Summary of the invention
The purpose of this invention is to provide a kind of preparation and improve Chinese medicine composition of using in the disease medicines such as the pudendum that vaginitis (except the senile vaginitis) causes is scorching hot, pruritus and preparation method thereof.
The present invention seeks to be achieved through the following technical solutions:
The inventor has developed a kind of Chinese medicine composition, and the crude drug of said composition makes up by following ratio:
Radix Sophorae Flavescentis 30~50 weight portion Radixs Stemonae 20~40 weight portion Rhizoma Smilacis Glabraes 20~40 weight portions
The Fructus Kochiae 20~40 weight portion Cortex Dictamni 20~40 weight portion Herba Agrimoniaes 5~20 weight portions
Radix Gentianae 10~20 weight portion Herba Menthaes 3~10 weight portion Radix Arnebiae (Radix Lithospermi)s 3~10 weight portions
Borneolum Syntheticum 0.01~0.05 weight portion
Definitely, the ratio of these crude drug is:
The Radix Sophorae Flavescentis 40 weight portion Radixs Stemonae 30 weight portion Rhizoma Smilacis Glabraes 30 weight portions
The Fructus Kochiae 30 weight portion Cortex Dictamni 30 weight portion Herba Agrimoniaes 10 weight portions
Radix Gentianae 15 weight portion Herba Menthaes 5 weight portion Radix Arnebiae (Radix Lithospermi)s 5 weight portions
Borneolum Syntheticum 0.02 weight portion
More than Chu Fang Chinese medicine extract can be made washing liquid, suppository, effervescent tablet, soft capsule, spray and gel.The inventor has studied washing liquid at the characteristics of indication, bolt, effervescent tablet, preparation of soft capsule technology:
The preparation method of washing liquid:
More than ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water 2~3 times, collecting decoction filters, filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted Aromatic water, the aqueous solution after the distillation, and device is preserved in addition, medicinal residues decoct with water, decocting liquid and above-mentioned aqueous solution merge, and filter, and merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, concentrate, leave standstill, filter, add Borneolum Syntheticum, Aromatic water, and add conventional adjuvant and make washing liquid.
Concrete technology after the parameters optimization is: above ten flavors, and the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water secondary, add 8 times of water gagings at every turn, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted the about 100ml of Aromatic water, the aqueous solution after the distillation, and device is preserved in addition, medicinal residues add 8 times of water gagings and decocted 40 minutes, decocting liquid and above-mentioned aqueous solution merge, and filter, and merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, be concentrated into about 800ml, left standstill 24 hours, and filtered, add Borneolum Syntheticum, Aromatic water adds conventional adjuvant and makes washing liquid.
The preparation method of suppository:
More than ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water 2~3 times, collecting decoction filters, filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted Aromatic water, the aqueous solution after the distillation, and device is preserved in addition, medicinal residues decoct with water, and decocting liquid and above-mentioned aqueous solution merge, and filter, merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, concentrate, leave standstill, filter, be condensed into clear paste, after the spray drying, add Borneolum Syntheticum, Aromatic water, and add conventional adjuvant and make suppository.
The preparation method of vagina effervescence:
More than ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water 2~3 times, collecting decoction filters, filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted Aromatic water, the aqueous solution after the distillation, and device is preserved in addition, and medicinal residues decoct with water, decocting liquid and above-mentioned aqueous solution merge, and filter, and merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, concentrate, leave standstill, filter, be condensed into clear paste, spray drying.Extract the volatile oil component in the Aromatic water, and it is used anhydrous alcohol solution, add Borneolum Syntheticum in the spray powder, and conventional adjuvant, granulate as binding agent with the ethanol solution of 1% 30 POVIDONE K 30 BP/USP 30 and the ethanol solution of volatile oil, make vagina effervescence.
The preparation method of vagina soft capsule:
More than ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water 2~3 times, collecting decoction filters, filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted Aromatic water, the aqueous solution after the distillation, and device is preserved in addition, medicinal residues decoct with water, and decocting liquid and above-mentioned aqueous solution merge, and filter, merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, concentrate, leave standstill, filter, extract the volatile oil component in the Aromatic water, and it is used the PEG400 mixing, after spray powder is crossed 120 mesh sieves, add Borneolum Syntheticum, the mixture of volatile oil and PEG400, and add conventional adjuvant and make vagina soft capsule.
The various dosage forms that above institute gets can be conveniently used in the improvement of gynaecopathia, and the inventor has tentatively reached goal of the invention.
