Summary of the invention
Technical problem to be solved by this invention is, a kind of Chinese medicine composition that is used for the treatment of chronic pelvic inflammatory disease and preparation method thereof is provided, and Chinese medicine composition of the present invention is for oral administration to combine with external, endo-medicine heat-clearing and toxic substances removing, and damp eliminating is treating stranguria, invigorating spleen and kidney; External used medicine heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling.Treating both the principal and secondary aspects of a disease, determined curative effect, side effect is little.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine composition for the treatment of chronic pelvic inflammatory disease, wherein, described Chinese medicine composition is comprised of endo-medicine and external used medicine, and described endo-medicine comprises following raw medicinal material: ear water Herba Amaranthi tricoloris, Herba Kummerowiae Striatae, Herba Clinopodii Polycephali, Herba Houttuyniae, Herba Crotalariae Ferrugineae, Semen Euryales, Rhizoma Pedicularis Davidii, Rhizoma Polygoni Cuspidati, Herba Emiliae, Caulis Fibraureae, gynura bicolor, Semen Nelumbinis and Herba Glechomae; Described external used medicine comprises following raw medicinal material: Radix Achyranthis, Herb Polygoni Chinensis, Radix Rubiae Yunnanensis, Flos Carthami, Herba Lycopi, Radix Arnebiae (Radix Lithospermi), Herba Sonchi Oleracei, Herba Melastomatis dodecandri, Helwingia himalaica and Cortex Moutan.
Wherein, in described Chinese medicine composition, the ratio of weight and number of each raw medicinal material can be preferably: in described endo-medicine, the ratio of weight and number of each raw medicinal material is: 20~30 parts of ear water Herba Amaranthi tricoloriss, 15~25 parts of Herba Kummerowiae Striatae, 10~20 parts of Herba Clinopodii Polycephalies, 5~10 parts of Herba Houttuyniae, 15~25 parts of Herba Crotalariae Ferrugineaes, 10~20 parts of Semen Euryaless, 10~20 parts of Rhizoma Pedicularis Davidii, 10~20 parts of Rhizoma Polygoni Cuspidati, 25~40 parts of Herba Emiliae, 5~10 parts of Caulis Fibraureaes, 20~35 parts of gynura bicolors, 10~20 parts of 10~20 parts, Semen Nelumbinis and Herba Glechomaes; In described external used medicine, the ratio of weight and number of each raw medicinal material is: 25~35 parts of Radix Achyranthis, 15~25 parts of Herb Polygoni Chinensiss, 15~25 parts of Radix Rubiae Yunnanensis, 15~25 parts, Flos Carthami, 20~35 parts of Herba Lycopi, 15~25 parts of Radix Arnebiae (Radix Lithospermi)s, 15~25 parts of Herba Sonchi Oleracei, 25~40 parts of Herba Melastomatis dodecandri, 15~25 parts of 15~25 parts of Helwingia himalaica and Cortex Moutans.
Wherein, in described Chinese medicine composition, the ratio of weight and number of each raw medicinal material can also be preferably: in described endo-medicine, the ratio of weight and number of each raw medicinal material is: 25~30 parts of ear water Herba Amaranthi tricoloriss, 15~20 parts of Herba Kummerowiae Striatae, 10~15 parts of Herba Clinopodii Polycephalies, 8~10 parts of Herba Houttuyniae, 20~25 parts of Herba Crotalariae Ferrugineaes, 15~20 parts of Semen Euryaless, 10~15 parts of Rhizoma Pedicularis Davidii, 10~15 parts of Rhizoma Polygoni Cuspidati, 30~40 parts of Herba Emiliae, 5~8 parts of Caulis Fibraureaes, 20~30 parts of gynura bicolors, 15~20 parts of 10~15 parts, Semen Nelumbinis and Herba Glechomaes; In described external used medicine, the ratio of weight and number of each raw medicinal material is: 30~35 parts of Radix Achyranthis, 15~20 parts of Herb Polygoni Chinensiss, 20~25 parts of Radix Rubiae Yunnanensis, 15~20 parts, Flos Carthami, 20~30 parts of Herba Lycopi, 20~25 parts of Radix Arnebiae (Radix Lithospermi)s, 20~25 parts of Herba Sonchi Oleracei, 30~40 parts of Herba Melastomatis dodecandri, 15~20 parts of 20~25 parts of Helwingia himalaica and Cortex Moutans.
Wherein, in described Chinese medicine composition, the ratio of weight and number of each raw medicinal material can be preferably again: in described endo-medicine, the ratio of weight and number of each raw medicinal material is: 28 parts of ear water Herba Amaranthi tricoloriss, 17 parts of Herba Kummerowiae Striatae, 14 parts of Herba Clinopodii Polycephalies, 9 parts of Herba Houttuyniae, 21 parts of Herba Crotalariae Ferrugineaes, 16 parts of Semen Euryaless, 13 parts of Rhizoma Pedicularis Davidii, 12 parts of Rhizoma Polygoni Cuspidati, 36 parts of Herba Emiliae, 6 parts of Caulis Fibraureaes, 23 parts of gynura bicolors, 19 parts of 14 parts, Semen Nelumbinis and Herba Glechomaes; In described external used medicine, the ratio of weight and number of each raw medicinal material is: 32 parts of Radix Achyranthis, 17 parts of Herb Polygoni Chinensiss, 25 parts of Radix Rubiae Yunnanensis, 18 parts, Flos Carthami, 24 parts of Herba Lycopi, 21 parts of Radix Arnebiae (Radix Lithospermi)s, 22 parts of Herba Sonchi Oleracei, 34 parts of Herba Melastomatis dodecandri, 17 parts of 22 parts of Helwingia himalaica and Cortex Moutans.
