Background technology
Women's postpartum lochiorrhea, wind pain, vaginitis, cervicitis and pruritus vulvae etc. are gynecological's common frdquently encountered diseases.Wherein, postpartum lochiorrhea comprises that full-term pregnancy divides after puerperium, the artificial abortion and the drug flow postpartum lochiorrhea.The record of postpartum lochiorrhea sees " Medical Treasures of the Golden Chamber " " seven or eight days puerperal, no sun card, few abdomen is hard logical, this lochiorrhea " the earliest, and " all source of disease marquis's opinions " record primary disease can be by " deficient " or " in blood stasis is arranged "; " tire produces heart method " then more comprehensively illustrated this sick pathogenesis, says: " lochia is more than ... hinder its menses during owing to product, deficient deficiency can not be received and take the photograph, or stagnant blood not to the utmost, and then the difficult peace of blood is also descended mutually, and is with the passing of time more than.... or it is too warm to exaggerate, or because of year power Fang Zhuan, and diet pharmaceutical chemistry degree of making amends for one's faults greatly causes the moving febrile disease of fire, and hematochezia is with the passing of time more than, the excess syndrome that has between this puerperal ".Postpartum lochiorrhea mostly is deficiency of YIN heat in blood, and the deficiency of vital energy, blood stasis or damp and hot are arranged more, be dash to appoint impaired, blood stasis due to qi deficiency, stasis of blood resistance envelope, escape of blood from meridian, heat to disturb to dash appoint, the absurd row of forcing blood.In view of the above, blood circulation promoting and blood stasis dispelling is primary, and removing damp-heat, promoting the circulation of QI to relieve pain are necessary, are aided with the QI invigorating tonify deficiency.
Chinese medicine preparation treatment gynecological diseases has special advantages, at present, clinical gynecological external use medicine kind is more, how in the majority to treat scorching card class medicine, relate to types such as Western medicine, Chinese patent medicine, Chinese medicine and western medicine mixture, and the Chinese patent medicine that is directed to women's postpartum lochiorrhea, wind pain, vaginitis, cervix uteri inflammation mostly is oral medicine, as gujing pill, Herba Clinopodii Tabellae, FUXUEKANG, the safe granule in Pu Qi palace, product Shu Kang etc.Existing patent search result shows that CN1161850A, 200510104274.6,200710121000.7,200710120999.3, patents such as 200710098552.0 are the oral drugs or the composite preparation of treatment postpartum lochiorrhea, and 200610128708.0 steep sufficient medicinal liquid for external for the deposited umbilicus agent of external, 200610128709.5.
The Nationality in Hainan Province folk medicine has a long history and curative effect preferably, especially it is splendid to prevent and treat gynecological's common frdquently encountered disease effects such as women's postpartum lochiorrhea, wind pain, vaginitis, cervicitis and pruritus vulvae, such folk medicine is widely used among the people, investigation, research and summary through the several years are found, characteristic more in Li nationality's medicine with specially good effect person, be worth further excavating and exploitation.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition for the treatment of gynaecopathia.
The present invention also aims to provide this preparation of drug combination method.
In order to realize purpose of the present invention, the invention provides a kind of pharmaceutical composition for the treatment of gynaecopathia, described pharmaceutical composition is the medicament of being made by the medical material of following weight proportioning: Herba Blumeae Balsamiferae 100 weight portions~1000 weight portions, preferred 200 weight portions~800 weight portions, more preferably 300 weight portions; Caulis Arcangelisiae 10 weight portions~300 weight portions, preferred 20 weight portions~200 weight portions, more preferably 60 weight portions; Skin of Fructus Garciniae oblongifoliae 10 weight portions~300 weight portions, preferred 20 weight portions~200 weight portions, more preferably 40 weight portions.
Wherein, described pharmacy optimization is suppository, washing liquid, tablet, vaginal tablet, effervescent tablet, ointment, ointment and spray.
