CN1579535A - Medicinal composition for auxiliary treatment of asthenia healthy qi and its quality control method - Google Patents
Medicinal composition for auxiliary treatment of asthenia healthy qi and its quality control method Download PDFInfo
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Abstract
The invention discloses a medicine compound for curing 'energy weak' and its quality control method. The compound is made up of glossy ganoderma fungus dried powder, mushroom extractive plaster powder, vitamin B6, ginseng powder. At the same time, the invention also provides a quality control method for ingredient incrimination, content measurement of the compound. The compound has function of body strengthening, and fatigue relieving.
Description
Invention field
The present invention relates to a kind of pharmaceutical composition, particularly be used for the pharmaceutical composition of auxiliary treatment " deficiency of vital QI " card, relate to the method for quality control of said composition simultaneously.
Background technology
Chinese medicine thinks that " healthy energy " has a very important role to human body, and Chinese classical doctor nationality (difficult through) is pointed out: " the gas person, the people at all also." " deficiency of vital QI " can cause a lot of diseases, many diseases " deficiency of vital QI card " can occur in evolution takes place.Though it is sick inequality, because " syndrome " performance is identical substantially, can adopt identical method of treatment, the traditional Chinese medical science said " treating different diseases with the same therapeutic principle " just, as diseases such as chronic bronchitis, asthma, neurasthenia, insomnia, inappetence, leukopenia, all appearance " syndrome of deficiency of QI " (containing insufficiency of lung-QI, deficiency of spleen-QI, asthenia of pulmonosplenic qi card) person all can use the present invention to carry out auxiliary treatment.
Summary of the invention
One object of the present invention is to disclose the pharmaceutical composition that a kind of new auxiliary treatment " deficiency of vital QI " is demonstrate,proved; Another object of the present invention is to disclose a kind of method of quality control of drug combination preparation of new auxiliary treatment " deficiency of vital QI " card.
The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):
Ganderma lucidum dry powder 60-150 weight portion mushroom extract powder 150-250 weight portion
Vitamin B
61-5 weight portion Radix Ginseng powder 60-150 weight portion.
Press practice of pharmacy, compositions of the present invention can be added adjuvant and be prepared into the various clinical pharmaceutical dosage form, comprise any in tablet, capsule, pill, suspensoid, drop pill, the oral liquid.
Described adjuvant is meant conventional excipient, as solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent etc.
The method of quality control that the present composition is made medicament comprises discriminating and/or assay:
Discrimination method comprises a kind of and/or several in the following method:
A. get present composition tablet, put microscopically and observe, calcium oxalate cluster crystal is arranged, diameter 20-68 μ m, the sharp point of corner angle; B. get 1 in present composition tablet, remove film-coat, porphyrize adds water 40ml, grinds, and filters, and gets filtrate 2ml, adds the about 2mg of 1,2,3-indantrione monohydrate, shakes up to put in the water-bath to heat the solution displaing amaranth about 5 minutes; C. get 1 in present composition tablet, remove film-coat, porphyrize, add 20% sodium acetate solution 5ml, grind, filter, filtrate splits in two test tubes of first, second, add water 1ml in the first pipe, add 4% boric acid solution 1ml in the second pipe, mixing, each rapid chlorination imido grpup-2,6-Phygon test solution 1ml, first Guan Zhongxian is dirty green, changes rufous after a few minutes into; Do not show dirty green in the second pipe;
Assay: comprise a kind of and/or several (measuring) in the following method: a. ginsenoside Rb according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2000)
1: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (15: 85)-(50: 50) gradient (0-15 minute) is a mobile phase; Column temperature 25-35 ℃; Flow velocity is per minute 1ml, and detecting wavelength 0-8 minute was 350nm, and 8-15 minute is 203nm; Number of theoretical plate is by ginsenoside Rb
1The peak calculates should be not less than 4000; Algoscopy: get 20 in present composition tablet, remove film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision takes by weighing in right amount (being equivalent to 2.5 approximately), puts in the tool plug conical flask, the accurate 45-55% methanol 20-30ml that adds, supersound process 30-50 minute, centrifugal, get supernatant, as need testing solution; Precision takes by weighing ginsenoside Rb in addition
1Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 0.1mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every in present composition tablet contains ginsenoside Rb
1(C
54H
92O
23) must not be less than 0.08mg; B. vitamin B
6: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Methanol: 0.05mol/L potassium dihydrogen phosphate 10-25: 80-90 is a mobile phase; The detection wavelength is 290nm; Number of theoretical plate is pressed vitamin B
6The peak calculates should be not less than 2500; Algoscopy is got 20 in present composition tablet, removes film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision takes by weighing in right amount, is equivalent to 1.25 approximately, puts in the tool plug conical flask, the accurate 50% methanol 25ml that adds, shake well was placed 10 minutes, got solution centrifugal, get supernatant, as need testing solution; Precision takes by weighing vitamin B in addition
6Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 1.0mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every in present composition tablet contains the rope B that supports one's family
6(C
8H
11NO
3HCl) must not be less than 1.601.80mg.
Described method of quality control is applicable to the various dosage forms that comprise tablet, and is suitable on the contained raw material dose of used dosage of each dosage form and above-mentioned tablet amounts; Every suitable crude drug 1.2g of described tablet.
Present composition preparation has health invigorating, and the effect of relieving fatigue has good effect to card such as chronic bronchitis, asthma, chronic hepatitis, neurasthenia, insomnia, inappetence, leukopenia " deficiency of vital QI " auxiliary treatment.
Following experimental example is used to further specify the present invention.Below experiment is the clever sheet of ginseng dimension with present composition preparation.
Experimental example to body weakness with emaciation in the chronic disease a little less than, the auxiliary treatment effect of positive QI-insufficiency syndrome
For investigating present composition preparation to the auxiliary treatment effect of chronic bronchitis, asthma, chronic hepatitis, neurasthenia, insomnia, inappetence, leukopenia etc. and to the safety of human body, we select to meet in the above-mentioned chronic disease weak, the positive QI-insufficiency syndrome type patient of traditional Chinese medical science body weakness with emaciation and observe.To the calendar year 2001 December, adopt the method for single blind controlled trial at random from JIUYUE, 2000, cumulative observation patient 450 examples, 300 examples are organized in treatment, matched group 150 examples.Wherein syndrome of deficiency of lung qi 180 examples comprise chronic bronchitis (chronic persistence, clinical relieving period) 90 examples, and 60 examples are organized in treatment, matched group 30 examples, and bronchial asthma (catabasis) 90 examples, 60 examples are organized in treatment, matched group 30 examples, the contrast medicine is ganoderma particles; Syndrome of deficiency of spleen qi (chronic persistent, chronic active hepatitis) 90 examples, 60 examples are organized in treatment, matched group 30 examples, the contrast medicine is a Ganoderma Radix Astragali sheet; Syndrome of deficiency of both heart and spleen (neurasthenia have a sleepless night card) 90 examples, 60 examples are organized in treatment, matched group 30 examples, the contrast medicine is a Ganoderma Radix Astragali sheet; Syndrome of deficiency of QI (leukopenia) 90 examples, 60 examples are organized in treatment, matched group 30 examples, the contrast medicine is the stilbene jujube granules.Now the result is summarized as follows.