Wherein, when the dosage form of described endo-medicine is capsule, its preparation method comprises the following steps:
The first step, is mixed in proportion described raw medicinal material, puts into marmite and fries 20 minutes~40 minutes, with pulverizer, is ground into smalls, is screened into 100 order~200 object powder;
Second step, the ethanol that the determining alcohol that adds 3~5 times of the powder qualities that obtain with respect to the first step is 75~85%, reflux 2~5 hours, extracts 2~3 times, merges extracting solution each time, filters acquisition alcohol extract, and alcohol extract concentrating under reduced pressure, is recycled to without alcohol taste; Filter the medicinal residues that obtain and add again the distilled water with respect to 4~8 times of medicinal residues quality, each decoction 1~3 hour, decoct 2~3 times, filter respectively, merging filtrate obtains water extraction liquid, water extraction liquid concentrating under reduced pressure, mix with the concentrated solution of the alcohol extract obtaining above, further concentrating under reduced pressure, removes desolventizing, dry, obtain and get dry extract;
The 3rd step, is broken into 200 order~400 object powder by described dried cream powder, adds excipient and disintegrating agent to mix, be dried, pulverize in the powder obtaining, and adds fluidizer, in finally incapsulating, obtains capsule;
Described excipient is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate or other pharmaceutic adjuvants, and its weight content in described capsule is 10~50%;
Described disintegrating agent is sodium carboxymethyl cellulose or hydroxypropyl cellulose, and its weight content in described capsule is 5~20%;
Described fluidizer is that magnesium stearate, differential silica gel or other have the pharmaceutic adjuvant of fluidizer effect, and its weight content in described capsule is 0.1~5%.
Wherein, when the dosage form of described external used medicine is suppository, its preparation method comprises the following steps:
The first step: described raw medicinal material is added to the water of 4~6 times of amounts, soak 2~5 hours, decoct 3~4 hours, filter filtrate for later use; Filtering residue adds the water of 3~4 times of amounts to heat for the second time, decocts 2~3 hours, filters filtrate for later use; Filtering residue adds the water of 2~3 times of amounts to heat for the third time again, decocts 1~2 hour, filters filtrate for later use; Three filtrates are combined, and heating is concentrated into pasty state, puts into after 80 ℃ of oven dry of baking oven coolingly, grinds to form fine powder.
Second step: get in semi-synthetic fatty acid glyceride, lanoline, Polyethylene Glycol and poloxamer poloxamer one or more as substrate; By described substrate heating and melting under ℃ condition of temperature 50 C~60, add first step gained fine powder, stir, be mixed into the liquid of thickness, be poured in plastic shape-forming pipe, insert tampon, cooling and shaping is made bullet-shaped suppository; The proportioning of described fine powder and substrate is 1: 2~1: 4; Described tampon is that afterbody is with the tampon of cotton thread.
Wherein, when the dosage form of described endo-medicine is granule, its preparation method comprises the following steps:
Step 1: described raw medicinal material is mixed in described ratio, add the ethanol that the determining alcohol with respect to 4~6 times, mixture is 80%~90%, be heated to boiling reflux 3~5 hours, filter, adopt percolation with the speed of 1~2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 50~60 ℃ subsequently under vacuum 0.06~0.09Mpa, relative density is 1.12~1.18, spraying is dry, 160~175 ℃ of the inlet temperature of spray dryer, 80~85 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Step 2: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.2~0.4 times of dried cream powder quality and the dextrin of 0.1~0.2 times, granulation, in 40~50 ℃ dry, obtain granule;
Wherein, when the dosage form of described external used medicine is lotion, its preparation method comprises the following steps:
The first step, described raw medicinal material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 0.1~10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%;
Second step, in the mixed powder that the first step obtains, add the ethanol that the determining alcohol with respect to 3~5 times of the quality of described mixed powder is 85%~95%, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 5 ℃~10 ℃ standing 24~36 hours, adopt percolation with the speed of 1~2ml per minute percolation slowly, collect percolate, concentrate and be dried, and again put into super micron mill and pulverize 40~60 minutes, obtain the mixed powder of the micron particles of 0.1~10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, adds deionized water with respect to mixed powder quality 2~3 times in the mixed powder obtaining at second step, decocts 2~4 hours, filters, and obtains medicine juice.
Beneficial effect of the present invention: Chinese medicine composition provided by the invention utilizes the traditional theory of Chinese medical science of China, takes orally and combines with external, endo-medicine heat-clearing and toxic substances removing, and damp eliminating is treating stranguria, invigorating spleen and kidney; External used medicine heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling.Treatment chronic pelvic inflammatory disease, treating both the principal and secondary aspects of a disease, determined curative effect, side effect is little.
The specific embodiment
The invention provides a kind of Chinese medicine composition for the treatment of chronic pelvic inflammatory disease, wherein, described Chinese medicine composition is comprised of endo-medicine and external used medicine, described endo-medicine comprises following raw medicinal material: ear water Herba Amaranthi tricoloris, Herba Kummerowiae Striatae, Herba Clinopodii Polycephali, Herba Houttuyniae, Herba Crotalariae Ferrugineae, Semen Euryales, Rhizoma Pedicularis Davidii, Rhizoma Polygoni Cuspidati, Herba Emiliae, Caulis Fibraureae, gynura bicolor, Semen Nelumbinis and Herba Glechomae; Described external used medicine comprises following raw medicinal material: Radix Achyranthis, Herb Polygoni Chinensis, Radix Rubiae Yunnanensis, Flos Carthami, Herba Lycopi, Radix Arnebiae (Radix Lithospermi), Herba Sonchi Oleracei, Herba Melastomatis dodecandri, Helwingia himalaica and Cortex Moutan.