The main component of pharmaceutical composition of the present invention is multitude's medicine-Herba Blumeae Balsamiferae (Blumeabalsamifera (L.) DC.), Caulis Arcangelisiae (Arcangelisia loureiri (Pierre) Diels), skin of Fructus Garciniae oblongifoliae (Garcinia multiflora Garcinia multiflora Champ. or south of the Five Ridges Cortex Garciniae Garcinia oblongifolia Champ.ex Benth).The present invention is based on Nationality in Hainan Province mountain area application feature among the people, it is in conjunction with cognition and the Therapeutic Principle of modern Chinese and western medical to diseases such as postpartum lochiorrhea, vaginitiss, the theoretical analysis side that combines with Chinese medical theory of Li nationality medicine is separated and optimize assembly, make it reach comparatively ideal drug effect.Wherein, the hot temperature of Herba Blumeae Balsamiferae, bitter in the mouth, tool expelling wind and removing dampness, promoting blood circulation to remove blood stasis, killing parasites for relieving itching, repercussive function are monarch drug, its refreshmentization is turbid, Xin Xiang walks to scurry, tying-in is used as medicine, the granulation promoting function also is adjuvant; Caulis Arcangelisiae is cold in nature, bitter in the mouth, and the tool clearing away heat-damp and promoting diuresis, detoxifcation analgesic function is ministerial drug; Skin of Fructus Garciniae oblongifoliae is cool in nature, bitter and puckery flavor, and the function of tool anti-inflammatory analgetic, convergence granulation promoting also is a ministerial drug, three medicines gather the function of its " blood circulation promoting and blood stasis dispelling, killing parasites for relieving itching, removing damp-heat, anti-inflammatory analgetic, convergence granulation promoting " altogether.We's three herbal medicine monarch match, the product of the thing of blood circulation promoting and blood stasis dispelling, expelling wind and removing dampness and anti-inflammatory analgetic, convergence granulation promoting mutually 5, and Each performs its own functions, complements each other, and reaches the hot stasis of blood of removing, the effect of expelling wind and removing dampness, anti-inflammatory analgetic, killing parasites for relieving itching.
The present invention also provides a kind of preparation of drug combination method for the treatment of gynaecopathia, and this method comprises the steps:
Use solvent extraction Herba Blumeae Balsamiferae, Caulis Arcangelisiae and skin of Fructus Garciniae oblongifoliae, make extract; And
Described extract and pharmaceutically acceptable carrier are mixed.
Wherein, described solvent is preferably one or more in water, alcohol, ether and the ethyl acetate.
Compare with existing medicine, pharmaceutical composition of the present invention is a kind of theoretical and in conjunction with separating and optimize assembly and the medicine made in traditional Chinese medicine theory analysis side according to Li nationality medicine, monarch matches, and reaches the effect of blood circulation promoting and blood stasis dispelling, expelling wind and removing dampness, anti-inflammatory analgetic, killing parasites for relieving itching.The needed component medical material of pharmaceutical composition of the present invention is the common authentic medicinal herbs in Hainan, with low cost, convenient and practical, and the made medicine indication of the present invention is more, short treating period, have no side effect, many gynaecopathias such as treatment puerpera lochia, puerperal exposure to wind pain, vaginitis, cervicitis and pruritus vulvae have effect preferably.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1 pharmaceutical composition suppository of the present invention
Take by weighing Herba Blumeae Balsamiferae (Blumea balsamifera (L.) DC.) 100 grams, Caulis Arcangelisiae (Arcangelisia loureiri (Pierre) Diels) 300 grams and skin of Fructus Garciniae oblongifoliae (Garcinia multiflora Garcinia multiflora Champ.) 10 grams, add 4 liters of distilled water, extracted 3 hours, filter, make filtrate.Filtrate is concentrated into the concentrate that density is 1.05 (30 ℃).Take by weighing mixture 280 grams of glycerol, gelatin, distilled water, wherein the weight proportion of glycerol, gelatin, distilled water is 70: 20: 10.In this mixture, add above-mentioned concentrate, stir, moulding, freezing, the sealing sterilization.
