CN1548138A

CN1548138A - Chinese medicine composition for treating consumptive disease and its quality control method

Info

Publication number: CN1548138A
Application number: CNA031361552A
Authority: CN
Inventors: 陈均耀; 张坚力
Original assignee: GUANGDONG MINGZHU PHARMACEUTICAL INDUSTRY Co Ltd
Current assignee: Guangdong Liankang Pharmaceutical Co ltd
Priority date: 2003-05-19
Filing date: 2003-05-19
Publication date: 2004-11-24
Anticipated expiration: 2023-05-19
Also published as: CN1248721C

Abstract

The Chinese medicine composition for treating consumptive disease is prepared with 26 kinds of Chinese medicinal materials, including ginseng, tuckahoe, astragalus root, oriental water plantain, Dangshen, etc. The present invention also provides the quality control method including component identification and content measurement. The Chinese medicine composition has the functions of benefiting vital energy and blood and invigorating spleen and kidney, and thus has high curative effect on consumptive disease.

Description

A kind of Chinese medicine composition and method of quality control thereof for the treatment of deficiency of five viscera

Invention field

The present invention relates to a kind of Chinese medicine composition, particularly be used for the treatment of the Chinese medicine composition of deficiency of five viscera, relate to the method for quality control of said composition simultaneously.

Background technology

Deficient, claim asthenia again.It is by due to the multiple reason, and with the internal organs loss, the negative and positive of qi and blood deficiency is the general name of the multiple chronic weak syndrome of main pathogenesis.Producing deficient main cause has the natural endowment weakness, and body constitution is not strong; Bother excessively, undermine the five internal organs; Eating and drinking without temperance, impairing the spleen and stomach; Serious disease prolonged illness is lost in conditioning, more than many reasons, all can produce deficient.The vigour loss, asthenia of both the spleen and kidney, deficiency of liver-blood then shows as shallow complexion, fatigue and weakness, the spontaneous perspiration of losing heart, severe palpitation, soreness of the waist and knees, impotence and premature ejaculation etc.; Spleen deficiency of kidney-QI, uncontrol of the urinary bladder then the enuresis or incontinence of urine can occur.Seminal emission, nocturnal emission or spermatorrhea then can appear in impairment caused by overstrain spleen kidney, gas not consolidating semen.Control and work as replenishing QI and blood, the spleen reinforcing kidney is main.

The Chinese medicine deficiency of five viscera has superiority, the present invention has characteristics evident in efficacy, that have no side effect through clinical a large amount of case checkings, show as Clinical Comparison Study that with prominent domestic product GUILU BUSHEN WAN the present invention is to deficiency of five viscera deficiency of both QI and blood, nephrasthenia syndrome, spleen deficiency of kidney-QI, uncontrol of the urinary bladder card, impairment caused by overstrain spleen kidney, gas is the consolidating semen card not, compares with GUILU BUSHEN WAN, learns by statistics and handles P＜0.05, there were significant differences, and do not find toxic and side effects.

Summary of the invention

One object of the present invention is to disclose a kind of Chinese medicine composition of new treatment deficiency of five viscera; The object of the invention also is to disclose a kind of method of quality control of new Chinese medicine composition.

The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):

Radix Ginseng 7-15 weight portion Poria 35-50 weight portion Radix Astragali Preparata 35-50 weight portion

Rhizoma Alismatis 10-20 weight portion Semen Trigonellae 8-20 weight portion Herba Cistanches 4-12 weight portion

Semen Euryales 70-95 weight portion Radix Codonopsis 25-40 weight portion Radix Rehmanniae Preparata 25-40 weight portion

Rhizoma Atractylodis Macrocephalae 10-20 weight portion Radix Paeoniae Alba 10-20 weight portion Rhizoma Acori Graminei 4-12 weight portion

Rhizoma Cibotii 25-40 weight portion Radix Morindae Officinalis 16-25 weight portion Rhizoma Dioscoreae 25-40 weight portion

Herba Cynomorii 4-12 weight portion Semen Ziziphi Spinosae 4-12 weight portion Fructus Amomi Rotundus 2-7 weight portion

Fructus Lycii 25-40 weight portion Radix Polygoni Multiflori 15-30 weight portion Radix Angelicae Sinensis 15-26 weight portion

Fructus Broussonetiae 4-12 weight portion Radix Glycyrrhizae Preparata 4-12 weight portion Herba Epimedii 4-12 weight portion

Semen Cuscutae 15-26 weight portion Radix Dipsaci 10-20 weight portion.

Wherein, Rhizoma Alismatis is preferably fried Rhizoma Alismatis, the preferred Semen Ziziphi Spinosae (parched) of Semen Ziziphi Spinosae, the preferred Herba Cistanches Deserticolae (processed) of Herba Cistanches, the preferred Rhizoma Atractylodis Macrocephalae of Rhizoma Atractylodis Macrocephalae system, the Radix Paeoniae Alba and preferably makes the Radix Paeoniae Alba, the preferred Radix Morindae Officinalis (processed) of Radix Morindae Officinalis, the preferred lockmaking sun of Herba Cynomorii, Fructus Amomi Rotundus and preferably make Fructus Amomi Rotundus, Semen Cuscutae and preferably make Semen Cuscutae, the preferred Radix Polygoni Multiflori Preparata of Radix Polygoni Multiflori.

This preparation of drug combination method:

More than 20 Six-element medical materials, get the Radix Ginseng powder and be broken into fine powder; 25-component pulverizing medicinal materials such as all the other Rhizoma Alismatis become fine powder, sieve, add above-mentioned fine powder, mixing, at last directly or add pharmaceutically acceptable excipient and make clinical acceptable forms, as pill, tablet, oral liquid, capsule, granule etc. through conventional operation.

The method of quality control that this compositions is made medicament comprises discriminating and/or assay.(following unit quantity is meant the finished medicines dosage that contains suitable crude drug 5 grams)

Discrimination method comprises a kind of and/or several in the following method:

A. this composite preparation, put microscopically and observe: the dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and dissolves; Hyphae colorless or light brown, diameter 4～6 μ m; The starch grain triangular shape is avette or square is circular, diameter 24～40 μ m, and omphalion short seam shape or herringbone shape parenchyma cell similar round have oval pit, integrated pit group; The parenchyma taupe brown is to dark brown, and the many shrinkages of cell include brown nuclear shape thing; Plant skin palisade cells 2 row, the outer row of interior row are long, and light line is arranged; It is faint yellow to plant the skin stone cell, the wavy bending of wall, and cell contains brown thing; Fiber bunchy or loose from, wall thickness, there is longitudinal crack on the surface, and two ends fragment into broom shape or more truncate, calcium oxalate cluster crystal diameter 24～68 μ m, the sharp point of corner angle;

