous solution after the distillation of filtrate and front two medicine merges, being evaporated to relative density is the extractum of 1.04-1.06 (80 ℃), add 95% ethanol and make and contain the alcohol amount and reach 60%, stir evenly, left standstill 48 hours;
4) get supernatant, reclaim ethanol to there not being the alcohol flavor;
5) left standstill below 10 ℃ 48 hours, filter;
6) get the Mentholum of Borneolum Syntheticum, 1g of 1g and the domiphen bromide of 1g and add ethanol 50ml dissolving, merge, stir evenly the back and add in the above-mentioned filtrate, be diluted with water to 1000ml, stir evenly and get final product with aforementioned volatile oil.
Compared with prior art, beneficial effect of the present invention:
Chinese medicine in this washing liquid mainly plays and dispels the wind, dampness, and the effect of heat radiation, Radix Sophorae Flavescentis and Cortex Phellodendri have parasite killing and bactericidal action preferably simultaneously, all can play certain curative effect to various types of vaginitiss.Domiphen bromide in the prescription is the spectrum antimicrobial drug, bacterial vaginitis is had better curative effect, and bacterial vaginitis proportion in all vaginitiss is higher.The method of this Chinese medicine and Western medicine partner treatment, will take stopgap measures and effect a permanent cure combines, and can treat the vaginitis disease comprehensively, and untoward reaction simultaneously is little, and safety is reliable.
The specific embodiment
First embodiment
Take off the row prescription:
Radix Sophorae Flavescentis 50g, Cortex Phellodendri 50g, Pericarpium Zanthoxyli 15g, Borneolum Syntheticum 0.5g, Fructus Cnidii 25g, Cortex Dictamni 25g, Mentholum 0.5g, domiphen bromide 0.5g.
Prescription according to above-mentioned component prepares itching relieving lotion by following step:
1) Pericarpium Zanthoxyli of the Fructus Cnidii of 25g and 15g is added the water logging bubble 1 hour of 20 times of amounts of its weight, redistillation was collected volatile oil after 5 hours, added the 5ml tween 80 and ground to form medicinal residues, and the aqueous solution after the distillation is collected in addition;
2) Radix Sophorae Flavescentis of medicinal residues and 50g, the Cortex Phellodendri of 50g and the Cortex Dictamni of 25g are merged, put in the multi-function extractor, add 12 times of weight parts waters and soaked 1 hour, decoct again after 1 hour decocting liquid is filtered with 100 eye mesh screens;
3) with step 2) medicinal residues after decocting boils add 10 times of weight parts waters respectively again and decoct 2 times, each 1 hour, after decocting liquid filters with 100 eye mesh screens, merging filtrate, the reuse filter press filters, and the aqueous solution after the described distillation of filtrate and step 1 merges, being evaporated to relative density is the extractum of 1.04-1.06 (80 ℃), add 95% ethanol and make and contain the alcohol amount and reach 60%, stir evenly, left standstill 48 hours;
4) get supernatant, reclaim ethanol to there not being the alcohol flavor;
5) left standstill below 10 ℃ 48 hours, filter;
6) get the Mentholum of Borneolum Syntheticum, 0.5g of 0.5g and the domiphen bromide of 0.5g and add ethanol 50ml dissolving, merge, stir evenly the back and add in the above-mentioned filtrate, be diluted with water to 1000ml, stir evenly and get final product with aforementioned volatile oil.
Second embodiment
Take off the row prescription:
Radix Sophorae Flavescentis 70g, Cortex Phellodendri 70g, Pericarpium Zanthoxyli 25g, Borneolum Syntheticum 2g, Fructus Cnidii 35g, Cortex Dictamni 35g, Mentholum 2g, domiphen bromide 2g.