Embodiment 2 pharmaceutical composition suppositorys of the present invention
Take by weighing Herba Blumeae Balsamiferae (Blumea balsamifera (L.) DC.) 1000 grams, Caulis Arcangelisiae (Arcangelisia loureiri (Pierre) Diels) 10 grams and skin of Fructus Garciniae oblongifoliae (south of the Five Ridges Cortex Garciniae Garcinia oblongifolia Champ.ex Benth) 300 grams, add 10 liters of distilled water, extracted 2 hours, filter, make filtrate.Filtrate is concentrated into the concentrate that density is 1.05 (30 ℃).Take by weighing mixture 280 grams of glycerol, gelatin, distilled water, wherein the weight proportion of glycerol, gelatin, distilled water is 70: 20: 10.In this mixture, add above-mentioned concentrate, stir, moulding, freezing, the sealing sterilization.
Embodiment 3 pharmaceutical composition lotions of the present invention
(1) 20 kilograms of Caulis Arcangelisiaes (Arcangelisia loureiri (Pierre) Diels) and 2 kilograms of pulverize separately of skin of Fructus Garciniae oblongifoliae (south of the Five Ridges Cortex Garciniae Garcinia oblongifolia Champ.ex Benth) also correspondingly are designated as A product and B product.
(2) 20 kilograms of Herba Blumeae Balsamiferaes (Blumea balsamifera (L.) DC.) are added the water logging bubble 0.5 hour of 5 times of amounts, vapor distillation 2 hours is collected 200 liters of saturated distilled water liquid of volatile oil as the C product, and the medicinal residues that produce are the D product, and Blumeae preparatum Tabellae is the E product.
(3) A is mixed with D, the water logging that adds 8 times of amounts was steeped 0.5 hour, merge to decoct 2 times, and each 2 hours, filter, merging filtrate is concentrated into relative density with filtrate and is 1.03~1.05 (30 ℃), and is for the F product, standby.
(4) water logging that B is added 8 times of amounts was steeped 0.5 hour, merge to decoct 2 times, and each 2 hours, filter, merging filtrate is concentrated into relative density with filtrate and is 1.03~1.05 (30 ℃), and is for the G product, standby.
(5) E product, F product and G product are mixed, add 10 liters of Tween 80s, 2 kilograms of sodium benzoate, stir; Adding distil water transfers to 1000 liters again, is 3.5~5.5 with the Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) acid for adjusting pH, leaves standstill, and filters, promptly.
Embodiment 4 pharmaceutical composition lotions of the present invention
(1) 2 kilograms of Caulis Arcangelisiaes (Arcangelisia loureiri (Pierre) Diels) and 20 kilograms of pulverize separately of skin of Fructus Garciniae oblongifoliae (south of the Five Ridges Cortex Garciniae Garcinia oblongifolia Champ.ex Benth) also correspondingly are designated as A product and B product.
(2) 80 kilograms of Herba Blumeae Balsamiferaes (Blumea balsamifera (L.) DC.) are added the water logging bubble 0.5 hour of 5 times of amounts, vapor distillation 2 hours is collected 300 liters of saturated distilled water liquid of volatile oil as the C product, and the medicinal residues that produce are the D product, and Blumeae preparatum Tabellae is the E product.
(3) A is mixed with D, the water logging that adds 8 times of amounts was steeped 0.5 hour, merge to decoct 2 times, and each 2 hours, filter, merging filtrate is concentrated into relative density with filtrate and is 1.03~1.05 (30 ℃), and is for the F product, standby.
(4) water logging that B is added 8 times of amounts was steeped 0.5 hour, merge to decoct 2 times, and each 2 hours, filter, merging filtrate is concentrated into relative density with filtrate and is 1.03~1.05 (30 ℃), and is for the G product, standby.
(5) E product, F product and G product are mixed, add 10 liters of Tween 80s, 2 kilograms of sodium benzoate, stir; Adding distil water transfers to 1000 liters again, is 3.5~5.5 with the Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus) acid for adjusting pH, leaves standstill, and filters, promptly.