Physical data
It is each clinical trial unit's outpatient service and partial hospitalization patient that this clinical verification is observed.Observe 450 routine patients altogether, wherein 300 examples are organized in treatment, matched group 150 examples.Be through agreeing the volunteer.All case meets the case choice criteria.Sex sees Table 1.
Table 1 is respectively organized patient's sex and is distributed relatively
Routine matched group is organized in treatment
Syndrome example number
Man (%) woman (%) number man (%) woman (%)
Syndrome of deficiency of lung qi 120 75 (62.50) 45 (37.50) 60 37 (61.67) 23 (38.33)
Syndrome of deficiency of spleen qi 60 34 (56.67) 26 (43.33) 30 20 (66.67) 10 (33.33)
Syndrome of deficiency of both heart and spleen 60 19 (31.67) 41 (68.33) 30 12 (40.00) 18 (60.00)
Syndrome of deficiency of QI 60 27 (45.00) 33 (55.00) 30 15 (50.00) 15 (50.00)
Through x
2Check, each is organized patient's sex and distributes relatively no difference of science of statistics P＞0.05.
Two, the age, see Table 2.
Table 2 respectively organize patient age (year) distribute relatively
Example treatment group matched group
Syndrome
The example number
Several 18～30～50～65 18～30～50～65
Syndrome of deficiency of lung qi 120 23 43 54 60 15 21 24
Syndrome of deficiency of spleen qi 60 8 38 14 30 5 17 8
Syndrome of deficiency of both heart and spleen 60 10 21 29 30 3 11 16
Syndrome of deficiency of QI 60 16 26 18 30 8 11 11
Through the Ridit check, each is organized patient age and distributes relatively no difference of science of statistics P＞0.05.
Three, the course of disease sees Table 3.
Table 3 is respectively organized patient's course of disease and is distributed relatively
Treatment group matched group
Syndrome example number
The example number
≤ March～1 year＞1 year≤March～1 year＞1 year
Syndrome of deficiency of lung qi 120 26 52 42 60 16 23 21
Syndrome of deficiency of spleen qi 60 5 16 39 30 2 10 18
Syndrome of deficiency of both heart and spleen 60 12 26 22 30 4 17 9
Syndrome of deficiency of QI 60 23 25 12 30 10 13 7
Through the Ridit check, each is organized patient's course of disease and distributes relatively no difference of science of statistics P＞0.05.
Four, clinical symptoms sees Table 4.
Table 4 a liang group clinical symptoms weight distributes relatively
Routine matched group is organized in treatment
Symptom example number
Gently do not have in the light numerous heavy in heavy
Lack of appetite poor appetite 287 55 126 106 13 145 33 53 59 5
Spiritlessness and sparing of words 272 68 112 92 28 134 33 54 47 16
Fatigue and asthenia 297 78 113 106 3 148 42 57 49 2
Aversion to wind fear of cold 117 23 44 50 63 56 14 19 23 34
The spontaneous perspiration 120 26 46 48 60 60 14 26 20 30 of breathing hard
Easy catching a cold 134 22 60 52 46 63 14 25 24 27
Dizzy weak breath 269 52 90 127 31 131 25 41 65 19
Insomnia and dreamful sleep 85 20 41 24 35 46 13 20 13 14
Palpitation and amnesia 82 18 36 28 38 40 7 16 17 20
Through the Ridit check, two groups of patient's clinical symptoms weights distribute relatively no difference of science of statistics P＞0.05.
Five, tongue, pulse condition see Table 5.
Table 5 liang group patient tongue, pulse condition distribute relatively
Tongue, pulse condition treatment group matched group
Pale tongue 300 150
Moderate pulse is thin by 109 55
Thready and weak pulse 191 95
Through x
2Check, two groups of patient's tongues, pulse conditions distribute relatively no difference of science of statistics P＞0.05.
Six, the sick kind sees Table 6.
Each sick kind of table 6 liang group distributes relatively
The chronic bronchial leukocyte god decline
Group example number
Chronic hepatitis
Bronchitis asthma reduces the card insomnia
Treatment organizes 300 60 60 60 60 60
Matched group 150 30 30 30 30 30
Through the Ridit check, two groups of sick kinds of patient distribute relatively no difference of science of statistics P＞0.05.
Seven, the preceding two groups of leukocyte measured values of leukopenia treatment relatively see Table 7.
The preceding two groups of leukocyte measured values comparison of table 7 treatment (x ± S)
Group example number WBC (X10
9/ L)
Treatment organizes 60 3.12 ± 0.52
Matched group 30 3.25 ± 0.44
Through the t check, the total white blood cells measured value compares no difference of science of statistics P＞0.05 in two groups of preceding peripheral bloods of leukopenia patient treatments.
By above statistical analysis as seen, two groups of patients have comparability at aspect no difference of science of statistics such as sex, age, the course of disease, symptom weight, the distributions of sick kind.
Test method
One, case choice criteria (reference " new Chinese medicine clinical research guideline " 1993, first volume) Western medicine diagnose and Chinese medical discrimination standard are chronic
(1) bronchitis (chronic persistence, clinical relieving period)
1, Western medicine diagnose standard
(1) clinically with cough, to cough up phlegm be cardinal symptom or with panting, annual morbidity continues 3 months, and continuous 2 years with on one.(2) get rid of have cough, other disease of the symptom of coughing up phlegm, pant (as pulmonary tuberculosis, pneumoconiosis, pulmonary abscess, bronchial asthma, bronchiectasis, heart disease, cardiac insufficiency, chronic naso-pharynageal disease etc.).(3) simple type: meet the chronic bronchitis diagnostic criteria, have cough, 2 symptoms of coughing up phlegm.(4) type of panting: meet the chronic bronchitis diagnostic criteria, have the symptom of panting, and often or repeatedly wheezing sound occurs.(5) chronic persistence: patient has coughing in various degree, expectorant, asthma shape, protracted course of disease; Or the acute attack stage symptom does not return to the preceding level of outbreak yet after 1 month.(6) clinical relieving period: patients undergo treatment or natural remission, it is slight that symptom is not enough, can keep more than 2 months.
2, Chinese medical discrimination standard
Insufficiency of lung-QI: sick sending out often to cough, it is unable to cough sound, and amount of expectoration is few, hyperhidrosis, aversion to wind, easy catching a cold, body of the tongue is normal or light slightly, thin white fur of tongue, stringy and thready pulse or slow thin.
3, test case standard
(1) includes the case standard in: meet chronic bronchitis (chronic persistence, clinical relieving period) diagnosis and Chinese medical discrimination standard person, can include the test case in.(2) get rid of the case standard: 1. acute episode of chronic bronchitis phase patient, Chinese medical discrimination belong to cold and heat phlegm dyspnea excess syndrome person.2. confirm on inspection by the patient that pants of the chronic cough due to the factors such as tuberculosis, fungus, tumor, irritative gas allergy.3. the concurrent severe cardiac of chronic bronchitis functional defect person.
