CN104435450A - Traditional Chinese medicine composition for treating qi stagnation and blood stasis type prostate hyperplasia and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating qi stagnation and blood stasis type prostate hyperplasia and preparation method thereof Download PDF

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CN104435450A
CN104435450A CN201410814774.8A CN201410814774A CN104435450A CN 104435450 A CN104435450 A CN 104435450A CN 201410814774 A CN201410814774 A CN 201410814774A CN 104435450 A CN104435450 A CN 104435450A
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parts
fructus
chinese medicine
blood stasis
stagnation
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王霄鹏
夏霞
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
    • A61K36/344Codonopsis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/58Reptiles
    • A61K35/586Turtles; Tortoises, e.g. terrapins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/487Psoralea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537Salvia (sage)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815Lycium (desert-thorn)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/884Alismataceae (Water-plantain family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

Abstract

The invention discloses a traditional Chinese medicine composition for treating qi stagnation and blood stasis type prostate hyperplasia, relating to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition disclosed by the invention is prepared from the medicinal raw materials including codonopsis pilosula, astragalus membranaceus, fructus psoraleae, wolfberry, pericarpium citri reticulatae, fructus liquidambaris, herba lycopi, the root of red-rooted salvia, rhizoma alismatis and turtle shell. The invention further provides a preparation method and use of the traditional Chinese medicine composition. The traditional Chinese medicine composition disclosed by the invention has the effects of invigorating the kidney, strengthening Yang, promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation, promoting the circulation of qi and removing stagnancy, and is accurate in curative effect, safe and convenient for qi stagnation and blood stasis type prostate hyperplasia.

Description

A kind ofly treat Chinese medicine composition of qi stagnation and blood stasis type hyperplasia of prostate and preparation method thereof
Technical field
The invention belongs to tcm field, be specifically related to a kind of Chinese medicine composition for the treatment of qi stagnation and blood stasis type hyperplasia of prostate.
Background technology
Prostatic hyperplasia (BPH) is one of male senile patient common disease, cumulative many with population in the world senescence onset of illness.The sickness rate of prostatic hyperplasia increased progressively with the age, but not necessarily had clinical symptoms when having preneoplastic lesions.Hyperplasia of prostate belongs to the category of motherland's medical science " difficulty in urination ".The name of " difficulty in urination ", first sees Huangdi's Internal Classics.As " Huang di's Canon of Medicine Ling Shu Miraculous Pivot or Divine Axis is originally defeated " section is said: " difficulty in urination, void is incontinence of urine then." " Huang di's Canon of Medicine Plain Questions declares five gas sections " also say: " bladder discord, for infirmity, is not about incontinence of urine.”
The medicine of existing this type of disease for the treatment of is a lot, the conventional medicine such as general employing " QIANLIEKANG ", " QIANLIETONG JIAONANG ", although these conventional medicines have certain therapeutic effect, existence is cured the symptoms, not the disease, curative effect is slow, the course for the treatment of is long, cure rate is low and the shortcoming of easily recurrence.Doctor trained in Western medicine then more adopts modern so-called high-tech laser surgery therapy, and this is a kind of invasive treatment, can cause infection, brings unnecessary trouble to patient.
The traditional Chinese medical science is thought, Patients with Prostatic Hyperplasia mostly occurs in the year of " seven or eight ", oldly suffers from a deficiency of the kidney, and gas (sun) deficiency of YIN of kidney, can cause stopping in blood stasis, and positive so-called gas general then blood, the deficiency of vital energy is blood stasis then, and yang deficiency is blood clotting also.Deficiency of kidney-QI, can not run QI and blood, and cloudy blood clotting gathers prostate and hypertrophy, urethra, causes urine and discharges not smooth.Compression of urethra narrows, then urine is as fine rule, or has bifurcated.Compression of urethra, voiding resistance increases, and urine need firmly be discharged, therefore each urine need divide several sections of discharges, and very painstakingly, dripping urination, row feels not to the utmost, or has Urethra astringent pain.If compression of urethra blocks, then urinary obstruction, perineum is suppressed swollen, little distention and fullness in the abdomen dull pain.Dark tongue quality or have ecchymosis, stringy and hesitant pulse is the tongue arteries and veins of qi depression to blood stasis, ownership traditional Chinese medical science qi depression to blood stasis disease type.