Prescription according to above-mentioned component prepares itching relieving lotion by following step:
1) Pericarpium Zanthoxyli of the Fructus Cnidii of 35g and 25g is added the water logging bubble 1 hour of 20 times of amounts of its weight, redistillation was collected volatile oil after 5 hours, added the 5ml tween 80 and ground to form medicinal residues, and the aqueous solution after the distillation is collected in addition;
2) Radix Sophorae Flavescentis of medicinal residues and 70g, the Cortex Phellodendri of 70g and the Cortex Dictamni of 35g are merged, put in the multi-function extractor, add 12 times of weight parts waters and soaked 1 hour, decoct again after 1 hour decocting liquid is filtered with 100 eye mesh screens;
3) with step 2) medicinal residues after decocting boils add 10 times of weight parts waters respectively again and decoct 2 times, each 1 hour, after decocting liquid filters with 100 eye mesh screens, merging filtrate, the reuse filter press filters, and the aqueous solution after the described distillation of filtrate and step 1 merges, being evaporated to relative density is the extractum of 1.04-1.06 (80 ℃), add 95% ethanol and make and contain the alcohol amount and reach 60%, stir evenly, left standstill 48 hours;
4) get supernatant, reclaim ethanol to there not being the alcohol flavor;
5) left standstill below 10 ℃ 48 hours, filter;
6) get the Mentholum of Borneolum Syntheticum, 2g of 2g and the domiphen bromide of 2g and add ethanol 50ml dissolving, merge, stir evenly the back and add in the above-mentioned filtrate, be diluted with water to 1000ml, stir evenly and get final product with aforementioned volatile oil.
The 3rd embodiment
Preferably, take off the row prescription:
Radix Sophorae Flavescentis 60g, Cortex Phellodendri 60g, Pericarpium Zanthoxyli 20g, Borneolum Syntheticum 1g, Fructus Cnidii 30g, Cortex Dictamni 30g, Mentholum 1g, domiphen bromide 1g.
Prescription according to above-mentioned component prepares itching relieving lotion by following step:
1) Pericarpium Zanthoxyli of the Fructus Cnidii of 30g and 20g is added the water logging bubble 1 hour of 20 times of amounts of its weight, redistillation was collected volatile oil after 5 hours, added the 5ml tween 80 and ground to form medicinal residues, and the aqueous solution after the distillation is collected in addition;
2) Cortex Dictamni of the Cortex Phellodendri of the Radix Sophorae Flavescentis of medicinal residues and 60g, 60g and 30g merges, and puts in the multi-function extractor, adds 12 times of weight parts waters and soaks 1 hour, decocts after 1 hour again decocting liquid is filtered with 100 eye mesh screens;
3) with step 2) medicinal residues after decocting boils add 10 times of weight parts waters respectively again and decoct 2 times, each 1 hour, after decocting liquid filters with 100 eye mesh screens, merging filtrate, the reuse filter press filters, and the aqueous solution after the distillation of filtrate and front two medicine merges, being evaporated to relative density is the extractum of 1.04-1.06 (80 ℃), add 95% ethanol and make and contain the alcohol amount and reach 60%, stir evenly, left standstill 48 hours;
4) supernatant reclaims ethanol to there not being the alcohol flavor;
5) left standstill below 0 ℃ 48 hours, filter;
6) get the Mentholum of Borneolum Syntheticum, 1g of 1g and the domiphen bromide of 1g and add ethanol 50ml dissolving, merge, stir evenly the back and add in the above-mentioned filtrate, be diluted with water to 1000ml, stir evenly and get final product with aforementioned volatile oil.
Chinese medicine in this itching relieving lotion mainly plays and dispels the wind, dampness, and the effect of heat radiation, Radix Sophorae Flavescentis and Cortex Phellodendri have parasite killing and bactericidal action preferably simultaneously, all can play certain curative effect to various types of vaginitiss.Domiphen bromide in the prescription is the spectrum antimicrobial drug, bacterial vaginitis is had better curative effect, and bacterial vaginitis proportion in all vaginitiss is higher.The method of this Chinese medicine and Western medicine partner treatment, will take stopgap measures and effect a permanent cure combines, and can treat the vaginitis disease comprehensively, and untoward reaction simultaneously is little, and safety is reliable.Itching relieving lotion of the present invention has clearing away heat-damp and promoting diuresis, the effect of killing parasites for relieving itching.