(2) bronchial asthma (catabasis)
1, Western medicine diagnose standard
(1) diagnosis of bronchial asthma mainly relies on medical history and sign, and gets rid of and can cause asthma or dyspneic other disease.(2) symptom feature: the outbreak of 1. panting maybe can be reviewed relevant with certain allergic effect source or stimulating factor; Pant when 2. often tranquillization being arranged, then cough suddenly; Small number of patients has slight cough before the outbreak of panting; 3. inhale the people with bronchodilator atomizing,, then can improve or end to pant as 1% isoproterenol or 0.2% salbutamol.
2, Chinese medical discrimination standard
Deficiency of the lung card: fear of cold, spontaneous perspiration, the complexion rolling is white, shortness of breath and low voice, flu is very easily whenever brought out light red tongue, white and thin fur, thready and weak pulse because of climate change.
3, test case standard
(1) includes the case standard in: meet primary disease (catabasis) diagnosis and dialectical standard person and can include the test case in.(2) get rid of the case standard: 1. acute bronchial asthma patient; Chinese medical discrimination belongs to cold and heat heavy breathing excess syndrome person.2. can cause asthma or dyspneic other disease patient.
(3) chronic hepatitis
1, Western medicine diagnose standard
(1) chronic delay hepatitis: have and make a definite diagnosis or suspicious acute hepatitis medical history, the course of disease surpasses the half a year of not recovery from illness as yet, the state of an illness is lighter, pain in the hepatic region and weak can be arranged, SGPT rising or slight liver function infringement can be arranged and not enough diagnosing chronic active hepatitis person, or the liver biopsy meets the Histological change of chronic persistent hepatitis, and all diagnosable is chronic persistent hepatitis.(2) chronic active hepatitis: 1. symptom: previously the hepatitis history is arranged, significantly hepatitis symptom is arranged at present, as weak, appetite is poor, abdominal distention, loose stool etc.2. sign: hepatomegaly more than the quality medium hardness, can have jaundice, spider angioma, hepatic facies, liver palm or splenomegaly, and get rid of other reason person.3. lab testing: SGPT repeatedly or continue to raise, or plasma albumin obviously reduces, or white/the globulin ratio is obviously unusual, or gamma globulin obviously raises, or SB is prolonged and repeated increases.
More than 3 positive, or 2. 3. two positive.Or the liver biopsy meets the person of Histological change of chronic active hepatitis, and all diagnosable is chronic active hepatitis.
2, Chinese medical discrimination standard
Is main performance with the deficiency of spleen-QI, disease is seen: fatigue and asthenia, and poor appetite, abdominal distention sometimes, the loose stool, or nauseating gastral cavity is vexed, tastelessness, pale tongue, white and thin fur, weak pulse.
3, test case standard
(1) includes the case standard in
Meet diagnosis of chronic persistent hepatitis or chronic active hepatitis and Chinese medical discrimination standard person, can include the test case in.(2) get rid of the case standard: 1. confirm on inspection by the hepatitis due to the factors such as drug intoxication, ethylism.2. acute hepatitis, Severe Viral Hepatitis, cholestatic hepatitis.3. Chinese medical discrimination belongs to excess syndrome, heat syndrome persons such as damp and hot, irritability stasis, excessive noxious heat.
(4) anypnia induced by nervous prostration
1, diagnostic criteria (with reference to Chinese mental sickness classification schemes and diagnostic criteria)
(1) classical symptom of insomnia is arranged: difficulty falling asleep, awakening often, sleep and unstable or wake up after can not sleep again, wake up morning too early; Can not fall asleep night, daytime lethargic and drowsy state; Do not have enough sleep 5 hours, the back sense of waking up is uncomfortable, and is tired or daytime is sleepy.(2) above-mentioned sleep disorder takes place weekly 3 times at least, and more than one month; It or not the part of any physical disease or mental disorder symptom.
2, Chinese medical discrimination standard
Deficiency of both the heart and spleen: insomnia and dreamful sleep, palpitation and amnesia, physical fatigue and lassitude of spirit, the food poor appetite is few, lustreless complexion, soft stool, pale tongue, corpulent tongue, white and thin fur, thready and weak pulse.
3, test case standard
(1) includes the case standard in: 1. have the insomnia classical symptom, meet above-mentioned diagnostic criteria and Chinese medical discrimination standard person.2. the course of disease continues person more than 1 month.(2) get rid of the case standard: though 1. have the classical symptom of neurasthenia's insomnia, Chinese medical discrimination belongs to excess syndrome person such as disturbs in pathogenic fire derived from stagnation of liver-QI or the expectorant heat.2. every systemic disease such as pain, heating, cough, operation etc., and external interference factor causer.3. excessive drinking and/or psychoactive drug substance, drug abuser and dependent (containing the medicine of sleeping peacefully) leukopenia.
(5) leukopenia
1, Western medicine diagnose standard (publishing) with reference to " practical internal medicine " People's Health Publisher
(1) the peripheral blood numeration of leukocyte continues to be lower than every cubic millimeter below 4,000.Be everlasting every cubic millimeter 2,000-4 is between 000.The neutrophilic granulocyte ratio is normal or slight to be reduced, and hemoglobin content and platelet count are normal.(2) because of chemicals or physical factor reach due to the q.s, as long-term contact benzene, arsenic preparation, ionizing radiation, X line and radioactive substance, the some drugs reaction, tumour patient is put, chemotherapeutic period, or agnogenic leukopenia.(3) patient can be asymptomatic, or nonspecific symptoms such as easy appearance is tired, weak, loss of appetite, low grade fever, sleep difference.General no special positive sign.(4) other causes leukopenic disease except, as aplastic anemia, agranulocytosis, hypersplenism, immune disease, leukemia etc.
2, Chinese medical discrimination standard
Syndrome of deficiency of QI: fatigue and asthenia, deficiency of QI with disinclination to talk, the poor appetite lack of appetite, dizziness, the complexion rolling is white, easy catching a cold, pale tongue, white and thin fur, deficient pulse is unable.
3, test case standard
(1) includes the case standard in: meet diagnosis of this disease and Chinese medical discrimination standard and get rid of other systemic disease person, can include the test case in.(2) get rid of the case standard: 1. by other as aplastic anemia, agranulocytosis, the disease of the pancytopenia that hypersplenism, PNH cause.2. secondary infection person is as oral cavity, throat, skin or respiratory tract infection person.Above-mentioned disease " get rid of case standard " is in (comprising incompatibility or rejecting standard), must get rid of followingly, can include the test case in.1. gestation or women breast-feeding their children are to this medicine allergy sufferers at under-18s or over-65s the age.2. be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, the psychotic.
3. all standards of including in that do not meet, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.
