CN102908579B - Traditional Chinese medicine preparation for treating gynecological diseases, liver diseases and prostatitis and preparation method of traditional Chinese medicine preparation - Google Patents
Traditional Chinese medicine preparation for treating gynecological diseases, liver diseases and prostatitis and preparation method of traditional Chinese medicine preparation Download PDFInfo
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- CN102908579B CN102908579B CN201210349049.9A CN201210349049A CN102908579B CN 102908579 B CN102908579 B CN 102908579B CN 201210349049 A CN201210349049 A CN 201210349049A CN 102908579 B CN102908579 B CN 102908579B
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Abstract
The invention provides a traditional Chinese medicine preparation for treating gynecological diseases, liver diseases and prostatitis and a preparation method of the traditional Chinese medicine preparation. The traditional Chinese medicine preparation is mainly prepared from raw material medicines, such as rhizoma sparganii with vinegar, rhizoma curcumae, radix paeoniae rubra, semen persicae, ramulus cinnamomi, radix astragali, dangshen, radix angelicae sinensis, rhizoma atractylodis macrocephalae, cortex moutan and poria cocos. Compared with the prior art, the medicine provided by the invention has effects on promoting circulation and removing stasis, and eliminating mass and removing stasis, and has magical effects on tonifying qi and strengthening the body resistance and tonifying spleen and nourishing blood. The research confirms that the traditional Chinese medicine compound preparation has a good efficacy on the gynecological diseases, the liver diseases and the prostatitis, has no obvious toxic and side effects, and does not produce drug resistance, so that the traditional Chinese medicine compound preparation is a new traditional Chinese medicine with safety, effectiveness and controllable quality, and is worthy of clinical popularization and application and industrial development and has a good social value and an economic value.
Description
Technical field
The present invention relates to a kind of gynaecopathia, hepatopathy, prostatitic Chinese medicine preparation and preparation method thereof for the treatment of, belong to technical field of Chinese medicines.
Background technology
Hysteromyoma is modal benign tumor in female sex organ, is also one of tumor common in human body, accounts for the women of child-bearing age's 30%.Hysteromyoma is mainly formed by Uterine Smooth Cell hypertrophy, wherein has a small amount of connective fiber only as a kind of supporting tissue, to exist.The cardinal symptom of hysteromyoma has: menoxenia, abdominal mass, pressure symptom, pain, leucorrhoea grow in quantity, sterility and infertility, blood circulation symptom etc.Clinical practice confirmation, hysteromyoma is concurrent fallopian tube or oophoropathy usually, also very easily exists with adenocarcinoma of corpus uteri and cervical cancer simultaneously.
Cyclomastopathy is the modal cystic hyperplasia of breast of women, and its sickness rate accounts for the first place of mastopathy, accounts for number of women more than 50%, and this disease sickness rate was the trend rising year by year in the last few years, and the age also more and more becomes younger.Cyclomastopathy is normal breast lobule physiological hypertrophy and subinvolution, and mammary gland normal configuration gets muddled.Be mainly in 30～50 years old women, onset peak is 35～40 years old.There is 20% breast carcinoma to merge cyclomastopathy, have 3%～5% cyclomastopathy to have the canceration may.Clinical symptoms is mainly manifested in: 1, mastalgia: be often distending pain or twinge, can involve one or both sides breast, heavy common with a lateral deviation, pain severe patient can not be touched, and even affects daily life and work.Pain can be to homonymy axillary fossa or the radiation of shoulder back; Part can show as sore nipples or itch.Mastalgia Chang Yuyue premenstrual a couple of days occurs or increases the weight of, and after passing through, pain obviously alleviates or disappears; Pain also can fluctuate with emotion changes, fatigue, Changes in weather.This pain relevant with menstrual cycle and emotion changes is the main feature of cyclomastopathy clinical manifestation.2, lump in breast: lump can be sent out in one-sided or bilateral breast, single or multiple, is generally apt to occur in the outside upper quadrant of breast.Show as lamellar not of uniform size, nodositas, streak etc., wherein take lamellar as common.Border is not obvious, and quality is medium or slightly hard, without adhesion, often has tenderness with surrounding tissue.Most of lump in breast also has the feature changing with menstrual cycle, and a month premenstrual lump increases hardening, and after menstrual onset, lump dwindles deliquescing.
Pelvic inflammatory disease is the one group of disease being caused by urogenital tract infection in women, comprises endometritis, salpingitis, tubo-ovarian abscess and pelvioperitonitis.Majority be take pain as main manifestations, accounts for more than 90%.And because pelvic organ is many by Visceral innervation, the normal location of pain perception is inaccurate, and inflammation itself is not to be only solely limited to certain pelvic organ, therefore, sometimes definite position that can not determine clinically inflammation is fallopian tube or ovary on earth, sometimes near the inflammation being confined to fallopian tube, ovary is called to adnexitis.Clinical symptoms performance: the lower abdominal pain heat that occurs together, can have shiver with cold, high heat, inappetence etc. if be in a bad way; During peritonitis, can occur feeling sick, the gastrointestinal symptom such as vomiting, abdominal distention; If any abscess, form, can have the swollen thing of lower abdomen and local compression irritation; Before swollen thing is positioned at, can there is urinary system symptom, if be positioned at rear, have the rectal distention stimulation symptoms such as diarrhoea, tenesmus and difficult defecation.This class disease is because the cause of disease is complicated and often with multiple severe complication, often prolongedly do not heal, and women's live and work is had a significant impact, and become a large disease of puzzlement modern female.Gynecological inflammation has become disease common in gynaecopathia, and in China, sickness rate reaches more than 46.5%.
Menoxenia is a kind of common gynaecopathia, shows as the disorder of menstrual cycle amount of bleeding, or stomachache and General Symptoms during month premenstrual, menstrual period, and the cause of disease may be organic disease or malfunction.Hematopathy, hypertension, hepatopathy, endocrinopathy, miscarriage, ectopic pregnancy, hydatidiform mole, endometriosis, reproductive tract infection, tumor (as ovarian tumor, hysteromyoma) etc. all can cause menoxenia.China's sterility and infertility sickness rate surpasses 10%, and menoxenia is one of its Etiological.Harvard University's research discovery, long-term menoxenia meeting promotes heart sickness rate more than 50%.Menoxenia has following several situation clinically: 1. irregular metrorrhagia.2. dysfunctional uterine hemorrhage.3. vaginal hemorrhage after menopause.4. amenorrhea.
