CN101612246B - Medicine composition for treating nephritis, preparation method and quality control method - Google Patents
Medicine composition for treating nephritis, preparation method and quality control method Download PDFInfo
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Abstract
The invention relates to a medicine composition for treating nephritis, a preparation method and a quality control method thereof, belonging to the traditional Chinese medicine. The medicine composition comprises the following raw material medicines according to parts by weight: 398 to 486 parts of herba ecliptae, 238 to 292 parts of glossy privet fruit, 238 to 292 parts of rehmannia root, 238 to 292 parts of angelica, 80 to 98 parts of rhizoma ligustici wallichii, 160 to 196 parts of red peony root, 238 to 292 parts of tuckahoe, 238 to 292 parts of madder, 398 to 486 parts of thistle, 398 to 486 parts of common cephalanoplos and 238 to 292 parts of gardenia. The medicine composition has the functions of reducing fever, removing heat from the blood, nourishing yin and nourishing the kidney. The medicine composition is mainly used for treating chronic glomerulonephritis analyzed and differentiated by the traditional Chinese medicine into the deficiency of liver-yin and kidney-yin and damp and fever symptoms, such as dry and astringent eyes or fuzzy vision, dizziness and tinnitus, dysphoria with feverish sensation in the chest, mouth and throat dryness, waist and ridge ache, throat gall, smothery gastral cavity, anorexia, mouth dryness without thinking of drinking, burning sensation during urination or astringent and painful urination, small and wiry pulse or small pulse, damp pulse or smooth pulse, reddened tongue, little mosses or yellow and oily tongue furs and the like.
Description
Technical field
The invention belongs to the field of Chinese medicines, refer in particular to Chinese medicine composition and the preparation method and the method for quality control of treatment nephritis.
Background technology
Nephropathy is a kind of common frdquently encountered disease of serious harm body health of people, and of all ages, sex all can be suffered from, and outbreak repeatedly, leads and prolongs difficult healing, and harm humans health influences development of social productivity.Though there is the medicine of many treatment nephritis at present, development therapeutic effect better medicament is served society, is served health of masses, also is very necessary.
Summary of the invention
The invention provides a kind of pharmaceutical composition and preparation method and method of quality control for the treatment of nephritis, be used for clearing away heat and cooling blood, YIN nourishing is supported kidney.
Nephritis was divided according to the time, was divided into acute nephritis and chronic nephritis.Chronic nephritis is called chronic glomerulonephritis again, how to be formed by the acute nephritis transformation, also has not obvious the reaching of part patients acuity phase clinical manifestation to become chronic to realizing.Belong to disease card categories such as motherland's medical science " edema ", " asthenia ", " lumbago ", " hematuria ", the generation of edema, the existing argumentation in " interior warp ", think and invade Gong Youguan, says as " element is asked hydro-thermal cave opinion " with wind, exopathogen such as wet: " brave and labor very, then kidney sweating; kidney sweating is met in wind, interiorly must not go into to hide internal organs; outward must not be more in skin; the visitor is in Xuan Fu, and row is in flesh side, pass into internal organs swollen; basis in kidney, say the edema due to wind pathogen ".Ming Dynasty's Zhang Jingyue thinks that then edema is lung, spleen, the kidney three dirty relevant diseases that are, is to be this with the kidney, is mark with the lung, is the dirty of controlling the water circulation with the spleen, has emphasized the importance of kidney in the edema disease morbidity.In recent years, according to chronic nephritis often with the clinical characters of edema, inherited the understanding of forefathers to the edema etiology and pathogenesis, the main cause that has proposed primary disease is wind, cold, the wet and spleen damage of suffering from a deficiency of the kidney, particularly the kidney yin deficiency of kidney-QI is particularly important, in influencing the domination of pathogen of primary disease (phlegm retention, blood stasis, damp and hot), damp and hot then is main pathological factor.By consulting the experience in studying data at home and abroad and the summary clinical position, we think that the cause system of primary disease does not save excess of sexual intercourse by fertility, in the unit of being impairment of the kidney, the kidney essense loss, eating and drinking without temperance is hungry full uncomfortable in addition, overstrain, deficiency of spleen-QI is transformation failure of spleen then, retention of water-damp in the body; Positive QI-insufficiency, then wind, cold, wet, heat and sore enemy intrusion or invasion follow through going into kidney, heresy lies prostrate in interior, the strongly fragrant and heat-transformation impairment of YIN of damp, the course of disease is long in addition, a large amount of albuminuria and life-time service hormone, impairment of YIN liquid more, certainly will form cloudy thanks to the vicious cycle of damp and hot reciprocal causation.It is a deficiency of kidney yin, involves in liver, forms hepatic and renal YIN deficiency, and it is designated as the damp-stagnancy heat-transformation, and intenseness of heat is escape of blood from meridians then, controls suitable clearing away heat and cooling blood, and YIN nourishing is supported kidney.Draft we in view of the above.
Monarch drug is selected Herba Ecliptae, Fructus Ligustri Lucidi for use in the side, and two medicines match, the side's of running after fame ERZHI WAN." collection of prescriptions with notes " releases cloud: " the waist knee joint is mended in the ERZHI WAN the kidney invigorating, strengthening bone and muscle, and kidney tonifying the moon, black beard and hair, inexpensive and merit is big.Sweet cold, the juice of Herba Ecliptae deceive mend into kidney smart, so under can benefit and in the honor, reinforcing YIN-essence and hair color be also.Fructus Ligustri Lucidi is sweet flat, the essence of few the moon, and do not wither midwinter, and its color is blue or green black, liver-kidney tonifying." the two must join kidney-supplementing liver-boosting, merit is concentrated one's efforts grand, for deficiency of the liver and kindey, and soreness of the waist and knees, early whitening of beard and hair, poor vision loses an eye dreaminess, and diseases such as tinnitus seminal emission are known and can be selected for use.The kidney root of body of making a living is the source of growth collection, and the course of disease is prolonged for a long time, healthy energy is lost empty, and should not abuse disappears cuts down, and kidney is hidden Kidney-Yin and the residence kidney-Yang, when principle, with the Jiyang, decrease positive because of the conversion of dampness into heat consumption is cloudy from YIN nourishing according to interdependence between yin and yang, and clear its, so with being principal agent, minister is with Radix Cirsii Japonici, Herba Cirsii, Radix Paeoniae Rubra, Radix Rubiae cooling blood for hemostasis, heat-clearing and toxic substances removing, the Poria invigorating spleen to remove dampness, diuretic leads to kidney, all medicines and the source of dehumidifying with spleen invigorating, clearing away heat,cooling blood and removing toxin and blood are from ending, to control the drug effect of slow kidney secondary infection.Assistant Chinese Angelica blood replonishing and blood, Rhizoma Chuanxiong promoting flow of QI and blood, Radix Rehmanniae nourishing YIN and supplementing blood, must join Radix Paeoniae Rubra both can increase the power of clearing away heat and cooling blood, can form tradition name side SIWU TANG again, to the Directorate-General DG for enriching blood, assistant helps monarch-minister drug to set upright with eliminating evil, giving consideration to both the incidental and fundamental, thus obtain the stable trend early recovery of nephropathy.Make and discongest hot and suffocatingly clearly thoroughly so that Fructus Gardeniae is kind, draw under its property flexing, reach down on certainly, the three warmers stagnated fire of having a thorough knowledge of makes heat from external genitalia urine and go out.All medicines share, and play clearing away heat and cooling blood altogether, and YIN nourishing is supported the effect of kidney.