B. this composite preparation 9g shreds, and adds the vitriolic 40-50% alcoholic solution of 6-8% 45ml, reflux 1-2 hour, put coldly, filter, filtrate adds 60～90 ℃ of petroleum ether joltings extracts 2 times, each 30ml, merge petroleum ether liquid, water 10ml washing discards cleaning mixture, it is an amount of that petroleum ether liquid adds anhydrous sodium sulfate, shakes up, and filters, filtrate is added on the neutral alumina post of having handled well, adds methanol 40ml eluting, collects eluent, evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Other gets Radix Ginseng control medicinal material 1g, shines medical material solution in pairs with legal system; Get panoxadiol, panaxatriol's reference substance again, add methanol and make the mixed solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned need testing solution 10 μ l, control medicinal material solution and reference substance solution, put respectively on same silica gel g thin-layer plate, with 4-7: 1-3 benzene-acetone is developing solvent, launches, and takes out, dry, spray is with the 25-35% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 100-110 ℃, puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color respectively;

C. this composite preparation 9g shreds, and adds methanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 15ml makes dissolving, extracts 2 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butyl alcohol liquid, water 20ml washing discards cleaning mixture, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 1ml makes dissolving, it is an amount of to add neutral alumina, mixes evaporate to dryness thoroughly, be added on the neutral alumina post, use 1-2: 1-2 ethyl acetate-methanol mixed solution 40ml eluting, collect eluent, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 35-45: 3-6: 8-12: 0.1-0.5 chloroform-ethyl acetate-methanol-formic acid is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

D. get and differentiate the neutral alumina post behind the eluting under the c item, with 35-45% methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Extracting liquorice control medicinal material 0.2g shines medical material solution in pairs with legal system in addition; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with 10-20: 1-2: 1-2: 1-3 ethyl acetate-formic acid-glacial acetic acid-water is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.

Assay: measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D), chromatograph chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; 10-15: 80-90 acetonitrile-water is mobile phase; The detection wavelength is 230nm, number of theoretical plate calculates by the peoniflorin peak should be not less than 4000, the preparation of reference substance solution: precision takes by weighing through 22-26 hour peoniflorin reference substance of phosphorus pentoxide drying under reduced pressure an amount of, adds 45-55% methanol and makes the solution that every 1ml contains 15 μ g, promptly; The preparation of need testing solution: get this product under the weight differential item, shred, mixing is got 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate Diluted Alcohol 25ml that adds, close plug claims to decide weight, floods 4 hours, supersound process 30 minutes is taken out, and puts cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with Diluted Alcohol, filter, get subsequent filtrate, promptly; Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, that is, this product contains the Radix Paeoniae Alba with peoniflorin (C ₂₃H ₂₈O ₁₁) meter, the per unit amount must not be less than 0.8-1.2mg.

Present composition preparation is safe and effective to the treatment of cards such as deficiency of five viscera " QI and blood deficiency ", " suffering from a deficiency of the kidney ", " spleen deficiency of kidney-QI, uncontrol of the urinary bladder (enuresis) ", " impairment caused by overstrain spleen kidney, gas is consolidating semen (seminal emission) not ".

Following experimental example further specifies the present invention.

Experimental example is to the clinical treatment of deficiency of five viscera

Syndromes such as this composite preparation treatment deficiency of five viscera " deficiency of both QI and blood ", " nephrasthenia syndrome ", " spleen deficiency of kidney-QI, uncontrol of the urinary bladder (enuresis) card ", " impairment caused by overstrain spleen kidney, gas is consolidating semen (seminal emission) card not " are carried out curative effect to be investigated.Observe deficiency of five viscera patient 403 examples altogether, 303 examples are organized in treatment, matched group 100 examples.Deficiency of both QI and blood 74 examples (58 examples are organized in treatment, matched group 16 examples) wherein; Nephrasthenia syndrome 56 examples (42 examples are organized in treatment, matched group 14 examples); Spleen deficiency of kidney-QI, uncontrol of the urinary bladder (enuresis) card 132 examples (102 examples are organized in treatment, matched group 30 examples); Impairment caused by overstrain spleen kidney, gas be consolidating semen (seminal emission) card 141 examples (101 examples are organized in treatment, matched group 40 examples) not.Result of the test: deficiency of both QI and blood treatment group cure-remarkable-effectiveness rate is 67.24%, and total effective rate is 93.10%, and the matched group cure-remarkable-effectiveness rate is 43.75%, and total effective rate is 62.50%; Nephrasthenia syndrome treatment group cure-remarkable-effectiveness rate is 57.14%, and total effective rate is 83.33%, and the matched group cure-remarkable-effectiveness rate is 50.00%, and total effective rate is 71.42%; Enuresis treatment group cure-remarkable-effectiveness rate is 65.68%, and total effective rate is 91.20%; The matched group cure-remarkable-effectiveness rate is 56.67%, and total effective rate is 76.66%: curing emission group cure-remarkable-effectiveness rate is 64.36%, and total effective rate is 92.10%; The matched group cure-remarkable-effectiveness rate is 47.50%, and total effective rate is 82.50%.Two groups of treatment back curative effects are relatively learned by statistics and are handled, and to the curative effect of deficiency of both QI and blood, have system juice to learn difference, P＜0.05; To the curative effect of nephrasthenia syndrome, no statistics difference P＞0.05; To the curative effect of the enuresis, significant difference P＜0.05 is arranged; Curative effect to seminal emission has significant difference P＜0.05.In the clinical verification process, the treatment group does not have obvious adverse reaction.

Physical data: one, case source: this clinical trial is each clinical trial unit's outpatient service and partial hospitalization patient.Observe deficiency of five viscera patient 403 examples altogether, wherein 303 examples are organized in treatment, matched group 100 examples.

Two, sex: each organizes patient's sex ratio, sees Table 1

Table 1 is respectively organized patient's sex ratio

Treatment group matched group

Syndrome example numerical example number

Man (%) woman (%) man (%) woman (%)

QI and blood deficiency 58 30 (51.72) 28 (48.27) 16 9 (56.25) 7 (43.75)

Suffer from a deficiency of the kidney 42 27 (64.28) 15 (35.71) 14 8 (57.14) 6 (42.85)

The enuresis 102 56 (54.90) 46 (45.09) 30 19 (63.33) 11 (36.66)

Pass out semen 101 101 0 40 40 0

Through X ²Check, each organizes patient's sex ratio, no difference of science of statistics P＞0.05.

Three, the age: each is organized patient age and distributes relatively, sees Table 2.

Table 2 respectively organize patient age distribute relatively (year)

Treatment group matched group

The example example

Syndrome

＜30 30～50 50～65 ＜30 30～50 50～65

The number number

(％) (％) (％) (％) (％) (％)

QI and blood

58 17(29.31) 28(48.27) 13(22.41) 16 5(31.25) 7(43.75) 4(25.00)

Two void

Suffer from a deficiency of the kidney 42 11 (26.19) 19 (45.23) 12 (28.57) 14 4 (28.57) 6 (42.85) 4 (28.57)

The enuresis 102 18 (17.65) 35 (34.31) 49 (48.04) 30 2 (6.67) 11 (36.66) 17 (56.67)

Pass out semen 101 59 (58.42) 29 (28.71) 13 (12.87) 40 25 (62.50) 10 (25.00) 5 (12.50)

Through the Ridit check, each is organized patient age and distributes relatively no difference of science of statistics P＞0.05.

Four, the course of disease: each is organized patient's course of disease and distributes relatively, sees Table 3.