Dysmenorrhea is one of world today's difficult medical problem.The English periodical report U.S. has in the women of periodically menstruation 90% to have dysmenorrhea, and 36% has dysmenorrhea always or often.In U.S.'s dysmenorrhea, it is the most important reason that maybe can not move absent from duty.According to Britain Yi Jia authorities,medical mechanism investigation report, point out 80% dysmenorrhea having in various degree in global women.Expert doctor Kennedy of Oxford University says in the meeting of Britain scientific achievement association: 2/3rds women suffer from dysmenorrhoea, and 3/4ths sick sending out cannot be worked. China dysmenorrhea person accounts for 33.19%, and maiden's primary dysmenorrhea accounts for 75%.Dysmenorrhea sickness rate is lasting ascendant trend every year both at home and abroad.Dysmenorrhea refers to that women, in menstrual period and front and back thereof, occurs lower abdomen or flank pain, even pain and waist sacrum.Often with menstrual cycle, send out, severe patient can be accompanied nausea and vomiting, dripping cold sweat, deadly cold hand and foot, even faints, and brings impact to work and life.Current clinical two kinds of constitutional and Secondary cases that are often divided into, primary dysmenorrhea refers to that genitals, without obvious pathological changes person, therefore claim again primary dysmenorrhea, is more common in adolescence, the unmarried and married person of not educating more.Many can the alleviation or disappear of this kind of dysmenorrhea pain after normal labor.Secondary dysmenorrhea is many to be had due to organic disease because of genitals.Dysmenorrhea is common gynecological disease and frequently-occurring disease, the cause of disease is many, pathogenesis is complicated, repeatability is large, treat thorny, especially Unmarried Females and menarche maiden more general, account for more than 70%, show as female menstrual period or pass through front and back, periodically there is hypogastric region distending pain, cold type of pain, causalgia, twinge, dull pain, pendant pain, angor, spasmic pain, lancinating pain, pain spreads to sacrum lower back, even relate to thigh and foot, often with General Symptoms: distending pain of the breast, rectal tenesmus, agitation uncomfortable in chest, sad irritability, the frightened insomnia of the heart, headache and dizzy, nausea and vomiting, stomachache diarrhoea, fatigue and weakness, pale complexion, extremity are ice-cold, the height of its morbidity, scope is wide, cycle is near, painful big, numerous women's working and learning have been had a strong impact on, reduced the quality of life.
Liver cirrhosis is clinical common chronic progressive external hepatopathy, or diffusivity hepatic injury that repeated action form long-term by one or more causes of disease.In China, great majority are posthepatitic cirrhosis, and small part is alcoholic cirrhosis and Cirrhosis In Schistosomiasis.China's chronic hepatitis B patients exceedes hundred million, wherein nearly 25%～30% chronic viral hepatitis B patient can develop into liver cirrhosis, 15% liver cirrhosis can develop into decompensated liver cirrhosis, 5%～20% can develop into hepatocellular carcinoma, Decompensated cirrhosis patient 5 annual survival rates are 55%, and decompensated liver cirrhosis patient 5 annual survival rates are 14%.In the histopathology of liver cirrhosis, there are widely hepatic necrosis, remaining hepatocyte nodular regeneration, connective tissue proliferation and fiber every formation, cause lobules of liver structural deterioration and pseudolobuli to form, liver distortion gradually, hardening and develop into liver cirrhosis.In early days because liver compensation more by force can non-evident sympton, it is main manifestations that stage be take liver function injury and portal hypertension, and have multisystem to get involved, often there is the complication such as upper gastrointestinal hemorrhage, hepatic encephalopathy, secondary infection, hypersplenism, ascites, canceration late period.
Prostatitis is male's commonly encountered diseases and frequently-occurring disease, be that Various Complex reason and inducement cause, take the disease that urethral stimulant symptom and chronic pelvic pain be main clinical manifestation., can there is perineum, suprapubic region, inguinal region, genitals pain discomfort in prostatitic clinical manifestation variation; Urethral symptom is the symptom that has the vexing uneasinesses such as burn feeling, urgent micturition, frequent micturition, dysurea, dysuria, nocturia increase, perineal position is touched a tender spot, distending pain while urinating, can be with urinating terminal hematuria or urethra purulent secretion; Actute infection can be with aversion to cold, heating, the General Symptoms such as weak.The person of being in a bad way can cause sexual dysfunction, makes troubles and misery to patient's daily life, work.In addition, prostatosis easily causes premature ejaculation, seminal emission, hemospermia, hyposexuality, sexual impotence, forfeiture sexual function.Prostatitis is one of commonly encountered diseases of adult male.Although it is not a kind of direct life-threatening disease, affects male's sexual and reproductive function, has a strong impact on patient's quality of life.Prostatitis patient accounts for Urologic Surgery Clinic patient's 8%～25%, approximately has 50% male can be subject to prostatitic impact in certain period in life.Prostatitis can affect the adult male of all age group, and the adult male prevalence of the right side of fifty is high, reaches more than 25%.
Chinese medicine research shows: the traditional Chinese medical science thinks that the pathogenesis of hysteromyoma is many because of zang-fu disharmony, QI and blood retardance, and knot in blood stasis, gas gathers for abdominal mass, and blood stasis is Disorder, and cold visitor is due to the uterus; The traditional Chinese medical science think cyclomastopathy pathogenic factor many with internal organs dysfunction, qi-blood disharmony relevant, people or the pungent delicious food savoury of surfeit of the native weakness of the liver spleen of pathological changes internal organs duty, especially spleen, damage spleen soil, and it is not normal to cause spleen soil transportation capabilities, poly-wetting as expectorant or innately introverted, emotion is constrained, good sulky or irascible temperament, moving irritability or because of damaged by excess of seven emotions, be worried excessively, and cause the liver failing to maintain the normal flow of QI, Yu Ercheng expectorant etc., all can cause phlegm-damp knot poly-, coagulation of QI-blood and form lump; The traditional Chinese medical science thinks that pelvic inflammatory disease belongs to Accumulation of Dampness Heat and Blood Stasis, cold and stagnate, the insufficiency of the spleen wet stasis of blood and ties mutually relevant with insufficiency of kidney-YANG; The traditional Chinese medical science is thought and is gone out all kidneys through water, points out that menopathy is relevant with renal function, and spleen, liver, QI and blood, chong channel, conception vessel, uterus are also relevant.Mainly be divided into two kinds: the one, deficiency syndrome, i.e. " Rong Ze pain ", because deficient qi and blood or deficiency of both the liver and kidney cause, should note at ordinary times adjusting and mend, benefiting qi and nourishing blood or nourishing the liver and kidney.The 2nd, excess syndrome, i.e. " stagnation of QI and blood may bring about pain ", and because QI-blood circulation does not freely cause, the silt pain relieving of should dispelling, the ventilation of invigorating blood circulation; The main pathogenesis of dysmenorrhea is volt in pathogen, and menses virtual loss, causes the QI-blood circulation of uterus not smooth, " stagnation of QI and blood may bring about pain "; Or uterus loses in moistening fosterly, " Rong Ze pain ", therefore causes dysmenorrhea, more with the qi depression to blood stasis cause of disease; The traditional Chinese medical science thinks that liver cirrhosis belongs to " tympanites " category, is divided into qi-stagnant damp-obstruction type, qi stagnation and blood stasis type; The traditional Chinese medical science thinks that prostatitis belongs to the category of " essence is turbid ", " stranguria caused by overstrain ", " excessive in vain ", is divided into clinically qi stagnation and blood stasis type, damp heat downward flowing type, kidney-Yang deficiency type, mainly with qi depression to blood stasis, is main.Theory of Chinese medical science think damp and hot malicious heresy make a bet at the beginning of, for it gradually, prostatitis later stage hypertrophy mostly is stasis blocking orifice for discharging seminal fluid to obstruction of collaterals by blood stasis.