Therefore, inventor thinks qi stagnation and blood stasis type hyperplasia of prostate, sick in QI and blood.Therapeutic rule should to hold up first tonify deficiency Zhi Qiben, and blood stasis dispelling softening the hard mass controls its mark.Void should be main spleen reinforcing of holding concurrently with kidney tonifying, makes the equilibrium between yin and yang of kidney, opens entire degree of having, the lifting of spleen in order, have under one's command and have the right; Take stopgap measures and answer blood circulation promoting and blood stasis dispelling, hard masses softening and resolving, circulation of qi promoting intestinal stasis relieving, body of gland is reduced, block degree and alleviate.
Summary of the invention
In order to realize object described above, inventor provide a kind of Chinese medicine composition for the treatment of qi stagnation and blood stasis type hyperplasia of prostate, it is characterized in that it is made up of following medical raw material: Radix Codonopsis, the Radix Astragali, Fructus Psoraleae, Fructus Lycii, Pericarpium Citri Reticulatae, Fructus Liquidambaris, Herba Lycopi, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis.
Fang Zhong: Carapax Trionycis nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving, with Herba Lycopi's blood circulation promoting and blood stasis dispelling, line water detumescence, Papillary blood circulation promoting and blood stasis dispelling, hard masses softening and resolving is monarch drug.Fructus Psoraleae warming the kidney to activate YANG, Fructus Lycii nourishing the liver and kidney, it is ministerial drug that two medicines 5 control its deficiency in origin with the kidney warming righting.Radix Salviae Miltiorrhizae stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, can strengthen monarch drug blood circulation promoting and blood stasis dispelling, the energy of hard masses softening and resolving; Rhizoma Alismatis, Fructus Liquidambaris diuretic are stimulated the menstrual flow, and can strengthen the merit of monarch drug line water detumescence, also can with the temperature of monarch drug, but amount can not be large; Radix Codonopsis invigorating the spleen and replenishing QI, spleen invigorating lung benefiting; Radix Astragali invigorating QI to consolidate the body surface resistance, diuresis granulation promoting, walk and do not keep; Pericarpium Citri Reticulatae regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm, the kidney invigorating does not forget spleen reinforcing, and tool is adjuvant.Full side's monarch prescription is clear and definite, and compatibility is rigorous, has effect of blood circulation promoting and blood stasis dispelling, hard masses softening and resolving, circulation of qi promoting intestinal stasis relieving combined into it.
Preferably, the Chinese medicine composition for the treatment of qi stagnation and blood stasis type hyperplasia of prostate described above, is characterized in that it is made up of the medical raw material of following weight portion: Radix Codonopsis 13-18 part, Radix Astragali 20-30 part, Fructus Psoraleae 13-18 part, Fructus Lycii 20-25 part, Pericarpium Citri Reticulatae 11-15 part, Fructus Liquidambaris 8-13 part, Herba Lycopi 13-17 part, Radix Salviae Miltiorrhizae 11-14 part, Rhizoma Alismatis 8-13 part, Carapax Trionycis 15-20 part.
Further preferably, the Chinese medicine composition for the treatment of qi stagnation and blood stasis type hyperplasia of prostate described above, is characterized in that it is made up of the medical raw material of following weight portion: Radix Codonopsis 15 parts, the Radix Astragali 25 parts, Fructus Psoraleae 16 parts, Fructus Lycii 22 parts, Pericarpium Citri Reticulatae 12 parts, Fructus Liquidambaris 10 parts, Herba Lycopi 14 parts, Radix Salviae Miltiorrhizae 13 parts, Rhizoma Alismatis 10 parts, Carapax Trionycis 18 parts.
The present invention's each medicinal raw-material pharmacology activity research used is as follows:
Radix Codonopsis: sweet is flat.Return spleen, lung meridian.Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.