The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components is for all having better curative effect in following ratio of weight and number scope:
398～486 parts of Herba Ecliptaes, 238～292 parts of Fructus Ligustri Lucidi, 238～292 parts of Radix Rehmanniae,
238～292 parts of Radix Angelicae Sinensis, 80～98 parts of Rhizoma Chuanxiongs, 160～196 parts of Radix Paeoniae Rubra,
238～292 parts in Poria, 238～292 parts in Radix Rubiae, 398～486 parts of Radix Cirsii Japonicis,
398～486 parts of Herba Cirsiis, 238～292 parts of Fructus Gardeniaes.
The present invention also comprises the crude drug of former following portions by weight ratio:
238～292 parts of Polyporus, 477～583 parts of Semen Plantaginis (parched with salt), 956～1168 parts of Herba Portulacaes, 795～971 parts of Radix Sanguisorbaes.
The present invention also comprises the crude drug of former following portions by weight ratio:
426～520 parts of Rhizoma Dioscoreaes are scalded 795～971 parts of Rhizoma Cibotii.
The present invention is preferred:
442 parts of Herba Ecliptaes, 265 parts of Fructus Ligustri Lucidi, 265 parts of Radix Rehmanniae,
265 parts of Radix Angelicae Sinensis, 89 parts of Rhizoma Chuanxiongs, 178 parts of Radix Paeoniae Rubra,
265 parts in Poria, 265 parts in Radix Rubiae, 442 parts of Radix Cirsii Japonicis,
442 parts of Herba Cirsiis, 265 parts of Fructus Gardeniaes.
The present invention also comprises the crude drug of former following portions by weight ratio:
265 parts of Polyporus, 530 parts of Semen Plantaginis (parched with salt), 1062 parts of Herba Portulacaes,
883 parts of Radix Sanguisorbaes.
The present invention also comprises the crude drug of former following portions by weight ratio:
473 parts of Rhizoma Dioscoreaes are scalded 883 parts of Rhizoma Cibotii.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.Preferably, the preparation method of medicine activity component of the present invention is as follows:
(1), Radix Angelicae Sinensis, Rhizoma Chuanxiong add 3～8 times of water gagings and extract volatile oil, aqueous solution after the distillation and volatile oil device are in addition collected, medicinal residues are standby;
(2), Fructus Ligustri Lucidi, Radix Paeoniae Rubra, Radix Rubiae be with 55～95% ethanol extractions 1～3 time, each 1～4 hour, make a living 5～12 times of dose of alcohol adding amount, merge extractive liquid,, filter, filtrate recycling ethanol, and survey when being concentrated into 60 ℃, relative density is 1.18～1.30 thick paste;
(3), Six-element such as residue Herba Ecliptae etc., adding 5～12 times of water gagings decocted 1～3 hour, filter, filtrate is placed, and medicinal residues mix with above-mentioned standby medicinal residues, adding 5～12 times of water gagings decocted 1～3 hour, filter, the aqueous solution behind filtrate and above-mentioned filtrate and the extraction volatile oil merges, and survey, relative density are 1.13～1.35 thick paste when being concentrated into 50 ℃, merge mixing with above-mentioned thick paste.
Method of quality control of the present invention comprises with thin layer chromatography discriminating two kinds of medical materials wherein; Content with two kinds of compositions of the described medicine of high effective liquid chromatography for measuring;
Differentiate wherein two kinds of medical material Herba Ecliptaes and Radix Rubiae with thin layer chromatography:
(1) get this product 15g, add water 100ml, put heating for dissolving in the water-bath, put coldly, put in the separatory funnel, add chloroform extraction secondary, each 30ml, combined chloroform liquid is put and is concentrated into 1ml in the water-bath, as need testing solution.Other gets Herba Ecliptae control medicinal material 2g, adds water 100ml and decocts 1 hour, puts coldly, filters, and puts in the separatory funnel, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with dimethylbenzene-ethyl acetate-normal hexane-methanol-formic acid (20: 10: 8: 0.5: 0.5) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get this product 20g, porphyrize adds methanol 40ml, supersound process 20 minutes filters the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, adds concentrated hydrochloric acid 1ml, boils 30 minutes, cooling, with extracted with diethyl ether twice, each 20ml, merge ether solution, volatilize, residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Radix Rubiae control medicinal material 1g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with dimethylbenzene-ethyl acetate-normal hexane-methanol-formic acid (20: 10: 8: 0.5: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Measure jasminoidin and peoniflorin according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water (15: 85) is mobile phase; The detection wavelength is 230nm; Number of theoretical plate is pressed the peoniflorin peak and is calculated, and should be not less than 4000.
The preparation precision of reference substance solution takes by weighing jasminoidin reference substance and each 10mg of peoniflorin reference substance, put in the 25ml measuring bottle, add dissolve with methanol and be diluted to scale, shake up, precision is measured 1ml, puts in the 10ml measuring bottle, add methanol and be diluted to scale, shake up, that is, contain each 0.04mg of jasminoidin and peoniflorin among every 1ml.
This product 2.5g is got in the preparation of need testing solution, porphyrize, and accurate the title, decide, accurate 70% alcoholic solution 100ml, supersound process (250W, 50KHz) 30 minutes of adding, put coldly, filter, precision is measured subsequent filtrate 50ml, evaporate to dryness, residue adds water 25ml dissolving, puts in the separatory funnel, adds chloroform and extracts twice, each 30ml, discard chloroform solution, use water saturation n-butanol extraction 5 times, each 20ml, merge n-butanol extracting liquid, put evaporate to dryness in the water-bath, residue adds dissolve with methanol and is transferred in the 10ml measuring bottle, adds methanol dilution scale, shake up, promptly.
Accurate reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
The every g of this product contains Radix Paeoniae Rubra by peoniflorin (C
23H
28O
11) meter, must not be less than 0.24mg; Contain Fructus Gardeniae with jasminoidin (C
17H
24O
10) meter, must not lack 0.31mg.
After above-mentioned active ingredient adds conventional adjuvant, make preparation according to a conventional method.Injection, tablet, capsule, granule etc. all can, oral liquid also can.
Granule of the present invention is that pale brown color is to brown granular; It is little sweet to distinguish the flavor of.
The present invention has: clearing away heat and cooling blood, YIN nourishing are supported the function of kidney.Cure mainly: chronic glomerulonephritis, Chinese medical discrimination are the double damp-heat syndrome of holding up of the hepatic and renal YIN deficiency, and disease is seen two dryness and uneasy feeling of the eye or blurred vision, dizziness and tinnitus, dysphoria with feverish sensation in the chest palms and soles, dry mouth and throat, ache of the spinal column, laryngopharynx swelling and pain, oppression sensation over the epigastrium and anorexia, xerostomia is not thought drink; burning sensation during urination or puckery pain are unfavorable; stringy and thready pulse or count accurately, moistens number or sliding number, few tongue of red tongue or yellowish fur etc.Think that through clinical experimental study this product truly has the effect of certain treatment chronic nephritis, total effective rate reaches 85.0%, and does not have obvious toxic-side effects, and taking convenience reduces the gastrointestinal stimulation, and the value of certain popularization is arranged.Usage and dosage: oral, a 5-15g, 3 times on the one.Every gram contains crude drug 0.32 gram.