The character of itching relieving lotion is described from the following aspects below.
One, quality research and stability study
Cortex Phellodendri in this product contains berberine, Fructus Cnidii contains osthole, Mentholum and Borneolum Syntheticum and is purer material, therefore in identification check, these four kinds of components have been carried out the thin layer identification check, shown that by methodological study institute's method suggested specificity and repeatability are all better.In checking item, stipulated that the pH value of this product is 4.5～5.5.The total solid residue of having stipulated this product simultaneously is greater than 1.8%.In the assay item matrine and domiphen bromide have been carried out assay, all adopted thin layer chromatography scanning, by the methodology checking, every indexs such as the method repeatability that is adopted, precision, the response rate, stability all meet the requirements.Adopt the quality standard drafted that test agent in three batches has been carried out Study on Stability, the result shows, at room temperature keeps sample 18 months, and every index has no significant change.Illustrate that itching relieving lotion is stable under commercially available back.
Two, pharmacodynamic study and toxicologic study
Pharmacodynamic study mainly comprises antibacterial tests, anti-trichomonal test, antiinflammatory test and antipruritic test.The in-vitro antibacterial test shows, itching relieving lotion has the obvious suppression effect to golden Portugal bacterium, second streptococcus, gonococcus, escherichia coli, Ghana Salmonella, bacillus pyocyaneus, Candida albicans, its antibacterial MIC50 is at 0.79～1.59mg/ml, and minimal bactericidal concentration is at 1.59～12.69mg/ml.Its fungistatic effect and JIEERYIN are suitable, the fungistatic effect of group B streptococcus, escherichia coli, Ghana Salmonella and bacillus pyocyaneus is better than JIEERYIN, but does not have significant difference.The in-vitro antibacterial test shows that itching relieving lotion and JIEERYIN all can make the wound healing of Cavia porcellus damaged skin infection Ghana Salmonella, bacteria growing inhibiting.The test of external anti-trichomonal shows, greater than with the JIEERYIN under the concentration, demonstrate itching relieving lotion has stronger anti-trichomonal effect to itching relieving lotion to the suppression ratio of infusorian.Adopt mice caused by dimethylbenzene xylene auricle edema and rat agar to cause the foot swelling test and show that itching relieving lotion has significantly antiinflammatory action.The pruritus that itching relieving lotion is caused by histamine Cavia porcellus has the obvious suppression effect, can significantly improve the itch-threshold of histamine to Cavia porcellus.
Toxicity test studies show that, itching relieving lotion gastric infusion avirulence, rabbit vagina administration 0.3,0.6ml/kg/d do not find the toxic action of rabbit parenchymal viscera (heart, liver, kidney) etc. is not seen tangible toxicity pathological changes to uterus, vagina and ovary in 2 weeks of successive administration.
Three, clinical effectiveness
Itching relieving lotion of the present invention is a vagina administration.With itching relieving lotion 33ml, with 2 times of dilutions of eliminating cold for resuscitation water, put into the 100ml irrigator, directly washing vagina.Flushing back reuse cotton balls dips in dilute liquid medicine and fills in the vagina depths.Once-a-day, took out in 24 hours.7 days is a course of treatment.
This carries out clinical trial in Second Hospital Attached To Tianjin Chinese Medicine College again, adopts itching relieving lotion of the present invention to treat mycotic, trichomonal vaginitis (damp heat downward flowing type leukorrhagia, pudendal pruritus).
Select out-patient's 240 examples, it is divided into two groups, test group 120 example and matched group 120 examples.Adopt at random, the principle of parallel control, double blinding.
Test group adopts itching relieving lotion of the present invention to treat; Matched group adopts JIEERYIN XIYE.