The treatment of chemical drugs to above-mentioned disease at present, exists effect not remarkable, and toxic and side effects is large, easily produces the series of problems such as drug resistance, and patient easily produces a feeling low thus, and resistance declines, and symptom repeatedly, is absorbed in vicious cycle.Existing Chinese medicine compound preparation exists dosage large mostly, and curative effect is unstable, and bioavailability is low, takes the shortcomings such as inconvenient.
This prescription derives from Chinese distinguished veteran doctors of TCM expert, the Production and Construction Corps of Xinjiang of former Chinese People's Liberation Army agriculture eight division hospital vice-presidents, former Shihezi City In Xinjiang medical expert's associating outpatient service director, department of Chinese medicine director Mr.'s Xie Long clinical experience side, this side be in the secret prescription handed down in the family from generation to generation that is handed down of Mr. Xie Long Qi Xie Shi family eight generations tcm family through more than 50 years face that card treats and crystallization and the distillation of the research of writing out a prescription, pass through stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Radix Paeoniae Rubra, Semen Persicae, Ramulus Cinnamomi, the Radix Astragali, Radix Codonopsis, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, Cortex Moutan, the compatibility of Poria, have main have from, each opens up its length, play altogether blood circulation promoting and blood stasis dispelling, Xiao Disorder eliminating stagnation, QI invigorating and body resistance strengthening, the effect of strengthening spleen and nourishing blood.Clinical use is clear and definite to hysteromyoma, cyclomastopathy, pelvic inflammatory disease, menoxenia, dysmenorrhea, hepatopathy and prostatitis curative effect, safe without toxic side effect, there is no at present the relevant research reports such as corresponding prescription, preparation and treatment mechanism, in order to develop efficient, quick-acting, long-acting Chinese medicine preparation, applicant carries out intensive research, and face card experience in conjunction with clinical several generations, sum up the significant Chinese medicine formula of effect and in conjunction with modern preparation process, be made into the modern Chinese medicine preparation of different dosage form, be easy to carry, convenient oral, short treating period, rapid-action.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of gynaecopathia, hepatopathy, prostatitic Chinese medicine preparation and preparation method for the treatment of.Pharmaceutical preparation of the present invention has the effect of blood circulation promoting and blood stasis dispelling, Xiao Disorder eliminating stagnation, QI invigorating and body resistance strengthening, strengthening spleen and nourishing blood, is a kind of new Chinese medicine of safe, effective, quality controllable treatment tumor, hysteromyoma and gynecological inflammation.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:
1. there is treatment gynaecopathia, hepatopathy, prostatitic Chinese medicine preparation, it is characterized in that: it is mainly to be made by the crude drug of following weight ratio example: Ramulus Cinnamomi 1%～20%, Poria 2%～30%, Cortex Moutan 1%～20%, Radix Paeoniae Rubra 1%～20%, Semen Persicae 1%～20%, stir-baked RHIZOMA SPARGANII with vinegar 2%～30%, Rhizoma Curcumae 2%～30%, 5%～40%, Radix Codonopsis 5%～40%, the Rhizoma Atractylodis Macrocephalae 2%～30%, Radix Angelicae Sinensis 1%～10%.
2. according to treating woman's disease, hepatopathy, prostatitic Chinese medicine preparation described in claim 1, it is characterized in that: the part by weight of described crude drug is: Ramulus Cinnamomi 3%～8%, Poria 5%～10%, Cortex Moutan 3%～8%, Radix Paeoniae Rubra 3%～8%, Semen Persicae 3%～10%, stir-baked RHIZOMA SPARGANII with vinegar 5%～10%, Rhizoma Curcumae 5%～10%, 15%～20%, Radix Codonopsis 15%～20%, the Rhizoma Atractylodis Macrocephalae 5%～10%, Radix Angelicae Sinensis 2%～5%.
3. treat as claimed in claim 1 or 2 gynaecopathia, hepatopathy, prostatitic Chinese medicine preparation, it is characterized in that described crude drug content is by weight percentage: Ramulus Cinnamomi 6.02%, Poria 9.04%, Cortex Moutan 6.02%, Radix Paeoniae Rubra 6.02%, Semen Persicae 6.02%, stir-baked RHIZOMA SPARGANII with vinegar 9.04%, Rhizoma Curcumae 9.04%, the Radix Astragali 18.07%, Radix Codonopsis 18.07%, the Rhizoma Atractylodis Macrocephalae 9.04%, Radix Angelicae Sinensis 3.62%.
4. according to thering is treatment gynaecopathia, hepatopathy, prostatitic Chinese medicine preparation described in claim 1, it is characterized in that described Chinese medicine preparation is the above peroral dosage form of pharmaceutics.
5. according to the preparation method of controlling gynaecopathia, hepatopathy, prostatitic Chinese medicine preparation described in claim 4, it is characterized in that operating as follows: a, stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, Radix Angelicae Sinensis powder are broken into coarse powder and add 6～20 times of water gagings, distill and within 2～10 hours, extract volatile oil, volatile oil is with betacyclodextrin enclose, the cyclodextrin of volatile oil clathrate of system, drying for standby;
After b, stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, Radix Angelicae Sinensis distillation, retain water extraction liquid, in medicinal residues, add Poria, Radix Paeoniae Rubra, Semen Persicae, the Radix Astragali, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, add water or 40%-90% ethanol extraction 1～3 time, each 1～3 hour, merge aqueous extract or alcohol extract and above-mentioned distillate, concentrating under reduced pressure, adds proper auxiliary materials, drying under reduced pressure or to be spray dried to fine powder standby.
C, above-mentioned cyclodextrin of volatile oil clathrate and extract fine powder fully mix, then make Chinese medicine preparation with the method for Chinese medicine preparation.
6. the preparation method of controlling as claimed in claim 5, is characterized in that in described step a it being with volatile oil and betacyclodextrin enclose, in volatile oil: betacyclodextrin: water (1: 5-20: ratio 5-30), adopt polishing enclose, make clathrate.
7. according to claim Isosorbide-5-Nitrae or 5 arbitrary described treatment gynaecopathias, hepatopathy, prostatitic pharmaceutical preparation, it is characterized in that: described pharmaceutical preparation is granule, oral liquid, tablet, capsule, soft capsule.
8. according to treating gynaecopathia, hepatopathy, prostatitic pharmaceutical preparation described in claim 1,4,5,7, it is characterized in that being used for the treatment of clinically the diseases such as hysteromyoma, cyclomastopathy, pelvic inflammatory disease, adnexitis, menoxenia, dysmenorrhea, liver cirrhosis, prostatitis.