The Radix Astragali: sweet, temperature.Return lung, spleen channel.Function cures mainly: invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, sore.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and burst for a long time and do not hold back, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.
Fructus Psoraleae: pungent, bitter, temperature.Return kidney, spleen channel.Function cures mainly: warming the kidney to activate YANG, improving inspiration by invigorating kidney-QI, antidiarrheal.For impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffers from a deficiency of the kidney and breathes heavily, Diarrhoea; External curing vitiligo, alopecia areata.
Fructus Lycii: sweet is flat.Return liver, kidney channel.Function cures mainly: nourishing the liver and kidney, replenishing vital essence to improve eyesight.For asthenia damage of essence, soreness of waist and knee joint, vertigo and tinnitus, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, and blurred vision is failed to understand.
Pericarpium Citri Reticulatae: bitter, pungent, temperature.Return lung, spleen channel.Function cures mainly: regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
Fructus Liquidambaris: bitter is flat.Return liver, kidney channel.Function cures mainly: dispelling, collateral-activating, and diuretic stimulates the menstrual flow.For arthralgia, numbness contracture, edema distension, the few amenorrhea of breast.
Herba Lycopi: bitter, pungent, tepor.Return liver, spleen channel.Function cures mainly: blood circulation promoting and blood stasis dispelling, line water detumescence.For menoxenia, amenorrhea, dysmenorrhea, postnatal blood stasis is suffered from abdominal pain, edema.
Radix Salviae Miltiorrhizae: bitter, is slightly cold.GUIXIN, Liver Channel.Function cures mainly: stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, and clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia; Hepatosplenomegaly, angina pectoris.
Rhizoma Alismatis: sweet, cold.Return kidney, urinary bladder channel.Function cures mainly: diuresis, clearing away damp-heat.For dysuria, edema distension, oliguria of having loose bowels, dizziness due to fluid-retention, the puckery pain of pyretic stranguria; Hyperlipidemia.
Carapax Trionycis: salty, is slightly cold.Return liver, kidney channel.Function cures mainly: nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving, brings down a fever except steaming.For fever due to yin deficiency, consumptive fever hectic fever due to YIN-deficiency, stirring-up of pathogenic wind in the interior resulting from deficiency, amenorrhea , WEIJIA, chronic malaria malaria with splenomegaly.
Chinese medicine composition of the present invention is active component by Radix Codonopsis, the Radix Astragali, Fructus Psoraleae, Fructus Lycii, Pericarpium Citri Reticulatae, Fructus Liquidambaris, Herba Lycopi, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis or its water or its extractive with organic solvent, adds pharmaceutically acceptable adjuvant or complementary composition and is prepared into pharmaceutically conventional medicament.
Described pharmaceutically acceptable carrier or complementary composition, as starch, dextrin, microcrystalline cellulose, amylum pregelatinisatum, magnesium stearate, micropowder silica gel, sucrose, carboxymethyl starch sodium, hydroxypropyl emthylcellulose, vegetable oil, lecithin, Polyethylene Glycol, propylene glycol, ethyl hydroxybenzoate etc.
Wherein, described medicament is tablet, capsule, pill, granule, oral liquid.
Present invention also offers the method for this pharmaceutical composition of preparation, it comprises the steps:
A, get raw material by prescription: Radix Codonopsis, the Radix Astragali, Fructus Psoraleae, Fructus Lycii, Pericarpium Citri Reticulatae, Fructus Liquidambaris, Herba Lycopi, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis;
B, get Fructus Psoraleae, Pericarpium Citri Reticulatae, Herba Lycopi, pulverize, add 70-80% alcoholic solution, decoct extraction 2 times, filter, filtrate concentrates;
C, get Radix Codonopsis, the Radix Astragali, Fructus Lycii, Fructus Liquidambaris, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis, decoct with water 2 times, filter, filtrate concentrates;
D, the concentrated solution of b and c step to be mixed, add pharmaceutically acceptable adjuvant or complementary composition and be prepared into pharmaceutically conventional preparation.