Table 3 is respectively organized patient's course of disease and is distributed relatively

Treatment group matched group

The example example

Syndrome

≤ March＞March～≤ 1 year＞1 year≤March＞March～≤ 1 year＞1 year

The number number

(％) (％) (％) (％) (％) (％)

QI and blood

58 24(41.37) 27(46.55) 7(12.06) 16 5(31.25) 8(50.00) 3(18.57)

Two void

Suffer from a deficiency of the kidney 42 13 (30.95) 21 (50.00) 8 (19.04) 14 5 (35.71) 6 (42.85) 3 (21.42)

The enuresis 102 32 (31.37) 42 (41.18) 28 (27.45) 30 7 (23.33) 15 (50.0) 8 (26.67)

Pass out semen 101 31 (30.69) 59 (58.42) 11 (10.87) 40 15 (37.50) 19 (47.50) 6 (15.00)

Through the Ridit check, each is organized patient's course of disease and distributes relatively no difference of science of statistics P＞0.05.

Five, clinical symptoms: two groups of patient's clinical symptoms weights distribute relatively, see Table 4.

Table 4 a liang group patient symptom weight distributes relatively

Treatment group matched group

Symptom example numerical example is counted P

Light nothing does not gently have in weighing in heavy

Fatigue and weakness 298 47 174 77 5 97 16 59 22 3＞0.05

Soreness of the waist and knees 259 62 127 70 44 82 18 42 22 18＞0.05

Lack of appetite 246 31 73 142 57 79 10 15 54 21＞0.05

The spontaneous perspiration 248 31 83 134 55 80 10 27 43 20＞0.05 of losing heart

Severe palpitation 239 40 89 110 64 73 13 27 33 27＞0.05

Big loose stool thin 225 30 62 133 78 68 8 22 38 32＞0.05

The enuresis 102 35 22 45 0 30 86 16 0＞0.05

Pass out semen 101 9 13 79 0 40 25 33 0＞0.05

Through the Ridit check, two groups of patient's clinical symptoms distribute relatively no difference of science of statistics P＞0.05.

Six, two groups of card marquis comparison that distributes, the card marquis comparison that distributes before two groups of patients treat, through the Ridit check, two groups of patient's syndromes distribute relatively no difference of science of statistics P＞0.05.By above statistical analysis as seen, treatment group and matched group have comparability at sex, age, the course of disease, symptom weight, syndrome distribution each side no difference of science of statistics before the treatment.

Test method

One, diagnostic criteria () deficiency of five viscera diagnostic criteria: with reference to " Chinese Internal Medicine " (high Chinese medicine universities and colleges teaching material), the title deficiency of five viscera is an asthenia, due to multiple reason, with the internal organs loss, the negative and positive of qi and blood deficiency is the general name of the multiple chronic weak syndrome of main pathogenesis.(2) Chinese medical discrimination standard: with reference to " Chinese Internal Medicine ", " Pediatrics of Chinese Medicine " (high Chinese medicine universities and colleges teaching material) asthenia, seminal emission, enuresis piece of writing related content.1, deficiency of both QI and blood: shallow complexion, fatigue and weakness, the spontaneous perspiration of losing heart, severe palpitation, thready and weak pulse, light red tongue.2, nephrasthenia syndrome: soreness of the waist and knees, impotence and premature ejaculation, frequent micturition, light red tongue, thin fur, thready and weak pulse.3, spleen deficiency of kidney-QI, the uncontrol of the urinary bladder card: the enuresis or incontinence of urine in sleeping, the then sx of overworking, fatigue and weakness, lack of appetite, soreness of the waist and knees, big loose stool is thin, light red tongue, thready and weak pulse.4, impairment caused by overstrain spleen kidney, gas consolidating semen card not: shallow complexion, fatigue and weakness, soreness of the waist and knees, labor is then passed out semen, or nocturnal emission, spermatorrhea, light red tongue, thin fur, weak pulse.(3) primary symptom weight grade scale: draft with reference to " new Chinese medicine (treatment syndrome of spleen-deficiency, seminal emission) clinical research guideline ".L, lack of appetite (more than the first quarter moon) light (+): do not have appetite, but keep former appetite.In (++): no appetite, appetite is than reducing 1/3 before sick.Heavy (+++): no appetite, appetite reduces more than 2/3.2, fatigue and weakness light (+): tired slightly, the power of not enduring hardships can be adhered to light physical labor.In (++): asthenia is supported daily routines more reluctantly.Heavy (+++): myasthenia of limbs, can not adhere to daily routines.3, big loose stool thin light (+): soft stool or mashed slightly, in heaps shapeless, 2-3 time/day.In (++): mashed just, loose stool 4-5 time/day, or 1-2 time/day of loose stool.Heavy (+++): loose stool, more than 3 times/day.4, soreness of the waist and knees light (+): idol has outbreak, does not influence orthobiosis.In (++): trial of strength, inconvenient activity, again and again outbreak can alleviate after the rest.Heavy (+++): serious, be difficult to after the rest alleviate, continue person more than month.5, severe palpitation light (+): during random thoughts are nervous (++): between light, heavy.Heavy (+++): nervous heavier, susceptible to fright probably.6, seminal emission light (+): 8-10 time/month, only feel weak.In (++): 11-15 time/month, feel weak, soreness of the waist and knees.Heavy (+++): more than 15 times/month, the lassitude loin and legs has palpitation and breathes hard complexion White or withered simple and unadorned.7, the enuresis light (+): urine does not influence orthobiosis frequently.In (++): incontinence of urine appears after the fatigue.Heavy (+++): the middle enuresis of sleeping, or incontinence of urine.

Two, test case standard () is included case standard 1 in, is met the diagnosis of traditional Chinese medical science deficiency of five viscera and the traditional Chinese medical science " deficiency of both QI and blood ", or " nephrasthenia syndrome ", or " spleen deficiency of kidney-QI, uncontrol of the urinary bladder card ", or " impairment caused by overstrain spleen kidney, gas is the consolidating semen card not " dialectical standard person.2, the age is at 18-65 between year.(enuresis card is not limited by this, though to the part age at under-18s, clearly for having a delicate constitution, " spleen deficiency of kidney-QI, uncontrol of the urinary bladder are demonstrate,proved " person also can include in) 3, do not take other benefiting QI and nourishing blood, related drugs persons such as invigorating spleen and kidney simultaneously.(2) get rid of case standard 1, age under-18s or over-65s person (enuresis card age can reduce).2, gestation or women breast-feeding their children; To this medicine allergy sufferers.3, be associated with primary diseases such as cardiovascular, liver, kidney, hemopoietic system, psychotic.4, do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data not umbra ring curative effect or safety judgement person.