Two, observational technique
Meet the case standard of including in, through agreeing to cooperate clinical observation.Adopt single blind simple randomization grouping, divide treatment group and matched group.Observing 30 days is a course of treatment.If 300 examples are organized in treatment, matched group 150 examples.Wherein:
60 routine matched groups (ganoderma particles), 30 examples are organized in chronic the scorching treatment of gas pail
60 routine matched groups (ganoderma particles), 30 examples are organized in the bronchial asthma treatment
60 routine matched groups (stilbene jujube granules), 30 examples are organized in the leukopenia treatment
60 routine matched groups (Ganoderma Radix Astragali sheet), 30 examples are organized in the anypnia induced by nervous prostration treatment
Chronic hepatitis treatment group 60 routine matched groups (Ganoderma Radix Astragali sheet) 30 examples
Observe medicine, the medicinal method consumption of contrast: the treatment group: the clever sheet of ginseng dimension, oral, each 4, every day 3 times.Matched group: 1. ganoderma particles, take after mixing it with water each 10 grams, every day 3 times.2. the stilbene jujube granules is taken after mixing it with water, each 15 grams, every day 3 times.3. Ganoderma Radix Astragali sheet is oral, and each 5, every day 3 times.
Observe in hospital or under the outpatient service condition, outpatient service is observed and is noted the control variable factor, remove chronic hepatitis and can take medicines such as protecting the liver, fall enzyme simultaneously, tumour patient is put in the leukopenia, chemotherapeutics can continue to use and record faithfully outside, must not use with curative or contrast the similar other medicines of medicine effect.
(1) observation index
1, safety is observed
(1) general health check-up project
(2) blood, urine, just routine test
(3) liver (ALT), kidney (BUN) functional check, Electrocardioscopy.Respectively at observing beginning and observing when finishing and respectively check once.
(4) untoward reaction.Note observing in detail, at any time record.Comprise untoward reaction (should specifically describe), reacting generating time, the extent of reaction, whether need drug withdrawal, whether need to handle and processing method etc.And judge relation between untoward reaction and the medicine, as relevant, probably relevant, may be relevant, irrelevant, can not wait certainly, make an appraisal with regard to this medicine safety.By observation doctor itemized record, and signature.
Above-mentioned disease meets traditional Chinese medical science insufficiency of lung-QI deficiency of spleen-QI, deficiency of both the heart and spleen, the dialectical standard of syndrome of deficiency of QI, according to the classification of primary symptom weight.(grade scale is drafted with reference to " new Chinese medicine treatment syndrome of spleen-deficiency (grade) clinical research guideline ")
Primary symptom weight grade scale:
(++) light (+) in the primary symptom heavy (+++)
The lack of appetite poor appetite does not have appetite, and appetite reduces no appetite more than 2/3, and appetite is poorer than reducing by 1/3 appetite before sick, or feels dull, but keeps former appetite
Spiritlessness and sparing of words spirit is tired, drowsy, few speech spirit is tired, be disinclined to speech, asks that answering spirit less owes to shake more, is not good at polylogia, pays no attention to and do not answer
Fatigue and asthenia myasthenia of limbs, not competent work asthenia more very, not anti-lasting work is tired slightly, and is easily tired, but can be competent at a job
The aversion to wind fear of cold is timid cold, need add the clothing aversion to wind and does not add the clothing micro evil wind
The spontaneous perspiration of breathing hard all has repeatedly every day, and often having then appears in the activity of pausing, and during light activity there is not obvious idol
Easy catching a cold often has once in a while sometimes and has
Insomnia and dreamful sleep 〉=5 time/3 ~ 5 times/week of week (3 times/week
Dizzy weak breath often has once in a while sometimes and has
Palpitation and amnesia often has once in a while sometimes and has
2. health giving quality is observed
(1) insufficiency of lung-QI primary symptom, tongue, arteries and veins change.
(2) deficiency of spleen-QI primary symptom, tongue, arteries and veins change.
(3) deficiency of both the heart and spleen primary symptom, tongue, arteries and veins change.
(4) syndrome of deficiency of QI primary symptom, tongue, arteries and veins change.
(2) curative effect determinate standard
Clinical recovery: symptomatology disappears.
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.
Effectively: 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.
Invalid: symptom does not have the improvement or the person of increasing the weight of.
The result
One, total effects sees Table 8 and figure below.
Table 8 liang group total effects relatively
Group example number clinical recovery (%) produce effects (%) is (%) invalid (%) total effective rate (%) effectively
Treatment organizes 300 57 (19.00) 98 (32.67) 108 (36.00) 37 (12.33) 87.67
Matched group 150 21 (14.00) 42 (28.00) 52 (34.67) 35 (23.33) 76.67
Through the Ridit check, two groups of treatment back deficiency of vital QI card curative effects compare no difference of science of statistics P＞0.05.
Two, respectively demonstrate,prove curative effect relatively for two groups, see Table 9.
Table 9 liang group is respectively demonstrate,proved curative effect relatively
Example treatment group total effective rate example matched group total effective rate
Disease
Number clinical recovery produce effects enabledisable (%) number clinical recovery produce effects enabledisable (%)
Syndrome of deficiency of lung qi 120 22 33 46 19 84.16 60 7 12 23 18 70.00
Syndrome of deficiency of spleen qi 60 11 27 16 3 95.00 30 4 10 10 6 80.00
Syndrome of deficiency of both heart and spleen 60 11 25 19 5 91.66 30 5 11 10 4 86.66
Syndrome of deficiency of QI 60 10 13 27 10 83.33 30 5997 76.67
Through the Ridit check, syndrome of deficiency of lung qi, syndrome of deficiency of spleen qi treatment group and matched group relatively have significant difference P＜0.05; Syndrome of deficiency of both heart and spleen, syndrome of deficiency of QI treatment group and matched group compare, no difference of science of statistics P＞0.05.
Three, two groups of symptom curative effects relatively see Table 10.
Table 10 liang group symptom curative effect relatively
Treatment group total effective rate example matched group
Symptom example number total effective rate (%)
The effective no change of the effective no change of disappearance produce effects (%) number disappearance produce effects
Lack of appetite poor appetite 287 91 84 97 15 94.77 145 20 40 58 27 81.37
Spiritlessness and sparing of words 272 70 83 102 17 93.75 134 24 40 48 22 83.58
Fatigue and asthenia 297 82 99 98 18 93.93 148 24 40 52 32 78.37
Aversion to wind fear of cold 117 28 37 42 10 91.45 56 7 11 26 12 78.57
The spontaneous perspiration 120 22 33 46 19 84 16 60 7 12 23 18 70.00 of breathing hard
Easy catching a cold 134 28 38 50 18 86.56 63 8 13 25 17 73.01
Dizzy weak breath 269 62 87 91 29 89.21 131 24 45 10 22 83.20
Insomnia and dreamful sleep 85 14 31 34 6 92.94 46 5 18 19 4 91.30
Palpitation and amnesia 82 11 26 38 7 91.46 40 4 13 17 6 85.00
Through the Ridit check, the treatment group compares the curative effect and the matched group of symptoms such as lack of appetite poor appetite, fatigue and asthenia, aversion to wind fear of cold, the spontaneous perspiration of breathing hard, easy catching a cold, and significant difference P＜0.05 is arranged; Curative effect to all the other symptoms compares no difference of science of statistics P＞0.05 for two groups.