It is below the clinical summary of medicine capsule of the present invention treatment qi stagnation and blood stasis type benign prostatic hyperplasia: A report of 100 cases
1. physical data: old BPH 100 example that the court's in December, 2011 is accepted for medical treatment in August ,-2012, at 55 ~ 73 years old age, 65.8 years old mean age, makes a definite diagnosis through ultrasound diagnosis, total-PSA (TPSA) inspection.Patient is divided into matched group and treatment group at random, and each 50 examples, two groups of patient's physical data no significant difference (P > 0.05), have comparability.
2. diagnostic criteria:
2.1 benign prostate hyperplasia Western medicine diagnose standards: the case person standard formulating this clinical research with reference to " International Coordinating Committee is about the recommendation suggestion of Patients of Prostatic Diseases Diagnosis and Treat ": more than 50 years old male, have frequent micturition, dysuria symptom, rectal touch, ultrasound diagnosis, total-PSA (TPSA) inspection and urinary flow inspection are diagnosed as prostatic hyperplasia.
2.2 Standards of Chinese Medical Syndrome Differentiations: disease belongs to qi depression to blood stasis, main symptom: urine is smooth, urine line attenuate or drop and under, or Urethra astringent pain, inaccessible obstructed; Secondary card: little distention and fullness in the abdomen dull pain, has hematuria once in a while; Tongue arteries and veins: body of the tongue is dim or have petechia ecchymosis, Tai Bai or BOHUANG, stringy pulse or puckery.
3. Excluded cases standard: oliguria or anuria caused by lithangiuria, carcinoma of prostate, acute or chronic renal failure: the dysuria that neurogenic bladder, neck of bladder fibrosis, urethral stricture cause; The frequent micturition that gonorrhea, urinary tract infection etc. cause: have the severe primary diseases such as cardiovascular and cerebrovascular vessel, liver and hemopoietic system, intractable diabetes and have diabetic neuropathy, psychotic: Benign prostate obstruction invasive Endodontic failure person: have operation on pelvis or damage history to have impact on the functional status persons such as local internal organs, muscle, nerve, muscle: B super generating now obviously diverticulum of bladder person or the upper urinary hydrops that causes because of BPH, impaired renal function person.
4. reject case standard: allergic constitution or to trial drug allergy sufferers; Share other drug; Allly do not meet inclusive criteria, not by regulation medication, cannot judge that curative effect or data are not congruent and affect the treatment or safety judgement person; Tested rear compliance is poor, serious adverse events occurs, should not continue tested, automatic bolter because of special physiological change.
5. Therapeutic Method:
5.1 treatment groups: medicine capsule prepared by the oral embodiment of the present invention 2, each 3-4 grain, every day three times 4 weeks was 1 course for the treatment of, observed 3 courses for the treatment of.
5.2 matched groups: proscar sheet (Proscar), specification 5mg/ sheet × 7 slice/box, every sheet is containing finasteride 5mg, and Hangzhou Mo Shadong pharmaceutical Co. Ltd produces, each 1 of medication, and every day 1 time is oral, within 4 weeks, is 1 course for the treatment of, observes 3 courses for the treatment of.
Two groups of patients allow to adopt following remedy measures and points for attention while carrying out Drug therapy: 1. bladder training.If 2. there is urine retention (residual urine volume > 400ml) feasible retention catheterization or suprapubic puncture fistulation drainage of urine.3. avoid and drink, avoid pungent food irritable food, keeps free movement of the bowels, by bike not long-distance, adheres to regular life.
6. observation index: measure as curative effect index using international contest (I-PSS), TCM syndrome evaluation and Qmax; Symptom of urinating on related symptoms such as the impacts of quality of life as secondary efficacy index.
7. efficacy assessment standard: judge curative effect according to " new Chinese medicine guideline of clinical investigations ".Cure: symptom disappears substantially, and residual urine volume improvement rate > 90% or IPSS improves > 90%; Effective: cardinal symptom disappears, residual urine volume improvement rate 70% ~ 90% or IPSS improve 70% ~ 90%; Effective: cardinal symptom is improved, residual urine volume improvement rate 30% ~ 70% or IPSS improve 30% ~ 70%; Invalid: cardinal symptom is not improved, residual urine volume and IPSS scoring are without significant change.