The specific embodiment
Further set forth the beneficial effect of medicine of the present invention below by clinical trial, medicine of the present invention is hereinafter to be referred as the nephritislin granule.
Test objective: definite evaluation is made in clinical efficacy and safety to nephritislin granule treatment chronic nephritis, and compares observation with known former dosage form nephritislin capsule, now clinical test results is reported as follows:
Physical data
The case source: treatment group and matched group 160 examples all are outpatient service or inpatient, adopt contrast grouping at random, press random table and distribute case, and 100 examples are organized in treatment, matched group 60 examples.Each organizes situation basically identicals (seeing Table 1) such as sex, age, the course of disease.
Table 1-A respectively organizes patient's sex composition relatively
X
2＝0.225，P＞0.10
Two groups of patient's sex ratios, through X
2Check P＞0.10, there was no significant difference has comparability.
The table 1-B respectively organize the patient age distribution situation (year)
X
2＝2.361，P＞0.10
Two groups of age distribution are learned by statistics and are handled P＞0.10, and indifference opposite sex difference has comparability.
Table 1-C respectively organizes patient's course of disease and compares (year)
X
2＝5.446 P＞0.10
Two groups of patient's courses of disease compare, through X
2Check P＞0.10, there was no significant difference has comparability.
Table 1-D respectively organizes state of an illness size scale
X
2＝0.16，P＞0.10
Two groups of state of an illness size scales are learned by statistics and are handled P＞0.10, and there was no significant difference has comparability.
The preceding two groups of tongues of table 1-E treatment, pulse condition are relatively
Through X
2Check, body of the tongue X
2=2.92, P＞0.05
Pulse condition X
2=6.84, P＞0.05
Treat preceding two groups of tongues, arteries and veins relatively, statistical procedures P＞0.05, there was no significant difference has comparability.
The comparison of two groups of tcm syndromes of table 1-F
Two groups of tcm syndromes compare there was no significant difference, P＞0.10.
Table 1-G treats the comparison of preceding two groups of immunoglobulins
Treat preceding two groups of immunoglobulins relatively, P＞0.10 has comparability.
Table 1-H treats the comparison of preceding two groups of hemorheology
Control preceding two groups of hemorheology relatively, there is comparability P＞0.10.
Table 1-I treats preceding two groups of kidney merits and the proteic comparison of twenty-four-hour urine
Control relatively P＞0.10 of preceding two groups of twenty-four-hour urine albumen, blood urea nitrogen and serum creatinine, comparability is arranged.By the statistical analysis of his-and-hers watches 1 as seen, two groups at aspects such as sex, age, the course of disease, the state of an illness, tcm syndrome, picture of the tongue, pulse condition, immunoglobulin, hemorheology, renal functioies at random selectivity comparability is better arranged.
Case is selected
One, diagnostic criteria
(1) Chinese medical discrimination standard
" new Chinese medicine treatment chronic nephritis clinical research guideline " and high medical college teaching material " Chinese Internal Medicine " the 5th edition according to Ministry of Public Health promulgation in 1993 are drafted.
Heat syndrome in the hepatic and renal YIN deficiency
Dryness with foreign body sensation in the eyes or blurred vision, dizziness and tinnitus, dysphoria with feverish sensation in the chest palms and soles, dry mouth and throat, ache of the spinal column, deep-coloured and hot urine, restlessness and thirst, uneasy sleeping at night, the few tongue of red tongue or red tongue, thready and rapid pulse or number.
(2) Western medicine diagnose standard
Carry out according to the standard that Ministry of Public Health bureau of drug administration issue in 1993 " new Chinese medicine treatment chronic nephritis clinical research guideline " is drafted with reference to second national nephropathy academic conference in 1985.
1, onset is slow, state of an illness delay, the time heavy when light, renal function progressively goes down, anemia can appear in the later stage, electrolyte disturbance, situations such as blood urea nitrogen, serum creatinine rising.
2, in various degree performances such as albuminuria, hematuria, edema and hypertension are arranged.
3, can bring out acute attack because of reasons such as respiratory tract infection in the course of disease, the performance of similar acute nephritis occur, also have some cases that the automatic catabasis can be arranged.
(3) chronic nephritis standard by stages
Plain edition: the various symptoms of nephritis are arranged, but do not have outstanding behaviours.
Hypertension type: except that general nephritis symptom, hypertensive outstanding behaviours is arranged.
Acute attack type: the acute nephritic syndrome performance in chronic process, occurs.
(4) chronic nephritis weight grade scale
(1) severe: 1. urine protein examination continues +++→ ++ ++ or the twenty-four-hour urine protein quantification is between 2.1～3.5g, serum albumin＞30g/L; 2. undesired (serum creatinine 〉=442umol/L) person should get rid of renal function.3. obvious edema and hypertension.
(2) moderate: 1. urine protein examination continues ++ → +++, or the twenty-four-hour urine protein quantification continues between 1～2g, and renal function is normal; 2. edema can gently can weigh, and hypertension can be arranged.
(3) slight: 1. urine protein examination continue+→ ++, or the twenty-four-hour urine protein quantification continues below 1g, renal function is normal; 2. edema is not obvious, and blood pressure is normal.
Two, test case standard
(1) includes the case standard in
All Chinese medical discrimination standard hepatic and renal YIN deficiency interior-heat syndromes that meets, Western medicine diagnose are the outpatient service and the inpatient (serum creatinine＜442umol/L) all can include the test case in of chronic glomerulonephritis plain edition and hypertension type.
(2) get rid of the case standard
1. the phase patient of renal insufficiency uremia
2. confirm on inspection by person due to the factors such as systemic lupus erythematosus (sle), medicine infringement.
3. the age is at under-18s or over-65s, gestation or age of sucking the patient, or to this medicine allergy sufferers.
4. be associated with the cardiovascular diseases, serious primary disease such as liver and hemopoietic system, psychotic.
5. all standards of including in that do not meet, not medication in accordance with regulations can't be judged not congruent factor affecting curative effect of curative effect or data or safety judgement person.
Observational technique
One, case grouping
Adopt the method for random packet to be divided into treatment group and matched group, the contrast of dividing into groups.Distribute treatment to organize 100 examples MethodsThe cases enrolled by table of random number, matched group 60 examples.
Two, method of administration
Test group: throw the nephritislin granule, each 1 bag (10g) every day three times, takes after mixing it with water.
Matched group: throw the nephritislin capsule, each 6 (1.5g), every day three times, oral.
Two groups was 1 course of treatment with three months all, inactive in principle other associated treatment medicines of duration of test.Cause acute attack and other accident to take place for protecting from infection, all throw penicillin 8,000,000 units for two groups when being admitted to hospital, be blended in 0.9% the normal saline 250ml dead point once a day, be two weeks (the penicillin anaphylaxis person selects erythromycin for use) service time.Serious complication person such as hypertension is arranged when suiting the medicine to the illness disposal.
Three, statistical method
Finish the course of treatment and carry out comprehensive review respectively when following up a case by regular visits to, judge curative effect, summarize.Wherein measurement data adopts the t check to carry out statistical procedures, and ranked data adopt the Ridit check to carry out statistical procedures, and enumeration data adopts X
2Statistical procedures is carried out in check.
Four, observation index
1. safety observation
(1) general physical examination project: body temperature, pulse, blood pressure
(2) blood, urine, just conventional;
(3) heart, liver, renal function
2. health giving quality observation
(1) mainly relevant tcm symptom situation of change
(2) sign situation of change
Edema position and degree (+++, ++ ,+,-) expression.
