CN105663705A - Medicine composition for treating kidney yin-yang deficiency type latent glomerulonephritis - Google Patents

Abstract

The invention belongs to the technical field of medicines and particularly relates to medicine composition for treating kidney yin-yang deficiency type latent glomerulonephritis. The medicine composition is prepared from traditional Chinese medicines in parts by weight as follows: 4-8 parts of Cerastium arvense L., 4-8 parts of rhizomes of largeleaf curculigo, 4-8 parts of pecteilis susannae, 4-8 parts of pleurotus ostreatus, 4-8 parts of dysosma majorensis, 4-8 parts of balanophora polyandra, 4-8 parts of aralia elata, 4-8 parts of herbs of creeping rattlesnake plantain, 4-8 parts of moutan bark, 4-8 parts of oriental waterplantain rhizomes and 4-8 parts of liquorice. The medicines are combined to perform the efficacy of benefiting qi, tonifying yang and nourishing yin and the kidney; the medicine composition can effectively reduce clinical symptoms of a patient suffering from latent glomerulonephritis, reduce the number of urine erythrocyte and the urine protein quantitation level in 24 hours and increase the glomerular filtration rate.

Description

A kind of pharmaceutical composition treating the invisible glomerulonephritis of kidney yin and yang deficiency type

Technical field

The invention belongs to medical art, it is specifically related to a kind of pharmaceutical composition treating the invisible glomerulonephritis of kidney yin and yang deficiency type.

Background technology

Invisible glomerulonephritis. External title asymptomatic hematuria or proteinuria are one common in primary glomerulonephritis. Being more common in teenager, age of onset is many below 30 years old, and the male sex, more than women, is approximately 2:1. According to the literature, the sickness rate of invisible glomerulonephritis accounts for the 0.79% of generaI investigation proper manners, is a difficult problem for current treatment of kidney disease. Though previously viewpoint thinks that this disease course of disease is touching more, but stable disease, prognosis is good. The progress report of Study of evidence based medicine and the up-to-date research for latent nephritis at present in recent years finds to think, latent nephritis has had pathology damage, and kidney starts fibrosis, as can not get treating in time control, some cases (about 30%) renal function goes down gradually, enters renal insufficiency, finally develops into uremia. To the early stage effective prevention of latent nephritis, minimizing or control kidney pathology are occurred and develop significant.

Modern medicine there is no reliable and effective method up to now, and the main rules for the treatment of have prevention and corntrol to infect, protect renal function, forbid to use the medicine of induced renal damage function. Main method has anti-freezing, expands blood vessel and suitably select the medicine such as hormone, immunosuppressor. The efficiency that always has of western medical treatment is 16% according to the literature. The preparation curative effect taking chemosynthesis for a long time is not good enough, and has certain side effect.

Kidney yin and yang deficiency type is the common card type of invisible glomerulonephritis, and patient's disease is seen: primary symptom: soreness of the waist and knees, fatigue and weak, and dry mouth and throat is dysphoria in chestpalms-soles, edema, aversion to cold and preference for warmth, deep-thready pulse, and tongue is red. Secondary disease: have a dizzy spell, yellowish or reddish urine, hectic fever night sweat, limb is cold, just quiet, and enuresis nocturna is long clearly, white,slippery and moist fur, and arteries and veins is thin. Have not yet to see the medicine for such invisible glomerulonephritis to report.

Summary of the invention

Technical problem to be solved by this invention avoids the weak point existing for above-mentioned prior art, it is provided that a kind of pharmaceutical composition treating the invisible glomerulonephritis of kidney yin and yang deficiency type.

The present invention is achieved through the following technical solutions:

Treat a pharmaceutical composition for the invisible glomerulonephritis of kidney yin and yang deficiency type, it be made up of the Chinese medicine of following weight part:

Field grasswort 4-8 part, Rhizome of Largeleaf Curculigo 4-8 part, white butterfly flower 4-8 part, 4-8 part of picking up the ears, white Dysosma versipellis 4-8 part, Herba Balanophorae polyandrae 4-8 part, thorn dragon tooth 4-8 part, rattlesnake plantain 4-8 part, root bark of tree peony 4-8 part, rhizoma alismatis 4-8 part, Radix Glycyrrhizae 4-8 part.

