CN104147329A - Method for preparing lotion for treating atrophic vaginitis - Google Patents

Abstract

The invention relates to a method for preparing a lotion for treating atrophic vaginitis. By adopting the method, the lotion is prepared by compatibility of rhizoma anemarrhenae, polygonum cuspidatum, saururus chinensis, lindley eupatorium herb, schisandra chinensis, licorice root, cortex pseudolaricis, acacia catechu, lysimachia chiristinae hance and common carpesium fruit, is a broad-spectrum high-efficiency contact fungicide, and does not form drug resistance. The lotion is capable of promoting vaginal mucosa epithelial cells to synthesize and secrete glycogen, promoting generation of lactic acid bacteria in a vagina and restoring a normal ecological system of the vagina, and can be used for treating colpitis mycotica and general vaginitis.

Description

A kind of preparation method of lotion for the treatment of atrophic vaginitis

Technical field

The present invention relates to technical field of Chinese medicines, be specifically related to a kind of preparation method of lotion for the treatment of atrophic vaginitis.

Background technology

Senile vaginitis is common in postclimacteric elderly woman, and because of ovarian function decline, estrogen level reduces, vaginal wall atrophy, mucosa attenuation, in epithelial cell, glycogen content reduces, intravaginal pH value rises, and local resistance reduces, and pathogenic bacterium are easily invaded breeding and cause inflammation.Cardinal symptom is that vaginal secretions increases and pruritus vulvae, burning sensation.Inspection is shown in that vagina is senile change, upper atrophoderma, and pleat disappears, and it is sliding, poor that epithelium flattens.Vaginal mucosa hyperemia, has little petechia, sometimes sees shallow table ulcer.

Senile vaginitis is common in postclimacteric elderly woman, and because of ovarian function decline, estrogen level reduces, vaginal wall atrophy, mucosa attenuation, in epithelial cell, glycogen content reduces, intravaginal pH value rises, and local resistance reduces, and pathogenic bacterium are easily invaded breeding and cause inflammation.Cardinal symptom is that vaginal secretions increases and pruritus vulvae, burning sensation.Inspection is shown in that vagina is senile change, upper atrophoderma, and pleat disappears, and it is sliding, poor that epithelium flattens.Vaginal mucosa hyperemia, has little petechia, sometimes sees shallow table ulcer.At present, of a great variety for the washing liquid for the treatment of gynecological inflammation, there is the yellow Pu Jie skin lotion of pure Chinese medicine; The effect of sterilization comes from the Chinese medicine medicines compositions such as Cortex Phellodendri, Rhizoma Coptidis and Herba Taraxaci, safe and non-stimulating; And be weakly acidic lotion, can safeguard the environmental balance of vagina self, improve the immunity of body.Also have Chinese medicine and chemical composition combination, as clean in: JIEERYIN, woman's inflammation, gynecological's a thousand pieces of gold washing liquid etc., utilizes the bactericidal action of chemical composition to take stopgap measures, and utilizes Chinese medicine ingredients to effect a permanent cure, and is a kind of mode for the treatment of both the principal and secondary aspects of a disease.But how seeking the new more reasonably lotion prescription of compatibility, improve the curative effect for the treatment of person in middle and old age gynecological inflammation, is emphasis and the direction that needs to continue further investigation.

Summary of the invention

The object of the invention is the deficiency for solving the problems of the technologies described above, a kind of preparation method of lotion for the treatment of atrophic vaginitis is provided.

The present invention is the deficiency solving the problems of the technologies described above, and the technical scheme adopting is: a kind of preparation method of lotion for the treatment of atrophic vaginitis, comprises the following steps:

(1) get the Rhizoma Anemarrhenae, with the alcohol reflux of 20 times of weight, extract altogether twice, each 2h, merge the ethanol extract of twice, filter, reclaim ethanol, concentrated alcohol is sink to containing alcohol 80%, reclaim ethanol, be diluted with water to 10 times of medical material weight, obtain medicinal liquid, then regulating PH is 4, and medicinal liquid is crossed to anion exchange resin, medicinal liquid has been crossed and washed post bed to effluent with water after post bed is colourless, it is colourless being eluted to effluent with 0.8% NaOH again, collect alkali eluent, adjusting pH value is 5, filter, water bath method, at 80 DEG C of temperature, dry, obtain powder I, get powder I and osmanthus flower fragrance mixes taking weight ratio as 10:1 again, stir, obtain mixed powder I, for subsequent use,