The case choice criteria
(1) diagnostic criteria and case inclusion criteria
1, tcm diagnosis standard
(1) leukorrhagia card: leukorrhagia amount showed increased, color, matter is unusual or foul smell is arranged, with part or General Symptoms person.
(2) pudendal pruritus card: pudendum and vagina are scratched where it itches and be can't bear, and very then scratch where it itches and increase unbearably or with leukorrhagia, or general malaise person is arranged.
2, differential diagnosis in tcm standard
Damp heat downward flowing type: profuse leukorrhea, Se Bai or Huang or yellow green are the bean dregs sample, or are foam water from washing rice sample.Pudendal pruritus, the pain of very then itching, bitter taste and be bored with, the sliding or cunning number of pulse condition.
(1) main symptom profuse leukorrhea, pudendum are itched bitterly.
(2) inferior card bitter taste and being bored with, indigestion and loss of appetite wrist is vexed, oliguria, frequency, puckery pain.
Main symptom indispensability, inferior card possess 2, and be with reference to the tongue arteries and veins, promptly diagnosable.
3, Western medicine diagnose standard
The mycete vaginitis
(1) leucorrhoea grow in quantity, the stiff that is white in color bean dregs sample.Companion's pruritus vulvae or burn feeling can have causalgia, touch a tender spot
(2) adhere to white membranoid substance on inspection visible nympha inboard and the vaginal mucosa, mucous hyperemia, even edema is rotten to the corn.
(3) lab testing, Candida albicans (+)
Trichomonal vaginitis
(1) leucorrhoea grow in quantity is yellow or yellow green, and cystose also can be purulence or band is courageous and upright, frowziness, companion's pruritus vulvae, pain or burn feeling, urine urgency-frequency and contact pain sometimes.
(2) checking can vaginal vestibule portion, the vaginal mucosa Mild edema, and the congested speckle of congested or being dispersed in property, posterior fornix has fluidity cystose or purulence foam secretions.
(3) lab testing infusorian (+)
4, score standard
Traditional Chinese medical science score standard
| Symptom | Slightly (branch) | Moderate (branch) | Severe (branch) | |
| Main symptom | Pudendum is itched bitterly | The uncomfortable even pruritus (2) of pudendum pudendum | The pudendum pudendal pruritus still can be stood (4) | The pudendum pudendal pruritus acutely is difficult to stand (6) |
| Profuse leukorrhea | The pudendum humidity is easypro (2) | Underwear has stain still need not fill up sanitary towel (4) | Underwear pollutes obviously to increase needs pad sanitary towel (6) | |
| Inferior card | Bitter taste and being bored with, indigestion and loss of appetite wrist is vexed, oliguria, frequency, puckery pain | There is (1) not have (0) | ||
| The tongue arteries and veins | Red tongue, yellow and greasy fur, the sliding or sliding number of pulse condition | Write down not scoring value of concrete tongue arteries and veins | ||
Local sign (gynecologial examination) weight standards of grading
Colpitis mycotica
| Local sign | (branch) | (branch) | (branch) |
| Profuse leukorrhea, the white stiff bean dregs of color sample | Vaginal secretions many slightly (2) | Posterior fornix of vagina has accumulation secretions, measures many (4) | Full vagina has secretions and flows out vaginal orifice outer (6) |
| Vaginal mucosa | The point lamellar is adhered to white membranoid substance, wipes back mucous hyperemia (1) | Whole vagina is covered with membranoid substance, wipes back mucous hyperemia, swelling (2) | Whole vagina is covered with membranoid substance, wipes the visible mucosal erosion in back, diabrosis (3) |
| Pudendum | Congested (1) | Congested, swelling (2) | Rubescent, ulceration (3) |
Trichomonal vaginitis
| Local sign | (branch) | (branch) | (branch) |
| Profuse leukorrhea, the thin show bubble of yellow skin | Vaginal secretions many slightly (2) | Posterior fornix of vagina has accumulation secretions, measures many (4) | Full vagina has secretions and flows out vaginal orifice outer (6) |
| Skin mucosa and vagina cervical mucosa | Congested (1) | Congested, swelling (2) | Vagina, cervical mucosa are dispersed in petechia or strawberry shape projection (3) |
| Pudendum | Congested (1) | Congested, swelling (2) | Rubescent, ulceration (3) |