Preferably, the pharmaceutical composition of the above-mentioned invisible glomerulonephritis for the treatment of kidney yin and yang deficiency type, is made up of the Chinese medicine of following weight part:

Field grasswort 5-7 part, Rhizome of Largeleaf Curculigo 5-7 part, white butterfly flower 5-7 part, 5-7 part of picking up the ears, white Dysosma versipellis 5-7 part, Herba Balanophorae polyandrae 5-7 part, thorn dragon tooth 5-7 part, rattlesnake plantain 5-7 part, root bark of tree peony 5-7 part, rhizoma alismatis 5-7 part, Radix Glycyrrhizae 5-7 part.

Preferred, the pharmaceutical composition of the above-mentioned invisible glomerulonephritis for the treatment of kidney yin and yang deficiency type, is made up of the Chinese medicine of following weight part:

Field grasswort 6 parts, Rhizome of Largeleaf Curculigo 6 parts, white butterfly spend 6 parts, pick up the ears 6 parts, white Dysosma versipellis 6 parts, Herba Balanophorae polyandrae 6 parts, thorn dragon tooth 6 parts, rattlesnake plantain 6 parts, the root bark of tree peony 6 parts, rhizoma alismatis 6 parts, 6 parts, Radix Glycyrrhizae.

The ratio of above weight proportion is through what science screening obtained, and for especial patient, such as severe or mild, fat or modest patient, it is possible to the proportioning of the amount of corresponding adjustment composition, increases or reduce being no more than 100%, and drug effect is substantially constant.

The weight part of said medicine, if in units of g, the normally consumption of 1 dose.

The indication of Chinese medicine of the present invention: be used for the treatment of the invisible glomerulonephritis of kidney yin and yang deficiency type.

The taboo item of Chinese medicine of the present invention: between treatment medication period, fasting is greasy, raw and cold, the smelling of fish or mutton, irritant and nondigestible food.

Grasswort another name field, field grasswort is the full grass of pinkwort field grasswort CerastiumrvenseL.. Lightly seasoned; Warm in nature. Function nourishing YIN and invigorating YANG. Main negative and positive virtual loss is demonstrate,proved.

Rhizome of Largeleaf Curculigo is the rhizome of bloodwort great Ye thizoma curculiginis Curculigocapitulata (Lour.) O.Kuntze [LeucojumcapitulataLour.]. Taste is pungent; Micro-hardship; Warm in nature. Return kidney; Lung; Liver Channel. Function kidney invigorating and YANG supporting; Dispel rheumatism; Promoting blood flow to regulate menstruation. Master suffers from a deficiency of the kidney to cough and breathes heavily; Impotence and seminal emission; Under gonorrhoea band; Soreness of the waist and knees; Rheumatic arthralgia; Palace is cold infertile; Menoxenia; Uterine bleeding; Uterine prolapse; Wound.

The white butterfly flower gentle grass of another name, root of Common Pecteilis, tap orchid, derive from the white butterfly flower Pecteilissusannae(L. of the orchid family) Rafin., is used as medicine with root. Taste is sweet, slightly warm in nature. Function kidney invigorating and YANG supporting, strong spleen. Cure mainly lumbago due to renal deficiency, chronic nephritis, testitis, weakness of the spleen and the stomach.

Pick up the ears that another name north wind bacterium, oyster bacterium, flat mushroom, seeds of a tung oil tree bacterium, tertia are picked up the ears, oyster bacterium, water wind bacterium, freeze bacterium, blue or green mushroom, ash mushroom. For the sporophore of Bai Mo section fungi oyster cap fungus Pleurotusostreatus (Jacq.exFr.) Quel. [AgaricusostreatusJacq.exFr.]. Taste is pungent; Sweet; Warm in nature. Return liver; Kidney channel. Function wind-evil dispelling and cold-evil expelling; Stimulate the circulation of the blood and cause the muscles and joints to relax; Kidney invigorating and YANG supporting. Main lumbago and skelalgia; Numb in every limb; Muscle network does not relax; Impotence and seminal emission, weakness of the waist and knees.

White Dysosma versipellis the another name trace of blood gold basin, Podophyllum emodi var chinense, nine mortars are the root and rhizome of Berberidaceae plant Guizhou Dysosma versipellis. Latin plant animal mineral name: Dysosmamajorensis (Gagnep.) Ying [PodophyllummajorenseGagnep.; DysosmalichuanensisChengsp.nov.Ined.]. Taste is sweet; Bitter; Property is put down. Function enriching yin and nourishing kidney; Clearing away lung-heat and moistening dryness; Detoxify and promote the subsdence of swelling. Main internal lesion caused by overexertion bones and muscles pain; Impotence; Stomachache; Innominate toxic swelling; Weapons wound.