In described Chinese medicine composition, the pharmacology of each raw medicinal material is as follows:
Ear water Herba Amaranthi tricoloris: sweet in the mouth, light, property is flat.Return spleen, urinary bladder channel.Invigorating spleen to remove dampness, circulation of qi promoting dissipating blood stasis.Spleen deficiency anorexia, chest and diaphragm is full vexed, acute and chronic cystitis, women's leukorrhagia, traumatic injury congestive edema is had a pain.
Herba Kummerowiae Striatae: sweet, pungent, flat.Heat-clearing and toxic substances removing, invigorating spleen to remove dampness.The heating that cures cold, heat-damp in summer is vomited and diarrhoea, malaria, dysentery, infectious hepatitis, pyretic stranguria, nebulousurine.< < Nanjing medicinal herbs > among the people >: diuresis.Chinese herbal medicine > > is commonly used in < < Shanghai: the heating that cures cold, cough chest pain, urinary tract infection, enteritis, dysentery.
Herba Clinopodii Polycephali: sweet, micro-hardship, flat.Return lung, Liver Channel.The improving eyesight of relieving inflammation or internal heat, dampness removing is treating stranguria.Cure mainly epistaxis, spitting of blood, gonorrhea, menorrhagia, enterorrhagia, urethritis, bleeding hemorrhoids, traumatic injury, knife injury, fracture.< < Tian Bao book on Chinese herbal medicine > >: control red white clouds nebula, remove wind, relieve inflammation or internal heat, dehumidifying, treating stranguria.< < Fujian traditional herbal medicine > >: improving eyesight, beneficial will, heat clearing away, diuresis.
Herba Houttuyniae: cold nature, bitter in the mouth.Enter liver, lung meridian.Heat-clearing and toxic substances removing, removing pus and relieving carbuncle, inducing diuresis for treating stranguria syndrome.Control pneumonia, lung abscess, hematodiarrhoea, malaria, edema, gonorrhea, leucorrhea, carbuncle, hemorrhoid, proctoptosis, eczema, tinea alba, scabies.< < detailed outline > >: the malicious carbuncle that dispels the heat, skin ulcer hemorrhoid proctoptosis , Duan Malaria disease, separates Nao poison.> > is wanted in the bun of < < medical center: row water, assault fortified position, and go miasma, expelling summer-heat.Treat snakeworm poison, control beriberi, the carbuncle of bursting, blood stasis removing blood.
Herba Crotalariae Ferrugineae: hardship, micro-acid, cold.Return lung meridian.The gas of astringing the lung, spleen reinforcing kidney, diuresis, detumescence poison.Control chronic cough expectorant blood, tinnitus, deafness, nocturnal emission, chronic nephritis, cystitis, renal calculus, tonsillitis, lymphadenitis, furunculosis, malignant boil.< < vegetation is square > > just: invigorating the spleen and replenishing QI, treat tinnitus, and the head is giddy, collapses pouring.< < classification medical herbs > >: large spleen reinforcing kidney, control deafness, the deficiency of vital energy.
Semen Euryales: sweet, puckery, flat.Enter spleen, kidney channel.Reinforcing the kindey to control nocturnal emission, spleen reinforcing stopping leak.Control seminal emission, stranguria with turbid discharge, leukorrhagia, incontinence of urine, loose stool and diarrhea.< < herbal classic > >: main arthralgia chiefly caused by damp pathogen spinal column gonalgia, invigorating middle warmer removes sudden and violent disease, beneficial vital essence, strong will, makes normal hearing and eyesight.< < Bencao Congxin > >: spleen reinforcing is reinforced the kidney, and helps gas arresting seminal emission.
Rhizoma Pedicularis Davidii: sweet in the mouth, micro-hardship, warm in nature.Enriching yin and nourishing kidney, replenishing QI to invigorate the spleen.Cure mainly asthenia of both the spleen and kidney, osteopyrexia and fever, arthralgia.< < Shaanxi Chinese herbal medicine > >: enriching yin and nourishing kidney, invigorating the spleen and replenishing QI, invigorating the spleen and regulating the stomach.Control physical weakness, the osteopyrexia and fever of suffering from a deficiency of the kidney, arthralgia.
Rhizoma Polygoni Cuspidati: micro-hardship, is slightly cold.Return liver, gallbladder, lung meridian.Heat-clearing and toxic substances removing, promoting the function of the gallbladder to alleviate jaundice, expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.For arthralgia, jaundice due to damp-heat, amenorrhea, postnatal blood stasis not under, cough with copious phlegm, burn due to hot liquid or fire, traumatic injury, carbuncle sore tumefacting virus.< < the southern regions of the Yunnan Province book on Chinese herbal medicine > >: attack all toxic swellings, only have sore throat, diuresis, walks meridians.Control five types of stranguria nebulousurine, anal fistula, carbuncle sore, married woman's leucorrhea with red and white discharge.
Herba Emiliae: hardship, cool.Heat clearing away, diuretic, removing heat from blood, removing toxic substances.Control dysentery, diarrhoea, have blood in stool, edema, acute appendicitis, engages ear, order also, throat moth, furuncle, toxic swelling.< < Fujian traditional herbal medicine > >: promoting blood circulation and detumescence, diuresis is relieved oedema or abdominal distension through diuresis or purgation.The practical Chinese herbal medicine in < < Guangxi newly selects > >: anti-inflammation.Control acute upper respiratory tract inflammation, pneumonia, tonsillitis, oral ulcer, mastitis, chronic pelvic inflammatory disease, dysentery, diarrhoea, venom.