The special examined standards of grading
Leucorrhea microscopy weight standards of grading
| Classification | Pathogenic bacterium |
| Colpitis mycotica | Mycete (10) | Do not have (0) |
| Trichomonal vaginitis | Infusorian (10) | Do not have (0) |
Vagina cleanness degree
| Project | (branch) | (branch) | (branch) |
| Vaginal smear | I degree: mainly be vaginal epithelial cell and bacterium vaginae (0) in the smear | II degree: remove vaginal epithelial cell and bacterium vaginae in the smear, visible leukocyte and other assorted bacterium (1) | The III degree: smear per vaginam epithelial cell and bacterium vaginae seldom, other assorted bacterium and leukocyte is more or only leukocyte and other assorted bacterium (2) |
5, severity extent standard
(1) slight: integration≤20 minute;
(2) moderate: integration 21～31 minutes;
(3) severe: integration＞31 minute.
6, test case standard
(1) includes the case standard in
Differential diagnosis in tcm belongs to pudendal pruritus leukorrheal diseases (damp heat downward flowing type) person
Western medicine diagnose is colpitis mycotica and trichomonal vaginitis person
Age: 18～50 years old
Signature Informed Consent Form person
(2) discharge the case standard
Differential diagnosis in tcm does not belong to pudendal pruritus leukorrheal diseases (damp heat downward flowing type) person
Western medicine diagnose does not belong to colpitis mycotica and trichomonal vaginitis person
Age: at under-18s, person more than 50 years old
The unmarried woman, menstrual period, gestation,
Be vaginitis associated treatment person in two weeks
Merge severe palace strength erosion, endometritis, gynecological tumor, leucorrhea abnormal that pelvic inflammatory disease, sexually transmitted disease (STD) etc. cause or pudendal pruritus patient
With primary diseases such as serious cardiovascular, liver, kidney, psychotic
(3) reject the case standard
Do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect or data not umbra sound curative effect and safety judgement person.
Test method
(1) II clinical trial phase adopts at random, the principle of parallel control, double blinding, test group and matched group each-example, wherein colpitis mycotica and trichomonal vaginitis respectively-right
1, packet design adopts 1: 1 group technology
2, the course of treatment and administrated method
Continuous use 7 days was a course of treatment, finished to carry out efficacy evaluation after 3 days, and the recovery from illness patient follows up a case by regular visits to behind three menstrual cycle.
Test group: with the dilution in 1: 2 of eliminating cold for resuscitation water, put into directly washing vagina of 100ml irrigator, flushing back reuse cotton balls dips in dilute liquid medicine and fills in vagina, once-a-day, takes out in 24 hours.
Matched group: JIEERYIN XIYE, the same test group of administrated method.
3, the enforcement of blind method:
I) random method: adopt district's group random method, and according to table of random number, selected serial number of patient and A, B grouping redesign table of random number, this table is filed by clinical research responsible department base office, each preservation sealing of research institute, notify each test unit when treating open-blind successively, each test unit must number be labeled in selected patient's sequence number and medicine on the observation table.
Ii) double blinding operational approach:
A is packed curative and curative by research institute with volume, and indicates medicine number by table of random number.B establishes one bag of sealing in addition, in put into and this bag medicine number and identical substitute medicine number so that patient when rejecting halfway, opens middle bag, and unlikely broken blind.C establishes pouch sealing in addition, writes warning exactly on the pouch front cover, only when serious adverse reaction takes place, can open pouch, in time rescue, and unlikely cause broken comprehensively blind.More than two bags all be kept at base office of test unit.D breaks blind method: after the off-test, by pharmacy unit, the clinical research responsible department according to table of random number notify two groups of each the experimenter A of test unit, B which be test group and matched group.