Three, test method: (one) group technology: take single at random blind counter point, treatment group and matched group case load ratio are no less than 3: 1.With qualified study subject method, be assigned in treatment group and the matched group by patient's sequence number of going to a doctor according to 3: 1 ratios with simple randomization.Tried case and can be outpatient and inpatient, the outpatient wants strict control variable factor.(2) Therapeutic Method: treatment group medicine: the ginseng hygiene pill, oral, each 9 grams. every day 1 time.Around the course of treatment.The matched group medicine: GUILU BUSHEN WAN, oral, each 9 grams, every day 1 time.Around the course of treatment.(3) observation index 1, the general health check-up project of safety observation (1).(2) blood, urine, stool routine chemical examination.(3) liver function (ALT), renal function (BUN) chemical examination, Electrocardioscopy.Before the treatment of above index and treatment each inspection record is once when finishing.(4) untoward reaction, record at any time.2, health giving quality observation (1) deficiency of both QI and blood primary symptom, tongue, arteries and veins change.(2) nephrasthenia syndrome primary symptom, tongue, arteries and veins change.(3) spleen deficiency of kidney-QI, uncontrol of the urinary bladder card primary symptom, tongue, arteries and veins change.(4) consolidating semen card primary symptom, tongue, arteries and veins do not change for impairment caused by overstrain spleen kidney, gas.Above index is before treatment, each write down once when second week of treatment beginning back and treatment finished.

Four, curative effect determinate standard: reference " new Chinese medicine clinical research guideline " (one) clinical recovery: symptomatology disappears.(2) produce effects: primary symptom improve person more than 2 grades (by +++-+); Though or primary symptom improves not as good as 2 grades, other symptom all disappears.(3) effective: primary symptom takes a turn for the better, and improves person more than 1 grade; Or 2 grades of other doing well,improvings (by +++-+) person.(4) invalid: symptom does not have the improvement or the person of increasing the weight of.

Five, untoward reaction record: observe emphatically whether medicine causes nausea, vomits, diarrhoea, dizzy and anaphylaxis.Untoward reaction to the duration of test appearance, its reactive species, degree, time of occurrence, persistent period, treatment measures etc. should be recorded in the observation table strictly according to the facts, on the basis of analysis-by-synthesis, with regard to the dependency of untoward reaction and trial drug (as irrelevant, may be relevant, relevant, can not wait certainly) make an appraisal.By observation doctor itemized record, and signature.

Six, observe requirement: (one) all cases strictness observes by above scheme, strictly according to the facts, conscientiously fills in the case observation log.(2) medicining condition of conscientious record patient, to take medicine on time, situation such as miss writes down, illustrates sometimes.(3) the case observation log must not be changed as protocol.When doing any change, must not change protocol, can only additional description and give reasons, by observing the physician's signature and dating.

Seven, the statistical analysis and the summarization of data: statistical method: enumeration data x ²Check, ranked data are analyzed or rank test with Ridit, and measurement data is checked with t between two means.After clinical trial finished, the clinical trial brief summary was write out by each test unit.All data are aggregated into the clinical trial responsible department and summarize, and just observe the clinical efficacy and the safety thereof of medicine and make final report.

Therapeutic outcome: one, the deficiency of five viscera curative effect relatively sees Table 5.

Table 5 deficiency of five viscera curative effect relatively

Group example number recovery from illness (%) produce effects (%) is (%) invalid (%) total effective rate (%) effectively

Treatment organizes 303 111 (36.63) 84 (27.72) 80 (26.41) 28 (9.24) 90.76

Matched group 100 21 (21.0) 29 (29.0) 26 (26.0) 24 (24.0) 76.00

Through the Ridit check, after two groups of treatments, the deficiency of five viscera curative effect relatively has significant difference P＜0.05.

Two, respectively organize therapeutic effect of syndrome relatively, see Table 6.

Table 6 is respectively organized therapeutic effect of syndrome relatively

Treatment group matched group

Example total effective rate example total effective rate

Syndrome

Clinical

Number % counts %

Produce effects enabledisable produce effects enabledisable

The recovery from illness recovery from illness

QI and blood

58 19 20 15 4 (93.10) 16 3 4 3 6 (62.50)

Two void

Suffer from a deficiency of the kidney 42 11 13 11 7 (83.33) 14 4334 (71.42)

The enuresis 102 42 25 26 9 (91.20) 30 7 10 67 (76.66)

Pass out semen 101 39 26 28 8 (92.10) 40 7 12 14 7 (82.50)

Through the Ridit check, treatment back QI and blood deficiency, the enuresis, seminal emission card treatment group compare with matched group respectively, and significant difference P＜0.05 is all arranged; Nephrasthenia syndrome treatment group with compare no difference of science of statistics P＜0.05.

Two, two groups of all ages and classes section patient curative effects relatively see Table 7.

Table 7 liang group all ages and classes section patient curative effect relatively

Treatment group matched group

The total effective routine total effective rate of age example

Clinical showing has or not clinical showing to have or not

(year), digit rate % counted %

Recovery from illness is imitated recovery from illness and is imitated

＜30 105 34 26 36 9 (91.42) 36 8 12 10 6 (83.33)

30～50 111 40 31 28 12 (89.18) 34 7 8 9 10 (70.58)

50～60 87 37 27 16 7 (91.95) 30 6 9 7 8 (73.33)

Through the Ridit check, the treatment group compares no difference of science of statistics P＞0.05 to each age group patient's curative effect; The treatment group to 30-65 year age bracket patient's curative effect and matched group relatively has significant difference P＜0.05.Curative effect and matched group to the patient of age below 30 years old compare no difference of science of statistics P＞0.05.

Three, two groups of symptom curative effects relatively see Table 8

Table 8 liang group symptom curative effect relatively

Treatment group matched group

Example does not have total effectively example not to be had effectively total

Symptom disappears to show the apparent P that has that disappears

Number variability % counts variability %

Losing efficacy, imitating lost efficacy imitates

Changeization

Asthenia

298 148 69 54 27 (90.93) 97 28 23 20 26 (73.19) ＜0.05

Weak

Lack of appetite 246 130 44 51 21 (91.46) 79 25 19 20 15 (81.01)＞0.05

Cardiopalmus

239 70 50 65 54 (77.40) 73 20 15 13 25 (65.75) ＞0.05

Palpitation with a distress feeling

The waist knee joint

259 145 48 44 22 (91.50) 82 27 24 14 17 (79.26) ＞0.05

Aching and limp

Complexion

193 61 41 52 39 (79.79) 61 9 11 15 26 (57.37) ＜0.05

Sallow

Lose heart

248 98 69 55 26 (89.51) 80 27 21 14 18 (77.50) ＞0.05

Spontaneous perspiration

Stool

225 67 62 47 49 (78.22) 68 19 14 11 24 (64.70) ＞0.05

Half congealed thin

The enuresis 102 42 25 26 9 (91.20) 30 7 10 67 (76.66)＜0.05

Pass out semen 101 39 26 28 8 (92.10) 40 7 12 14 7 (82.50)＜0.05

Through the Ridit check, the treatment group compares the curative effect and the matched group of symptoms such as fatigue and weakness, shallow complexion, the enuresis, seminal emission, and significant difference P＜0.05 is all arranged; Curative effect and matched group to all the other symptoms compare no difference of science of statistics P＞0.05

Five, two groups of different course of disease patient curative effects relatively see Table 9.

The table 9 liang different course of disease patient's curative effects of group relatively

Age always has

Treatment group matched group

(year) the total effective routine efficient % of example

Number is clinical to be shown and to have or not rate % number clinical showing to have or not

Recovery from illness is imitated recovery from illness and is imitated

≤ March 100 49 26 19 6 (96.00) 32 89 10 5 (84.37)

＞March～≤ 1 149 49 47 42 11 (92.61) 48 9 15 12 12 (75.00)

Year

＞1 year 54 13 11 19 11 (79.62) 20 4547 (65.00)

Through the Ridit check, the treatment group compares different course of disease curative effects and matched group, and significant difference P＜0.05 is all arranged.