Caulis Fibraureae: sweet, hardship, cold.GUIXIN, sweet warp.Heat clearing away, removing toxic substances, diuresis, relieving constipation.Control food poisoning, heat stagnation constipation, dysentery, infectious hepatitis, carbuncle sore, acute conjunctivitis, laryngopharynx swelling and pain.< < Luchuan book on Chinese herbal medicine > >: the removing toxic substances of purging heat, relieving constipation, the poison that anhydrates, detumescence.Control heat stagnation constipation, dysentery, stony edema, carbuncle sore, epidemic blisters, acute conjunctivitis.
Gynura bicolor: sweet, pungent, cool.Cooling blood for hemostasis, clearing heat for detumescence.For hemoptysis, metrorrhagia, dysmenorrhea, vim and vigour pain, bronchitis, pelvic inflammatory disease, heatstroke, amebic dysentery; Wound hemorrhage is controlled in external, and ulcer does not close up for a long time, furuncle carbuncle, paronychia.
Semen Nelumbinis: sweet, puckery, flat.Enter the heart, spleen, liver, kidney channel.Nourish heart, kidney tonifying, spleen reinforcing.Astringing intestine to stop diarrhea.Control the dreaminess of sleeping night, seminal emission, stranguria with turbid discharge, chronic dysentery, diarrhea of deficiency type, married woman's bleeding not during menses.Semen Caesalpiniae Minacis energy preventing or arresting vomiting, appetizing, the conventional fasting dysentery of controlling.
Herba Glechomae: pungent, micro-hardship, is slightly cold.Return liver, kidney, urinary bladder channel.Dampness removing is treating stranguria, heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling.For pyretic stranguria, stranguria caused by urinary stone, jaundice due to damp-heat, sore, carbuncle and painful swelling, injury from falling down.
Radix Achyranthis: hardship, acid, flat.Enter the heart, liver, large intestine three warps.Promoting blood circulation to remove blood stasis, damp eliminating diuresis, heat-clearing and toxic substances removing.Control gonorrhea, hematuria, women's amenorrhea, lump in the abdomen, rheumatism husband's arthralgia, beriberi, edema, dysentery, malaria, diphtheria, carbuncle, traumatic injury.Chinese herbal medicine handbook > > is commonly used in < < Shanghai: the diuresis of stimulating the menstrual flow, heat-clearing and toxic substances removing, promoting blood circulation and stopping pain.Control beriberi swelling, arthritis, rheumatalgia, diphtheria, acute/chronic pharyngitis.
Herb Polygoni Chinensis: acid, sweet, cool.Heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling, suppressing the hyperactive liver improving eyesight, relaxing muscles and tendons to promote blood circulation.Main dysentery, has loose bowels, laryngopharynx swelling and pain, diphtheria, cough due to lung-heat, pertussis, hepatitis, leukorrhagia, cancerous protuberance, otitis media, eczema, vertigo and tinnitus, corneal nebula, traumatic injury.The < < of Guangzhou army commonly uses Chinese herbal medicine handbook > >: eliminating damp-heat, stagnant removing toxic substances disappears.Control dysentery, enteritis, dyspepsia, hepatitis, tonsillitis, pharyngolaryngitis, furuncle and phyma, osteopatia sprain, dermatitis, eczema, pruritus.
Radix Rubiae Yunnanensis: sweet, temperature.The function with promoting blood circulation and hemostasis, blood circulation promoting and blood stasis dispelling.Cure mainly epistaxis, spit blood, have blood in stool, the disease such as hematuria, metrorrhagia, menoxenia, amenorrhea stomachache, rheumatic arthritis, hepatitis; The diseases such as external treatment traumatic injury, furuncle and phyma, neurodermatitis.< < Red River Chinese herbal medicine > >: cooling blood for hemostasis, the promoting the circulation of blood of stimulating the menstrual flow, stasis-dispelling and pain-killing.
Flos Carthami: pungent, temperature.GUIXIN, Liver Channel.Blood circulation promoting and blood stasis dispelling, relieving pain of dysmenorrhea, dispersing the stagnated liver-QI and dredging collateral.< < detailed outline > >: invigorate blood circulation, moisturize, pain relieving, loose swollen, stimulate the menstrual flow.
Herba Lycopi: tepor, bitter in the mouth, pungent.Return liver, spleen channel.Blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis stomachache, edema.
Radix Arnebiae (Radix Lithospermi): cold in nature, sweet in the mouth, one-tenth.Removing heat from blood, invigorates blood circulation, removing toxic substances rash.For heat in blood poison contain, macule purple is black, measles without adequate eruption, skin infection, eczema, burn due to hot liquid or fire.Clearing away heat and cooling blood, for measles, calentura skin eruption, eczema, hematuria, stranguria with blood, dysentery, skin infection, erysipelas, burn, constipation with heat retention.> > is wanted in the bun of < < medical center: reinforcing the heart, and slow liver, dissipating blood stasis, invigorates blood circulation.< < Shaanxi Chinese herbal medicine > >: control burn, dermatitis, eczema, urinary tract infection.
Herba Sonchi Oleracei: acrid in the mouth, hardship, be slightly cold.Return liver, stomach, large intestine channel.Heat-clearing and toxic substances removing, removing heat from blood, eliminating carbuncle evacuation of pus, stasis-dispelling and pain-killing.For acute appendicitis, the high heat of lung abscess, coughs vomiting bloody pus, pyretic toxicity skin ulcer furuncle, and furuncle is bitterly swollen, breast abdomen pain, appendicitis, enteritis, dysentery, puerperal abdonimal pain, dysmenorrhea.
Herba Melastomatis dodecandri: sweet in the mouth, micro-puckery, property is slightly cool.Enter liver,kidney,spleen, lung four warps.Promoting blood circulation and hemostasis, heat-clearing and toxic substances removing.Control dysmenorrhea, puerperal abdonimal pain, metrorrhagia, leukorrhagia, has blood in stool, dysentery, carbuncle, furuncle.< < Luchuan book on Chinese herbal medicine > >: hemostasis, removing toxic substances, antiinflammatory.Control metrorrhagia, dysentery, the carbuncle sore redness of festering.