Iii) adopt the principle of parallel control.
Observation index
1, safety observation
(1) general health check-up project (all cases);
(2) respectively look into once before and after blood, urine, just routine test (all cases) treatment;
(3) electrocardiogram, liver, renal function (ALT, BuN, Cr) are all respectively looked into once before and after the case treatment.
2, health giving quality observation
(1) clinical manifestation: pruritus vulvae causalgia, leukorrhagia amount, color, matter, flavor, urgent micturition, frequent micturition, dysurea, bitter taste and be bored with situations such as picture of the tongue pulse condition.
(2) gynecologial examination comprises pudendum, vagina, cervix uteri and pelvioscopy.
(3) vaginal secretions inspection comprises smear and physical behavior inspection under the mirror
(4) vagina cleanness degree inspection
(5) inspection of vaginal pathogenic (mycete, infusorian)
(6) vagina PH value inspection
Difference observed and recorded before and after test (all cases)
Curative effect determinate standard
(1) total effects criterion
1, recovery from illness: Syndrome in TCM marquis's main symptom, (pudendal pruritus, leukorrhagia is unusual) disappears, inferior card is most of to disappear, and doctor trained in Western medicine checks that secretions transfers to normally, and laboratory is not found mycete and infusorian, therapeutic index reduces more than 90%, does not have recurrence behind three menstrual cycle of drug withdrawal, and multiple inspection is all normal.
2, produce effects: Syndrome in TCM marquis's main symptom, (pudendal pruritus, leukorrhagia is unusual) disappearance, time card part of holding concurrently alleviates, and lab testing is normal, 70～90% before therapeutic index reduces to and treats.
3, effective: the vaginal secretions inspection is normal, and other symptom exists; Or other transference cure, alleviate, and the vaginal secretions inspection is unusual 30～70% before therapeutic index reduces to and treats.
4, invalid: treatment back symptom and the no significant change of inspection, therapeutic index reduces below 30%.
(2) main symptom, (pudendal pruritus, leukorrhagia is unusual) curative effect determinate standard
1, recovery from illness: 0 fen person is all reduced in the unusual scoring of pudendal pruritus and leukorrhagia.
2, produce effects: the unusual scoring of pudendal pruritus and leukorrhagia two grades that respectively descend do not reach 0 fen person.
3, effective: the unusual scoring of pudendal pruritus and the leukorrhagia grade that respectively descends does not reach 0 fen person.
4, invalid: pudendal pruritus and the leukorrhagia no change of marking unusually.
(3) special examined curative effect determinate standard
1, pathogenic bacterium curative effect judging standard
1) infusorian, treatment back check that infusorian is negative to be recovery from illness; The infusorian positive is invalid.
2) mycete, treatment back check that mycete is negative to be recovery from illness; The mycete positive is invalid.
2, vagina cleanness degree curative effect judging standard
1) recovery from illness: vagina cleanness degree is the I degree.
2) produce effects: vagina cleanness degree becomes the I degree by III degree or II degree.
3) effective: vagina cleanness degree becomes the II degree by the III degree.
4) invalid: the vagina cleanness degree no change.