Waist is kowtowed pain with (+,-) expression.
(3) tongue fur and pulse condition situation of change and record.
(4) routine urinalysis, 24h urine protein quantitation, Urine sediments analyzer.
(5) routine blood test, renal function (serum creatinine, blood urea nitrogen, endogenous creatinine clearance rate), liver function, electrolyte inspection.
(6) blood glucose, immunoglobulin inspection.
(7) hemorheology is learned and is checked.
Observed result
One, curative effect determinate standard (the clinical research guideline for the treatment of chronic nephritis by the new Chinese medicine of Ministry of Public Health formulation in 1993 is carried out)
(-), tcm syndrome curative effect
Weight classification score standard scale during tcm symptom is light
Above-mentioned symptom is remembered 1 fen with every (+), and finish the back and carry out statistical procedures by ranked data with the Ridit analytical method course of treatment, and disease more finally draws the statistics conclusion with matched group.
(2), general curative effect
Draft with reference to new drug treatment by Chinese herbs chronic nephritis clinical research guideline.
1. alleviation fully: symptom and sign complete obiterations such as edema, the lasting feminine gender of urine protein examination or (±) are more than 2 months, or the twenty-four-hour urine protein quantification is lasting less than 0.2g, and urine erythrocyte disappears under the high power lens, and Urine sediments analyzer is counted normally, and renal function is normal.
2. basic the alleviation: symptom such as edema and sign disappear substantially, and the urine protein continuous decrease is more than 50%, and urine erythrocyte is no more than 3 under the high power lens, and the Urine sediments analyzer counting is near normal, and renal function normally or normal substantially (differ be no more than 15% with normal value).
3. effective: symptoms such as edema are clearly better with sign, 1 of urine protein examination continuous decrease "+", or twenty-four-hour urine protein quantification continuous decrease 25～49%, and urine erythrocyte is no more than 5 under the high power lens, and renal function is normally or improvement arranged.
4. invalid: clinical manifestation and above-mentioned lab testing all do not have the obvious improvement or the person of increasing the weight of.
Three, interpretation of result
(1) two group of general curative effect relatively sees Table 2.
Two groups of general curative effects of table 2-1 relatively
Analyze u=1.76, P＞0.10 through Ridit
By table 10 as seen, treatment group total effective rate 85.0%; Matched group total effective rate 81.7% is analyzed P＞0.10 through Ri dit, and there was no significant difference illustrates that treatment group and matched group all have curative effect preferably to chronic nephritis.
The comparison of table 2-2 constituent parts curative effect
By curative effect there was no significant difference between the visible constituent parts of table 2-2.
(2) two groups of tcm syndromes change relatively (seeing Table 3) before and after the treatment.
Two groups of tcm syndromes change relatively before and after table 3 treatment
Through carrying out statistical procedures with the Ridit check, more obviously improve in treatment group and the matched group group, there is significant differences before and after the treatment, and compares there was no significant difference between two groups.
(3) two groups of edema recovery extent compare (seeing Table 4).
The comparison of table 4 liang group edema recovery extent
By table 4 as seen, treatment group and matched group all have the effect that improves edema-symptom, have significant differences (P＜0.01) before and after the treatment, there was no significant difference more then between two groups.
The comparison of (four) two groups of urine protein recovery extent (seeing Table 5).
The comparison of table 5 liang group urine protein recovery extent
By table 5 as seen, treatment group and matched group all have the effect that reduces urine protein, have significant differences (P＜0.01) before and after the treatment, there was no significant difference more then between two groups.
Compare (seeing Table 6) before and after (five) two groups of ERY treatments.
Comparison before and after the table 6 liang group ERY treatment
By table 6 as seen, treatment group and matched group all have the effect that improves ERY, have significant differences (P＜0.01) before and after the treatment, compare there was no significant difference between two liang of groups.
(6) the nephritislin granule is to the influence (seeing Table 7) of twenty-four-hour urine protein quantification
The comparison of table 7 liang group twenty-four-hour urine protein quantification
By the t check analysis of his-and-hers watches 7 as can be seen, treatment group and matched group all have the effect that reduces by 24 hours protein quantifications, have significant differences (P＜0.01) before and after the treatment.And comparison there was no significant difference (P＞0.01) between two groups.
(7) the nephritislin granule is to the influence (seeing Table 8) of renal function
Table 8 liang group is to the influence and the comparison of renal function
By table 8 as seen, nephritislin granule and nephritislin capsule all have the trend that reduces blood urea nitrogen and serum creatinine, but there was no significant difference before and after the treatment, and compare there was no significant difference between two groups.
(8) the nephritislin granule is to the influence (seeing Table 9) of routine blood test etc.
By table 9 as seen, treatment group and matched group all do not have obvious influence to routine blood test, more yet there was no significant difference between group.
(9) the nephritislin granule is to the influence (seeing Table 10) of electrolyte etc.
The table 10 liang electrolytical comparison of group
By the t check analysis of his-and-hers watches 10 as can be seen, before and after treatment group and the treatment of control group blood potassium, sodium, chlorine, calcium and blood glucose all there is not obvious influence, there was no significant difference relatively between two groups.
(10), the nephritislin granule is to the influence (seeing Table 11) of immunoglobulin etc.
The table 11 liang comparison that the group immunoglobulin quantitatively waits
By the t check analysis of his-and-hers watches 11 as can be seen, the nephritislin granule has the effect of rising immunoglobulin IgG, and between two groups relatively, be better than matched group aspect the rising IgG.
(11), two groups of treatment front and back are to hemorheological influence (seeing Table 12).
Before and after table 12 treatment to hemorheological influence (X ± SD)
Treatment group as seen from the above table can make the low value of cutting of whole blood contrast viscosity descend, and significant difference is arranged before and after the treatment.Matched group can make whole blood contrast viscosity descend, and has significant difference before and after the treatment.And comparison there was no significant difference between two groups.
The comparison (seeing Table 13) of (12), two groups of treatment front and back tongue arteries and veins
Two groups of tongues, arteries and veins change relatively before and after table 13 treatment
Through X
2Relatively treatment group X in the check body of the tongue group
2=77.49, P＜0.01
Matched group X
2=48.40, P＜0.01
X between group
2=0.227, P＞0.05
Relatively treatment group X in the pulse condition group
2=78.44, P＜0.01
Matched group X
2=42.9, P＜0.01
X between group
2=2.535, P＞0.05
Analyzed as can be seen by the X 2 test of his-and-hers watches 13, treatment group and matched group all have the effect that improves pathologic picture of the tongue and pulse condition, there was no significant difference more then between two groups.
(13), the state of an illness and curative effect correlation analysis
Gently: in, P＞0.05, u=1.65
Gently: heavy, P＜0.05, u=2.74
In: heavy, P＞0.05, u=1.66
By table 16 as seen, the treatment group state of an illness and curative effect have certain dependency, and credit is analysed by statistics, with state of an illness the lighter good effect, and state of an illness weight person weak curative effect.
(14), age and curative effect correlation analysis (seeing Table 15).
Table 15 age and curative effect correlation analysis
Certain dependency is arranged by visible age of table 15 and curative effect, relatively poor with 51～60 age bracket curative effects, this may count the patient with this age bracket patient certain dependency.