Side of the present invention separates: this prescription derives from Chinese distinguished veteran doctors of TCM expert, the Production and Construction Corps of Xinjiang of former Chinese People's Liberation Army agriculture eight division hospital vice-presidents, former Shihezi City In Xinjiang medical expert's associating outpatient service director, department of Chinese medicine director Mr.'s Xie Long clinical experience side, this side be in the secret prescription handed down in the family from generation to generation that is handed down of Mr. Xie Long Qi Xie Shi family eight generations tcm family through more than 50 years face that card treats and crystallization and the distillation of the research of writing out a prescription, we have not only strengthened blood circulation promoting and blood stasis dispelling, the merit of Xiao Disorder eliminating stagnation, also there is QI invigorating and body resistance strengthening, the effect of strengthening spleen and nourishing blood, reinforcement and elimination in combination, therein wonderful.Rhizoma Sparganii acrid in the mouth, hardship, property is flat.Return liver, spleen channel.The circulation of qi promoting of function removing blood stasis, removing food stagnancy pain relieving.Stir-baked RHIZOMA SPARGANII with vinegar enters blood system, strengthens removing blood stasis softening the hard mass and analgesic effect, for blood stasis amenorrhea, lumps in the chest and abdomen.Rhizoma Curcumae acrid in the mouth, hardship, warm in nature.Return liver, spleen channel.Function circulation of qi promoting removing blood stasis, removing food stagnancy pain relieving.For promoting the circulation of QI to relieve pain, removing blood stasis.In we, stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae are regulated the flow of vital energy, are invigorated blood circulation, removing blood stasis with potent drugs is monarch drug; Radix Paeoniae Rubra bitter in the mouth cold nature, returns liver, spleen channel.Function clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.Semen Persicae bitter in the mouth, sweet, property is flat, GUIXIN, liver, large intestine channel.Function blood circulation promoting and blood stasis dispelling, loosening bowel to relieve constipation.Ramulus Cinnamomi acrid in the mouth, sweet, warm in nature, return bladder, the heart, lung meridian.Function expelling cold and relieving exterior syndrome, promoting the flow of QI-blood by warming the meridian, activating YANG and prormoting functioning of QI.Radix Paeoniae Rubra, Semen Persicae, Ramulus Cinnamomi temperature three-way meridian in we, blood circulation promoting and blood stasis dispelling is ministerial drug; Radix Astragali sweet in the mouth is warm in nature.Return spleen, lung meridian.The raw sun of function QI invigorating, strengthening superficial resistance to stop perspiration, inducing diuresis to remove edema, promoting pus discharge and tissue regeneration strengthening, qi-supplementing, blood-engendering.Radix Codonopsis sweet in the mouth is flat.Return spleen, lung meridian.Strengthening the spleen and tonifying the lung, supplementing QI for promoting the production of body fluid.Radix Angelicae Sinensis sweet in the mouth, pungent, bitter, warm in nature.Return liver, the heart, spleen channel.Function is enriched blood, and invigorates blood circulation, and menstruction regulating and pain relieving, moisturizes laxation.Rhizoma Atractylodis Macrocephalae bitter in the mouth, sweet, warm in nature.Return spleen, stomach warp.Function invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.The Radix Astragali, Radix Codonopsis, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae strongly invigorating QI and blood, invigorating the spleen and regulating the stomach, hemopoietic consolidate as adjuvant drug; Cortex Moutan acrid in the mouth, hardship, cool in nature.GUIXIN, liver, kidney channel.Function clearing away heat and cooling blood, vanishing sputum and dispelling knot.Poria sweet in the mouth, light, property is flat.GUIXIN, spleen, lung, kidney channel.Function promoting diuresis to eliminate damp pathogen, invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming.Cortex Moutan, Poria blood circulation promoting and blood stasis dispelling, clearing away heat-damp and promoting diuresis are for making medicine.All medicines share, bring out the best in each other, monarch, have main have from, each is opened up, and it is long, plays altogether blood circulation promoting and blood stasis dispelling, Xiao Disorder eliminating stagnation, the effect of QI invigorating and body resistance strengthening, strengthening spleen and nourishing blood.
Function of the present invention cures mainly: medicine of the present invention has blood circulation promoting and blood stasis dispelling, Xiao Disorder eliminating stagnation, the effect of QI invigorating and body resistance strengthening, strengthening spleen and nourishing blood.
Toxicity test and pharmacodynamics test situation are as follows:
1, acute toxicity test
Because this compound recipe medicinal substances extract toxicity is lower, be subject to reagent not measure LD
50, do the maximum dosage-feeding test of ig.Before ig administration, mice fasting be can't help water 12 hours, and tested medicine is mixed with after Cmax, and 20 mices (♂ ♀ half and half) are ig compound extract (0.40ml10g respectively
-1), the response situation of observing immediately mice after administration, and Continuous Observation 14 days, after administration, mice obviously suppressed in 12 hours, but had no dead.
2, long term toxicity test
Rat gives the continuous gavage of compound recipe medicinal substances extract 24 weeks, observe the 12nd week, 24 weeks and drug withdrawal after the toxic reaction situations of 2 weeks (26 weeks) rats.Rat is divided into 4 groups at random: matched group, compound recipe medicinal substances extract little, in, heavy dose of group (be equivalent to quantity 25 times, 50 times, 100 times), ig administration, every day 2 times, continuous 24 weeks, when medication 12 weeks, 24 weeks and drug withdrawal recover 2 weeks, femoral artery blood-letting, execution animal, do index of correlation and detect.Result shows: with matched group comparison, and in the time of 12 weeks, the heavy dose of group of compound recipe medicinal substances extract cruor time extending, TBIL and AST raise, and CHOL reduces.In the time of 24 weeks, compound recipe medicinal substances extract is little, in, heavy dose of group cruor time extending, little, in, heavy dose of group TBIL raises, small dose group AST raises, and middle dosage group GLU raises, and heavy dose of group CHOL reduces, in, heavy dose of group ovary organ coefficient increases, heavy dose of group uterus organ coefficient reduces.After drug withdrawal, when 2 weeks (26 weeks), above index is all recovered normally, only compound recipe medicinal substances extract little, in, heavy dose of group TBIL raises compared with matched group, but compare during with 24 weeks, is remarkable reduction trend, middle dosage group ALT rising; Middle dosage group ovary organ coefficient slightly increases.Result demonstration, 24 weeks toxicity of the continuous ig administration of compound recipe medicinal substances extract Three doses is humble, clinical use safety.