Four, two groups of different course of disease curative effects relatively see Table 11.
The table 11 liang different course of disease curative effects of group relatively
Treatment group matched group
Example total effective rate example total effective rate
Disease is clinical
Digital display is imitated enabledisable (%) digital display and is imitated enabledisable (%)
The recovery from illness recovery from illness
≤3 66 13 20 26 7 89.39 32 8 8 10 6 81.25
~ 1 year 119 20 42 43 14 88.23 63 9 20 20 14 77.77
＞1 year 115 24 36 39 16 86.08 55 4 14 22 15 72.72
Through the Ridit check, treatment is organized different course of disease curative effects relatively, no difference of science of statistics P＞0.05; To two groups of curative effects of the course of disease＜1 year patient relatively, no difference of science of statistics P＞0.05; To two groups of curative effects of the course of disease＞1 year patient relatively, significant difference P＜0.05 is arranged.
Five, two groups of tongues, pulse conditions change relatively, see Table 12.
Table 12 liang group tongue, pulse condition change relatively
Routine number matched group is organized in treatment
Tongue, pulse condition example number improvement rate (%) improvement rate (%)
The improvement treatment back commentaries on classics of the normal treatment of commentaries on classics back was normal after the improvement of treatment back was treated
Pale tongue 300 126 81 69.00 150 54 33 58.00
Moderate pulse is thin by 109 51 23 67.88 55 17 12 52.72
Thready and weak pulse 191 80 53 69.63 95 34 18 54.73
Through the Ridit check, the two groups of patient's picture of the tongues in treatment back compare no difference of science of statistics P＞0.05; Pulse condition changes relatively, and significant difference P＜0.05 is arranged.Six, treatment group all ages and classes section patient curative effect relatively sees Table 13.
Table 13 treatment group all ages and classes section patient curative effect relatively
Age (year) the apparent number of routine number clinical recovery enabledisable total effective rate (%)
18～30 57 12 17 21 7 87.71
～50 128 25 47 45 11 91.40
～65 115 20 34 42 19 83.47
Through the Ridit check, treatment group all ages and classes section patient curative effect compares, no difference of science of statistics P＞0.05.
Seven, two groups of leukocyte change relatively, see Table 14.
Table 14 liang group leukocyte variation comparison (X ± S)
(WBC * 10, treatment back before the treatment of group example number
9/ L)
Treatment organizes 60 3.12 ± 0.52 3.86 ± 0.69
Matched group 30 3.25 ± 0.44 3.85 ± 0.59
Through t check, 60 routine leukopenia patients are organized in treatment, around the treatment back before blood middle leukocytes sum measured value and the treatment relatively, significant difference P＜0.05 is arranged; No difference of science of statistics P＞0.05 is compared for two groups in the treatment back.
Eight, safety indexes
(1) the security inspection result sees Table 15.
Table 15 security inspection result
After treating before the treatment
Project example numerical example number
Normal unusual normal unusual
Routine blood test 292 224 68 286 276 10
Routine urinalysis 287 287 0 279 279 0
Just conventional 274 274 0 271 271 0
Liver function (ALT) 283 245 38 284 252 32
Renal function (BUN) 283 283 0 285 285 0
Electrocardiogram 288 268 20 289 276 13
(2) untoward reaction is observed: viewing duration does not find that side effect of digestive tract such as nausea,vomiting,diarrhea appear in the treatment group.Do not find drug anaphylaxis and other untoward reaction such as dizzy, heating, erythra.
Model case
Example one: the king *, man, 60 years old, retired worker.First visit on October 8 in 2000.Nearly 10 years of main suit's cough and asthma, whenever cough with asthma increases the weight of when winter, spring temperature decline, and Western medicine diagnose is " chronic asthmatic bronchitis ".Cough during outbreak, cough up phlegm, pant and increase the weight of, a small amount of white expectorant is coughed up in cough usually.Cough with asthma is lighter closely over the past half year, and malaise is obvious, and spirit, appetite is poor, easy catching a cold, and easily sweating, aversion to wind is examined and is seen pale tongue, thin white fur of tongue, moderate pulse is thin.Look into: T36.6 ℃, P80 time/minute, R22 time/minute, BP16/9kpa.Two pulmonary respiration sounds are thick.A little does the ring sound audible, heart rate 80 times/minute, and rule is neat, and each auscultatory valve areas is not heard and pathologic murmur.Routine blood test: WBC6.8 * 10
9/ L, N70%, L30%.X line: two increased bronchovascular shadows.Diagnosis: chronic asthmatic bronchitis (clinical relieving period).Chinese medical discrimination: cough illness belongs to syndrome of deficiency of lung qi.The rule of treatment: QI invigorating strengthening the body resistance.Give the clever sheet of ginseng dimension, oral, each 4, every day 3 times.The further consultation in 10 days of taking medicine: patient's spirit is slightly better, weak alleviating, and the food of receiving slightly increases, still cough, the amount of coughing up phlegm is few, asthma.Further consultation after 20 days: asthma, cough alleviates, and idol is coughed up rare white expectorant, and spirit, appetite are clearly better, and sweating obviously reduces, and aversion to wind alleviates.The clothes medicine-feeding that continues was examined in 30 days again: spirit is shaken, and malaise obviously alleviates, and removes still cough, coughs up a small amount of white expectorant, has outside the sweating when breathing heavily after the activity, does not have uncomfortable main suit.Pale tongue, white and thin fur, thready pulse are strong.Every chemical examination is normal.
Example two: open *, man, 50 years old, peasant.The prescription on individual diagnosis on the 20th of calendar year 2001 JIUYUE.Chemotherapy half a year after the row resection of gastric carcinoma.Appetite obviously goes down over nearly 2 months, and appetite reduces, dizziness, fatigue and asthenia, deficiency of QI with disinclination to talk.Examine and see: the complexion rolling is white, pale tongue, and thin lingual fur is few, and deficient pulse is unable.Look into: T36.2 ℃, BP16/10Kpa.Two pulmonary respiration sounds are clear, heart rate 78 times/minute, and rule is neat, and each auscultatory valve areas is not heard and pathologic murmur.Electrocardiogram is normal.Blood test routine: Hb 8.4g/L, RBC3.8 * 10
12/ L, WBC2.9 * 10
9/ L, N54%, L46%.Western medicine diagnose: 1. postoperative gastric cancer, 2. leukopenia.Chinese medical discrimination belongs to syndrome of deficiency of QI.Control with QI invigorating and set upright.Give the clever sheet of ginseng dimension, oral, each 4, every day 3 times.Further consultation after 10 days: dizzy, weak alleviating, appetite slightly increases, and surplus disease is the same.Examined in 20 days: spirit, appetite take a turn for the better again.Food-intake increases, and fatigue and asthenia, dizziness, deficiency of QI with disinclination to talk obviously alleviate, but the weak limb in movable back is tired.The further consultation in 30 days of taking medicine: spirit, appetite are clearly better, after activity, still feel weak, surplus disease disappearance blood test routine: Hb11.2g/L, RBC4.5 * 10
12/ L, WBC5.2 * 10
9/ L, N62%, L38%.