Six, two groups of treatment back tongues, pulse conditions change relatively, see Table 10.

Table 10 liang group treatment back tongue, pulse condition change relatively

Treatment group matched group

Often change after improving treatment after preceding treatment of the normal treatment of treatment back improvement treatment back commentaries on classics before tongue, the pulse condition treatment

Unusually (%) (%) unusual (%) (%)

Pale tongue 265 108 (40.75) 52 (19.62) 55 21 (38.18) 14 (25.45)

Thready and weak pulse 275 117 (42.54) 72 (26.81) 64 23 (35.93) 16 (25.00)

Through X ²: check, the two groups of tongues in treatment back, pulse condition change relatively no difference of science of statistics P＞0.05.

Seven, safety indexes: (one) lab testing: blood, urine, stool routine, liver (ALT), kidney (BUN) function and Electrocardioscopy before and after two groups of patient treatments, all no abnormal variation.(2) viewing duration is not found side effect of digestive tract such as curative causes nausea, vomits, diarrhoea, does not find anaphylaxis and other any untoward reaction such as dizzy, heating, erythra.Conclusion: by above to 403 routine deficiency of five viscera deficiency of both QI and blood, nephrasthenia syndrome, spleen deficiency of kidney-QI, uncontrol of the urinary bladder (enuresis) card, impairment caused by overstrain spleen kidney, gas is the clinical verification of consolidating semen (seminal emission) card not, therapeutic outcome to deficiency of five viscera shows: 303 examples are organized in treatment, cure-remarkable-effectiveness rate 64.35%, total effective rate 90.76%; Matched group 100 examples, cure-remarkable-effectiveness rate 50.00%, total effective rate 76.00%.Two groups of cure-remarkable-effectiveness rates and total effects are relatively handled P＜0.05 by statistics, and significant difference is arranged.The treatment group does not have obvious adverse reaction.This Clinical results shows: this composite preparation (ginseng hygiene pill) is used for the deficiency of five viscera deficiency of both QI and blood, nephrasthenia syndrome, and spleen deficiency of kidney-QI, uncontrol of the urinary bladder (enuresis) card, impairment caused by overstrain spleen kidney, gas is the treatment of consolidating semen (seminal emission) card not, and is safe and effective.

Following examples all can realize effect of the present invention

Embodiment 1 pill

Radix Ginseng 10.5g Poria 42.1g Radix Astragali Preparata 42.1g Rhizoma Alismatis (stir-fry) 15.7g

Semen Trigonellae 12.6g Herba Cistanches (system) 7.8g Semen Euryales 84.2g Radix Codonopsis 31.6g

Radix Rehmanniae Preparata 31.6g art (system) the 15.7g Radix Paeoniae Alba (system) 15.7g Rhizoma Acori Graminei 7.8g

Rhizoma Cibotii 31.6g Radix Morindae Officinalis (system) 21g Rhizoma Dioscoreae 31.6g Herba Cynomorii (system) 7.8g

Semen Ziziphi Spinosae (stir-fry) 7.8g Fructus Amomi Rotundus (system) 4.1g Fructus Lycii 31.6g Radix Polygoni Multiflori Preparata 21g

Radix Angelicae Sinensis 21g Fructus Broussonetiae 7.4g Radix Glycyrrhizae Preparata 7.8g Herba Epimedii 7.8g

Semen Cuscutae (system) 21g Radix Dipsaci 15.7g Mel (refining) 445.3g,

More than 20 Six-element medical materials, get the Radix Ginseng powder and be broken into fine powder; 25-component pulverizing medicinal materials such as all the other Rhizoma Alismatis become fine powder, sieve, and add above-mentioned fine powder, and mixing adds refined honey to make small honey pill or big honeyed pills, makes 1000g (small honey pill) or 111 balls (big honeyed pills), and is oral, one time 1 ball of big honeyed pills, 9g of small honey pill, 1 time on the one.The heavy 1.5g of per 10 balls of small honey pill; The heavy 9g of the every ball of big honeyed pills.

Embodiment 2 tablets

The Radix Rehmanniae Preparata 31.6g Rhizoma Atractylodis Macrocephalae (system) the 15.7g Radix Paeoniae Alba (system) 15.7g Rhizoma Acori Graminei 7.8g

Semen Cuscutae (system) 21g Radix Dipsaci 15.7g

More than 20 Six-element medical materials, get Rhizoma Acori Graminei, Fructus Amomi Rotundus and extract volatile oil, use an amount of dissolve with ethanol, standby.The Radix Ginseng powder is broken into coarse powder, with 70% ethanol extraction 2 times, each 2 hours, reclaims ethanol to there not being the alcohol flavor; Above-mentioned two residues add 23 flavors such as all the other Poria and decoct with water 2 times, and each 2 hours, collecting decoction filtered, and concentrates.With water, two clear paste reconcentration of alcohol to relative density 1.28-1.30 (98 ℃), put cold after, add appropriate amount of auxiliary materials, drying is ground into fine powder, mixing is made granule with volatile oil alcoholic solution and an amount of ethanol, is pressed into 333, wraps film-coat, promptly.Oral, each 3, day 2 times.

Embodiment 3 oral liquids

Radix Ginseng 13g Poria 48g Radix Astragali Preparata 46g Rhizoma Alismatis (stir-fry) 18g

Semen Trigonellae 18g Herba Cistanches (system) 10.8g Semen Euryales 90g Radix Codonopsis 37g

The Radix Rehmanniae Preparata 28g Rhizoma Atractylodis Macrocephalae (system) the 12g Radix Paeoniae Alba (system) 12g Rhizoma Acori Graminei 5g

Rhizoma Cibotii 29g Radix Morindae Officinalis (system) 18g Rhizoma Dioscoreae 27g Herba Cynomorii (system) 6g

Semen Ziziphi Spinosae (stir-fry) 10g Fructus Amomi Rotundus (system) 6g Fructus Lycii 36g Radix Polygoni Multiflori Preparata 27g

Radix Angelicae Sinensis 18g Fructus Broussonetiae 6 Radix Glycyrrhizae Preparata 6g Herba Epimedii 6g

Semen Cuscutae (system) 24g Radix Dipsaci 17g

More than 20 Six-element medical materials, get Rhizoma Acori Graminei, Fructus Amomi Rotundus and extract volatile oil, use an amount of dissolve with ethanol, standby.The Radix Ginseng powder is broken into coarse powder, with 70% ethanol extraction 2 times, each 2 hours, filters filtrate for later use.Above-mentioned two residues add 23 flavors such as all the other Poria and decoct with water 2 times, each 2 hours, filter, it is about 1.20 that filtrate is concentrated into relative density, adds ethanol triplication mixing, places, filter, filtrate and Radix Ginseng ethanol extract merge, and reclaim ethanol, add water and dilute in right amount, it is an amount of to add antiseptic again, mixing, supernatant is got in cold preservation, adds the volatile oil alcoholic solution, it is an amount of to add Mel, makes 1111ml, promptly.Oral, each 10ml, day 2 times.