8. statistical method: measurement data with ( ± s) represent, measurement data compares employing pairing t inspection, and ranked data compare employing rank test, and enumeration data compares employing Ridit inspection.
9. result
Through the treatment of 3 courses for the treatment of, and the return visit to healing person, the comparison of two groups of clinical efficacies is as shown in table 1.
The comparison of table 1, two groups of clinical efficacies, example (%)
Group Case load Cure Effective Effectively Invalid Total effective rate
Treatment group 50 23 14 10 3 94%
Matched group 50 12 14 13 11 78%
As can be seen from Table 1, the pharmaceutical preparation total effective rate taking the embodiment of the present invention 2 is 94%, and the total effective rate of matched group only has 78%; As can be seen from cure rate also, the cure rate of the pharmaceutical preparation of the embodiment of the present invention 12 is much larger than matched group.Thus pharmaceutical preparation of the present invention compared with prior art has very significant advantage.As can be seen here, present invention also offers a kind of pharmaceutical applications, i.e. the application of Chinese medicine composition of the present invention in the medicine of preparation treatment qi stagnation and blood stasis type hyperplasia of prostate.
Chinese medicine composition of the present invention has effect of kidney invigorating and YANG supporting, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving, circulation of qi promoting intestinal stasis relieving.For qi stagnation and blood stasis type hyperplasia of prostate, disease is seen: urine is discharged not smooth, and urine is as fine rule or have bifurcated, and each urine need divide several sections of discharges, and very painstakingly, Urethra astringent pain, row feels not to the utmost, even urine blocking barrier, perineum is suppressed swollen, little distention and fullness in the abdomen dull pain.Dark tongue quality or have ecchymosis, stringy and hesitant pulse.Curative effect of medication of the present invention is definite, safe ready.
Detailed description of the invention
The detailed description of the invention of form by the following examples, is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention is only limitted to following example.All technology realized based on foregoing of the present invention all belong to scope of the present invention.
The preparation of embodiment 1 medicinal granule of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 15 parts, the Radix Astragali 25 parts, Fructus Psoraleae 16 parts, Fructus Lycii 22 parts, Pericarpium Citri Reticulatae 12 parts, Fructus Liquidambaris 10 parts, Herba Lycopi 14 parts, Radix Salviae Miltiorrhizae 13 parts, Rhizoma Alismatis 10 parts, Carapax Trionycis 18 parts.
Preparation method:
A, get raw material by prescription: Radix Codonopsis, the Radix Astragali, Fructus Psoraleae, Fructus Lycii, Pericarpium Citri Reticulatae, Fructus Liquidambaris, Herba Lycopi, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis;
B, get Fructus Psoraleae, Pericarpium Citri Reticulatae, Herba Lycopi, pulverize, add 70-80% alcoholic solution, the 4-7 of material gross weight of getting it filled that the weight adding ethanol is this step doubly, decoct extraction 2 times, each 1.0-1.5 hour, by 6-8 layer gauze filtered while hot, filtrate is concentrated into relative density when being 1.05-1.15(60 DEG C), for subsequent use;
C, get Radix Codonopsis, the Radix Astragali, Fructus Lycii, Fructus Liquidambaris, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis, decoct with water 2 times, each 1.5-2.0 hour, the 6-9 of material gross weight of getting it filled that each amount of water is this step doubly, filtered while hot, filtrate is concentrated into relative density when being 1.0-1.2(60 DEG C), for subsequent use;
D, the concentrated solution of b and c step to be mixed, inlet temperature 140 ~ 145 DEG C, spraying dry is carried out, spray powder and adjuvant, proportionally (spray powder: soluble starch: cyclodextrin: microcrystalline Cellulose=4: 2: 2:1) under leaving air temp 75 ~ 80 DEG C of conditions, mixing, add 85% ethanol, wet granulation, dry, granulate, obtains medicinal granule of the present invention.