(2) get Rhizoma Polygoni Cuspidati, pulverized 50 orders, then adding mass concentration is 3% calcium hydroxide spice, then adds the water of 10 times to heat to 60 DEG C, is incubated 2 hours, filters, and obtains extracting solution; Regulate the pH value to 9 of extracting solution, upper macroporous adsorbent resin after filtering, adsorb, adsorb saturated after washing, cylinder filler after washing is first used 0.3% sodium hydroxide eluting, do not collect eluent, after be that 60% alcoholic solution and mass concentration are the eluent eluting of 1% sodium hydroxide with containing volumetric concentration again, collecting eluent, is 2 rear centrifugal by eluent with sulphuric acid adjust pH, and cold drying obtains powder II, get powder II and vanillin mixes taking weight ratio as 12:1 again, stir, obtain mixed powder II, for subsequent use;

(3) get the rhizome of Rhizoma Saururi (Herba Saururi), after pulverizing, add the methanol of 8 times of weight, heating and refluxing extraction 2h, filtering residue adds the methanol of 6 times of weight again, and heating and refluxing extraction 1h filters, merge filtrate twice, vacuum concentration obtains extractum, then extractum is spread with the hot water of 3 times of extractum weight, then with isopyknic ethyl acetate extraction 4 times, extract is after reclaim under reduced pressure ethyl acetate, obtain extractum, vacuum becomes dry powder, obtains powder III, get powder III and gardenia compound mixes taking weight ratio as 15:1 again, stir, obtain mixed powder III, for subsequent use;

(4) according to parts by weight get mixed powder I 30-50 part, mixed powder II 20-40 part,

Mixed powder III 20-40 part, Herba Eupatorii Lindleyani 50-80 part, Fructus Schisandrae Chinensis 40-60 part, Radix Glycyrrhizae 40-60 part, Cortex Pseudolaricis 10-20 part, catechu 15-20 part, Herba Lysimachiae 10-20 part, Fructus Carpesii 10-20 part, Radix Ranunculi Ternati 15-20 part and Alumen 40-60 part are for subsequent use;

(5) get Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati, be placed in multi-function extractor, add 8 times to the drinking-water of drug weight, heating extraction 1 hour, filters; Add again 6 times of water gagings and extract 1 hour, filter; Add 4 times of water gagings again and extract 0.5 hour, filter, merging filtrate, makes extracting solution, then the mixed powder I of taking-up, mixed powder II and mixed powder III is added in extracting solution, stirs 5-10min, obtains mixed extract;

(6) above-mentioned mixed extract is placed in settling tank, adds Alumen to dissolve, staticly settle 14 hours, then get the supernatant of the medicinal liquid after precipitation, be placed in high speed centrifuge, carry out centrifugal filtration; After filtering, filtrate is put in concentrating under reduced pressure tank, is concentrated into relative density to 1.25 through concentrating under reduced pressure, takes out concentrated solution and is transported in Agitation Tank; By concentrated solution in Agitation Tank, adjust relative density to 1.04, add the sodium benzoate of liquor capacity 0.3% simultaneously, take out medicinal liquid, put clean container, make the colpitic lotion for the treatment of.

The addition of the middle calcium hydroxide of described step (2) is 0.1 times of Rhizoma Polygoni Cuspidati weight.

beneficial effect

Lotion of the present invention is by the Rhizoma Anemarrhenae, Rhizoma Polygoni Cuspidati, Rhizoma Saururi (Herba Saururi), Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati compatibility, the contact antibacterial of the lotion broad-spectrum high efficacy making, and do not form Drug resistance, can promote that vaginal epithelium is synthetic and secrete glycogen, promote the generation of vagina lactobacillus, recover the normal ecosystem of vagina, can be used for the treatment of colpitis mycotica and general vaginitis, the atrophic vaginitis of middle aged and aged women is had to significant especially effect.

Summary of the invention

The object of the invention is the deficiency for solving the problems of the technologies described above, a kind of preparation method of lotion for the treatment of atrophic vaginitis is provided, the lotion product making can effectively be treated the gynecological inflammation of middle aged and aged women.

The present invention is the deficiency solving the problems of the technologies described above, and the technical scheme adopting is: a kind of preparation method of lotion for the treatment of atrophic vaginitis, comprises the following steps:

(1) get the Rhizoma Anemarrhenae, with the alcohol reflux of 20 times of weight, extract altogether twice, each 2h, merge the ethanol extract of twice, filter, reclaim ethanol, concentrated alcohol is sink to containing alcohol 80%, reclaim ethanol, be diluted with water to 10 times of medical material weight, obtain medicinal liquid, then regulating PH is 4, and medicinal liquid is crossed to anion exchange resin, medicinal liquid has been crossed and washed post bed to effluent with water after post bed is colourless, it is colourless being eluted to effluent with 0.8% NaOH again, collect alkali eluent, adjusting pH value is 5, filter, water bath method, at 80 DEG C of temperature, dry, obtain powder I, get powder I and osmanthus flower fragrance mixes taking weight ratio as 10:1 again, stir, obtain mixed powder I, for subsequent use,