(4) Syndrome in TCM marquis curative effect determinate standard
1, recovery from illness: treatment back clinical symptoms disappears therapeutic index 〉=90% substantially
2, produce effects: after the treatment, clinical symptoms obviously alleviates 90% 〉=therapeutic index 〉=70%
3, effective: treatment back clinical symptom relief 70%＞therapeutic index 〉=30%
4, invalid: treatment back clinical symptoms no change therapeutic index＜30%
The statistical disposition of clinical data
(1) ranked data are checked with Ridit
(2) enumeration data X
2Check
(3) measurement data is checked with t
Result of the test
Health giving quality is observed between two groups
Two groups of total effectses relatively see the following form
| The sick kind | Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Cure-remarkable-effectiveness rate (%) | Total effective rate (%) | U | P |
| Mycete | Test group | 60 | 30 | 21 | 5 | 4 | 85 | 93.33 | 1.65 | ＞0.05 |
| Matched group | 60 | 23 | 19 | 10 | 8 | 70.00 | 86.67 | |||
| Infusorian | Test group | 60 | 12 | 19 | 21 | 8 | 51.67 | 86.67 | 1.56 | ＞0.05 |
| Matched group | 60 | 7 | 16 | 25 | 12 | 38.33 | 80.00 |
Through the Ridit check, colpitis mycotica test group and matched group compare: U=1.65 P＞0.05
Trichomonal vaginitis test group and matched group compare: U=1.56 P＞0.05
Through X
2Check: colpitis mycotica: two groups of cure rates compare: X
2=1.22 P＞0.05
Two groups of cure-remarkable-effectiveness rates compare: X
2=3.06 P＞0.05
Trichomonal vaginitis: two groups of cure rates compare: X
2=1.00 P＞0.05
Two groups of cure-remarkable-effectiveness rates compare: X
2=1.65 P＞0.05
Two groups of recoveries from illness, cure-remarkable-effectiveness rates there are no significant difference P＞0.05
Two groups of Syndrome in TCM marquis curative effects relatively see the following form:
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Cure-remarkable-effectiveness rate (%) | Total effective rate (%) | U | P |
| Test group | 120 | 54 | 20 | 36 | 10 | 61.67 | 91.67 | 1.97 | ＜0.05 |
| Matched group | 120 | 37 | 25 | 44 | 14 | 51.67 | 88.33 |
Check through Ridit: relatively there were significant differences for U=1.97 P＜0.05 a liang group Syndrome in TCM marquis curative effect, and prompting treatment group curative effect is better than matched group.
Clinical research shows that itching relieving lotion not only can be treated vaginitis and Pruritus Vulva, and bacterial vaginosis and colpitis mycotica are also had curative effect preferably.Gram lotion washout treatment candidiasis balanoposthitis can yet be regarded as a kind of efficient, safety, the method easily of relaxing of itching.
Claims (4)
1, a kind of itching relieving lotion is characterized in that, contains in per 1000 milliliters of washing liquids:
Radix Sophorae Flavescentis 50g～70g, Cortex Phellodendri 50g～70g, Pericarpium Zanthoxyli 15g～25g, Borneolum Syntheticum 0.5g～2g, Fructus Cnidii 25g～35g, Cortex Dictamni 25g～35g, Mentholum 0.5g～2g, domiphen bromide 0.5g～2g.
2, itching relieving lotion as claimed in claim 1 is characterized in that, contains in per 1000 milliliters of washing liquids:
Radix Sophorae Flavescentis 60g, Cortex Phellodendri 60g, Pericarpium Zanthoxyli 20g, Borneolum Syntheticum 1g, Fructus Cnidii 30g, Cortex Dictamni 30g, Mentholum 1g, domiphen bromide 1g.
3, a kind of preparation method of itching relieving lotion is characterized in that, comprises the steps:
1) Pericarpium Zanthoxyli of the Fructus Cnidii of 25g～35g and 15g～25g is added the water logging bubble 1 hour of 20 times of amounts of its weight, redistillation was collected volatile oil after 5 hours, added the 5ml tween 80 and ground to form medicinal residues, and the aqueous solution after the distillation is collected in addition;
2) Cortex Dictamni of the Cortex Phellodendri of the Radix Sophorae Flavescentis of medicinal residues and 50g～70g, 50g～70g and 25g～35g merges, and puts in the multi-function extractor, adds 12 times of weight parts waters and soaks 1 hour, decocts after 1 hour again decocting liquid is filtered with 100 eye mesh screens;
3) with step 2) medicinal residues after decocting boils add 10 times of weight parts waters respectively again and decoct 2 times, each 1 hour, after decocting liquid filters with 100 eye mesh screens, merging filtrate, the reuse filter press filters, and the aqueous solution after the described distillation of filtrate and step 1 merges, being evaporated to relative density is the extractum of 1.04-1.06 (80 ℃), add 95% ethanol and make and contain the alcohol amount and reach 60%, stir evenly, left standstill 48 hours;
4) get supernatant, reclaim ethanol to there not being the alcohol flavor;
5) left standstill below 10 ℃ 48 hours, filter;
6) get the Mentholum of Borneolum Syntheticum, 0.5g～2g of 0.5g～2g and the domiphen bromide of 0.5g～2g and add ethanol 50ml dissolving, merge, stir evenly the back and add in the above-mentioned filtrate, be diluted with water to 1000ml, stir evenly and get final product with aforementioned volatile oil.