(15) course of disease and curative effect correlation analysis (seeing Table 16).
Table 16 course of disease (year) and curative effect correlation analysis
By table 16 as seen, the course of disease and curative effect do not have obvious dependency.
Three, safety observed result
(1) to blood, urine, conventional influence (seeing Table 17).
Table 17 treatment group blood, the just influence of routine
By last Table X
2Check analysis as seen, this product does not have obvious influence to routine blood test and routine urinalysis, there was no significant difference before and after the treatment, its P value is equal＞0.10.This product then has certain influence to routine urinalysis, can improve routine urinalysis, has significant difference before and after the treatment.
(2) the nephritislin granule is to the influence (seeing Table 18) of electrocardio, liver, renal function
Table 18, nephritislin granule are to the influence of electrocardio and liver, renal function
Through X
2Check analysis, no significant difference P value＞0.01 before and after the treatment illustrates that this product do not have influence to the heart, liver, renal function.
Four, follow up a case by regular visits to situation analysis
1, treats afterwards and follows up a case by regular visits to Comparison of therapeutic analysis (table 19)
Table 19 liang group general curative effect relatively
Curative effect does not have obvious change during by stable the following up a case by regular visits to of the visible this product late result of table 19.
Two groups of tcm syndromes change relatively (seeing Table 20) when 2, treating afterwards and following up a case by regular visits to.
Two groups of tcm syndromes changed relatively when table 20 was treated afterwards and followed up a case by regular visits to
By table 20 as seen, follow up a case by regular visits to and treat the back no significant difference aspect the tcm syndrome improving.
The comparison (seeing Table 21) of twenty-four-hour urine protein quantification when 3, treating the back and following up a case by regular visits to
The comparison of twenty-four-hour urine protein quantification when table 21 is treated the back and followed up a case by regular visits to
By table 21 as seen, following up a case by regular visits to the back urine protein has decline to have significant difference, and visible this product late result is stable.
The comparison (seeing Table 22) that when 4, treating the back and following up a case by regular visits to renal function is influenced
Table 22 treatment back when following up a case by regular visits to the influence and the comparison of renal function
By table 22 as seen, comparing blood urea nitrogen when treating the back and following up a case by regular visits to has decline, has significant difference.Serum creatinine and endogenous creatinine clearance rate there was no significant difference show that this product late result is stable.
Model case 1
Patient Bai, the man, 26 years old, the workman, this suffer from October, 1998 anasarca, soreness of the waist and knees appear, the whole body is weak, once be " chronic glomerulonephritis " at local hospital diagnosis, through multi-treatment, curative effect does not show, and dizziness and tinnitus, dryness with foreign body sensation in the eyes, uneasy sleeping at night, dysphoria with feverish sensation in the chest palms and soles, dry mouth and throat, ache of the spinal column, blurred vision appear in recent months, the present, my institute went to a doctor, and outpatient service is treated the district with " edema " income.Patient's yellowish complexion body is thin when being admitted to hospital, the puffiness of the eyes, and lassitude, 36.5 ℃ of body temperature, pulse 80 times/minute, blood pressure 120/80 millimetres of mercury, two kidneys district does not have the pain of kowtowing.Routine urianlysis: urine protein+, occult blood +++, erythrocyte 20～25, mix cast 1～2, leukocyte 1～2, twenty-four-hour urine protein quantification 0.45 gram, renal function is normal, hemorheology learn to be checked the whole blood contrast viscosity height value of cutting, is hanged down the value of cutting, plasma viscosity all raises, and other routine blood tests, just routine, liver function, blood glucose, electrocardiogram are all normal.Be diagnosed as " chronic glomerulonephritis (plain edition) ".Throw " nephritislin granule ", each one bag, every day three times, take after mixing it with water.The patient feels that in the 6th week of taking medicine subjective symptoms alleviates, symptom complete obiterations such as blurred vision, vexed xerostomia, and urine protein+, occult blood ±, middle red blood cell of urine is reduced to 0～5, and the state of an illness is clearly better.The patient has repeatedly slightly because of diseases caused by exogenous pathogenic factor cause the state of an illness during to the 7th week.During to the 10th week, patient's other symptoms except that soreness of the spinal column, uneasy sleeping at night disappear substantially.The every symptom of patient disappeared substantially when treatment finished, and urine examination is normal, and pulse condition is gentle, shape such as ordinary person.Follow up a case by regular visits to after 3 months, the patient has rosy cheeks, weight increase, and the every index of laboratory examination all belongs to normally.Clinical judgment is basic the alleviation.
Model case 2
Patient Yu Shuqin, the women, 44 years old, lumbago was 1 year repeatedly, increases the weight of for 1 week.This is suffered from because of 1 year tired conscious lumbago, weak of cause, Jilin examination in hospital ERY+, erythrocyte 10-15/HP, be diagnosed as chronic glomerulonephritis.Nearly 1 all above-mentioned symptoms increase the weight of, half soreness of waist, xerostomia, vexed, sleep night etc., go to a doctor then in my institute.This is suffered from when JIUYUE was admitted to hospital on the 14th in 1999, and tangible dryness with foreign body sensation in the eyes, dizziness and tinnitus, dysphoria with feverish sensation in the chest palms and soles, dry mouth and throat, aching pain in waist and back are arranged, deep-coloured and hot urine, companion's restlessness and thirst, uneasy sleeping at night.Red tongue, white and thin fur, thready and rapid pulse.No edema, the about 1500ml of twenty-four-hour urine amount.Look into Bp12.6/9.33kpa, waist is kowtowed pain ().Have a routine urine test: PRO (+), BLD (+++), RBC20-35/HP; Twenty-four-hour urine protein quantification 1.2g.Be diagnosed as chronic nephritis, oral nephritislin granule 10g, day three times.After 8 weeks of medication, this just yellow red scorching hot, restlessness and thirst, uneasy sleeping at night disappear.Light red tongue, white and thin fur.Check routine urinalysis daily paper: PRO (+), BLD (-).9 weeks back check routine urinalysis: PRO (-), after this RBC0/HP checks and follows up a case by regular visits to the state of an illness and all do not take place repeatedly.
Discuss and conclusion
Chronic glomerulonephritis belongs to common, the frequently-occurring disease of internal medicine, it is many with person between twenty and fifty, and the male is more than the women, clinical long with the course of disease, slowly carry out being characteristics, with hematuria, albuminuria, cylinderuria, edema, hypertension is main clinical manifestation, and this disease is often controlled wrong treatment because of mistake, disease progression and develop into chronic renal failure and jeopardize patient's life.Therefore actively treat chronic nephritis effectively, prevent the depletion of kidney merit, prolong patient's life-span, improve quality of life when being one of effective ways.The nephritislin capsule is a kind of new drug for the treatment of chronic nephritis, for the chronic nephritis that is difficult to effect a radical cure better curative effect is arranged.Because its former medicine standard formation time early, the control of quality means are not sufficiently complete, and it is on the high side to take a number, and it is convenient inadequately to use, and the granule of development newly developed has overcome above-mentioned deficiency, makes patient's taking convenience, brings into play drug effect better.