(2) get Rhizoma Polygoni Cuspidati, pulverized 50 orders, then adding mass concentration is 3% calcium hydroxide spice, then adds the water of 10 times to heat to 60 DEG C, is incubated 2 hours, filters, and obtains extracting solution; Regulate the pH value to 9 of extracting solution, upper macroporous adsorbent resin after filtering, adsorb, adsorb saturated after washing, cylinder filler after washing is first used 0.3% sodium hydroxide eluting, do not collect eluent, after be that 60% alcoholic solution and mass concentration are the eluent eluting of 1% sodium hydroxide with containing volumetric concentration again, collecting eluent, is 2 rear centrifugal by eluent with sulphuric acid adjust pH, and cold drying obtains powder II, get powder II and vanillin mixes taking weight ratio as 12:1 again, stir, obtain mixed powder II, for subsequent use;

(3) get the rhizome of Rhizoma Saururi (Herba Saururi), after pulverizing, add the methanol of 8 times of weight, heating and refluxing extraction 2h, filtering residue adds the methanol of 6 times of weight again, and heating and refluxing extraction 1h filters, merge filtrate twice, vacuum concentration obtains extractum, then extractum is spread with the hot water of 3 times of extractum weight, then with isopyknic ethyl acetate extraction 4 times, extract is after reclaim under reduced pressure ethyl acetate, obtain extractum, vacuum becomes dry powder, obtains powder III, get powder III and gardenia compound mixes taking weight ratio as 15:1 again, stir, obtain mixed powder III, for subsequent use;

(4) according to parts by weight get mixed powder I 30-50 part, mixed powder II 20-40 part,

Mixed powder III 20-40 part, Herba Eupatorii Lindleyani 50-80 part, Fructus Schisandrae Chinensis 40-60 part, Radix Cyathulae 40-60 part, Radix Glycyrrhizae 40-60 part, Cortex Pseudolaricis 10-20 part, catechu 15-20 part, Herba Lysimachiae 10-20 part, Fructus Carpesii 10-20 part, Radix Ranunculi Ternati 15-20 part and Alumen 40-60 part are for subsequent use;

(5) get Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Cyathulae, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati, be placed in multi-function extractor, add 8 times to the drinking-water of drug weight, heating extraction 1 hour, filters; Add again 6 times of water gagings and extract 1 hour, filter; Add 4 times of water gagings again and extract 0.5 hour, filter, merging filtrate, makes extracting solution, then the mixed powder I of taking-up, mixed powder II and mixed powder III is added in extracting solution, stirs 5-10min, obtains mixed extract;

(6) above-mentioned mixed extract is placed in settling tank, adds Alumen to dissolve, staticly settle 14 hours, then get the supernatant of the medicinal liquid after precipitation, be placed in high speed centrifuge, carry out centrifugal filtration; After filtering, filtrate is put in concentrating under reduced pressure tank, is concentrated into relative density to 1.25 through concentrating under reduced pressure, takes out concentrated solution and is transported in Agitation Tank; By concentrated solution in Agitation Tank, adjust relative density to 1.04, add the sodium benzoate of liquor capacity 0.3% simultaneously, take out medicinal liquid, put clean container, make the colpitic lotion for the treatment of.

The addition of the middle calcium hydroxide of described step (2) is 0.1 times of Rhizoma Polygoni Cuspidati weight.

beneficial effect

Lotion of the present invention is by the Rhizoma Anemarrhenae, Rhizoma Polygoni Cuspidati, Rhizoma Saururi (Herba Saururi), Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Cyathulae, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati compatibility, the contact antibacterial of the lotion broad-spectrum high efficacy making, and do not form Drug resistance, can promote that vaginal epithelium is synthetic and secrete glycogen, promote the generation of vagina lactobacillus, recover the normal ecosystem of vagina, can be used for the treatment of colpitis mycotica and general vaginitis, the vaginitis of middle aged and aged women is had to significant especially effect.