Helwingia himalaica: bitter, micro-puckery, cool.Blood circulation promoting and blood stasis dispelling, heat-clearing and toxic substances removing.For traumatic injury, fracture, rheumatic arthritis, stomachache, dysentery, menoxenia; Burn and scald is controlled in external, furuncle carbuncle, venom.
Cortex Moutan: bitter in the mouth, pungent, is slightly cold.GUIXIN, liver, kidney channel.Clearing away heat and cooling blood, promoting blood circulation to remove blood stasis.Control amenorrhea due to stagnation of blood, dysmenorrhea, carbuncle sore tumefacting virus, falls and flutters the pain of injury, rheumatism pyretic arthralgia.< < Japan hanako materia medica > >: except pathogen, happy color, the natural fibre line of meat blood vessels of being open to the custom, evacuation of pus, logical menstruation, disappears and flutters damage blood stasis, reuniting the fractured tendons and bones, except migratory arthralgia, the tire lower eyelid that falls, puerperal all cold and hot vim and vigour.
Wherein, in described Chinese medicine composition, the ratio of weight and number of each raw medicinal material can be preferably: in described endo-medicine, the ratio of weight and number of each raw medicinal material is: 20~30 parts of ear water Herba Amaranthi tricoloriss, 15~25 parts of Herba Kummerowiae Striatae, 10~20 parts of Herba Clinopodii Polycephalies, 5~10 parts of Herba Houttuyniae, 15~25 parts of Herba Crotalariae Ferrugineaes, 10~20 parts of Semen Euryaless, 10~20 parts of Rhizoma Pedicularis Davidii, 10~20 parts of Rhizoma Polygoni Cuspidati, 25~40 parts of Herba Emiliae, 5~10 parts of Caulis Fibraureaes, 20~35 parts of gynura bicolors, 10~20 parts of 10~20 parts, Semen Nelumbinis and Herba Glechomaes; In described external used medicine, the ratio of weight and number of each raw medicinal material is: 25~35 parts of Radix Achyranthis, 15~25 parts of Herb Polygoni Chinensiss, 15~25 parts of Radix Rubiae Yunnanensis, 15~25 parts, Flos Carthami, 20~35 parts of Herba Lycopi, 15~25 parts of Radix Arnebiae (Radix Lithospermi)s, 15~25 parts of Herba Sonchi Oleracei, 25~40 parts of Herba Melastomatis dodecandri, 15~25 parts of 15~25 parts of Helwingia himalaica and Cortex Moutans.
Wherein, in described Chinese medicine composition, the ratio of weight and number of each raw medicinal material can also be preferably: in described endo-medicine, the ratio of weight and number of each raw medicinal material is: 25~30 parts of ear water Herba Amaranthi tricoloriss, 15~20 parts of Herba Kummerowiae Striatae, 10~15 parts of Herba Clinopodii Polycephalies, 8~10 parts of Herba Houttuyniae, 20~25 parts of Herba Crotalariae Ferrugineaes, 15~20 parts of Semen Euryaless, 10~15 parts of Rhizoma Pedicularis Davidii, 10~15 parts of Rhizoma Polygoni Cuspidati, 30~40 parts of Herba Emiliae, 5~8 parts of Caulis Fibraureaes, 20~30 parts of gynura bicolors, 15~20 parts of 10~15 parts, Semen Nelumbinis and Herba Glechomaes; In described external used medicine, the ratio of weight and number of each raw medicinal material is: 30~35 parts of Radix Achyranthis, 15~20 parts of Herb Polygoni Chinensiss, 20~25 parts of Radix Rubiae Yunnanensis, 15~20 parts, Flos Carthami, 20~30 parts of Herba Lycopi, 20~25 parts of Radix Arnebiae (Radix Lithospermi)s, 20~25 parts of Herba Sonchi Oleracei, 30~40 parts of Herba Melastomatis dodecandri, 15~20 parts of 20~25 parts of Helwingia himalaica and Cortex Moutans.
Wherein, in described Chinese medicine composition, the ratio of weight and number of each raw medicinal material can be preferably again: in described endo-medicine, the ratio of weight and number of each raw medicinal material is: 28 parts of ear water Herba Amaranthi tricoloriss, 17 parts of Herba Kummerowiae Striatae, 14 parts of Herba Clinopodii Polycephalies, 9 parts of Herba Houttuyniae, 21 parts of Herba Crotalariae Ferrugineaes, 16 parts of Semen Euryaless, 13 parts of Rhizoma Pedicularis Davidii, 12 parts of Rhizoma Polygoni Cuspidati, 36 parts of Herba Emiliae, 6 parts of Caulis Fibraureaes, 23 parts of gynura bicolors, 19 parts of 14 parts, Semen Nelumbinis and Herba Glechomaes; In described external used medicine, the ratio of weight and number of each raw medicinal material is: 32 parts of Radix Achyranthis, 17 parts of Herb Polygoni Chinensiss, 25 parts of Radix Rubiae Yunnanensis, 18 parts, Flos Carthami, 24 parts of Herba Lycopi, 21 parts of Radix Arnebiae (Radix Lithospermi)s, 22 parts of Herba Sonchi Oleracei, 34 parts of Herba Melastomatis dodecandri, 17 parts of 22 parts of Helwingia himalaica and Cortex Moutans.