By selecting 160 routine chronic glomerulonephritis Chinese medical discriminations to belong to hepatic and renal YIN deficiency interior-heat syndrome patient, adopt random packet, single blind contrast method carries out clinical experimental study, wherein 100 examples are organized in treatment, matched group 60 examples obtain comparatively satisfied curative effect, now observed result are summarized as follows:
1, this clinical trial adopts the single blind contrast method of random packet to carry out, test group clinical observation 100 examples, and with nephritislin capsule controlled observation 60 examples, and compare there was no significant difference at items such as sex, age, the course of disease, the state of an illness, tcm syndrome distribution, tongue fur pulse condition and immunoglobulin, hemorheology before two groups of treatments, illustrate that two groups is balanced comparable.The choice criteria of awarding the examination object is clear and definite, the operability of the semi-quantitative standards of traditional Chinese medical science disease, and as seen this clinical trial design is reasonable substantially, and clinical manipulation is fair, and clinical test results is credible.
2, this clinical trial shows, nephritislin granule and matched group all have the effect of tcm syndromes such as improving dryness with foreign body sensation in the eyes, blurred vision, dizziness and tinnitus, dysphoria with feverish sensation in the chest palms and soles, dry mouth and throat, ache of the spinal column, burning sensation during urination, restlessness and thirst, uneasy sleeping at night, and compare there was no significant difference between two groups.
3, this clinical trial shows, nephritislin granule and matched group all have the effect that improves pathology picture of the tongue and pulse condition, and compares there was no significant difference between two groups.
4, this clinical trial also illustrates, nephritislin granule and matched group also have certain effect that recovers edema and reduce urine protein, and compare zero difference between two groups.The nephritislin granule has the effect that improves ERY, has significant differences before and after the treatment, and compares zero difference between two groups.
5, this clinical trial proves, the nephritislin granule has the twenty-four-hour urine of reduction protein quantification, and compares there was no significant difference between two groups.This product does not have obvious influence to renal function.Raise the in addition trend of erythrocyte, hemoglobin and hematoblastic effect of nephritislin granule is seen the comparison zero difference for two groups.
6, this clinical trial proves, the nephritislin granule is by adjusting body's immunity, and the effect of blood viscosity lowering relatively, is being better than matched group aspect adjustment Immunoglobulin IgA and the IgG between two groups.
7, the state of an illness, age and the course of disease and curative effect correlation analysis result of study show, its 3 with curative effect all do not have obvious dependency.
8, the safety testing result shows, does not find that this product has pair liver function, renal function, electrocardio, routine blood test, routine urinalysis, the just harmful effect of routine.Do not find obvious toxic and side effects in the clinical trial yet.
9, clinical test results shows and shows that the test group total effective rate is 85.0%, and significantly rate is 51.0%, and the matched group total effective rate is 81.7%, and comparing difference is not remarkable between 35.0%, two group of obvious effective rate.
10, follow up a case by regular visits to 3 months observation late results, illustrate that this product late result is stable.
The preparation of embodiment 1 tablet of the present invention
Herba Ecliptae 398g, Fructus Ligustri Lucidi 238g, Radix Rehmanniae 23g, Radix Angelicae Sinensis 238g, Rhizoma Chuanxiong 80g, Radix Paeoniae Rubra 160g, Poria 238g, Radix Rubiae 238g, Radix Cirsii Japonici 398g, Herba Cirsii 398g, Fructus Gardeniae 238g.
(1), Radix Angelicae Sinensis, Rhizoma Chuanxiong add 3～8 times of water gagings and extract volatile oil, aqueous solution after the distillation and volatile oil device are in addition collected, medicinal residues are standby;
(2), Fructus Ligustri Lucidi, Radix Paeoniae Rubra, Radix Rubiae be with 55～95% ethanol extractions 1～3 time, each 1～4 hour, make a living 5～12 times of dose of alcohol adding amount, merge extractive liquid, filters, filtrate recycling ethanol, and be concentrated into the thick paste that relative density is 1.18～1.30 (60 ℃);
(3), Six-element such as residue Herba Ecliptae etc., adding 5～12 times of water gagings decocted 1～3 hour, filter, filtrate is placed, medicinal residues mix with above-mentioned standby medicinal residues, add 5～12 times of water gagings and decoct 1～3 hour, filter, aqueous solution merging behind filtrate and above-mentioned filtrate and the extraction volatile oil is concentrated into thick paste and the above-mentioned thick paste that relative density is 1.13～1.35 (50 ℃) and merges mixing.
(4), add the conventional adjuvant for preparing tablet, tabletting.
Embodiment 2
Herba Ecliptae 442g, Fructus Ligustri Lucidi 265g, Radix Rehmanniae 265g, Radix Angelicae Sinensis 265g, Rhizoma Chuanxiong 89g, Radix Paeoniae Rubra 178g, Poria 265g, Radix Rubiae 265g, Radix Cirsii Japonici 442g, Herba Cirsii 442g, Fructus Gardeniae 265g.
(1), Radix Angelicae Sinensis, Rhizoma Chuanxiong add 3～8 times of water gagings and extract volatile oil, aqueous solution after the distillation and volatile oil device are in addition collected, medicinal residues are standby;
(2), Fructus Ligustri Lucidi, Radix Paeoniae Rubra, Radix Rubiae be with 55～95% ethanol extractions 1～3 time, each 1～4 hour, make a living 5～12 times of dose of alcohol adding amount, merge extractive liquid, filters, filtrate recycling ethanol, and be concentrated into the thick paste that relative density is 1.18～1.30 (60 ℃);
(3), Six-element such as residue Herba Ecliptae etc., adding 5～12 times of water gagings decocted 1～3 hour, filter, filtrate is placed, medicinal residues mix with above-mentioned standby medicinal residues, add 5～12 times of water gagings and decoct 1～3 hour, filter, aqueous solution merging behind filtrate and above-mentioned filtrate and the extraction volatile oil is concentrated into thick paste and the above-mentioned thick paste that relative density is 1.13～1.35 (50 ℃) and merges mixing.
(4), press 1 part of thick paste, 4 parts of sucrose, the ratio that dextrin is 0.8 part, and ethanol an amount of, make granule; With the volatile oil beta-cyclodextrin inclusion compound, with above-mentioned granule mixing, drying, granulate, make 10000g, every gram contains crude drug 0.32 gram.
Embodiment 3
Herba Ecliptae 486g, Fructus Ligustri Lucidi 292g, Radix Rehmanniae 292g, Radix Angelicae Sinensis 292g, Rhizoma Chuanxiong 98g, Radix Paeoniae Rubra 196g, Poria 292g, Radix Rubiae 292g, Radix Cirsii Japonici 486g, Herba Cirsii 486g, Fructus Gardeniae 292g.
(1), Radix Angelicae Sinensis, Rhizoma Chuanxiong add 3～8 times of water gagings and extract volatile oil, aqueous solution after the distillation and volatile oil device are in addition collected, medicinal residues are standby;
(2), Fructus Ligustri Lucidi, Radix Paeoniae Rubra, Radix Rubiae be with 55～95% ethanol extractions 1～3 time, each 1～4 hour, make a living 5～12 times of dose of alcohol adding amount, merge extractive liquid, filters, filtrate recycling ethanol, and be concentrated into the thick paste that relative density is 1.18～1.30 (60 ℃);
(3), Six-element such as residue Herba Ecliptae etc., adding 5～12 times of water gagings decocted 1～3 hour, filter, filtrate is placed, medicinal residues mix with above-mentioned standby medicinal residues, add 5～12 times of water gagings and decoct 1～3 hour, filter, aqueous solution merging behind filtrate and above-mentioned filtrate and the extraction volatile oil is concentrated into thick paste and the above-mentioned thick paste that relative density is 1.13～1.35 (50 ℃) and merges mixing.