Herba Balanophorae polyandrae another name soil desert cistanche, exceedingly high candle, wood fungus. For the complete stool of Balanophoraceae plant Herba Balanophorae polyandrae. Function enriching yin and nourishing kidney. Control the deficiency of blood, hemorrhage, gonorrhoea.

Ci Longya calls herba siehesbeckiae, magpie does not step on, Root-bark of Japanese Aralia, tiger sun thorn, is Araliaceae east area of the Liao River, coextensive with eastern and southern Liaoning Province wood Araliaelata (Miq.) Seem. [Dimor-phanthuselatusMiq.; AraliamandshuricaMaxim.] root skin and bark.Taste is pungent; Micro-hardship; Sweet; Property is put down. Function vital energy benefiting and the kidney invigorating; Expelling wind and removing dampness; Promoting blood circulation and stopping pain. The main deficiency of vital energy is weak; Suffer from a deficiency of the kidney impotence; Gastric abscess; Quench one's thirst; Insomnia and dreamful sleep; Rheumatoid bone bi-syndrome; Weakness of the waist and knees; Wound; Fracture; Expand; Oedema; Prolapse of the anus; Mange.

Rattlesnake plantain another name silver line basin, nine layers of lid, Root of Sessile Primrose, little general, leaflet is blue or green, fiber crops leaf is blue or green, green bamboo snake, long-nosed pit viper medicine, point leaf mountain butterfly, the little green grass or young crops of the leaf of bamboo, lung angle grass, Rhizome of Cordate Pinellia, Oxyria sinensis Hemsl., white fungus ring, for the big rattlesnake plantain GoodyeraschlechtendalianaReichb.f. of orchid, little rattlesnake plantain goodyerarepens (L.) R.Br. [SatyriumrepensL.], the full grass of blue Goodyerabifora (Lindl.) Hook.f. [GeorchisbifloraLindl.] of big piebald or suede leaf rattlesnake plantain GoodyeravelutinaMaxim.. taste is sweet, pungent, property is put down. function moistens the lung and relieve the cough, kidney tonifying benefit gas, promoting flow of QI and blood, subduing swelling and detoxicating. main pulmonary tuberculosis cough, trachitis, dizzy weak, neurasthenia, impotence, wound, arthralgia, swelling and pain in the throat, acute mastitis, sore furuncle, scrofula, venomous snake bite.

In the pharmaceutical composition of the present invention, other medicine all records in 2015 editions pharmacopeia one.

Without " latent nephritis " name of disease in China's Gu doctor's nationality document, so see the discussion of doctor at all times, this disease is when belonging to the categories such as motherland's medical science " hematuria ", " turbid urine ", " pain in the back ", " empty labor ", but regardless of name of disease, its etiology and pathogenesis surely belongs to nephropathy and suffers from a deficiency of the kidney and so on. "Nei Jing" speech " healthy tendency deposit in, heresy can not be done ", " being gathered of heresy, its gas must void ", " kidney is without real example and illness that has not attacked the vital organs of the human body ", illustrates that the generation of any nephropathy is all based on suffering from a deficiency of the kidney. Ancients also have saying of " the many asthenic symptoms of ephrosis ". So, suffering from a deficiency of the kidney is the pathologic basis that all nephropathys are fallen ill. The development and evolution rule of the etiology and pathogenesis of latent nephritis is also like this. The interpretation of the cause, onset and process of an illness of invisible glomerulonephritis is relevant with kidney insufficiency, therefore with " benefit gas establishing-Yang, enriching yin and nourishing kidney " for principle treats the invisible glomerulonephritis of kidney yin and yang deficiency type.

The pharmaceutical composition of the present invention, its prescription machine is as follows:

Monarch's medicine: field grasswort merit is with nourishing YIN and invigorating YANG.

Ministerial drug: Rhizome of Largeleaf Curculigo, Bai Diehua, merit of picking up the ears are with kidney invigorating and YANG supporting; White Dysosma versipellis, Herba Balanophorae polyandrae merit are with enriching yin and nourishing kidney;

Adjutant: Ci Longya, rattlesnake plantain merit are with kidney tonifying benefit gas. Root bark of tree peony merit is with clearing heat and cooling blood, and promoting blood circulation and removing blood stasis, rhizoma alismatis merit is with diuresis, and clearing away damp-heat, two medicines share in case nourished greasy, hinder gas to hinder stomach.

Make medicine: Radix Glycyrrhizae merit is with coordinating the actions of various ingredients in a prescription.