The specific embodiment
Pharmaceutical preparation of the present invention has heat-clearing and toxic substances removing, the function of removing damp to relieve itching.The inventor cures mainly according to its function, from aspects such as antiinflammatory, anti-vaginitis, trichomonas vaginitises its pharmacodynamics is studied.
1 antiinflammatory action
By influence the influence experimental result that experimental result and this product preparation xylol cause mice capillary permeability of this product preparation subcutaneous injection to mice ear, the inventor finds: this product preparation 0.5~3g/kg * 4d has obvious inhibitory action to Oleum Tiglii induced mice ear swelling; This product preparation 0.5~2g/kg * the equal xylol of 4d subcutaneous injection causes the mice capillary permeability has obvious inhibitory action, positive control solution---and BAIAI XIYE 1.0g/kg * 4d also has obvious inhibitory action.Illustrate that this product preparation has certain antiinflammatory action.
2 pairs of colpitic observation of curative effect of rat experiment
Female rats is made the rat ovary excision with after the 10% urethane lumbar injection 1ml/100g anesthesia, 3 weeks of postoperative 1 time every other day gavage diethylstilbestrol 2mg/kg, when vaginal smear examination confirms to have produced puppet during rutting period, carry out candida albicans infection, the bacterium amount is 8 * 10
5Individual/0.2ml/, once a day, for three days on end, stopped to infect back 4 days, vaginal smear will infect male animal again and be divided into 6 groups at random, 10 every group after confirming to infect successfully, use this product preparation 3.9g, 1.95g, 1.3g (containing the crude drug amount) and 10% BAIAI XIYE respectively, FUYANPING, normal saline flushing vagina, every day 1 time, each 10ml, continuous 7 days, 9 days, turning out cloudy with vaginal smear respectively was the treatment index.
The result shows: this product preparation 3.9g (crude drug) medication was 40%, 50% to vagina fungal infection negative conversion rate in 7 days, 9 days; 10% BAIAI XIYE 10ml (is about 10g (crude drug)/kg) negative conversion rate and is respectively 30%, 60%; Positive control drug FUYANPING 10ml negative conversion rate is respectively 20%, 30%, and experimental result shows that this product preparation has therapeutical effect preferably to vaginitis.
The inhibitory action of 3 pairs of trichomonas vaginitises
Get 72 in 10 * 15mm test tube, this product preparation is respectively established three parallel group with BAIAI XIYE, and 11 every group, numbering z-11, b-11, all the other 6 is matched group.Each pipe adds liver infusion culture fluid 7ml, aseptic calf serum 2ml.This product preparation serves as a beginning concentration with 8mg/ml, BAIAI XIYE 20mg/ml, be made into 11 drug level with two-fold dilution's method respectively, press the test tube numbering test tube of drug level adding from high to low 1ml respectively, then, every pipe adds infusorian 100 microlitres, put in the incubator 37 ℃ and cultivated 48 hours, measure the minimum worm concentration that presses down of this product preparation and BAIAI XIYE.
The result shows: it is that 0.5% (1: 40) can make the infusorian death more than 75% that this product preparation minimum presses down worm concentration, shows that this product preparation has good inhibitory effect to trichomonas vaginitis.
Further specify technical scheme of the present invention by the following examples.
Embodiment one
[prescription]
Radix Sophorae Flavescentis 40g Radix Stemonae 30g Rhizoma Smilacis Glabrae 30g
Fructus Kochiae 30g Cortex Dictamni 30g Herba Agrimoniae 10g
Radix Gentianae 15g Herba Menthae 5g Radix Arnebiae (Radix Lithospermi) 5g
Borneolum Syntheticum 0.02g
[method for making] above ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water secondary, add 8 times of water gagings at every turn, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted the about 100ml of Aromatic water, the aqueous solution after the distillation, and device is preserved in addition, and medicinal residues add 8 times of water gagings and decocted 40 minutes, decocting liquid and above-mentioned aqueous solution merge, and filter, and merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, be concentrated into about 800ml, left standstill 24 hours, filter, add Borneolum Syntheticum, Aromatic water, tween 80 10ml and sorbic acid 2g, stir evenly, left standstill 24 hours, get supernatant, adjust total amount to 1000ml, packing, promptly.