(4), press 1 part of thick paste, 4 parts of sucrose, the ratio that dextrin is 0.8 part, and ethanol an amount of, make granule; With the volatile oil beta-cyclodextrin inclusion compound, with above-mentioned granule mixing, drying, granulate, make 10000g.
Embodiment 4
Herba Ecliptae 398g, Fructus Ligustri Lucidi 238g, Radix Rehmanniae 23g, Radix Angelicae Sinensis 238g, Rhizoma Chuanxiong 80g, Radix Paeoniae Rubra 160g, Poria 238g, Radix Rubiae 238g, Radix Cirsii Japonici 398g, Herba Cirsii 398g, Fructus Gardeniae 238g, Polyporus 238g, Semen Plantaginis (parched with salt) 477g, Herba Portulacae 956g, Radix Sanguisorbae 795g.
Preparation only all adds Polyporus, Semen Plantaginis (parched with salt), Herba Portulacae, Radix Sanguisorbae in step (three) with embodiment 1.
Embodiment 5
Herba Ecliptae 442g, Fructus Ligustri Lucidi 265g, Radix Rehmanniae 265g, Radix Angelicae Sinensis 265g, Rhizoma Chuanxiong 89g, Radix Paeoniae Rubra 178g, Poria 265g, Radix Rubiae 265g, Radix Cirsii Japonici 442g, Herba Cirsii 442g, Fructus Gardeniae 265g, Polyporus 265g, Semen Plantaginis (parched with salt) 530g, Herba Portulacae 1062g, Radix Sanguisorbae 883g.
Preparation only all adds Polyporus, Semen Plantaginis (parched with salt), Herba Portulacae, Radix Sanguisorbae in step (three) with embodiment 2.
Embodiment 6
Herba Ecliptae 486g, Fructus Ligustri Lucidi 292g, Radix Rehmanniae 292g, Radix Angelicae Sinensis 292g, Rhizoma Chuanxiong 98g, Radix Paeoniae Rubra 196g, Poria 292g, Radix Rubiae 292g, Radix Cirsii Japonici 486g, Herba Cirsii 486g, Fructus Gardeniae 292g, Polyporus 292g, Semen Plantaginis (parched with salt) 583g, Herba Portulacae 1168g, Radix Sanguisorbae 971g.
Preparation only all adds Polyporus, Semen Plantaginis (parched with salt), Herba Portulacae, Radix Sanguisorbae in step (three) with embodiment 3.
Embodiment 7
Herba Ecliptae 398g, Fructus Ligustri Lucidi 238g, Radix Rehmanniae 23g, Radix Angelicae Sinensis 238g, Rhizoma Chuanxiong 80g, Radix Paeoniae Rubra 160g, Poria 238g, Radix Rubiae 238g, Radix Cirsii Japonici 398g, Herba Cirsii 398g, Fructus Gardeniae 238g, Polyporus 238g, Semen Plantaginis (parched with salt) 477g, Herba Portulacae 956g, Radix Sanguisorbae 795g, Rhizoma Dioscoreae 426g scalds Rhizoma Cibotii 795g.
Preparation only all adds Rhizoma Dioscoreae, boiling hot Rhizoma Cibotii in step (three) with embodiment 4.
Embodiment 8
Herba Ecliptae 442g, Fructus Ligustri Lucidi 265g, Radix Rehmanniae 265g, Radix Angelicae Sinensis 265g, Rhizoma Chuanxiong 89g, Radix Paeoniae Rubra 178g, Poria 265g, Radix Rubiae 265g, Radix Cirsii Japonici 442g, Herba Cirsii 442g, Fructus Gardeniae 265g, Polyporus 265g, Semen Plantaginis (parched with salt) 530g, Herba Portulacae 1062g, Radix Sanguisorbae 883g, Rhizoma Dioscoreae 473g scalds Rhizoma Cibotii 883g.
Preparation only all adds Rhizoma Dioscoreae, boiling hot Rhizoma Cibotii in step (three) with embodiment 5.
Embodiment 9
Herba Ecliptae 442g, Fructus Ligustri Lucidi 265g, Radix Rehmanniae 265g, Radix Angelicae Sinensis 265g, Rhizoma Chuanxiong 89g, Radix Paeoniae Rubra 178g, Poria 265g, Radix Rubiae 265g, Radix Cirsii Japonici 442g, Herba Cirsii 442g, Fructus Gardeniae 265g, Polyporus 265g, Semen Plantaginis (parched with salt) 530g, Herba Portulacae 1062g, Rhizoma Dioscoreae 520g scalds Rhizoma Cibotii 971g.
Preparation only all adds Rhizoma Dioscoreae, boiling hot Rhizoma Cibotii in step (three) with embodiment 6.
Embodiment 10
Differentiate wherein two kinds of medical material Herba Ecliptaes and Radix Rubiae with thin layer chromatography: sample is obtained by embodiment 2.
(1) get this product 15g, add water 100ml, put heating for dissolving in the water-bath, put coldly, put in the separatory funnel, add chloroform extraction secondary, each 30ml, combined chloroform liquid is put and is concentrated into 1ml in the water-bath, as need testing solution.Other gets Herba Ecliptae control medicinal material 2g, adds water 100ml and decocts 1 hour, puts coldly, filters, and puts in the separatory funnel, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with dimethylbenzene-ethyl acetate-normal hexane-methanol-formic acid (20: 10: 8: 0.5: 0.5) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get this product 20g, porphyrize adds methanol 40ml, supersound process 20 minutes filters the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, adds concentrated hydrochloric acid 1ml, boils 30 minutes, cooling, with extracted with diethyl ether twice, each 20ml, merge ether solution, volatilize, residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Radix Rubiae control medicinal material 1g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with dimethylbenzene-ethyl acetate-normal hexane-methanol-formic acid (20: 10: 8: 0.5: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
Measure jasminoidin and peoniflorin according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water (15: 85) is mobile phase; The detection wavelength is 230nm; Number of theoretical plate is pressed the peoniflorin peak and is calculated, and should be not less than 4000.
The preparation precision of reference substance solution takes by weighing jasminoidin reference substance and each 10mg of peoniflorin reference substance, put in the 25ml measuring bottle, add dissolve with methanol and be diluted to scale, shake up, precision is measured 1ml, puts in the 10ml measuring bottle, add methanol and be diluted to scale, shake up, that is, contain each 0.04mg of jasminoidin and peoniflorin among every 1ml.
This product 2.5g is got in the preparation of need testing solution, porphyrize, and accurate the title, decide, accurate 70% alcoholic solution 100ml, supersound process (250W, 50KHz) 30 minutes of adding, put coldly, filter, precision is measured subsequent filtrate 50ml, evaporate to dryness, residue adds water 25ml dissolving, puts in the separatory funnel, adds chloroform and extracts twice, each 30ml, discard chloroform solution, use water saturation n-butanol extraction 5 times, each 20ml, merge n-butanol extracting liquid, put evaporate to dryness in the water-bath, residue adds dissolve with methanol and is transferred in the 10ml measuring bottle, adds methanol dilution scale, shake up, promptly.
Accurate reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
The every g of this product contains Radix Paeoniae Rubra by peoniflorin (C
23H
28O
11) meter, must not be less than 0.24mg; Contain Fructus Gardeniae with jasminoidin (C
17H
24O
10) meter, must not lack 0.31mg.