Wherein, when the dosage form of described endo-medicine is capsule, its preparation method comprises the following steps:
The first step, is mixed in proportion described raw medicinal material, puts into marmite and fries 20 minutes~40 minutes, with pulverizer, is ground into smalls, is screened into 100 order~200 object powder;
Second step, the ethanol that the determining alcohol that adds 3~5 times of the powder qualities that obtain with respect to the first step is 75~85%, reflux 2~5 hours, extracts 2~3 times, merges extracting solution each time, filters acquisition alcohol extract, and alcohol extract concentrating under reduced pressure, is recycled to without alcohol taste; Filter the medicinal residues that obtain and add again the distilled water with respect to 4~8 times of medicinal residues quality, each decoction 1~3 hour, decoct 2~3 times, filter respectively, merging filtrate obtains water extraction liquid, water extraction liquid concentrating under reduced pressure, mix with the concentrated solution of the alcohol extract obtaining above, further concentrating under reduced pressure, removes desolventizing, dry, obtain and get dry extract;
The 3rd step, is broken into 200 order~400 object powder by described dried cream powder, adds excipient and disintegrating agent to mix, be dried, pulverize in the powder obtaining, and adds fluidizer, in finally incapsulating, obtains capsule;
Described excipient is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate or other pharmaceutic adjuvants, and its weight content in described capsule is 10~50%;
Described disintegrating agent is sodium carboxymethyl cellulose or hydroxypropyl cellulose, and its weight content in described capsule is 5~20%;
Described fluidizer is that magnesium stearate, differential silica gel or other have the pharmaceutic adjuvant of fluidizer effect, and its weight content in described capsule is 0.1~5%.
Wherein, when the dosage form of described external used medicine is suppository, its preparation method comprises the following steps:
The first step: described raw medicinal material is added to the water of 4~6 times of amounts, soak 2~5 hours, decoct 3~4 hours, filter filtrate for later use; Filtering residue adds the water of 3~4 times of amounts to heat for the second time, decocts 2~3 hours, filters filtrate for later use; Filtering residue adds the water of 2~3 times of amounts to heat for the third time again, decocts 1~2 hour, filters filtrate for later use; Three filtrates are combined, and heating is concentrated into pasty state, puts into after 80 ℃ of oven dry of baking oven coolingly, grinds to form fine powder.
Second step: get in semi-synthetic fatty acid glyceride, lanoline, Polyethylene Glycol and poloxamer poloxamer one or more as substrate; By described substrate heating and melting under ℃ condition of temperature 50 C~60, add first step gained fine powder, stir, be mixed into the liquid of thickness, be poured in plastic shape-forming pipe, insert tampon, cooling and shaping is made bullet-shaped suppository; The proportioning of described fine powder and substrate is 1: 2~1: 4; Described tampon is that afterbody is with the tampon of cotton thread.
Wherein, when the dosage form of described endo-medicine is granule, its preparation method comprises the following steps:
Step 1: described raw medicinal material is mixed in described ratio, add the ethanol that the determining alcohol with respect to 4~6 times, mixture is 80%~90%, be heated to boiling reflux 3~5 hours, filter, adopt percolation with the speed of 1~2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 50~60 ℃ subsequently under vacuum 0.06~0.09Mpa, relative density is 1.12~1.18, spraying is dry, 160~175 ℃ of the inlet temperature of spray dryer, 80~85 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Step 2: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.2~0.4 times of dried cream powder quality and the dextrin of 0.1~0.2 times, granulation, in 40~50 ℃ dry, obtain granule;
Wherein, when the dosage form of described external used medicine is lotion, its preparation method comprises the following steps:
The first step, described raw medicinal material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 0.1~10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%;
Second step, in the mixed powder that the first step obtains, add the ethanol that the determining alcohol with respect to 3~5 times of the quality of described mixed powder is 85%~95%, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 5 ℃~10 ℃ standing 24~36 hours, adopt percolation with the speed of 1~2ml per minute percolation slowly, collect percolate, concentrate and be dried, and again put into super micron mill and pulverize 40~60 minutes, obtain the mixed powder of the micron particles of 0.1~10 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, adds deionized water with respect to mixed powder quality 2~3 times in the mixed powder obtaining at second step, decocts 2~4 hours, filters, and obtains medicine juice.
Below adopt example to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Capsule (endo-medicine) prepared by embodiment 1 the present invention
Get ear water Herba Amaranthi tricoloris 280g, Herba Kummerowiae Striatae 170g, Herba Clinopodii Polycephali 140g, Herba Houttuyniae 90g, Herba Crotalariae Ferrugineae 210g, Semen Euryales 160g, Rhizoma Pedicularis Davidii 130g, Rhizoma Polygoni Cuspidati 120g, Herba Emiliae 360g, Caulis Fibraureae 60g, gynura bicolor 230g, Semen Nelumbinis 140g and Herba Glechomae 190g;
Its preparation method comprises the following steps:
The first step, is mixed in proportion above-mentioned raw materials medical material, puts into marmite and fries 30 minutes, with pulverizer, is ground into smalls, is screened into 200 object powder;
Second step, the ethanol that the determining alcohol that adds 5 times of the powder qualities that obtain with respect to the first step is 80%, reflux 4 hours, extracts 3 times, merges extracting solution each time, filters acquisition alcohol extract, and alcohol extract concentrating under reduced pressure, is recycled to without alcohol taste; Filter the medicinal residues that obtain and add again the distilled water with respect to 6 times of medicinal residues quality, decoct 2 hours at every turn, decoct 2 times, filter respectively, merging filtrate obtains water extraction liquid, and water extraction liquid concentrating under reduced pressure mixes with the concentrated solution of the alcohol extract obtaining above, further concentrating under reduced pressure, except desolventizing, dry, obtain and get dry extract;
The 3rd step, is broken into 300 object powder by dried cream powder, adds excipient and disintegrating agent to mix, be dried, pulverize in the powder obtaining, and adds fluidizer, in finally incapsulating, obtains capsule;
Excipient is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate or other pharmaceutic adjuvants, and its weight content in capsule is 30%;
Disintegrating agent is sodium carboxymethyl cellulose or hydroxypropyl cellulose, and its weight content in capsule is 10%;
Fluidizer is that magnesium stearate, differential silica gel or other have the pharmaceutic adjuvant of fluidizer effect, and its weight content in capsule is 0.8%.