Embodiment two
[prescription]
Radix Sophorae Flavescentis 30g Radix Stemonae 20g Rhizoma Smilacis Glabrae 20g
Fructus Kochiae 20g Cortex Dictamni 20g Herba Agrimoniae 10g
Radix Gentianae 10g Herba Menthae 5g Radix Arnebiae (Radix Lithospermi) 5g
Borneolum Syntheticum 0.02g
[method for making] above ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water secondary, add 8 times of water gagings at every turn, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted the about 100ml of Aromatic water, aqueous solution after the distillation, device is preserved in addition, medicinal residues add 8 times of water gagings and decocted 40 minutes, and decocting liquid and above-mentioned aqueous solution merge, and filter, merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, be condensed into the clear paste of relative density about 1.20 (60 ℃), spray drying, spray is done to such an extent that spray powder is standby; With above-mentioned Aromatic water, with petroleum ether volatile oil is extracted, petroleum ether reclaims, add Arlacel-80 5g in the volatile oil that extraction obtains, stir evenly, add above-mentioned spray powder again, Borneolum Syntheticum fully grinds well, mixture is joined in the fused 36 type mixed aliphatic esters (60 ℃), adjust total amount, mixing, moulding, take out the cooling back, the system bolt, promptly.
Embodiment three
[prescription]
Radix Sophorae Flavescentis 50g Radix Stemonae 40g Rhizoma Smilacis Glabrae 40g
Fructus Kochiae 40g Cortex Dictamni 40g Herba Agrimoniae 20g
Radix Gentianae 20g Herba Menthae 10g Radix Arnebiae (Radix Lithospermi) 10g
Borneolum Syntheticum 0.05g
[method for making] above ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water secondary, add 8 times of water gagings at every turn, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted the about 100ml of Aromatic water, aqueous solution after the distillation, device is preserved in addition, medicinal residues add 8 times of water gagings and decocted 40 minutes, and decocting liquid and above-mentioned aqueous solution merge, and filter, merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, be condensed into the clear paste of relative density about 1.20 (60 ℃), spray drying, spray is done to such an extent that spray powder is standby; With above-mentioned Aromatic water, with petroleum ether volatile oil is extracted, petroleum ether reclaims, and adds a small amount of dehydrated alcohol in the volatile oil and makes dissolving, and is standby, gets citric acid, and 100 ℃ of dryings make air slaking, pulverize, and cross 120 mesh sieves, and are standby; Get 60 ℃ of dryings of sodium bicarbonate, pulverize, cross 120 mesh sieves, get 62g and join among the fused Polyethylene Glycol 25g, stir, put coldly, pulverize, cross 120 mesh sieves, standby; Get citric acid 70g, sodium bicarbonate-polyethylene glycol 6000 mixture 87g, evenly mixed, standby.Get spray powder and add Borneolum Syntheticum, citric acid-sodium bicarbonate-polyethylene glycol 6000 mixture, low-substituted hydroxypropyl methylcellulose 20g, adjust total amount to 300g with microcrystalline Cellulose, mix homogeneously, with the alcoholic solution that contains volatile oil and the ethanol solution of 1% 30 POVIDONE K 30 BP/USP 30 is adhesive system soft material, cross 16 mesh sieves and granulate, 20 mesh sieve granulate are crossed in 50 ℃ of oven dry, be pressed into 1000, promptly.
Embodiment four
[prescription]
Radix Sophorae Flavescentis 30g Radix Stemonae 20g Rhizoma Smilacis Glabrae 20g
Fructus Kochiae 20g Cortex Dictamni 20g Herba Agrimoniae 5g
Radix Gentianae 10g Herba Menthae 3g Radix Arnebiae (Radix Lithospermi) 3g
Borneolum Syntheticum 0.01g
[method for making] above ten flavors, the Poria that fetches earth, the Radix Stemonae, Radix Sophorae Flavescentis, Cortex Dictamni, the Fructus Kochiae decoct with water secondary, add 8 times of water gagings at every turn, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered filtrate for later use; Herba Agrimoniae, Radix Gentianae, Radix Arnebiae (Radix Lithospermi), Herba Menthae are extracted the about 100ml of Aromatic water, aqueous solution after the distillation, device is preserved in addition, medicinal residues add 8 times of water gagings and decocted 40 minutes, and decocting liquid and above-mentioned aqueous solution merge, and filter, merge with five kinds of Chinese medicine decocting liquid such as above-mentioned Rhizoma Smilacis Glabrae again, be condensed into the clear paste of relative density about 1.20 (60 ℃), spray drying, spray powder is standby; With above-mentioned Aromatic water, with petroleum ether volatile oil is extracted, petroleum ether reclaims, and adds a spot of PEG400 in the volatile oil, and is standby, spray powder add after by 120 mesh sieves Borneolum Syntheticum, propylene glycol 50g, Polyethylene Glycol mixture of volatile oil, Polyethylene Glycol-400 in right amount to total amount be 200g, mix homogeneously, colloid mill ground 10 minutes, the dress soft capsule, be pressed into 1000, promptly.