Example three: Liu *, man, 65 years old, peasant.In calendar year 2001 first visit on November 26.The main suit: ictal asthma 12 years is diagnosed as " bronchial asthma ".Pant and increase the weight of in during climate change or flu back.In recent years, the state of an illness increases the weight of gradually, can not put down for sleeping inly during outbreak, needs dead point aminophylline and antibiotic medicine to alleviate.Lighter during prescription on individual diagnosis, cough up a small amount of white rare expectorant, the limb software is tired, loss of appetite, fear of cold, spontaneous perspiration, easy catching a cold, faint low voice, pale tongue, white and thin fur, thready and weak pulse.Have a medical check-up: T36.8 ℃, P84 time/minute, R23 time/minute, BP17/10kpa, two lung audibles and dried ring sound and wheezing sound, heart rate 84 times/minute, rule is neat, and each auscultatory valve areas is not heard and pathologic murmur.Routine blood test: WBC7.8 * 10
9/ L, N65%, L35%.X line: two increased bronchovascular shadows.Western medicine diagnose: bronchial asthma (catabasis).Chinese medical discrimination: insufficiency of lung-QI.Control with the QI invigorating strengthening the body resistance.Give the clever sheet of ginseng dimension, oral, each 4, every day 3 times.Further consultation after 10 days: appetite slightly increases, and spirit is slightly better, and surplus disease is the same.Further consultation after clothes were added medicine to 20 days: asthma alleviates, and still coughs up a small amount of white rare expectorant, and the limb software is tired to be alleviated, and spirit, appetite are clearly better, and food-intake increases, and fear of cold, spontaneous perspiration also alleviate.After taking medicine 30 days, appetite, food-intake obviously increase, and language is strong, and spontaneous perspiration disappears.Pale tongue, white and thin fur, thready pulse is strong.Look into: BP17/10kpa.Electrocardiogram (one).Routine blood test: WBC6.8 * 10
9/ L, N62%, L38%.
Example four: congratulate * *, woman, 45 years old, office worker.On October 16th, 2000 went to a doctor.Tell difficulty falling asleep during prescription on individual diagnosis, nighttime sleep less than 4 hours, dreaming often and waking easily is interrupted and increases the weight of nearly 2 months of the sixth of the twelve Earthly Branches.Spiritlessness and sparing of words, fatigue and weakness, forgetful cardiopalmus usually, dizziness. attention is difficult to concentrate, poor appetite, anorexia, lusterless complexion, the loose stool feels weak, pale tongue, white and thin fur, thready and weak pulse after an action of the bowels.Look into: P70 time/minute, rule is neat, BP17/11kpa.Be interrupted and take diazepam, poor effect.Diagnosis: anypnia induced by nervous prostration.Chinese medical discrimination belongs to deficiency of both the heart and spleen, and the heart is become homeless foster.It is oral to give the clever sheet of ginseng dimension, and each 4, every day 3 times.Further consultation after ten days: appetite increases, and fatigue and weakness alleviates, and weak after an action of the bowels sense disappears.Three examine after 20 days: nighttime sleep can reach 5 hours, and the dream at night reduces, and spirit significantly takes a turn for the better, and dizzy, cardiopalmus obviously alleviates.Examine after 30 days: spirit is shaken again, and sleep can reach 6-7 hour, and sleep is dull, dizziness, cardiopalmus, the basic disappearance such as absent minded, and appetite is often changeed, and appetite obviously increases.Light red tongue, white and thin fur, thready pulse is strong.
Example five: the week *, the man, 42 years old, went to a doctor May 9 calendar year 2001.The patient is surplus January because of the acute hepatitis B hospitalization in October, 2000, adheres to liver protecting therapy after leaving hospital.Existing conscious weak, the hepatic region is stranded, and dull pain has then sx of fatigue slightly sometimes, dizziness sometimes, down in spirits, tastelessness, asthenia, poor, the loose stool of appetite, and abdominal distention after the supper, shallow complexion, pale tongue, thin white fur of tongue, deficient pulse is unable.Chemical examination: AI, T52
u/ L, AST43
u/ L, TTT6
uHBsAg (+), HBeAg (+), anti--HBc (+).Diagnosis: B-mode chronic persistent hepatitis.Chinese medical discrimination: deficiency-weakness of spleen-QI, deficient vital QI leading to lingering of pathogen.Control the plan replenishing QI to invigorate the spleen, strengthening vital QI to eliminate pathogenic factors.It is oral to give the clever sheet of ginseng dimension, and each 4, every day 3 times.Two examine (after ten days), and spirit, appetite take a turn for the better.Three examine (after 20 days): appetite, tastelessness are dull, fatigue and weakness, dizziness etc. are clearly better, and the hepatic region is stranded, abdominal distention obviously alleviates after the supper.The four diagnostic methods (after 30 days) spirit is shaken, and appetite is good, and appetite obviously increases, and dizziness is weak, and abdominal distention disappears, and body of the tongue is light red, white and thin fur, thready and stringy pulse.Chemical examination: ALT43
u/ L, AST36
u/ L, TTT6
uAll the other results of laboratory test are the same.
Conclusion: above observed result shows that the treatment of the clever sheet treatment of ginseng dimension syndrome of deficiency of lung qi is organized 120 examples, cure-remarkable-effectiveness rate 45.83%, total effective rate 84.16%; Matched group 60 examples, cure-remarkable-effectiveness rate 31.66%, total effective rate 70.00%.60 examples are organized in the syndrome of deficiency of spleen qi treatment, cure-remarkable-effectiveness rate 68.33%, total effective rate 95.00%; Matched group 30 examples, cure-remarkable-effectiveness rate 46.66%, total effective rate 80.00%.60 examples are organized in the syndrome of deficiency of both heart and spleen treatment, cure-remarkable-effectiveness rate 60.00%, total effective rate 91.66%; Matched group 30 examples, cure-remarkable-effectiveness rate 53.33%, total effective rate 86.66%.60 examples are organized in the syndrome of deficiency of QI treatment, cure-remarkable-effectiveness rate 38.33%, total effective rate 83.33%; Matched group 30 examples, cure-remarkable-effectiveness rate 46.66%.Total effective rate 76.67%.Two groups of treatment back curative effects are relatively learned by statistics and are handled, and the curative effect of syndrome of deficiency of lung qi is had significant difference P＜0.05; Curative effect to syndrome of deficiency of spleen qi has significant difference P＜0.05; To curative effect no difference of science of statistics P＞0.05 of syndrome of deficiency of both heart and spleen, to curative effect no difference of science of statistics P＞0.05 of syndrome of deficiency of QI.In the clinical verification process, the treatment group does not have obvious adverse reaction.This time Clinical results shows: the clever sheet of ginseng dimension is used for chronic bronchitis (chronic persistence, clinical relieving period), bronchitis asthma (catabasis), chronic hepatitis, anypnia induced by nervous prostration, leukopenia, Chinese medical discrimination belongs to weak, the positive QI-insufficiency patient's of body weakness with emaciation such as insufficiency of lung-QI, deficiency-weakness of spleen-QI, deficiency of both the heart and spleen, syndrome of deficiency of QI auxiliary treatment, and is safe and effective.