Detailed description of the invention

embodiment 1:

A preparation method for the treatment of the lotion of atrophic vaginitis, comprises the following steps:

(1) get the Rhizoma Anemarrhenae, with the alcohol reflux of 20 times of weight, extract altogether twice, each 2h, merge the ethanol extract of twice, filter, reclaim ethanol, concentrated alcohol is sink to containing alcohol 80%, reclaim ethanol, be diluted with water to 10 times of medical material weight, obtain medicinal liquid, then regulating PH is 4, and medicinal liquid is crossed to anion exchange resin, medicinal liquid has been crossed and washed post bed to effluent with water after post bed is colourless, it is colourless being eluted to effluent with 0.8% NaOH again, collect alkali eluent, adjusting pH value is 5, filter, water bath method, at 80 DEG C of temperature, dry, obtain powder I, get powder I and osmanthus flower fragrance mixes taking weight ratio as 10:1 again, stir, obtain mixed powder I, for subsequent use,

(2) get Rhizoma Polygoni Cuspidati, pulverized 50 orders, then adding mass concentration is 3% calcium hydroxide spice (in described step (2), the addition of calcium hydroxide is 0.1 times of Rhizoma Polygoni Cuspidati weight), then add the water of 10 times to heat to 60 DEG C, be incubated 2 hours, filter, obtain extracting solution; Regulate the pH value to 9 of extracting solution, upper macroporous adsorbent resin after filtering, adsorb, adsorb saturated after washing, cylinder filler after washing is first used 0.3% sodium hydroxide eluting, do not collect eluent, after be that 60% alcoholic solution and mass concentration are the eluent eluting of 1% sodium hydroxide with containing volumetric concentration again, collecting eluent, is 2 rear centrifugal by eluent with sulphuric acid adjust pH, and cold drying obtains powder II, get powder II and vanillin mixes taking weight ratio as 12:1 again, stir, obtain mixed powder II, for subsequent use;

(3) get the rhizome of Rhizoma Saururi (Herba Saururi), after pulverizing, add the methanol of 8 times of weight, heating and refluxing extraction 2h, filtering residue adds the methanol of 6 times of weight again, and heating and refluxing extraction 1h filters, merge filtrate twice, vacuum concentration obtains extractum, then extractum is spread with the hot water of 3 times of extractum weight, then with isopyknic ethyl acetate extraction 4 times, extract is after reclaim under reduced pressure ethyl acetate, obtain extractum, vacuum becomes dry powder, obtains powder III, get powder III and gardenia compound mixes taking weight ratio as 15:1 again, stir, obtain mixed powder III, for subsequent use;

(4) according to parts by weight get 30 parts of mixed powder I, 20 parts of mixed powder II,

40 parts, 20 parts of mixed powder III, 50 parts of Herba Eupatorii Lindleyanis, 40 parts of Fructus Schisandrae Chinensis, 40 parts, Radix Glycyrrhizae, 10 parts of Cortex Pseudolariciss, 15 parts, catechu, 10 parts of Herba Lysimachiaes, 10 parts of Fructus Carpesiis, 15 parts of Radix Ranunculi Ternatis and Alumen, for subsequent use;

(5) get Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati, be placed in multi-function extractor, add 8 times to the drinking-water of drug weight, heating extraction 1 hour, filters; Add again 6 times of water gagings and extract 1 hour, filter; Add 4 times of water gagings again and extract 0.5 hour, filter, merging filtrate, makes extracting solution, then the mixed powder I of taking-up, mixed powder II and mixed powder III is added in extracting solution, stirs 5-10min, obtains mixed extract;

(6) above-mentioned mixed extract is placed in settling tank, adds Alumen to dissolve, staticly settle 14 hours, then get the supernatant of the medicinal liquid after precipitation, be placed in high speed centrifuge, carry out centrifugal filtration; After filtering, filtrate is put in concentrating under reduced pressure tank, is concentrated into relative density to 1.25 through concentrating under reduced pressure, takes out concentrated solution and is transported in Agitation Tank; By concentrated solution in Agitation Tank, adjust relative density to 1.04, add the sodium benzoate of liquor capacity 0.3% simultaneously, take out medicinal liquid, put clean container, make the colpitic lotion for the treatment of.

embodiment 2:

A preparation method for the treatment of the lotion of atrophic vaginitis, comprises the following steps:

(1) get the Rhizoma Anemarrhenae, with the alcohol reflux of 20 times of weight, extract altogether twice, each 2h, merge the ethanol extract of twice, filter, reclaim ethanol, concentrated alcohol is sink to containing alcohol 80%, reclaim ethanol, be diluted with water to 10 times of medical material weight, obtain medicinal liquid, then regulating PH is 4, and medicinal liquid is crossed to anion exchange resin, medicinal liquid has been crossed and washed post bed to effluent with water after post bed is colourless, it is colourless being eluted to effluent with 0.8% NaOH again, collect alkali eluent, adjusting pH value is 5, filter, water bath method, at 80 DEG C of temperature, dry, obtain powder I, get powder I and osmanthus flower fragrance mixes taking weight ratio as 10:1 again, stir, obtain mixed powder I, for subsequent use,