The preparation of embodiment 2 medicine capsule of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 15 parts, the Radix Astragali 25 parts, Fructus Psoraleae 16 parts, Fructus Lycii 22 parts, Pericarpium Citri Reticulatae 12 parts, Fructus Liquidambaris 10 parts, Herba Lycopi 14 parts, Radix Salviae Miltiorrhizae 13 parts, Rhizoma Alismatis 10 parts, Carapax Trionycis 18 parts.
Preparation method: by the method granule of embodiment 1, add appropriate silicon dioxide, incapsulate shell and get final product.
The preparation of embodiment 3 medicine capsule of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 13 parts, the Radix Astragali 20 parts, Fructus Psoraleae 13 parts, Fructus Lycii 20 parts, Pericarpium Citri Reticulatae 11 parts, Fructus Liquidambaris 8 parts, Herba Lycopi 13 parts, Radix Salviae Miltiorrhizae 11 parts, Rhizoma Alismatis 8 parts, Carapax Trionycis 15 parts.
Preparation method: by the method granule of embodiment 1, add appropriate silicon dioxide, incapsulate shell and get final product.
The preparation of embodiment 4 medicine capsule of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 18 parts, the Radix Astragali 30 parts, Fructus Psoraleae 18 parts, Fructus Lycii 25 parts, Pericarpium Citri Reticulatae 15 parts, Fructus Liquidambaris 13 parts, Herba Lycopi 17 parts, Radix Salviae Miltiorrhizae 14 parts, Rhizoma Alismatis 13 parts, Carapax Trionycis 20 parts.
Preparation method: by the method granule of embodiment 1, add appropriate silicon dioxide, incapsulate shell and get final product.
The preparation of embodiment 5 medicine capsule of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 16 parts, the Radix Astragali 24 parts, Fructus Psoraleae 13 parts, Fructus Lycii 20 parts, Pericarpium Citri Reticulatae 15 parts, Fructus Liquidambaris 10 parts, Herba Lycopi 14 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Alismatis 10 parts, Carapax Trionycis 18 parts.
Preparation method: by the method granule of embodiment 1, add appropriate silicon dioxide, incapsulate shell and get final product.
The preparation of embodiment 6 medicine capsule of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 15 parts, the Radix Astragali 26 parts, Fructus Psoraleae 15 parts, Fructus Lycii 25 parts, Pericarpium Citri Reticulatae 11 parts, Fructus Liquidambaris 8 parts, Herba Lycopi 17 parts, Radix Salviae Miltiorrhizae 14 parts, Rhizoma Alismatis 13 parts, Carapax Trionycis 15 parts.
Preparation method: by the method granule of embodiment 1, add appropriate silicon dioxide, incapsulate shell and get final product.
The preparation of embodiment 7 medicine capsule of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 18 parts, the Radix Astragali 20 parts, Fructus Psoraleae 18 parts, Fructus Lycii 20 parts, Pericarpium Citri Reticulatae 13 parts, Fructus Liquidambaris 13 parts, Herba Lycopi 13 parts, Radix Salviae Miltiorrhizae 11 parts, Rhizoma Alismatis 8 parts, Carapax Trionycis 20 parts.
Preparation method: by the method granule of embodiment 1, add appropriate silicon dioxide, incapsulate shell and get final product.
The preparation of embodiment 8 medicinal tablet of the present invention
Prescription forms: the medical raw material getting following weight parts: Radix Codonopsis 15 parts, the Radix Astragali 25 parts, Fructus Psoraleae 16 parts, Fructus Lycii 23, Pericarpium Citri Reticulatae 15 parts, Fructus Liquidambaris 11 parts, Herba Lycopi 15 parts, Radix Salviae Miltiorrhizae 12 parts, Rhizoma Alismatis 9 parts, Carapax Trionycis 17 parts.
Preparation method: by the method granule of embodiment 1, add magnesium stearate, tabletting, be prepared into tablet.