Granule (endo-medicine) prepared by embodiment 2 the present invention
Get ear water Herba Amaranthi tricoloris 260g, Herba Kummerowiae Striatae 190g, Herba Clinopodii Polycephali 120g, Herba Houttuyniae 80g, Herba Crotalariae Ferrugineae 240g, Semen Euryales 180g, Rhizoma Pedicularis Davidii 110g, Rhizoma Polygoni Cuspidati 130g, Herba Emiliae 330g, Caulis Fibraureae 70g, gynura bicolor 270g, Semen Nelumbinis 120g and Herba Glechomae 150g;
Its preparation method comprises the following steps:
Step 1: above-mentioned raw materials medical material is mixed in proportion, add the ethanol that the determining alcohol with respect to 5 times, mixture is 85, be heated to boiling reflux 4 hours, filter, adopt percolation with the speed of 1ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 50 ℃ subsequently under vacuum 0.07Mpa, relative density is 1.13, spraying is dry, 165 ℃ of the inlet temperature of spray dryer, 85 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Step 2: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.35 times of dried cream powder quality and the dextrin of 0.15 times, granulation, in 50 ℃ dry, obtain granule;
Suppository (external used medicine) prepared by embodiment 3 the present invention
The Radix Achyranthis Bidentatae 320g that fetches earth, Herb Polygoni Chinensis 170g, Radix Rubiae Yunnanensis 250g, Flos Carthami 180g, Herba Lycopi 240g, Radix Arnebiae (Radix Lithospermi) 210g, Herba Sonchi Oleracei 220g, Herba Melastomatis dodecandri 340g, Helwingia himalaica 220g and Cortex Moutan 170g;
Its preparation method comprises the following steps:
The first step: above-mentioned raw materials medical material is added to the water of 5 times of amounts, soak 4 hours, decoct 4 hours, filter filtrate for later use; Filtering residue adds the water of 3 times of amounts to heat for the second time, decocts 3 hours, filters filtrate for later use; Filtering residue adds the water of 2 times of amounts to heat for the third time again, decocts 2 hours, filters filtrate for later use; Three filtrates are combined, and heating is concentrated into pasty state, puts into after 80 ℃ of oven dry of baking oven coolingly, grinds to form fine powder.
Second step: get in semi-synthetic fatty acid glyceride, lanoline, Polyethylene Glycol and poloxamer poloxamer any one as substrate; By described substrate heating and melting under 55 ℃ of conditions of temperature, add first step gained fine powder, stir, be mixed into the liquid of thickness, be poured in plastic shape-forming pipe, insert tampon, cooling and shaping is made bullet-shaped suppository; The proportioning of fine powder and substrate is 1: 3; Tampon is that afterbody is with the tampon of cotton thread.
Lotion (external used medicine) prepared by embodiment 4 the present invention
The Radix Achyranthis Bidentatae 340g that fetches earth, Herb Polygoni Chinensis 180g, Radix Rubiae Yunnanensis 230g, Flos Carthami 160g, Herba Lycopi 270g, Radix Arnebiae (Radix Lithospermi) 230g, Herba Sonchi Oleracei 240g, Herba Melastomatis dodecandri 370g, Helwingia himalaica 250g and Cortex Moutan 160g;
Its preparation method comprises the following steps:
The first step, above-mentioned raw materials medical material is mixed in proportion, put into the mixed powder that super micron mill is ground into the micron particles of 5 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%;
Second step, in the mixed powder that the first step obtains, add the ethanol that the determining alcohol with respect to 4 times of the quality of described mixed powder is 95%, stirring and dissolving obtains alcoholic solution, by alcoholic solution under the condition of 7 ℃ standing 33 hours, adopt percolation with the speed of 1ml per minute percolation slowly, collect percolate, concentrate and be dried, and again put into super micron mill and pulverize 60 minutes, obtain the mixed powder of the micron particles of 2 μ m volume average particle size and the nano-scale particle composition that particle diameter is less than 0.1 μ m volume average particle size, the powder rate that obtains of described mixed powder is at least 95%,
The 3rd step, adds deionized water with respect to mixed powder quality 2.5 times in the mixed powder obtaining at second step, decocts 3 hours, filters, and obtains medicine juice.
Toxicity test:
Endo-medicine acute toxicity testing: 60 of application mices, male and female half and half, body weight 26~36g, carries out acute toxicity test.Mice is divided into two groups at random, be matched group and administration group, before experiment, fasting is 12 hours, and the endo-medicine capsule of embodiments of the invention 1 preparation is dissolved in water, (concentration is 6.54g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (being that single-dose dosage is 32.7 crude drugs/kg), matched group gives equivalent normal saline, administration in one day 2 times, delivery time 6 hours, after administration, Continuous Observation is 14 days, and record mice toxic reaction and death toll.Experimental result shows: with matched group comparison, after administration, mice has no notable difference, experiment Continuous Observation 14 days, and mice overall health of patients, diet, drinking-water, body weight gain are all normal.Mice oral administration gavage tablet of the present invention is LD50 > 32.7 crude drugs/kg, and every day, maximum dosage-feeding was 65.4 crude drugs/kg/ day.Chinese medicine composition clinical application amount of the present invention is 4.6g crude drug/day/people, becomes body weight for humans in 60KG, and average dosage is 0.077g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight take 31g) oral administration gavage Chinese medicine composition of the present invention is quantity 849 times.Therefore Chinese medicine composition acute toxicity of the present invention is extremely low, clinical drug safety.