(2) get Rhizoma Polygoni Cuspidati, pulverized 50 orders, then adding mass concentration is 3% calcium hydroxide spice (in described step (2), the addition of calcium hydroxide is 0.1 times of Rhizoma Polygoni Cuspidati weight), then add the water of 10 times to heat to 60 DEG C, be incubated 2 hours, filter, obtain extracting solution; Regulate the pH value to 9 of extracting solution, upper macroporous adsorbent resin after filtering, adsorb, adsorb saturated after washing, cylinder filler after washing is first used 0.3% sodium hydroxide eluting, do not collect eluent, after be that 60% alcoholic solution and mass concentration are the eluent eluting of 1% sodium hydroxide with containing volumetric concentration again, collecting eluent, is 2 rear centrifugal by eluent with sulphuric acid adjust pH, and cold drying obtains powder II, get powder II and vanillin mixes taking weight ratio as 12:1 again, stir, obtain mixed powder II, for subsequent use;

(3) get the rhizome of Rhizoma Saururi (Herba Saururi), after pulverizing, add the methanol of 8 times of weight, heating and refluxing extraction 2h, filtering residue adds the methanol of 6 times of weight again, and heating and refluxing extraction 1h filters, merge filtrate twice, vacuum concentration obtains extractum, then extractum is spread with the hot water of 3 times of extractum weight, then with isopyknic ethyl acetate extraction 4 times, extract is after reclaim under reduced pressure ethyl acetate, obtain extractum, vacuum becomes dry powder, obtains powder III, get powder III and gardenia compound mixes taking weight ratio as 15:1 again, stir, obtain mixed powder III, for subsequent use;

(4) according to parts by weight get 50 parts of mixed powder I, 40 parts of mixed powder II,

60 parts, 40 parts of mixed powder III, 80 parts of Herba Eupatorii Lindleyanis, 60 parts of Fructus Schisandrae Chinensis, 60 parts, Radix Glycyrrhizae, 20 parts of Cortex Pseudolariciss, 20 parts, catechu, 20 parts of Herba Lysimachiaes, 20 parts of Fructus Carpesiis, 20 parts of Radix Ranunculi Ternatis and Alumen, for subsequent use;

(5) get Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati, be placed in multi-function extractor, add 8 times to the drinking-water of drug weight, heating extraction 1 hour, filters; Add again 6 times of water gagings and extract 1 hour, filter; Add 4 times of water gagings again and extract 0.5 hour, filter, merging filtrate, makes extracting solution, then the mixed powder I of taking-up, mixed powder II and mixed powder III is added in extracting solution, stirs 5-10min, obtains mixed extract;

(6) above-mentioned mixed extract is placed in settling tank, adds Alumen to dissolve, staticly settle 14 hours, then get the supernatant of the medicinal liquid after precipitation, be placed in high speed centrifuge, carry out centrifugal filtration; After filtering, filtrate is put in concentrating under reduced pressure tank, is concentrated into relative density to 1.25 through concentrating under reduced pressure, takes out concentrated solution and is transported in Agitation Tank; By concentrated solution in Agitation Tank, adjust relative density to 1.04, add the sodium benzoate of liquor capacity 0.3% simultaneously, take out medicinal liquid, put clean container, make the colpitic lotion for the treatment of.

embodiment 3:

A preparation method for the treatment of the lotion of atrophic vaginitis, comprises the following steps:

(1) get the Rhizoma Anemarrhenae, with the alcohol reflux of 20 times of weight, extract altogether twice, each 2h, merge the ethanol extract of twice, filter, reclaim ethanol, concentrated alcohol is sink to containing alcohol 80%, reclaim ethanol, be diluted with water to 10 times of medical material weight, obtain medicinal liquid, then regulating PH is 4, and medicinal liquid is crossed to anion exchange resin, medicinal liquid has been crossed and washed post bed to effluent with water after post bed is colourless, it is colourless being eluted to effluent with 0.8% NaOH again, collect alkali eluent, adjusting pH value is 5, filter, water bath method, at 80 DEG C of temperature, dry, obtain powder I, get powder I and osmanthus flower fragrance mixes taking weight ratio as 10:1 again, stir, obtain mixed powder I, for subsequent use,

(2) get Rhizoma Polygoni Cuspidati, pulverized 50 orders, then adding mass concentration is 3% calcium hydroxide spice (in described step (2), the addition of calcium hydroxide is 0.1 times of Rhizoma Polygoni Cuspidati weight), then add the water of 10 times to heat to 60 DEG C, be incubated 2 hours, filter, obtain extracting solution; Regulate the pH value to 9 of extracting solution, upper macroporous adsorbent resin after filtering, adsorb, adsorb saturated after washing, cylinder filler after washing is first used 0.3% sodium hydroxide eluting, do not collect eluent, after be that 60% alcoholic solution and mass concentration are the eluent eluting of 1% sodium hydroxide with containing volumetric concentration again, collecting eluent, is 2 rear centrifugal by eluent with sulphuric acid adjust pH, and cold drying obtains powder II, get powder II and vanillin mixes taking weight ratio as 12:1 again, stir, obtain mixed powder II, for subsequent use;