4, the preparation method of the described itching relieving lotion of claim 1, it is characterized in that, comprise the steps: 1) Pericarpium Zanthoxyli of the Fructus Cnidii of 30g and 20g is added the water logging bubble 1 hour of 20 times of amounts of its weight, redistillation was collected volatile oil after 5 hours, add the 5ml tween 80 and grind to form medicinal residues, the aqueous solution after the distillation is collected in addition;
2) Cortex Dictamni of the Cortex Phellodendri of the Radix Sophorae Flavescentis of medicinal residues and 60g, 60g and 30g merges, and puts in the multi-function extractor, adds 12 times of weight parts waters and soaks 1 hour, decocts after 1 hour again decocting liquid is filtered with 100 eye mesh screens;
3) medicinal residues after step 2) decocting boils add 10 times of weight parts waters respectively again and decoct 2 times, each 1 hour, after decocting liquid filters with 100 eye mesh screens, merging filtrate, the reuse filter press filters, and the aqueous solution after the distillation of filtrate and front two medicine merges, being evaporated to relative density is the extractum of 1.04-1.06 (80 ℃), add 95% ethanol and make and contain the alcohol amount and reach 60%, stir evenly, left standstill 48 hours;
4) get supernatant, reclaim ethanol to there not being the alcohol flavor;
5) left standstill below 10 ℃ 48 hours, filter;
6) get the Mentholum of Borneolum Syntheticum, 1g of 1g and the domiphen bromide of 1g and add ethanol 50ml dissolving, merge, stir evenly the back and add in the above-mentioned filtrate, be diluted with water to 1000ml, stir evenly and get final product with aforementioned volatile oil.
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| CN200510109434A CN100581567C (en) | 2005-10-18 | 2005-10-18 | Vaginitis lotion preparation method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104138445A (en) * | 2013-05-10 | 2014-11-12 | 艾白媛 | Traditional Chinese medicinal external lotion for treating leukoplakia vulvae |
| CN110123986A (en) * | 2019-05-17 | 2019-08-16 | 湖南天大生物科技股份有限公司 | A kind of composition improving microecology in vaginas |
| CN116509936A (en) * | 2023-06-12 | 2023-08-01 | 合肥华威药业有限公司 | Preparation process of lotion for treating colpitis |
-
2005
- 2005-10-18 CN CN200510109434A patent/CN100581567C/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104138445A (en) * | 2013-05-10 | 2014-11-12 | 艾白媛 | Traditional Chinese medicinal external lotion for treating leukoplakia vulvae |
| CN110123986A (en) * | 2019-05-17 | 2019-08-16 | 湖南天大生物科技股份有限公司 | A kind of composition improving microecology in vaginas |
| CN110123986B (en) * | 2019-05-17 | 2021-05-18 | 湖南天大生物科技股份有限公司 | Composition for improving vaginal microecology |
| CN116509936A (en) * | 2023-06-12 | 2023-08-01 | 合肥华威药业有限公司 | Preparation process of lotion for treating colpitis |
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| Publication number | Publication date |
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| CN100581567C (en) | 2010-01-20 |
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