Embodiment 4 capsules

Radix Ginseng 10g Poria 40g Radix Astragali Preparata 40g Rhizoma Alismatis (stir-fry) 15g

Semen Trigonellae 10g Herba Cistanches (system) 10g Semen Euryales 80g Radix Codonopsis 30g

The Radix Rehmanniae Preparata 30g Rhizoma Atractylodis Macrocephalae (system) the 14g Radix Paeoniae Alba (system) 16g Rhizoma Acori Graminei 9g

Rhizoma Cibotii 30g Radix Morindae Officinalis (system) 20g Rhizoma Dioscoreae 30g Herba Cynomorii (system) 7g

Semen Ziziphi Spinosae (stir-fry) 7g Fructus Amomi Rotundus (system) 4g Fructus Lycii 30g Radix Polygoni Multiflori Preparata 20g

Radix Angelicae Sinensis 20g Fructus Broussonetiae 7g Radix Glycyrrhizae Preparata 7g Herba Epimedii 7g

Semen Cuscutae (system) 20g Radix Dipsaci 15g

More than 20 Six-element medical materials, get Rhizoma Acori Graminei, Fructus Amomi Rotundus and extract volatile oil, use an amount of dissolve with ethanol, standby.The Radix Ginseng powder is broken into coarse powder, with 70% ethanol extraction 2 times, and each 2 hours, reclaim ethanol to there not being the alcohol flavor, clear paste is standby.Above-mentioned two residues add 23 flavors such as all the other Poria and decoct with water 2 times, and each 2 hours, collecting decoction filtered, and concentrates, and clear paste is standby.Water, two clear paste of alcohol are concentrated into relative density 1.28-1.30 (98 ℃), put cold after, add appropriate amount of auxiliary materials, drying is ground into fine powder, mixing, with the volatile oil alcoholic solution and in right amount ethanol make granule, drying incapsulates, and makes 333, promptly.Oral each 3, day 2 times.

Embodiment 5 capsules

Radix Ginseng 9g Poria 39g Radix Astragali Preparata 39g Rhizoma Alismatis (stir-fry) 13g

Semen Trigonellae 10g Herba Cistanches (system) 6g Semen Euryales 80g Radix Codonopsis 28g

The Radix Rehmanniae Preparata 34g Rhizoma Atractylodis Macrocephalae (system) the 18g Radix Paeoniae Alba (system) 18g Rhizoma Acori Graminei 10g

Rhizoma Cibotii 36g Radix Morindae Officinalis (system) 21g Rhizoma Dioscoreae 38g Herba Cynomorii (system) 10g

Semen Ziziphi Spinosae (stir-fry) 5g Fructus Amomi Rotundus (system) 3g Fructus Lycii 27g Radix Polygoni Multiflori Preparata 18g

Radix Angelicae Sinensis 24g Fructus Broussonetiae 9g Radix Glycyrrhizae Preparata 10g Herba Epimedii 10g

Semen Cuscutae (system) 17g Radix Dipsaci 12g

The method of quality control of embodiment 6 pills

Differentiate: a. gets this product, and put microscopically and observe: the dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and dissolves; Hyphae colorless or light brown, diameter 4～6 μ m; The starch grain triangular shape is avette or square is circular, diameter 24～40 μ m, and omphalion short seam shape or herringbone shape parenchyma cell similar round have oval pit, integrated pit group; The parenchyma taupe brown is to dark brown, and the many shrinkages of cell include brown nuclear shape thing; Plant skin palisade cells 2 row, the outer row of interior row are long, and light line is arranged; It is faint yellow to plant the skin stone cell, the wavy bending of wall, and cell contains brown thing; Fiber bunchy or loose from, wall thickness, there is longitudinal crack on the surface, and two ends fragment into broom shape or more truncate, calcium oxalate cluster crystal diameter 24～68 μ m, the sharp point of corner angle;

B. get this product 9g, shred, add 7% vitriolic 45% alcoholic solution 45ml, reflux 1 hour is put coldly, filters, filtrate adds 60～90 ℃ of petroleum ether joltings and extracts 2 times, each 30ml merges petroleum ether liquid, water 10ml washing, discard cleaning mixture, it is an amount of that petroleum ether liquid adds anhydrous sodium sulfate, shakes up, and filters, filtrate is added on 100～200 orders of having handled well, 1.5g, on the internal diameter 1.5cm neutral alumina post, add methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Other gets Radix Ginseng control medicinal material 1g, shines medical material solution in pairs with legal system; Get panoxadiol, panaxatriol's reference substance again, add methanol and make the mixed solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned need testing solution 10 μ l, control medicinal material solution and reference substance solution, put respectively on same silica gel g thin-layer plate, with 5: 2 benzene-acetone was developing solvent, launched, and took out, dry, spray is with 30% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃, puts under the 365nm ultra-violet lamp and inspects; In the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color respectively;

C. get this product 9g, shred, add methanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 15ml makes dissolving, extracts 2 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butyl alcohol liquid, water 20ml washing discards cleaning mixture, n-butyl alcohol liquid evaporate to dryness, residue add methanol 1ml makes dissolving, and it is an amount of to add neutral alumina, mix thoroughly, evaporate to dryness is added on 100～200 orders, 2g, on the internal diameter 1cm neutral alumina post, with 1: 1 ethyl acetate-methanol mixed solution 40ml eluting, collect eluent, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

D. get and differentiate the neutral alumina post behind the eluting under the c item, with 40% methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Extracting liquorice control medicinal material 0.2g shines medical material solution in pairs with legal system in addition; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with 15: 1: 1: 2 ethyl acetates-formic acid-glacial acetic acid-water was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.Assay: measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D), chromatograph chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; 13: 87 acetonitrile-water is mobile phase; The detection wavelength is 230nm.Number of theoretical plate calculates by the peoniflorin peak should be not less than 4000.The preparation of reference substance solution: precision takes by weighing through 24 hours peoniflorin reference substance of phosphorus pentoxide drying under reduced pressure an amount of, adds 50% methanol and makes the solution that every 1ml contains 15 μ g, promptly.The preparation of need testing solution: get this product under the weight differential item, shred, mixing is got 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate Diluted Alcohol 25ml that adds, close plug claims to decide weight, floods 4 hours, supersound process 30 minutes is taken out, and puts cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with Diluted Alcohol, filter, get subsequent filtrate, promptly.Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.This product contains the Radix Paeoniae Alba with peoniflorin (C ₂₃H ₂₈O ₁₁) meter, the every 1g of small honey pill must not be less than 0.11mg; Big honey nine every balls must not be less than 1.0mg.

Claims

1, a kind of Chinese medicine composition is characterized in that this pharmaceutical composition is made up of following raw material medicaments:

Semen Cuscutae (system) 15-26 weight portion Radix Dipsaci 10-20 weight portion.