(3) get the rhizome of Rhizoma Saururi (Herba Saururi), after pulverizing, add the methanol of 8 times of weight, heating and refluxing extraction 2h, filtering residue adds the methanol of 6 times of weight again, and heating and refluxing extraction 1h filters, merge filtrate twice, vacuum concentration obtains extractum, then extractum is spread with the hot water of 3 times of extractum weight, then with isopyknic ethyl acetate extraction 4 times, extract is after reclaim under reduced pressure ethyl acetate, obtain extractum, vacuum becomes dry powder, obtains powder III, get powder III and gardenia compound mixes taking weight ratio as 15:1 again, stir, obtain mixed powder III, for subsequent use;

(4) according to parts by weight get 40 parts of mixed powder I, 30 parts of mixed powder II,

50 parts, 30 parts of mixed powder III, 60 parts of Herba Eupatorii Lindleyanis, 50 parts of Fructus Schisandrae Chinensis, 50 parts, Radix Glycyrrhizae, 15 parts of Cortex Pseudolariciss, 17 parts, catechu, 15 parts of Herba Lysimachiaes, 15 parts of Fructus Carpesiis, 16 parts of Radix Ranunculi Ternatis and Alumen, for subsequent use;

(5) get Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati, be placed in multi-function extractor, add 8 times to the drinking-water of drug weight, heating extraction 1 hour, filters; Add again 6 times of water gagings and extract 1 hour, filter; Add 4 times of water gagings again and extract 0.5 hour, filter, merging filtrate, makes extracting solution, then the mixed powder I of taking-up, mixed powder II and mixed powder III is added in extracting solution, stirs 5-10min, obtains mixed extract;

(6) above-mentioned mixed extract is placed in settling tank, adds Alumen to dissolve, staticly settle 14 hours, then get the supernatant of the medicinal liquid after precipitation, be placed in high speed centrifuge, carry out centrifugal filtration; After filtering, filtrate is put in concentrating under reduced pressure tank, is concentrated into relative density to 1.25 through concentrating under reduced pressure, takes out concentrated solution and is transported in Agitation Tank; By concentrated solution in Agitation Tank, adjust relative density to 1.04, add the sodium benzoate of liquor capacity 0.3% simultaneously, take out medicinal liquid, put clean container, make the colpitic lotion for the treatment of.

test the therapeutic effect of lotion of the present invention to rat vagina inflammation

Adopt 40 female, not healthy rats of copulation of sexual maturity, body weight is 250 ± 20g.

Test group medication is the prepared Chinese medicine lotion of embodiment of the present invention l; Positive drug control group medication is JIEERYIN XIYE, buys from hospital or pharmacy.

Experimental strain: staphylococcus aureus and escherichia coli plastc ring concentration: l09cfu/mL, i.e. staphylococcus aureus bacterium; Suspension concentration is 5 × l08cfulmL, and escherichia coli bacteria suspension concentration is 5 × l08cfulmL.

test method

1, by normal female mouse carotid back subcutaneous injection estradiol benzoate injection 2mg/mLO. 05mL, continuous 3 times, 2 days 1 time.In the 6th day, staphylococcus aureus and the uncommon mattress plastc ring 20uL of large intestine dust are injected to operation absorption styptic sponge, the hands wood absorption styptic sponge plug that oneself is injected to strain is in mouse vagina, got vaginal secretions smear for microscopic examination in postvaccinal the 4th day, the growing state of observing mycelia and blastopore, infects successfully to determine.

2, rat is fed after l week in adaptability, is divided at random 4 groups, 10 every group, is respectively: blank group, model group, positive drug control group, test group.Model group and blank group are given respectively normal saline, and positive drug control group is given with JIEERYIN XIYE, test group

Chinese medicine lotion of the present invention, all administrations 10 days, medication is that medicinal liquid is injected in rat vagina.After model group and each administration group rat inoculation bacterium, observe day by day, not inoculated bacteria of blank group rat, except blank group, model group and each administration group rat all present vaginitis symptom after injecting antibacterial 5d.After there is typical vaginitis symptom, each administration group gives respectively Drug therapy.Blank group gives intravaginal saline injection, and successive administration lOd is a course for the treatment of, every day 1 time.

observation index

Rat vagina secretions is measured: within the 1st, 4 days after last administration, get vaginal swab smear for microscopic examination, 2 microscopy results are negative patient and turn out cloudy for this pathogen, to determine its situation of turning out cloudy.