Pharmacodynamic test of active extract result
The present invention adopts several animal models research, and contrasts with existing medicine, and its Pharmacodynamics result of study is as follows:
1, on the hemorheological impact of rat acute blood stasis model
Get 48 of SD rats, ♀ ♂ half and half, is divided into 6 groups at random, i.e. matched group, blood stasis model group, compound recipe medicinal substances extract is little, in, heavy dose of group (0.5,1.5,3.0gkg
-1), positive drug group, matched group and blood stasis model control rats are with 2ml/100g excipient gavage, all the other four groups of rats give relative medicine gavage, continuous 20 days, in gavage the 19th day, except Normal group, all the other respectively organize the equal subcutaneous injection adrenalin hydrochloride of rat injection 0.7mg/kg, totally 2 times, 2 minor tick 4h, between 2 times, (each interval, front and back 2h), is dipped in 5min in 0～2 ℃ of frozen water by rat, and 18h stops eating after disposal, abdominal aortic blood after next day last gavage 1h, detects hemorheology index.
Result shows, blood stasis model matched group and matched group comparison, hemorheology index generation significant change, whole blood is high to be cut and lowly cuts that viscosity, plasma viscosity, erythrocyte sedimentation rate, whole blood are high cuts and the low low relative viscosity, erythrocyte aggregation index, ESR equation K value all raise (P < 0.05) of cutting of reduced viscosity, whole blood of cutting; In compound recipe medicinal substances extract, heavy dose of group can obviously reduce the low viscosity (shear rate 5/s and 1/s) of cutting of blood stasis model control rats whole blood, erythrocyte sedimentation rate, low relative viscosity, low reduced viscosity, erythrocyte aggregation index, the ESR equation K value (P < 0.05) of cutting of cutting of whole blood, show that compound recipe medicinal substances extract has the effect of the rat's blood stasis model of improvement hemorheology, in Table 1,2.
Table 1 compound recipe medical material is on the impact of hemorheology of rat (x ± S, n=8)
Note: with matched group comparison, * P < 0.05, * * P < 0.01
With the comparison of blood stasis model group,
△p < 0.05,
△ △p < 0.01
Table 2 compound recipe medicinal substances extract is on the impact of hemorheology of rat (x ± S, n=8)
Note: with matched group comparison, * P < 0.05, * * P < 0.01
With the comparison of blood stasis model group,
△p < 0.05,
△ △p < 0.01
2, the impact on rat acute blood stasis model platelet function
Get 60 of rats, be divided at random 6 groups, matched group, blood stasis model group, compound recipe medicinal substances extract little, in, heavy dose of group (0.5,1.5 and 3.0gkg
-1) and positive drug group.Matched group and blood stasis model group are with 2ml/100g excipient ig, all the other four groups give relative medicine ig, continuous 20 days, every day 1 time, in ig19 days, except matched group, all the other respectively organize rat skin lower injection adrenalin hydrochloride injection 0.7mg/kg, totally 2 times, 2 minor tick 4h, between 2 times, (each interval, front and back 2h) is dipped in 5min in 0～2 ℃ of frozen water by rat, 18h stops eating after disposal, 1h after next day last 1 ig, abdominal aortic blood 1.8ml injects silication sebific duct, be fixed on the rotation disc of T hrombosis inducer, with 17PRM rotation 15 minutes, general measure thrombosis length and weight in wet base, after again thrombosis being placed in to 64 ℃ of drying baker inner drying 20min, claim dry weight.Simultaneously by 1ml anticoagulation (109mmol/L sodium citrate: blood=1: 9) inject and adhere to aryballos, the same 17RPM rotation 15min minute, measures platelet adhesion rate.Again two parts of non-anticoagulations of 0.5ml are put into EDTA-formalin solution (0.077mmol/L, EDTA3ml, 4% formalin 5ml, PH7.4 phosphate buffer 2ml, distilled water 10ml) and each 2ml solution of EDTA solution (0.077mmol/L, EDTA3ml, phosphate buffer 5ml, distilled water 12ml), mix under rear room temperature and place 15 minutes, centrifugalize (1000rpm, 10min) obtain platelet rich plasma (PRP), difference platelet Counting numerical value, and calculate thus platelet aggregation rate.
Result demonstration, compound recipe medicinal substances extract can suppress rat's blood stasis model platelet adhesion and external thrombus forms, and can suppress rat's blood stasis model platelet aggregation, in Table 3,4.
Table 3 compound recipe medicinal substances extract is on the impact of Functions of Blood Platelet (x ± S, n=10)
Note: with matched group comparison, * * P < 0.01, * P < 0.05
With the comparison of blood stasis model group,
△ △p < 0.01,
△p < 0.05
Table 4 compound recipe medicinal substances extract is on the thrombotic impact of rats in vitro (x ± S, n=10)
Note: with matched group comparison, * * P < 0.01, * P < 0.05
With the comparison of blood stasis model group,
△ △p < 0.01,
△p < 0.05
3, the impact on rat hormone in vivo level
Get 60 of SD ♀ rats, be divided at random 6 groups, matched group, model control group, compound recipe medicinal substances extract little, in, heavy dose of group (0.5,1.5 and 3.0gkg
-1), positive drug group.Matched group and model control group are with 2ml/100g excipient gavage, all the other four groups of rats give relative medicine gavage, continuous 30 days, and in gavage the 11st day, except matched group, all the other respectively organized rat muscle injection estradiol benzoate injection 0.5mg/kg, every day 1 time, totally 20 days, each got blood separation of serum after organizing last 1 the gavage 1h of rat, put the method for exempting from and measured each Mus serum estradiol (E
2), progesterone (P), testosterone (T) content.
Result shows after rat muscle injection estradiol, and the female alcohol of model control group serum, progesterone content be apparently higher than matched group, testosterone concentration no significant difference; Compound recipe medicinal substances extract is little, in, heavy dose of group all can obviously reduce rat blood serum estradiol and progesterone content, prompting compound recipe medicinal substances extract has the effect that regulates rat hormone in vivo level, in Table 5.
Table 5 compound recipe medicinal substances extract is to rat blood serum estradiol (E
2), the impact (x ± S, n=10) of progesterone (P), testosterone (T)
Note: with matched group comparison, * * P < 0.01
With model control group comparison,
△ △p < 0.01,
△p < 0.0
4, analgesic activity
4.1 lick on mice hot plate the impact that foot reacts
Before experiment, ♀ mice is placed on 55 ℃ of water bath with thermostatic control metallic plates, the mice of take licks right back foot as pain reaction index, recording mice, to lick the foot response latency be that Basic Pain Threshold (is rejected Basic Pain Threshold and is less than 5S, be greater than the mice of 30S), 50 qualified ♀ mices of screening are divided into matched group at random, compound recipe medicinal substances extract is little, in, heavy dose of group (0.7,2.0,4.0g) and indometacin group (9mgkg
-1), 10 every group, each organizes mouse stomach administration, and totally 20 days (indometacin group only gavage 1 time), each organizes mice after last administration 1h, measures by the same method mice and licks the sufficient response latency.
Result demonstration, with matched group comparison, the heavy dose of (4.0gkg of compound recipe medicinal substances extract
-1) group can extend mice and lick the sufficient response latency, in Table 6.