2, Chinese medicine composition as claimed in claim 1 is characterized in that this pharmaceutical composition is made up of following raw material medicaments:

Radix Ginseng 10.5 weight portion Poria 42.1 weight portion Radix Astragali Preparatas 42.1 weight portions

Rhizoma Alismatis 15.7 weight portion Semen Trigonellae 12.6 weight portion Herba Cistanches 7.8 weight portions

Semen Euryales 84.2 weight portion Radix Codonopsis 31.6 weight portion Radix Rehmanniae Preparata 31.6 weight portions

The Rhizoma Atractylodis Macrocephalae 15.7 weight portion Radix Paeoniae Albas (system) 15.7 weight portion Rhizoma Acori Graminei 7.8 weight portions

Rhizoma Cibotii 31.6 weight portion Radix Morindae Officinaliss 21 weight portion Rhizoma Dioscoreaes 31.6 weight portions

Herba Cynomorii 7.8 weight portion Semen Ziziphi Spinosaes 7.8 weight portion Fructus Amomi Rotunduss 4.1 weight portions

Fructus Lycii 31.6 weight portion Radix Polygoni Multiflori 21 weight portion Radix Angelicae Sinensis 21 weight portions

Fructus Broussonetiae 7.4 weight portion Radix Glycyrrhizae Preparatas 7.8 weight portion Herba Epimedii 7.8 weight portions

Semen Cuscutae 21 weight portion Radix Dipsacis 15.7 weight portions.

3,, it is characterized in that in this Chinese medicine composition that Rhizoma Alismatis preferably fries Rhizoma Alismatis, the preferred Semen Ziziphi Spinosae (parched) of Semen Ziziphi Spinosae, the preferred Herba Cistanches Deserticolae (processed) of Herba Cistanches, the preferred Rhizoma Atractylodis Macrocephalae of Rhizoma Atractylodis Macrocephalae system, the Radix Paeoniae Alba and preferably make the Radix Paeoniae Alba, the preferred Radix Morindae Officinalis (processed) of Radix Morindae Officinalis, the preferred lockmaking sun of Herba Cynomorii, Fructus Amomi Rotundus and preferably make Fructus Amomi Rotundus, Semen Cuscutae and preferably make Semen Cuscutae, the preferred Radix Polygoni Multiflori Preparata of Radix Polygoni Multiflori as claim 1,2 described Chinese medicine compositions.

4, Chinese medicine composition as claimed in claim 3 is characterized in that the preparation method of this Chinese medicine composition is: above 20 Six-element medical materials, and get the Radix Ginseng powder and be broken into fine powder; 25-component pulverizing medicinal materials such as all the other Rhizoma Alismatis become fine powder, sieve, and add above-mentioned fine powder, mixing, at last directly or add pharmaceutically acceptable excipient and make pill, tablet, oral liquid, capsule, granule through conventional operation.

5, Chinese medicine composition method of quality control as claimed in claim 3 is characterized in that discrimination method in this method comprises one or more in the following discriminating:

B. this composite preparation 9g shreds, and adds the vitriolic 40-50% alcoholic solution of 6-8% 45ml, reflux 1-2 hour, put coldly, filter, filtrate adds 60～90 ℃ of petroleum ether joltings extracts 2 times, each 30ml, merge petroleum ether liquid, water 10ml washing discards cleaning mixture, it is an amount of that petroleum ether liquid adds anhydrous sodium sulfate, shakes up, and filters, filtrate is added on the neutral alumina post of having handled well, adds methanol 40ml eluting, collects eluent, evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Other gets Radix Ginseng control medicinal material 1g, shines medical material solution in pairs with legal system; Get panoxadiol, panaxatriol's reference substance again, add methanol and make the mixed solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned need testing solution 10 μ l, control medicinal material solution and reference substance solution, put respectively on same silica gel g thin-layer plate, with 4-7: 1-3 benzene-acetone is developing solvent, launches, and takes out, dry, spray is with the 25-35% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 100-110 ℃, puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color respectively;

C. this composite preparation 9g shreds, and adds methanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 15ml makes dissolving, extracts 2 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butyl alcohol liquid, water 20ml washing discards cleaning mixture, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 1ml makes dissolving, it is an amount of to add neutral alumina, mixes evaporate to dryness thoroughly, be added on the neutral alumina post, use 1-2: 1-2 ethyl acetate-methanol mixed solution 40ml eluting, collect eluent, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 35-45: 3-6: 8-12: 0.1-0.5 chloroform-ethyl acetate-methanol-formic acid is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

D. get and differentiate the neutral alumina post behind the eluting under the c item, with 35-45% methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Extracting liquorice control medicinal material 0.2g shines medical material solution in pairs with legal system in addition; Test according to thin layer chromatography, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with 10-20: 1-2: 1-2: 1-3 ethyl acetate-formic acid-glacial acetic acid-water is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.

6, Chinese medicine composition method of quality control as claimed in claim 5, the discrimination method that it is characterized in that pill comprises one or more in the following discriminating:

A. get pill, put microscopically and observe: the dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and dissolves; Hyphae colorless or light brown, diameter 4～6 μ m; The starch grain triangular shape is avette or square is circular, diameter 24～40 μ m, and omphalion short seam shape or herringbone shape parenchyma cell similar round have oval pit, integrated pit group; The parenchyma taupe brown is to dark brown, and the many shrinkages of cell include brown nuclear shape thing; Plant skin palisade cells 2 row, the outer row of interior row are long, and light line is arranged; It is faint yellow to plant the skin stone cell, the wavy bending of wall, and cell contains brown thing; Fiber bunchy or loose from, wall thickness, there is longitudinal crack on the surface, and two ends fragment into broom shape or more truncate, calcium oxalate cluster crystal diameter 24～68 μ m, the sharp point of corner angle;

B. get pill 9g, shred, add 7% vitriolic 45% alcoholic solution 45ml, reflux 1 hour is put coldly, filters, filtrate adds 60～90 ℃ of petroleum ether joltings and extracts 2 times, each 30ml merges petroleum ether liquid, water 10ml washing, discard cleaning mixture, it is an amount of that petroleum ether liquid adds anhydrous sodium sulfate, shakes up, and filters, filtrate is added on 100～200 orders of having handled well, 1.5g, on the internal diameter 1.5cm neutral alumina post, add methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Other gets Radix Ginseng control medicinal material 1g, shines medical material solution in pairs with legal system; Get panoxadiol, panaxatriol's reference substance again, add methanol and make the mixed solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned need testing solution 10 μ l, control medicinal material solution and reference substance solution, put respectively on same silica gel g thin-layer plate, with 5: 2 benzene-acetone was developing solvent, launched, and took out, dry, spray is with 30% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃, puts under the 365nm ultra-violet lamp and inspects; In the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color respectively;

C. get pill 9g, shred, add methanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 15ml makes dissolving, extracts 2 times with water saturated n-butyl alcohol jolting, each 20ml, merge n-butyl alcohol liquid, water 20ml washing discards cleaning mixture, n-butyl alcohol liquid evaporate to dryness, residue add methanol 1ml makes dissolving, and it is an amount of to add neutral alumina, mix thoroughly, evaporate to dryness is added on 100～200 orders, 2g, on the internal diameter 1cm neutral alumina post, with 1: 1 ethyl acetate-methanol mixed solution 40ml eluting, collect eluent, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;

D. get and differentiate the neutral alumina post behind the eluting under the c item, with 40% methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Extracting liquorice control medicinal material 0.2g shines medical material solution in pairs with legal system in addition; Test according to thin layer chromatography, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with 15: 1: 1: 2 ethyl acetates-formic acid-glacial acetic acid-water was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.