Claims (4)
1. pharmaceutical composition for the treatment of chronic glomerulonephritis is characterized in that being made by the crude drug of following parts by weight:
398～486 parts of Herba Ecliptaes, 238～292 parts of Fructus Ligustri Lucidi, 238～292 parts of Radix Rehmanniae,
238～292 parts of Radix Angelicae Sinensis, 80～98 parts of Rhizoma Chuanxiongs, 160～196 parts of Radix Paeoniae Rubra, 238～292 parts in Poria,
238～292 parts in Radix Rubiae, 398～486 parts of Radix Cirsii Japonicis, 398～486 parts of Herba Cirsiis,
238～292 parts of Fructus Gardeniaes, 238～292 parts of Polyporus, 477～583 parts of Semen Plantaginis (parched with salt), 956～1168 parts of Herba Portulacaes, 795～971 parts of Radix Sanguisorbaes.
2. the pharmaceutical composition of treatment chronic glomerulonephritis according to claim 1 is characterized in that being made by the crude drug of following parts by weight:
442 parts of Herba Ecliptaes, 265 parts of Fructus Ligustri Lucidi, 265 parts of Radix Rehmanniae, 265 parts of Radix Angelicae Sinensis, 89 parts of Rhizoma Chuanxiongs, 178 parts of Radix Paeoniae Rubra, 265 parts in Poria, 265 parts in Radix Rubiae, 442 parts of Radix Cirsii Japonicis, 442 parts of Herba Cirsiis, 265 parts of Fructus Gardeniaes.265 parts of Polyporus, 530 parts of Semen Plantaginis (parched with salt), 1062 parts of Herba Portulacaes, 883 parts of Radix Sanguisorbaes.
3. treat the preparation of drug combination method of chronic glomerulonephritis according to claim 1, it is characterized in that comprising the following steps:
(1), Radix Angelicae Sinensis, Rhizoma Chuanxiong add 3～8 times of water gagings and extract volatile oil, aqueous solution after the distillation and volatile oil device are in addition collected, medicinal residues are standby;
(2), Fructus Ligustri Lucidi, Radix Paeoniae Rubra, Radix Rubiae be with 55～95% ethanol extractions 1～3 time, each 1～4 hour, make a living 5～12 times of dose of alcohol adding amount, merge extractive liquid,, filter, filtrate recycling ethanol, and survey when being concentrated into 60 ℃, relative density is 1.18～1.30 thick paste;
(3), ten flavors such as residue Herba Ecliptae etc., adding 5～12 times of water gagings decocted 1～3 hour, filter, filtrate is placed, and medicinal residues mix with above-mentioned standby medicinal residues, adding 5～12 times of water gagings decocted 1～3 hour, filter, the aqueous solution behind filtrate and above-mentioned filtrate and the extraction volatile oil merges, and survey, relative density are 1.13～1.35 thick paste when being concentrated into 50 ℃, merge mixing with above-mentioned thick paste.
4. treat the detection method of the pharmaceutical composition of chronic glomerulonephritis according to claim 1, it is characterized in that: comprise with thin layer chromatography discriminating two kinds of medical materials wherein; With the content of two kinds of compositions of the described medicine of high effective liquid chromatography for measuring, wherein:
Differentiate wherein two kinds of medical material Herba Ecliptaes and Radix Rubiae with thin layer chromatography:
(1) get this product 15g, add water 100ml, put heating for dissolving in the water-bath, put coldly, put in the separatory funnel, add chloroform extraction secondary, each 30ml, combined chloroform liquid is put and is concentrated into 1ml in the water-bath, as need testing solution; Other gets Herba Ecliptae control medicinal material 2g, adds water 100ml and decocts 1 hour, puts cold, filter, put in the separatory funnel, shine medical material solution in pairs with legal system, according to thin layer chromatography, each 5 μ l of above-mentioned two kinds of solution are drawn in an appendix VI of Chinese Pharmacopoeia version in 2000 B test, put respectively on same silica gel g thin-layer plate, with dimethylbenzene: ethyl acetate: normal hexane: methanol: formic acid=20: 10: 8: be developing solvent at 0.5: 0.5, launches, and takes out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(2) get this product 20g, porphyrize adds methanol 40ml, supersound process 20 minutes filters the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, adds concentrated hydrochloric acid 1ml, boils 30 minutes, cooling, with extracted with diethyl ether twice, each 20ml, merge ether solution, volatilize, residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Rubiae control medicinal material 1g, shines medical material solution in pairs with legal system; According to thin layer chromatography, an appendix VI of Chinese Pharmacopoeia version in 2000 B test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with dimethylbenzene: ethyl acetate: normal hexane: methanol: formic acid=20: 10: 8: be developing solvent at 0.5: 1, launches, and takes out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
According to high performance liquid chromatography, an appendix VI of Chinese Pharmacopoeia version in 2000 D measures jasminoidin and peoniflorin;
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile: water=15: 85 is mobile phase; The detection wavelength is 230nm; Number of theoretical plate is pressed the peoniflorin peak and is calculated, and should be not less than 4000;
The preparation precision of reference substance solution takes by weighing jasminoidin reference substance and each 10mg of peoniflorin reference substance, put in the 25ml measuring bottle, add dissolve with methanol and be diluted to scale, shake up, precision is measured 1ml, puts in the 10ml measuring bottle, add methanol and be diluted to scale, shake up, that is, contain each 0.04mg of jasminoidin and peoniflorin among every 1ml;
This product 2.5g is got in the preparation of need testing solution, porphyrize, and accurate the title, decide, accurate 70% alcoholic solution 100ml, 250W, the 50KHz supersound process 30 minutes of adding, put coldly, filter, precision is measured subsequent filtrate 50ml, evaporate to dryness, residue adds water 25ml dissolving, puts in the separatory funnel, adds chloroform and extracts twice, each 30ml, discard chloroform solution, use water saturation n-butanol extraction 5 times, each 20ml, merge n-butanol extracting liquid, put evaporate to dryness in the water-bath, residue adds dissolve with methanol and is transferred in the 10ml measuring bottle, adds methanol dilution scale, shake up, promptly;
Accurate reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly;
The every g of this product contains Radix Paeoniae Rubra by peoniflorin, must not be less than 0.24mg; Contain Fructus Gardeniae in jasminoidin, must not lack 0.31mg.
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| CN1704071A (en) * | 2004-06-02 | 2005-12-07 | 倪吉志 | Chinese medicine for treating chronic nephritis |
| CN1943737A (en) * | 2005-10-08 | 2007-04-11 | 刘国飞 | A Chinese traditional medicinal composition used for treatment of nephritis and its preparation method |
| CN101085258A (en) * | 2007-06-26 | 2007-12-12 | 北京艺信堂医药研究所 | Traditional Chinese medicine composition for treating acute nephritis |
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| CN1704071A (en) * | 2004-06-02 | 2005-12-07 | 倪吉志 | Chinese medicine for treating chronic nephritis |
| CN1943737A (en) * | 2005-10-08 | 2007-04-11 | 刘国飞 | A Chinese traditional medicinal composition used for treatment of nephritis and its preparation method |
| CN101085258A (en) * | 2007-06-26 | 2007-12-12 | 北京艺信堂医药研究所 | Traditional Chinese medicine composition for treating acute nephritis |
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