Pathological study: get vagina tissue section after execution rat and do pathological examination, be divided into 0-111 level by pathology, 0 grade is that mucosal epithelium is smooth, comes off without necrosis; Nothing hyperemia, edema, hemorrhage under mucosa, scorching delicate infiltration; Intravaginal is without inflammatory exudate.I level is that mucosal epithelium comes off without necrosis; Congested, edema under mucosa; Intravaginal is without inflammatory exudate.II level is that mucosal epithelium has focal necrosis to come off; Hyperemia under mucosa, edema, petechial hemorrhage, a small amount of cell infiltration; Intravaginal has a small amount of inflammatory exudate.III level is that mucosal epithelium necrosis comes off; Hyperemia under mucosa, edema, lamellar are hemorrhage, cell infiltration; Intravaginal has a large amount of inflammatory exudates.

Result is as follows:

Table 1 is the each group of impact on rat vagina secretions

Blank treated animal vaginal secretion microscopy is all negative, and with model control group comparison, difference has statistical significance (P<0.05); Prompting bacterial vaginitis mouse model modeling success; After test group, positive controls drug withdrawal animal vaginal secretion microscopy staphylococcus aureus turn out cloudy number and escherichia coli turn out cloudy number respectively with model group comparison, difference has statistical significance (P<0.05); But compare and there is no statistical significance between test group and positive drug control group.

Table 2 is the each group of impact on rat vagina secretions

Grade situation and the model control group comparison of blank treated animal vaginal infection specimen histopathologic examination, difference has statistical significance; Test group, the positive are wanted grade situation and the model control group comparison of control animals vaginal infection specimen histopathologic examination, and difference has statistical significance (P<0.05). but compare and there is no statistical significance between test group and positive drug control group.Animal test results shows: the lotion that the present invention makes all has obvious therapeutical effect to rat bacterial vaginitis, and animal vaginal mucosa tissue is had to significant protective effect.

human clinical trial's data of lotion of the present invention

Select in May, 2012 in December ,-20 13 to be diagnosed as atrophic vaginitis 106 examples, 49 years old～69 years old age, diagnosis mark Huaihe River: with reference to " obstetrics and gynecology " (the 5th edition), all cases is all clarified a diagnosis according to medical history, gynecologial examination.Symptom is xerosis vulae, pale or the flushing of vaginal mucosa or have little petechia, vaginal health scoring <15 divides, serum follicle stimulating hormone (FSH) >=40 work U/L, serum estradiol (E2)≤llOpmol/L, abdominal ultrasound examination endometrium thickness <5mm.All patients all carry out vaginal secretions inspection and get rid of trichomonal vaginitis, monilial vaginitis before treatment, and urine is cultivated negative, without vulvar dystrophy and dermatosis.All cases are got rid of hormone-dependent tumor, do not accept hormone medicine treatment over nearly 3 months.

Matched group 53 example and test group 53 examples compare before two groups of patient treatments in age, the state of an illness, the course of disease, and difference not statistically significant (P>0.05), has comparability.

Matched group adopts 1% lactic acid solution washout, the red and swollen significantly local antibiotic that uses of pudendum

Emulsion, 1 time/d.The lotion washout that test group makes with the embodiment of the present invention 1,1 ld.

Observation index: conventional inquiry medical history before and after medication, and according to vaginal health point system (VHS) scoring, determine symptom improvement situation.

Criterion of therapeutical effect: with reference to " obstetrics and gynecology ", recovery from illness: clinical condition is held up, sign disappears; Effective: clinical symptoms, sign turn for the better by and large; Effective: clinical symptoms, sign alleviate; Invalid: clinical symptoms, sign are unchanged.

Statistical analysis: SPSS 13.0 carries out statistical analysis.Vaginal health scoring single index adopts nonparametric statistics, and measurement data is checked with t, and enumeration data is checked with X2.

Result of the test:

Vaginal symptoms is improved situation: after medication 5d, and the patient of matched group 60.52%, and all case vagina drying of test group, dyspareunia symptom all start to obtain improvement in various degree.Gynecologial examination vaginal wall elasticity increases, and fold is deepened, and pale, the flushing in surface and bleeding are clearly better.According to vaginal health standards of grading, the summation that vaginal health scoring is elasticity, wettability, pH, mucosa, 5 project score values of secretions.Before test group patient's medication, scoring is 8.27 ± 1.74, and the average of marking after medication 14d is 14.26 ± 1.93.

Two groups of Comprehensive Clinical curative effects comparison: after medication 14d, matched group cure rate, obvious effective rate, effective percentage, inefficiency are respectively 20.75%, 35.85%, 35.85%, 7.55%; The cure rate of test group, obvious effective rate, effective percentage, inefficiency are respectively 56. 60%, 33. 96%, 9.43%, 0.00%.