7, Chinese medicine composition method of quality control as claimed in claim 3, it is characterized in that the content assaying method in this method is: according to high effective liquid chromatography for measuring, chromatograph chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; 10-15: the 80-90 acetonitrile-water is a mobile phase; The detection wavelength is 230nm, number of theoretical plate calculates by the peoniflorin peak should be not less than 4000, the preparation of reference substance solution: precision takes by weighing through 22-26 hour peoniflorin reference substance of phosphorus pentoxide drying under reduced pressure an amount of, adds 45-55% methanol and makes the solution that every 1ml contains 15 μ g, promptly; The preparation of need testing solution: get this product under the weight differential item, shred, mixing is got 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate Diluted Alcohol 25ml that adds, close plug claims to decide weight, floods 4 hours, supersound process 30 minutes is taken out, and puts cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with Diluted Alcohol, filter, get subsequent filtrate, promptly; Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly; This product contains the Radix Paeoniae Alba in peoniflorin, and the per unit amount must not be less than 0.8-1.2mg.

8, Chinese medicine composition method of quality control as claimed in claim 7, it is characterized in that the content assaying method of pill is: with octadecylsilane chemically bonded silica is filler; 13: 87 acetonitrile-waters are mobile phase; The detection wavelength is 230nm.Number of theoretical plate calculates by the peoniflorin peak should be not less than 4000.The preparation of reference substance solution: precision takes by weighing through 24 hours peoniflorin reference substance of phosphorus pentoxide drying under reduced pressure an amount of, adds 50% methanol and makes the solution that every 1ml contains 15 μ g, promptly.The preparation of need testing solution: get this product under the weight differential item, shred, mixing is got 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate Diluted Alcohol 25ml that adds, close plug claims to decide weight, floods 4 hours, supersound process 30 minutes is taken out, and puts cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with Diluted Alcohol, filter, get subsequent filtrate, promptly.Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.This product contains the Radix Paeoniae Alba in peoniflorin, and the every 1g of small honey pill must not be less than 0.11mg; The every ball of big honeyed pills must not be less than 1.0mg.

9, the method for quality control of drug combination preparation as claimed in claim 3 comprises the steps:

Differentiate: this composite preparation of a., put microscopically and observe: the dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and dissolves; Hyphae colorless or light brown, diameter 4～6 μ m; The starch grain triangular shape is avette or square is circular, diameter 24～40 μ m, and omphalion short seam shape or herringbone shape parenchyma cell similar round have oval pit, integrated pit group; The parenchyma taupe brown is to dark brown, and the many shrinkages of cell include brown nuclear shape thing; Plant skin palisade cells 2 row, the outer row of interior row are long, and light line is arranged; It is faint yellow to plant the skin stone cell, the wavy bending of wall, and cell contains brown thing; Fiber bunchy or loose from, wall thickness, there is longitudinal crack on the surface, and two ends fragment into broom shape or more truncate, calcium oxalate cluster crystal diameter 24～68 μ m, the sharp point of corner angle;

D. get and differentiate the neutral alumina post behind the eluting under the c item, with 35-45% methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Extracting liquorice control medicinal material 0.2g shines medical material solution in pairs with legal system in addition; Test according to thin layer chromatography, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with 10-20: 1-2: 1-2: 1-3 ethyl acetate-formic acid-glacial acetic acid-water is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;

Assay: with octadecylsilane chemically bonded silica is filler; 10-15: the 80-90 acetonitrile-water is a mobile phase; The detection wavelength is 230nm, number of theoretical plate calculates by the peoniflorin peak should be not less than 4000, the preparation of reference substance solution: precision takes by weighing through 22-26 hour peoniflorin reference substance of phosphorus pentoxide drying under reduced pressure an amount of, adds 45-55% methanol and makes the solution that every 1ml contains 15 μ g, promptly; The preparation of need testing solution: get this product under the weight differential item, shred, mixing is got 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate Diluted Alcohol 25ml that adds, close plug claims to decide weight, floods 4 hours, supersound process 30 minutes is taken out, and puts cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with Diluted Alcohol, filter, get subsequent filtrate, promptly; Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly; This product contains the Radix Paeoniae Alba in peoniflorin, and the per unit amount must not be less than 0.8-1.2mg.

10, the method for quality control of drug combination preparation as claimed in claim 9 is characterized in that the method for quality control of pill comprises the steps:

Differentiate: a. gets pill, and put microscopically and observe: the dendritic agglomerate of irregular branch is colourless, meets chloral hydrate liquid and dissolves; Hyphae colorless or light brown, diameter 4～6 μ m; The starch grain triangular shape is avette or square is circular, diameter 24～40 μ m, and omphalion short seam shape or herringbone shape parenchyma cell similar round have oval pit, integrated pit group; The parenchyma taupe brown is to dark brown, and the many shrinkages of cell include brown nuclear shape thing; Plant skin palisade cells 2 row, the outer row of interior row are long, and light line is arranged; It is faint yellow to plant the skin stone cell, the wavy bending of wall, and cell contains brown thing; Fiber bunchy or loose from, wall thickness, there is longitudinal crack on the surface, and two ends fragment into broom shape or more truncate, calcium oxalate cluster crystal diameter 24～68 μ m, the sharp point of corner angle;

D. get and differentiate the neutral alumina post behind the eluting under the c item, with 40% methanol 40ml eluting, collect eluent, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Extracting liquorice control medicinal material 0.2g shines medical material solution in pairs with legal system in addition; Test according to thin layer chromatography, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on the silica gel g thin-layer plate of same usefulness 0.5% sodium hydroxide solution preparation, with 15: 1: 1: 2 ethyl acetates-formic acid-glacial acetic acid-water was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color; Assay: with octadecylsilane chemically bonded silica is filler; 13: 87 acetonitrile-waters are mobile phase; The detection wavelength is 230nm.Number of theoretical plate calculates by the peoniflorin peak should be not less than 4000.The preparation of reference substance solution: precision takes by weighing through 24 hours peoniflorin reference substance of phosphorus pentoxide drying under reduced pressure an amount of, adds 50% methanol and makes the solution that every 1ml contains 15 μ g, promptly.The preparation of need testing solution: get this product under the weight differential item, shred, mixing is got 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate Diluted Alcohol 25ml that adds, close plug claims to decide weight, floods 4 hours, supersound process 30 minutes is taken out, and puts cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with Diluted Alcohol, filter, get subsequent filtrate, promptly.Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly.This product contains the Radix Paeoniae Alba in peoniflorin, and the every 1g of small honey pill must not be less than 0.11mg; The every ball of big honeyed pills must not be less than 1.0mg.

11, the application of pharmaceutical composition as claimed in claim 3 in the deficient card medicine of the preparation treatment traditional Chinese medical science.

12,, it is characterized in that in preparation treatment " deficiency of both QI and blood " " nephrasthenia syndrome ", " spleen deficiency of kidney-QI, uncontrol of the urinary bladder card ", the application in the medicine of " impairment caused by overstrain spleen kidney, gas is the consolidating semen card not " as application as described in the claim 11.