Embodiment 5 medicinal composition sprays of the present invention
Herba Blumeae Balsamiferae (Blumea balsamifera (L.) DC.) 300 grams, Caulis Arcangelisiae (Arcangelisialoureiri (Pierre) Diels) 60 grams and skin of Fructus Garciniae oblongifoliae (south of the Five Ridges Cortex Garciniae Garciniaoblongifolia Champ.ex Benth) 40 grams mix, distilled water extraction with 8 times of amounts, merge extractive liquid,, concentrated and propellant adds sprayer unit promptly together.
Embodiment 6 pharmaceutical composition suppositorys of the present invention
Take by weighing Herba Blumeae Balsamiferae (Blumea balsamifera (L.) DC.) 300 grams, Caulis Arcangelisiae (Arcangelisia loureiri (Pierre) Diels) 60 grams and skin of Fructus Garciniae oblongifoliae (south of the Five Ridges Cortex Garciniae Garcinia oblongifolia Champ.ex Benth) 40 grams, add 6 liters of distilled water, extracted 3 hours, filter, make filtrate.Filtrate is concentrated into the concentrate that density is 1.05 (30 ℃).Take by weighing mixture 280 grams of glycerol, gelatin, distilled water, wherein the weight proportion of glycerol, gelatin, distilled water is 70: 20: 10.In this mixture, add above-mentioned concentrate, stir, moulding, freezing, the sealing sterilization.
Experimental example
Test principle and method are referring to the clinical research guideline of female genital disease " new Chinese medicine treatment ", " the clinical research guideline of new Chinese medicine treatment cervical erosion " (Ministry of Public Health, new Chinese medicine clinical research guideline first is seized (1993)) and the clinical research guideline of pelvic inflammatory disease " new Chinese medicine treatment " (Zheng Xiao cornel etc., new Chinese medicine clinical research guideline (trying) (2002 May the 1st edition)).See for details following.
1. clinical data:
(1) physical data: 35 examples are organized in treatment, 41.05 ± 10.12 years old age, matched group 35 examples, 40.94 ± 9.98 years old age.Treatment group and matched group, severe extent there was no significant difference before two groups of age distribution and the treatment.
(2) diagnostic criteria: meeting Western medicine diagnose is vaginitis, cervicitis and pruritus vulvae person; Simultaneously with reference to gynecologial examination and ultrasound diagnosis diagnosis data.
2. Therapeutic Method:
Matched group: oral " FUYANNING JIAONANG " (Kang Fu comes Pharmaceutical available from Sichuan, lot number 080105), each 4 (0.45g/ grain) 3 times on the one, 15 is a course of treatment, administration time the shortest 1 course of treatment, the longest 3 courses of treatment.
The pharmaceutical composition suppository of treatment group 1: embodiment 1.Using method: every night this suppository is pushed vagina deep (apart from the about 8cm of vaginal orifice) one of every day, 1 week was a course of treatment.
The pharmaceutical composition lotion of treatment group 2: embodiment 3, using method: 5~10 times of water dilutions, washout, demibain, flushing all can, every day 1~2 time, 1 week was a course of treatment.
The pharmaceutical composition suppository of treatment group 3: embodiment 6.Using method: every night this suppository is pushed vagina deep (apart from the about 8cm of vaginal orifice) one of every day, 1 week was a course of treatment.
3. therapeutic outcome
Checking clinical symptoms by gynecologial examination and ultrasound diagnosis, is the standard that diagnosis is cured with the clinical symptom disappearance.As a result, the cure rate of matched group is 65%, and the cure rate of treatment group 1 is 82%, and the cure rate of treatment group 2 is 85%, and the cure rate of treatment group 3 is 94%.The cure rate of treatment group is significantly higher than the cure rate of matched group, and the cure rate of wherein treatment group 3 is significantly higher than the cure rate of treatment group 1 and treatment group 2.