Endo-medicine long term toxicity test: the capsule of Chinese medicine composition embodiment of the present invention 1 preparation to mice by 9.45,19.83 and 16 weeks (1.0ml/100g body weight of 37.46g crude drug/kg continuous use, every day 2 times) and drug withdrawal after 4 weeks, result shows: Chinese medicine preparation of the present invention all has no significant effect indexs such as the hair of rat, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat, internal organs naked eyes do not find that difference changes and histological examination result shows, medication 16 weeks and drug withdrawal are after 4 weeks, and each internal organs of rat are all without obviously changing.Illustrate that toxicity is little after Chinese medicine composition of the present invention is to rat long-term prescription, after drug withdrawal, also there is no difference reaction, application safety.
External used medicine toxicity test: 1, experimental technique: get 80 Cavia porcelluss, guinea pig back spinal column both sides are evenly coated depilatory, make approximately 40 square centimeters of unhairing scopes, clean depilatory returns cage to observe 24 hours.Cavia porcellus is divided into four groups at random, three medication group Cavia porcelluss are coated with respectively external used medicine lotion 0.3,0.5 and the 0.8ml of the embodiment of the present invention 4 preparations, containing crude drug 95mg, 188mg and 370mg, a matched group is coated with solvent 0.8ml, every twice-daily respectively, continuous one week, after experiment finishes, Cavia porcellus is put to death to the heart, liver, kidney and depilation skin are done pathological examination.2, result: the Cavia porcellus trunk depilation district of three medication groups, having no local skin has edema, hyperemia, erythema, petechia and ulcer.The Cavia porcellus chroma of hair of medication group, ingest, extremity activity etc. and matched group no significant difference, histopathologic examination, the medication group heart, liver, kidney and depilation skin and matched group be no significant difference more also.Results suggest, external used medicine of the present invention, without local irritant effect, also has no general toxicity performance.Show that Chinese medicine external medicine of the present invention is used safety.
Clinical data:
Case selection: whole 90 routine cases are my Out-patient Department patient of in August, 2009~2012 year April.Be divided at random treatment group and matched group, treatment group 40 people wherein, 23~49 years old age; Matched group 50 people, men age 25~46 years old.Two groups at aspects such as age, sex, clinical manifestations Epidemiological Analysis there was no significant difference (p > 0.05) by statistics.
Diagnostic criteria: all cases are all with reference to sixth version obstetrics and gynecology) > > is about the diagnostic criteria of chronic pelvic inflammatory disease.(1) symptom: hypogastric region falling inflation pain, lumbosacral region is ached, menoxenia, leucorrhoea grow in quantity or be purulence.(2) sign: uterus is rear position, limitation of activity more; Adnexa thickens, tenderness, and hardening, can touch enclosed mass sometimes.(3) ultrasound diagnosis: inflammatory mass, pelvic hydrops, hydrosalpinx etc.Get rid of tubo-ovarian cyst, pelvic cavity inner tissue is optimum or malignant tumor, and the important organ disease such as heart and brain Liver and kidney.
Therapeutic Method: treatment group: take 1 capsule every day of the embodiment of the present invention 3 times, each 2.The suppository of the external embodiment of the present invention 3 is filled in vagina depths, 1 dose of every day.Within 15 days, be 1 course for the treatment of, treat 2 courses for the treatment of.
Matched group: add ceftriaxone sodium 4g with normal saline 250ml, dexamethasone 5mg intravenous drip; First nitre file 250ml intravenous drip.Equal every day 1 time, 15 days was 1 course for the treatment of, treated 2 courses for the treatment of.
Curative effect judging standard: cure: the transference cures such as lower abdomen and lumbosacral pain, gynecological and ultrasound diagnosis pelvic cavity are interior without inflammatory feature.Effective: transference cures such as lower abdomen and lumbosacral pain or obviously alleviate, gynecological and ultrasound diagnosis have clear improvement.Effective: the symptoms such as lower abdomen and lumbosacral pain alleviate, gynecological and ultrasound diagnosis make moderate progress.Invalid: symptom, sign and Gynaecological B ultrasound check without improving.
Therapeutic outcome:
|
n |
Cure |
Effective |
Effectively |
Invalid |
Effectively total |
Treatment group |
40 |
21 |
13 |
5 |
1 |
39(97.5%) |
Matched group |
50 |
13 |
14 |
14 |
9 |
41(82.0%) |
Concrete case:
Case 1: Wu, women, 30 years old, menstruation front and back leukorrhagia is half a year.Over nearly 1 month, leukorrhagia is yellow as lost ovum, stench abnormal as bad egg flavor, and companion's pruritus vulvae, aching pain in waist and back, hypogastric region falls pain, poor appetite, stool malt sugar, yellow urine heat, malaise, dimly red tongue, yellow and greasy fur, the micro-number of rolling pulse.Gynecologial examination: pudendum is normal, vagina is smooth, middle amount HUANGBAI(sic) band; Cervical hypertrophy, moderate is rotten to the corn; Palace body is slightly large, tenderness.Pelvic cavity B ultrasonic shows: bilateral adnexa thickens, left side attachment cyst; The a small amount of hydrops in Tao Shi chamber; Cervix uteri is loose.Be diagnosed as chronic pelvic inflammatory disease.The capsule of the embodiment of the present invention 1 for oral administration one day 3 times, one time 2; The suppository of external embodiment 3 one day 1 time.After treating 2 courses for the treatment of, fully recover, follow up a case by regular visits to and do not recur half a year.
The above, be only preferred embodiment of the present invention, is not the present invention to be done to the restriction of other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not depart from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.