Claims (7)

1. treat a Chinese medicine composition for qi stagnation and blood stasis type hyperplasia of prostate, it is characterized in that being made up of following medicinal raw material: Radix Codonopsis, the Radix Astragali, Fructus Psoraleae, Fructus Lycii, Pericarpium Citri Reticulatae, Fructus Liquidambaris, Herba Lycopi, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis.
2. treat the Chinese medicine composition of qi stagnation and blood stasis type hyperplasia of prostate as claimed in claim 1, it is characterized in that being made up of the medicinal raw material of following weight portion: Radix Codonopsis 13-18 part, Radix Astragali 20-30 part, Fructus Psoraleae 13-18 part, Fructus Lycii 20-25 part, Pericarpium Citri Reticulatae 11-15 part, Fructus Liquidambaris 8-13 part, Herba Lycopi 13-17 part, Radix Salviae Miltiorrhizae 11-14 part, Rhizoma Alismatis 8-13 part, Carapax Trionycis 15-20 part.
3. treat the Chinese medicine composition of qi stagnation and blood stasis type hyperplasia of prostate as claimed in claim 2, it is characterized in that being made up of the medicinal raw material of following weight portion: Radix Codonopsis 15 parts, the Radix Astragali 25 parts, Fructus Psoraleae 16 parts, Fructus Lycii 22 parts, Pericarpium Citri Reticulatae 12 parts, Fructus Liquidambaris 10 parts, Herba Lycopi 14 parts, Radix Salviae Miltiorrhizae 13 parts, Rhizoma Alismatis 10 parts, Carapax Trionycis 18 parts.
4. the Chinese medicine composition for the treatment of qi stagnation and blood stasis type hyperplasia of prostate as described in as arbitrary in claim 1-3, it is characterized in that by Radix Codonopsis, the Radix Astragali, Fructus Psoraleae, Fructus Lycii, Pericarpium Citri Reticulatae, Fructus Liquidambaris, Herba Lycopi, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis be active component, or be active component by the water of above-mentioned medicinal raw material or extractive with organic solvent, then add pharmaceutically acceptable adjuvant or complementary composition is prepared into pharmaceutically conventional medicament.
5. Chinese medicine composition as claimed in claim 4, is characterized in that described medicament is tablet, capsule, pill, granule, oral liquid.
6. as described in as arbitrary in claim 1-5, a preparation method for the Chinese medicine composition for the treatment of qi stagnation and blood stasis type hyperplasia of prostate, is characterized in that comprising the steps:
A, get raw material by prescription: Radix Codonopsis, the Radix Astragali, Fructus Psoraleae, Fructus Lycii, Pericarpium Citri Reticulatae, Fructus Liquidambaris, Herba Lycopi, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis;
B, get Fructus Psoraleae, Pericarpium Citri Reticulatae, Herba Lycopi, pulverize, add 70-80% alcoholic solution, decoct extraction 2 times, filter, filtrate concentrates;
C, get Radix Codonopsis, the Radix Astragali, Fructus Lycii, Fructus Liquidambaris, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Carapax Trionycis, decoct with water 2 times, filter, filtrate concentrates;
D, the concentrated solution of b and c step to be mixed, add pharmaceutically acceptable adjuvant or complementary composition and be prepared into pharmaceutically conventional preparation.
7. the application of the Chinese medicine composition of the arbitrary described treatment qi stagnation and blood stasis type hyperplasia of prostate of claim 1-3 in the medicine of preparation treatment qi stagnation and blood stasis type hyperplasia of prostate.
CN201410814774.8A 2014-12-25 2014-12-25 Traditional Chinese medicine composition for treating qi stagnation and blood stasis type prostate hyperplasia and preparation method thereof Withdrawn CN104435450A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103784804A (en) * 2014-03-05 2014-05-14 陈磊 Pharmaceutical composition for treating benign prostatic hyperplasia

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103784804A (en) * 2014-03-05 2014-05-14 陈磊 Pharmaceutical composition for treating benign prostatic hyperplasia

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Application publication date: 20150325