Following embodiment all can realize the effect of above-mentioned experimental example.
Embodiment 1Tablet
Ganderma lucidum dry powder 100g mushroom extract powder 200g
Vitamin B
62g Radix Ginseng powder 100g
Add adjuvant and make 1000, oral, one time 2,3 times on the one.
The method of quality control of tablet:
Discrimination method: a. gets this product, puts microscopically and observes, and calcium oxalate cluster crystal is arranged, diameter 20-68 μ m, the sharp point of corner angle; B. get 1 of this product, remove film-coat, porphyrize adds water 40ml, grinds, and filters, and gets filtrate 2ml, adds the about 2mg of 1,2,3-indantrione monohydrate, shakes up to put in the water-bath to heat the solution displaing amaranth about 5 minutes;
C. get 1 of this product, remove film-coat, porphyrize, add 20% sodium acetate solution 5ml, grind, filter, filtrate splits in two test tubes of first, second, add water 1ml in the first pipe, add 4% boric acid solution 1ml in the second pipe, mixing, each rapid chlorination imido grpup-2,6-Phygon test solution 1ml, first Guan Zhongxian is dirty green, changes rufous after a few minutes into; Do not show dirty green in the second pipe;
Assay: (measuring) according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2000):
A. ginsenoside Rb
1: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (25: 75)-(40: 60) gradient (0-15 minute) is a mobile phase; 30 ℃ of column temperatures; Flow velocity is per minute 1ml, and detecting wavelength 0-8 minute was 350nm, and 8-15 minute is 203nm; Number of theoretical plate is by ginsenoside Rb
1The peak calculates should be not less than 4000; Algoscopy: get 20 of this product, remove film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision take by weighing in right amount (being equivalent to 2.5 approximately), put in the tool plug conical flask, the accurate 50% methanol 25ml that adds, supersound process 40 minutes, centrifugal, get supernatant, as need testing solution; Precision takes by weighing ginsenoside Rb in addition
1Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 0.1mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every of this product contains ginsenoside Rb
1(C
54H
92O
23) must not be less than 0.10mg; B. vitamin B
6: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Methanol: 0.05mol/L potassium dihydrogen phosphate (contain 1.1% sodium heptanesulfonate, 0.2% triethylamine, regulating pH value with phosphoric acid is 2.5) (15: 85) is a mobile phase; The detection wavelength is 290nm; Number of theoretical plate is pressed vitamin B
6The peak calculates should be not less than 2500; Algoscopy is got 20 of this product, removes film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision takes by weighing in right amount (being equivalent to 1.25 approximately), put in the tool plug conical flask accurate 50% methanol 25ml, the shake well of adding, placed 10 minutes, get solution centrifugal, get supernatant, as need testing solution; Precision takes by weighing vitamin B in addition
6Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 1.0mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Contain the rope B that supports one's family
6(C
8H
11NO
3HCl) must not be less than 1.70mg.
Embodiment 2Capsule
Ganderma lucidum dry powder 130g mushroom extract powder 230g
Vitamin B
64g Radix Ginseng powder 130g
Add adjuvant and make 1000 of capsules.
Embodiment 3Capsule
Ganderma lucidum dry powder 80g mushroom extract powder 180g
Vitamin B6 3g Radix Ginseng powder 90g
Add adjuvant and make 1000 of capsules.Every suitable crude drug 1 gram.
Claims (10)
1, the pharmaceutical composition of a kind of auxiliary treatment " deficiency of vital QI " card is characterized in that pharmaceutical composition mainly made by following raw material medicaments:
Ganderma lucidum dry powder 60-150 weight portion mushroom extract powder 150-250 weight portion
Vitamin B
61-5 weight portion Radix Ginseng powder 60-150 weight portion.
2, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition mainly made by following raw material medicaments:
Ganderma lucidum dry powder 100 weight portions mushroom extract powder 200 weight portions
Vitamin B
62 weight portion Radix Ginseng powder, 100 weight portions.
3, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition mainly made by following raw material medicaments:
Ganderma lucidum dry powder 130 weight portions mushroom extract powder 230 weight portions
Vitamin B
64 weight portion Radix Ginseng powder, 130 weight portions.
4, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition mainly made by following raw material medicaments:
Ganderma lucidum dry powder 80 weight portions mushroom extract powder 180 weight portions
Vitamin B
63 weight portion Radix Ginseng powder, 90 weight portions.
5,, it is characterized in that this pharmaceutical composition can add adjuvant and be prepared into any in tablet, capsule, pill, suspensoid, drop pill, the oral liquid as the described pharmaceutical composition of claim 1-4.
6, require the method for quality control of 5 described drug combination preparations as profit, it is characterized in that discrimination method in this method comprises one or more in the following discriminating:
A. get present composition tablet, put microscopically and observe, calcium oxalate cluster crystal is arranged, diameter 20-68 μ m, the sharp point of corner angle; B. get 1 in present composition tablet, remove film-coat, porphyrize adds water 40ml, grinds, and filters, and gets filtrate 2ml, adds the about 2mg of 1,2,3-indantrione monohydrate, shakes up to put in the water-bath to heat the solution displaing amaranth about 5 minutes; C. get 1 in present composition tablet, remove film-coat, porphyrize, add 20% sodium acetate solution 5ml, grind, filter, filtrate splits in two test tubes of first, second, add water 1ml in the first pipe, add 4% boric acid solution 1ml in the second pipe, mixing, each rapid chlorination imido grpup-2,6-Phygon test solution 1ml, first Guan Zhongxian is dirty green, changes rufous after a few minutes into; Do not show dirty green in the second pipe.
7, require the method for quality control of 5 described drug combination preparations as profit, it is characterized in that content assaying method in this method comprises one or more in the following method:
A. ginsenoside Rb
1: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (15: 85)-(50: 50) gradient (0-15 minute) is a mobile phase; Column temperature 25-35 ℃; Flow velocity is per minute 1ml, and detecting wavelength 0-8 minute was 350nm, and 8-15 minute is 203nm; Number of theoretical plate is by ginsenoside Rb
1The peak calculates should be not less than 4000; Algoscopy: get 20 in present composition tablet, remove film-coat, 60 ℃ of dryings 1 hour, the accurate title, decide, porphyrize, precision take by weighing in right amount, are equivalent to 2.5 approximately, put in the tool plug conical flask, the accurate 45-55% methanol 20-30ml that adds is supersound process 30-50 minute, centrifugal, get supernatant, as need testing solution; Precision takes by weighing ginsenoside Rb in addition
1Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 0.1mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every in present composition tablet contains ginsenoside Rb
1Must not be less than 0.08mg; B. vitamin B
6: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Methanol: 0.05mol/L potassium dihydrogen phosphate 10-25: 80-90 is a mobile phase; The detection wavelength is 290nm; Number of theoretical plate is pressed vitamin B
6The peak calculates should be not less than 2500; Algoscopy is got 20 in present composition tablet, removes film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision takes by weighing in right amount, is equivalent to 1.25 approximately, puts in the tool plug conical flask, the accurate 50% methanol 25ml that adds, shake well was placed 10 minutes, got solution centrifugal, get supernatant, as need testing solution; Precision takes by weighing vitamin B in addition
6Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 1.0mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every in present composition tablet contains the rope B that supports one's family
6Must not be less than 1.60-1.80mg.