This result of study shows, lotion for treatment atrophic vaginitis total effective rate of the present invention is 100%, has that untoward reaction is light, the higher advantage of safety, and in 3 months, relapse rate is low.

Claims (2)

1. a preparation method for the treatment of the lotion of atrophic vaginitis, is characterized in that: comprise the following steps:

(1) get the Rhizoma Anemarrhenae, with the alcohol reflux of 20 times of weight, extract altogether twice, each 2h, merge the ethanol extract of twice, filter, reclaim ethanol, concentrated alcohol is sink to containing alcohol 80%, reclaim ethanol, be diluted with water to 10 times of medical material weight, obtain medicinal liquid, then regulating PH is 4, and medicinal liquid is crossed to anion exchange resin, medicinal liquid has been crossed and washed post bed to effluent with water after post bed is colourless, it is colourless being eluted to effluent with 0.8% NaOH again, collect alkali eluent, adjusting pH value is 5, filter, water bath method, at 80 DEG C of temperature, dry, obtain powder I, get powder I and osmanthus flower fragrance mixes taking weight ratio as 10:1 again, stir, obtain mixed powder I, for subsequent use,

(2) get Rhizoma Polygoni Cuspidati, pulverized 50 orders, then adding mass concentration is 3% calcium hydroxide spice, then adds the water of 10 times to heat to 60 DEG C, is incubated 2 hours, filters, and obtains extracting solution; Regulate the pH value to 9 of extracting solution, upper macroporous adsorbent resin after filtering, adsorb, adsorb saturated after washing, cylinder filler after washing is first used 0.3% sodium hydroxide eluting, do not collect eluent, after be that 60% alcoholic solution and mass concentration are the eluent eluting of 1% sodium hydroxide with containing volumetric concentration again, collecting eluent, is 2 rear centrifugal by eluent with sulphuric acid adjust pH, and cold drying obtains powder II, get powder II and vanillin mixes taking weight ratio as 12:1 again, stir, obtain mixed powder II, for subsequent use;

(3) get the rhizome of Rhizoma Saururi (Herba Saururi), after pulverizing, add the methanol of 8 times of weight, heating and refluxing extraction 2h, filtering residue adds the methanol of 6 times of weight again, and heating and refluxing extraction 1h filters, merge filtrate twice, vacuum concentration obtains extractum, then extractum is spread with the hot water of 3 times of extractum weight, then with isopyknic ethyl acetate extraction 4 times, extract is after reclaim under reduced pressure ethyl acetate, obtain extractum, vacuum becomes dry powder, obtains powder III, get powder III and gardenia compound mixes taking weight ratio as 15:1 again, stir, obtain mixed powder III, for subsequent use;

(4) according to parts by weight get mixed powder I 30-50 part, mixed powder II 20-40 part,

Mixed powder III 20-40 part, Herba Eupatorii Lindleyani 50-80 part, Fructus Schisandrae Chinensis 40-60 part, Radix Glycyrrhizae 40-60 part, Cortex Pseudolaricis 10-20 part, catechu 15-20 part, Herba Lysimachiae 10-20 part, Fructus Carpesii 10-20 part, Radix Ranunculi Ternati 15-20 part and Alumen 40-60 part are for subsequent use;

(5) get Herba Eupatorii Lindleyani, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Cortex Pseudolaricis, catechu, Herba Lysimachiae, Fructus Carpesii and Radix Ranunculi Ternati, be placed in multi-function extractor, add 8 times to the drinking-water of drug weight, heating extraction 1 hour, filters; Add again 6 times of water gagings and extract 1 hour, filter; Add 4 times of water gagings again and extract 0.5 hour, filter, merging filtrate, makes extracting solution, then the mixed powder I of taking-up, mixed powder II and mixed powder III is added in extracting solution, stirs 5-10min, obtains mixed extract;

(6) above-mentioned mixed extract is placed in settling tank, adds Alumen to dissolve, staticly settle 14 hours, then get the supernatant of the medicinal liquid after precipitation, be placed in high speed centrifuge, carry out centrifugal filtration; After filtering, filtrate is put in concentrating under reduced pressure tank, is concentrated into relative density to 1.25 through concentrating under reduced pressure, takes out concentrated solution and is transported in Agitation Tank; By concentrated solution in Agitation Tank, adjust relative density to 1.04, add the sodium benzoate of liquor capacity 0.3% simultaneously, take out medicinal liquid, put clean container, make the colpitic lotion for the treatment of.

2. the preparation method of a kind of lotion for the treatment of atrophic vaginitis as claimed in claim 1, is characterized in that: the addition of the middle calcium hydroxide of described step (2) is 0.1 times of Rhizoma Polygoni Cuspidati weight.