Table 6 compound recipe medicinal substances extract is licked the impact (x ± S, n=10) of foot reaction on mice hot plate
Note: with comparison before administration, * P < 0.05, * * P < 0.01
4.2 impacts that mouse writhing is reacted
Get 50 mices, ♀ ♂ half and half, is divided into 5 groups at random, 10 every group, i.e. matched group, compound recipe medicinal substances extract is little, in, heavy dose of group (0.7,2.0 and 4.0gkg
-1) and indometacin group (9mgkg
-1).Each mouse stomach administration, totally 20 days (indometacin group only gavage 1 time), 1h after last administration, experiment mice ip0.7% glacial acetic acid 0.2ml, records mouse writhing number of times in 15min.
Result shows, the heavy dose of group (4.0gkg of compound recipe medicinal substances extract
-1) can suppress the mouse writhing reaction that glacial acetic acid causes, in Table 7.
The impact (x ± S, n=10) of table 7 compound recipe medicinal substances extract on mouse writhing reaction
Note: with matched group comparison, * P < 0.05, * * P < 0.01
5, antiinflammatory action
The method of 5.1 dimethylbenzene inducing mouse ear swellings
Get 50 of Kunming mouses, ♀ ♂ half and half, body weight 20 ± 2g, is divided into 5 groups at random, and 10 every group, i.e. model group, positive drug control group (indometacin 9mgkg
-1), compound recipe medicinal substances extract is little, in, large three dosage groups (0.7,2.0 and 4.0gkg
-1).Ig administration, every day 1 time, continuously 20d.1h after last administration, on mouse right ear two sides, be coated with 100% dimethylbenzene 0.03ml, left ear is contrast, after 2h, the dislocation of mice cervical vertebra is put to death, along auricle baseline, cut two ears, with diameter 9mm card punch, at same position, lay round auricle respectively, with electronic balance, claim weight in wet base, using the difference of two ear weight as swelling (inflammation index).
Result shows, compound recipe medicinal substances extract (2.0 and 4.0gkg
-1) can obviously suppress the mice ear that dimethylbenzene is induced, in Table 8.
The impact (x ± S, n=10) of the mice ear of table 8 compound recipe medicinal substances extract xylol induction
Note: with matched group comparison, * * P < 0.01
The preparation of 5.2 Oleum Terebinthinae induction rat air bag granulation hyperplasia models
Get 50 of SD rats, ♂, body weight 180 ± 20g, is divided into 5 groups at random, 10 every group, model group, positive drug control group, compound recipe medicinal substances extract little, in, large three dosage (0.5,1.5 and 3.0gkg
-1).Ig administration, every day 1 time, continuous 20 days, the 12nd day, in the time of ig administration, prepare model,, under the shallow fiber crops of ether, in the scapular region of back subcutaneous injection 20ml of every Mus air, to form air bag, then in air bag, inject genuine turpentine oil 1ml, after 24h, extract air in capsule out.After last administration, 1h puts to death rat, and peels off wall internal granuloma, after normal saline rinsing, puts 80 ℃ of baking box baking 6h and claims dry weight.Result shows, compound recipe medicinal substances extract (1.5 and 3.0gkg
-1) can obviously suppress the rat air bag granuloma hypertrophy that Oleum Terebinthinae is induced, in Table 9.
Table 9 compound recipe medicinal substances extract is on the impact of rat granuloma model (x ± S, n=10)
Note: with matched group comparison, * * P < 0.01
6, the impact on clotting time of mice
Get 50 of Kunming mouses, ♀ ♂ half and half, is divided into 5 groups at random, 10 every group, matched group, compound recipe medicinal substances extract little, in, heavy dose of group (0.7,2.0 and 4.0gkg
-1), positive drug group, ig * 20 day, every day 1 time, 1h after last ig administration, each mice plucks rapidly a branch hole ball with the curved tweezer of ophthalmology, have blood to flow out, in microscope slide two ends, each one is bled, and uses immediately manual time-keeping, with clean pin menses edge, provoke gently inwards, until choose filament, stop timing, writing time, this period is clotting time, and another is bled and reviews, and getting both means is result.Result shows, compound recipe medicinal substances extract 4.0gkg
-1can extend the clotting time of mice, in Table 10.
Table 10 compound recipe medicinal substances extract is on the impact of clotting time of mice (x ± S, n=10)
Note: with matched group comparison, * P < 0.05
7, the impact on rabbit hyperplasia of mammary gland model
Select 40 of ♀ rabbit, be divided at random 5 groups (matched group, model group, 2 dosage groups of compound recipe medicinal substances extract and positive drug control group).Except matched group, each group adopts abdominal operation to extract bilateral ovaries through local anaesthesia.Within postoperative the 4th day, start E0.3mg/kg, the next day 1 time, inject altogether 15 times and cause hyperplasia of mammary gland model.The group of administration simultaneously gavages compound recipe medicinal substances extract, every day 1 time, is total to administration 30d, and matched group and model group gavage ordinary water 1ml/kg.After last administration 1h, put to death and respectively organize rabbit, win a pair of mammary gland and make outward appearance observation and histology's light microscopy checking.Visible model group rabbit mammary gland body obviously increases, and color is slightly red.Under mirror, visible lobules of mammary gland number increases, and acinus number increases, and acinus is obviously expanded, and compares and is changed significantly with matched group.Model 0.5g/kg administration group rabbit mammary gland volume obviously dwindles, and under mirror, visible lobules of mammary gland number obviously reduces, and acinus number obviously reduces, and compares with model group, has significant change.Model 1.0g/kg dosage group mammary gland volume significantly reduces, and lobules of mammary gland number, acinus number and alveolar lumen obviously reduce, and the results are shown in Table 11.Show that compound recipe medicinal substances extract has the effect of obvious inhibition cyclomastopathy.
Table 11 compound recipe medicinal substances extract is on the impact of rabbit hyperplasia of mammary gland model (X ± S)
8, the therapeutical effect of compound recipe medicinal substances extract to pelvic inflammatory disease
60 of rats, are divided into 6 groups at random, compound recipe medicinal substances extract little, in, large (0.15g/kg, 0.3g/kg, 0.6g/kg), Normal group, model control group, contrast medicine group.Except normal group, all the other animals are made vagina and Cervicitis model with 25% phenol rubber cement, with taper venotomy pin, enter vagina deep and inject phenol rubber cement, every 0.3ml, every 3d1 time, totally 3 times.Within after modeling the 3rd day first, play drug treatment 15d.After 15d, kill Mus, the histopathology that detects hemorheology index and observation uterus changes.The results are shown in Table 12.