8, require the method for quality control of 7 described pharmaceutical composition tablets as profit, it is characterized in that content assaying method in this method comprises one or more in the following method:
A. ginsenoside Rb
1: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (25: 75)-(40: 60) gradient (0-15 minute) is a mobile phase; 30 ℃ of column temperatures; Flow velocity is per minute 1ml, and detecting wavelength 0-8 minute was 350nm, and 8-15 minute is 203nm; Number of theoretical plate is by ginsenoside Rb
1The peak calculates should be not less than 4000; Algoscopy: get 20 of this product, remove film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision takes by weighing in right amount, is equivalent to 2.5 approximately, puts in the tool plug conical flask, the accurate 50% methanol 25ml that adds, supersound process 40 minutes, centrifugal, get supernatant, as need testing solution; Precision takes by weighing ginsenoside Rb in addition
1Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 0.1mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every of this product contains ginsenoside Rb
1Must not be less than 0.10mg; B. vitamin B
6: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Methanol: the 0.05mol/L potassium dihydrogen phosphate is a mobile phase at 15: 85; The detection wavelength is 290nm; Number of theoretical plate is pressed vitamin B
6The peak calculates should be not less than 2500; Algoscopy is got 20 of this product, removes film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision take by weighing in right amount, are equivalent to 1.25 approximately, put in the tool plug conical flask, the accurate 50% methanol 25ml that adds, shake well was placed 10 minutes, got solution centrifugal, got supernatant, as need testing solution; Precision takes by weighing vitamin B in addition
6Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 1.0mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Contain the rope B that supports one's family
6Must not be less than 1.70mg.
9, the method for quality control of drug combination preparation as claimed in claim 5 is characterized in that this method may further comprise the steps:
Differentiate: a. gets present composition tablet, puts microscopically and observes, and calcium oxalate cluster crystal is arranged, diameter 20-68 μ m, the sharp point of corner angle; B. get 1 in present composition tablet, remove film-coat, porphyrize adds water 40ml, grinds, and filters, and gets filtrate 2ml, adds the about 2mg of 1,2,3-indantrione monohydrate, shakes up to put in the water-bath to heat the solution displaing amaranth about 5 minutes; C. get 1 in present composition tablet, remove film-coat, porphyrize, add 20% sodium acetate solution 5ml, grind, filter, filtrate splits in two test tubes of first, second, add water 1ml in the first pipe, add 4% boric acid solution 1ml in the second pipe, mixing, each rapid chlorination imido grpup-2,6-Phygon test solution 1ml, first Guan Zhongxian is dirty green, changes rufous after a few minutes into; Do not show dirty green in the second pipe;
Assay: d. ginsenoside Rb
1: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Acetonitrile-0.05% phosphoric acid solution (15: 85)-(50: 50) gradient (0-15 minute) is a mobile phase; Column temperature 25-35 ℃; Flow velocity is per minute 1ml, and detecting wavelength 0-8 minute was 350nm, and 8-15 minute is 203nm; Reason is sunk the plate number by ginsenoside Rb
1The peak calculates should be not less than 4000; Algoscopy: get 20 in present composition tablet, remove film-coat, 60 ℃ of dryings 1 hour, the accurate title, decide, porphyrize, precision take by weighing in right amount, are equivalent to 2.5 approximately, put in the tool plug conical flask, the accurate 45-55% methanol 20-30ml that adds is supersound process 30-50 minute, centrifugal, get supernatant, as need testing solution; Precision takes by weighing ginsenoside Rb in addition
1Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 0.1mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every in present composition tablet contains ginsenoside Rb
1Must not be less than 0.08mg; E. vitamin B
6: chromatographic condition and chromatographic condition employment and suitability test (E ﹠ ST) are filler with octadecylsilane chemically bonded silica; Methanol: 0.05mol/L potassium dihydrogen phosphate 10-25: 80-90 is a mobile phase; The detection wavelength is 290nm; Number of theoretical plate is pressed vitamin B
6The peak calculates should be not less than 2500; Algoscopy is got 20 in present composition tablet, removes film-coat, 60 ℃ of dryings 1 hour, accurate claim fixed, porphyrize, precision takes by weighing in right amount, is equivalent to 1.25 approximately, puts in the tool plug conical flask, the accurate 50% methanol 25ml that adds, shake well was placed 10 minutes, got solution centrifugal, get supernatant, as need testing solution; Precision takes by weighing vitamin B in addition
6Reference substance is an amount of, add dissolve with methanol and quantitatively dilution make the solution product solution in contrast that contains 1.0mg among every 1ml; Precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, promptly; Every in present composition tablet contains the rope B that supports one's family
6Must not be less than 1.60mg.
10, as the method for quality control of the described drug combination preparation of claim 7-9, it is characterized in that potassium dihydrogen phosphate contains 1.1% sodium heptanesulfonate, 0.2% triethylamine, regulating pH value with phosphoric acid is 2.5.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100404038C (en) * | 2006-06-06 | 2008-07-23 | 赵一弘 | A health product of lucid ganoderma and preparation method thereof |
| CN100473389C (en) * | 2006-02-21 | 2009-04-01 | 广州汉方现代中药研究开发有限公司 | Method for controlling quality of ganoderma lucidum spore and ganoderma lucidium spore oil and preparation thereof |
| CN100515434C (en) * | 2005-05-30 | 2009-07-22 | 广州汉方现代中药研究开发有限公司 | Ganoderma lucidum spore oil, ganoderma lucidum spore powder and method for controlling quality of preparation of ganoderma lucidum |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1173640C (en) * | 2001-04-19 | 2004-11-03 | 张士舜 | Nutritive health-care food |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100515434C (en) * | 2005-05-30 | 2009-07-22 | 广州汉方现代中药研究开发有限公司 | Ganoderma lucidum spore oil, ganoderma lucidum spore powder and method for controlling quality of preparation of ganoderma lucidum |
| CN100473389C (en) * | 2006-02-21 | 2009-04-01 | 广州汉方现代中药研究开发有限公司 | Method for controlling quality of ganoderma lucidum spore and ganoderma lucidium spore oil and preparation thereof |
| CN100404038C (en) * | 2006-06-06 | 2008-07-23 | 赵一弘 | A health product of lucid ganoderma and preparation method thereof |
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