The impact (X ± S) of table 12 compound recipe medicinal substances extract on pelvic inflammatory disease hemorheology of rat index and Endometrial Diseases degree
9, compound recipe medicinal substances extract is to prostatitic inhibitory action development test
SD rat, hero, 60, be divided at random 6 groups: normal group, model group, contrast medicine group, the low middle high dose group of compound recipe medicinal substances extract (0.15g/kg, 0.3g/kg, 0.6g/kg), successive administration 7 days, after administration 4 days, except normal control treated animal, all the other each treated animal modelings, after modeling, animal continues administration, and puts to death after administration in 7 days, cut open the belly rapidly, get prostatic fluid and measure leukocyte count, check lecithin density simultaneously, then get prostatic fluid enumeration of bacterial colonies number.Result compound recipe medicinal substances extract has obvious inhibitory action to rat bacterial prostatitis, can improve lecithin density in prostate, reduces leukocyte count, suppresses colibacillary growth in body of prostate.In Table 13
The impact (X ± S) of table 13 compound recipe medicinal substances extract on prostatitis rat prostate lecithin density and total white blood cells, clump count
Compare * * P < 0.01 with matched group; With model group comparison
△p < 0.05;
△ △p < 0.01
Table 14 compound recipe medicinal substances extract is on the histological impact of rat bacterial prostatitis (X ± S)
With model group comparison
*p < 0.05;
*p < 0.01.
10, the inhibitory action development test of compound recipe medicinal substances extract to liver cirrhosis
Get 30 of SD rats, be divided at random 3 groups, be i.e. matched group, N-nitrosodimethylamine (DMN) group, compound recipe medicinal substances extract group (3.0gkg
-1).Matched group is with 2ml/100g excipient gavage, and continuous 4 weeks administration N-nitrosodimethylamines (DMN) of all the other 2 groups of rats make alanine aminotransferase and aspartic transaminase in blood plasma be increased to 4 times, and can be observed rat and have obvious liver cirrhosis.After modeling, compound recipe medicinal substances extract group (3.0gkg
-1) continue to compound recipe medicinal substances extract group (3.0gkg
-1).Continuous 3 weeks, and after 3 weeks, kill Mus, observation.
Result shows that the increase of rat bilirubin is suppressed significantly, and liver cirrhosis also obviously improves, in Table 15, table 16:
Table 15ALT, AST, r-GT and bilirubin value
The inhibition of table 16 compound recipe medicinal substances extract to hepatic tissue sclerosis
**P＜0.05；
**P＜0.01。
The specific embodiment
Embodiment 1: Chinese medicinal granule of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 8 times of amount distilled water immersions 6 hours, heating extraction volatile oil, continuous still 6 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 8 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 10 times of water gagings, heating and refluxing extraction 3 times, each 2 hours, merge extractive liquid, and above-mentioned distillate, concentrating under reduced pressure, is concentrated into relative density 1.25 (60 ℃), add water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, are ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, then matters adjuvant, correctives in addition, wet method granulation, sieve, granulate, packing, check, warehouse-in.
Embodiment 2: Chinese medicinal granule of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 6 hours, heating extraction volatile oil, continuous still 8 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 10 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 12 times of water gagings, heating and refluxing extraction 3 times, each 1.5 hours, merge extractive liquid, and above-mentioned distillate, concentrating under reduced pressure, is concentrated into relative density 1.25 (60 ℃), add water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, are ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, then matters adjuvant, correctives in addition, wet method granulation, sieve, granulate, packing, check, warehouse-in.
Embodiment 3: Chinese medicinal granule of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 8 times of amount distilled water immersions 6 hours, heating extraction volatile oil, continuous still 6 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 8 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 10 times of amount 70% ethanol, heating and refluxing extraction 2 times, each 2 hours, merge ethanol extract, concentrating under reduced pressure reclaims ethanol to concentrated solution and adds and state distillate, concentrating under reduced pressure without alcohol taste, be concentrated into relative density 1.25 (60 ℃), add water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, be ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, then matters adjuvant, correctives in addition, wet method granulation, sieves, granulate, packing, check, warehouse-in.
Embodiment 4: Chinese medicinal granule of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 10 hours, heating extraction volatile oil, continuous still 5 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 15 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 8 times of amount 80% ethanol, heating and refluxing extraction 3 times, each 1.5 hours, merge ethanol extract, concentrating under reduced pressure reclaim ethanol to concentrated solution without alcohol taste, add and state distillate, concentrating under reduced pressure, is concentrated into relative density 1.25 (60 ℃), adds water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, be ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, then matters adjuvant, correctives in addition, wet method granulation, sieve, granulate, packing, check, warehouse-in.
Embodiment 5: dispersible tablets of Chinese medicine of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 6 hours, heating extraction volatile oil, continuous still 8 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 10 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 12 times of water gagings, heating and refluxing extraction 3 times, each 1.5 hours, merge extractive liquid, and above-mentioned distillate, concentrating under reduced pressure, is concentrated into relative density 1.25 (60 ℃), add water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, are ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, then matters adjuvant, correctives in addition, wet method granulation, sieve, granulate, is pressed into dispersible tablet, packing, check, warehouse-in.
Embodiment 6: dispersible tablets of Chinese medicine of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 10 hours, heating extraction volatile oil, continuous still 5 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 15 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 8 times of amount 80% ethanol, heating and refluxing extraction 3 times, each 1.5 hours, merges ethanol extract, concentrating under reduced pressure reclaim ethanol to concentrated solution without alcohol taste, add and state distillate, concentrating under reduced pressure, is concentrated into relative density 1.25 (60 ℃), add water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, are ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, matters adjuvant, correctives in addition again, wet method granulation, sieves, granulate, be pressed into dispersible tablet, packing, check, warehouse-in.
Embodiment 7: Chinese medicinal capsule of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 6 hours, heating extraction volatile oil, continuous still 8 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 10 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 12 times of water gagings, heating and refluxing extraction 3 times, each 1.5 hours, merge extractive liquid, and above-mentioned distillate, concentrating under reduced pressure, is concentrated into relative density 1.25 (60 ℃), add water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, are ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, again in addition matters adjuvant, incapsulate, packing, check, warehouse-in.
Embodiment 8: Chinese medicinal capsule of the present invention extracts preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 10 hours, heating extraction volatile oil, continuous still 5 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 15 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 8 times of amount 80% ethanol, heating and refluxing extraction 3 times, each 1.5 hours, merge ethanol extract, concentrating under reduced pressure recovery ethanol, is added and is stated distillate without alcohol taste to concentrated solution, concentrating under reduced pressure, is concentrated into relative density 1.25 (60 ℃), adds water solublity dextrin, 60 ℃ of drying under reduced pressure 10 hours, are ground into fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, again in addition matters adjuvant, pack Capsules into, packing, check, warehouse-in.
Embodiment 9: Chinese medicine oral liquid of the present invention is extracted preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 6 hours, heating extraction volatile oil, continuous still 8 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 10 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 12 times of water gagings, heating and refluxing extraction 3 times, and each 1.5 hours, merge extractive liquid, and above-mentioned distillate, then add above-mentioned volatile oil betacyclodextrin clathrate, correctives in addition, filters again, adds water to full dose, and bottling, rolls lid, sterilizing, packing, check, warehouse-in.
Embodiment 10: Chinese medicine oral liquid of the present invention is extracted preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 10 times of amount distilled water immersions 10 hours, heating extraction volatile oil, continuous still 5 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 15 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 8 times of amount 80% ethanol, heating and refluxing extraction 3 times, each 1.5 hours, merge ethanol extract, concentrating under reduced pressure reclaim ethanol to concentrated solution without alcohol taste, add and state distillate, add above-mentioned volatile oil betacyclodextrin clathrate, more in addition matters adjuvant, pack Capsules into, packing, check, warehouse-in.
Embodiment 11: Chinese medicinal soft capsule of the present invention is extracted preparation method:
Stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, the Radix Angelicae Sinensis of getting recipe quantity are ground into respectively coarse powder, add 8 times of amount distilled water immersions 10 hours, heating extraction volatile oil, continuous still 5 hours, collects volatile oil, distillate after distillation is collected standby, the betacyclodextrin of getting 15 times of amounts of volatile oil adds water and grinds to form pasty state, after grinding well, slowly adds volatile oil to grind after 60 minutes, 40 ℃ following dry, obtains volatile oil betacyclodextrin clathrate.6 tastes such as medicinal residues and all the other Radixs Astragali add 8 times of amount 80% ethanol, heating and refluxing extraction 3 times, each 1.5 hours, merge ethanol extract, concentrating under reduced pressure recovery ethanol, is added and is stated distillate without alcohol taste to concentrated solution, concentrating under reduced pressure, add matters adjuvant, be spray dried to fine powder, add above-mentioned volatile oil betacyclodextrin clathrate, again in addition matters adjuvant, be pressed into soft capsule, packing, check, warehouse-in.
Claims (9)
1. the Chinese medicine preparation with treatment gynaecopathia, hepatopathy, prostatitis effect, its crude drug by following weight ratio example is made: Ramulus Cinnamomi 1%～20%, Poria 2%～30%, Cortex Moutan 1%～20%, Radix Paeoniae Rubra 1%～20%, Semen Persicae 1%～20%, stir-baked RHIZOMA SPARGANII with vinegar 2%～30%, Rhizoma Curcumae 2%～30%, the Radix Astragali 5%～40%, Radix Codonopsis 5%～40%, the Rhizoma Atractylodis Macrocephalae 2%～30%, Radix Angelicae Sinensis 1%～10%; The preparation method of this Chinese medicine preparation is as follows:
A) stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, Radix Angelicae Sinensis powder are broken into coarse powder, add 6～20 times of water gagings, distill and extract volatile oil in 2～10 hours, and volatile oil, with betacyclodextrin enclose, makes cyclodextrin of volatile oil clathrate, drying for standby;
B) step a) in after stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, Radix Angelicae Sinensis distillation, retain water extraction liquid; In medicinal residues, add Poria, Radix Paeoniae Rubra, Semen Persicae, the Radix Astragali, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, add water or 40%-90% ethanol extraction 1～3 time, each 1～3 hour, merge aqueous extract or alcohol extract and above-mentioned distilled water extract, concentrating under reduced pressure, add proper auxiliary materials, drying under reduced pressure or be spray dried to fine powder, standby;
C) by step a) gained cyclodextrin of volatile oil clathrate and by step b) extract obtained fine powder fully mixes, then makes Chinese medicine preparation with the method for Chinese medicine preparation.
2. according to the Chinese medicine preparation of claim 1, the part by weight of described crude drug is: Ramulus Cinnamomi 3%～8%, Poria 5%～10%, Cortex Moutan 3%～8%, Radix Paeoniae Rubra 3%～8%, Semen Persicae 3%～10%, stir-baked RHIZOMA SPARGANII with vinegar 5%～10%, Rhizoma Curcumae 5%～10%, the Radix Astragali 15%～20%, Radix Codonopsis 15%～20%, the Rhizoma Atractylodis Macrocephalae 5%～10%, Radix Angelicae Sinensis 2%～5%.
3. according to the Chinese medicine preparation of claim 1, described crude drug is by weight proportion: Ramulus Cinnamomi 6.02%, Poria 9.04%, Cortex Moutan 6.02%, Radix Paeoniae Rubra 6.02%, Semen Persicae 6.02%, stir-baked RHIZOMA SPARGANII with vinegar 9.04%, Rhizoma Curcumae 9.04%, the Radix Astragali 18.07%, Radix Codonopsis 18.07%, the Rhizoma Atractylodis Macrocephalae 9.04%, Radix Angelicae Sinensis 3.62%.
4. according to Chinese medicine preparation claimed in claim 1, it is peroral dosage form.
5. according to Chinese medicine preparation claimed in claim 1, wherein step a) in, in volatile oil: the ratio of betacyclodextrin: water=1: 5-20: 5-30, adopt polishing enclose, make clathrate.
6. according to the Chinese medicine preparation of claim 4, wherein said peroral dosage form is selected from: granule, oral liquid, tablet, capsule, soft capsule.
7. according to the Chinese medicine preparation of claim 1, it is used for the treatment of and is selected from following disease: hysteromyoma, cyclomastopathy, pelvic inflammatory disease, adnexitis, menoxenia, dysmenorrhea, liver cirrhosis, prostatitis.
8. the method for preparing Chinese medicine preparation described in claim 1, it comprises the steps:
A) stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, Radix Angelicae Sinensis powder are broken into coarse powder, add 6～20 times of water gagings, distill and extract volatile oil in 2～10 hours, and volatile oil, with betacyclodextrin enclose, makes cyclodextrin of volatile oil clathrate, drying for standby;
B) step a) in after stir-baked RHIZOMA SPARGANII with vinegar, Rhizoma Curcumae, Ramulus Cinnamomi, Cortex Moutan, Radix Angelicae Sinensis distillation, retain water extraction liquid, in medicinal residues, add Poria, Radix Paeoniae Rubra, Semen Persicae, the Radix Astragali, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, add water or 40%-90% ethanol extraction 1～3 time, each 1～3 hour, merge aqueous extract or alcohol extract and above-mentioned distilled water extract, concentrating under reduced pressure, add proper auxiliary materials, drying under reduced pressure or be spray dried to fine powder, standby;
C) by step a) gained cyclodextrin of volatile oil clathrate and by step b) extract obtained fine powder fully mixes, then makes Chinese medicine preparation with the method for Chinese medicine preparation.
9. method as claimed in claim 8, wherein step a) in, in volatile oil: the ratio of betacyclodextrin: water=1: 5-20: 5-30, adopt polishing enclose, make clathrate.
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| CN105169206A (en) * | 2015-10-19 | 2015-12-23 | 烟台瑞智生物医药科技有限公司 | Traditional Chinese medicine for treating qi stagnation and blood stasis syndrome type abdominal mass |
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| CN101612360A (en) * | 2009-07-17 | 2009-12-30 | 肖嘉惠 | The medicine of treatment hepatitis, liver cirrhosis, hepatocarcinoma |
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