We's compatibility is reasonable, and all medicines share plays benefit gas establishing-Yang, the effect of enriching yin and nourishing kidney altogether. The interpretation of the cause, onset and process of an illness of the invisible glomerulonephritis of the kidney yin and yang deficiency type that links closely. Can effectively improve the clinical symptom of invisible glomerulonephritis patient, lower urine erythrocyte quantity and twenty-four-hour urine protein quantification level, improve glomerular filtration rate(GFR, the disease progression of control latent nephritis, and present method and drug safety used are good, there is promotional value.

Embodiment

Below in conjunction with specific embodiment, the present invention is further described, so that the technician of this area more understands the present invention, but does not therefore limit the present invention.

Embodiment 1

Treating a pharmaceutical composition for the invisible glomerulonephritis of kidney yin and yang deficiency type, each bulk drug weight proportion is as follows:

Field grasswort 6g, Rhizome of Largeleaf Curculigo 6g, white butterfly flower 6g, the 6g that picks up the ears, white Dysosma versipellis 6g, Herba Balanophorae polyandrae 6g, thorn dragon tooth 6g, rattlesnake plantain 6g, root bark of tree peony 6g, rhizoma alismatis 6g, Radix Glycyrrhizae 6g.

Embodiment 2

Treating a pharmaceutical composition for the invisible glomerulonephritis of kidney yin and yang deficiency type, each bulk drug weight proportion is as follows:

Field grasswort 5g, Rhizome of Largeleaf Curculigo 7g, white butterfly flower 5g, the 7g that picks up the ears, white Dysosma versipellis 5g, Herba Balanophorae polyandrae 7g, thorn dragon tooth 5g, rattlesnake plantain 7g, root bark of tree peony 5g, rhizoma alismatis 7g, Radix Glycyrrhizae 5g.

Embodiment 3

Treating a pharmaceutical composition for the invisible glomerulonephritis of kidney yin and yang deficiency type, each bulk drug weight proportion is as follows:

Field grasswort 7g, Rhizome of Largeleaf Curculigo 5g, white butterfly flower 7g, the 5g that picks up the ears, white Dysosma versipellis 7g, Herba Balanophorae polyandrae 5g, thorn dragon tooth 7g, rattlesnake plantain 5g, root bark of tree peony 7g, rhizoma alismatis 5g, Radix Glycyrrhizae 7g.

Embodiment 4

Treating a pharmaceutical composition for the invisible glomerulonephritis of kidney yin and yang deficiency type, each bulk drug weight proportion is as follows:

Field grasswort 4g, Rhizome of Largeleaf Curculigo 8g, white butterfly flower 4g, the 8g that picks up the ears, white Dysosma versipellis 4g, Herba Balanophorae polyandrae 8g, thorn dragon tooth 4g, rattlesnake plantain 8g, root bark of tree peony 4g, rhizoma alismatis 8g, Radix Glycyrrhizae 4g.

Embodiment 5

Treating a pharmaceutical composition for the invisible glomerulonephritis of kidney yin and yang deficiency type, each bulk drug weight proportion is as follows:

Field grasswort 8g, Rhizome of Largeleaf Curculigo 4g, white butterfly flower 8g, the 4g that picks up the ears, white Dysosma versipellis 8g, Herba Balanophorae polyandrae 4g, thorn dragon tooth 8g, rattlesnake plantain 4g, root bark of tree peony 8g, rhizoma alismatis 4g, Radix Glycyrrhizae 8g.

The pharmaceutical composition of the present invention has been carried out clinical pharrnacokinetics test, and Details as Follows:

1. data and method

1.1 research objects

Choose invisible glomerulonephritis (kidney yin and yang deficiency type) patient 150 example, wherein man 99 example, female 51 example, the mean age (42.86 ± 14.92) year.

The Case definition of 1.2 latent nephritis

Correction standard is formulated: (1), without obvious clinical symptom and sign, mainly shows as and urinates without symptom proteinuria and pleomorphic type red corpuscle according to the 2nd national nephropathy academic conference. (2) in the past without acute and chronic ephritis or ephrosis medical history. (3) renal function is good. (4) blood urine of the outer reason of kidney and functional blood urine is got rid of. (5) urine examination is abnormal as based on a small amount of urine protein, urine protein is less than 1.0g/24 hour, can be called that asymptomatic proteinuria is as based on blood urine under persistence mirror, accidental gross hematuria, phase differential mirror inspection urine erythrocyte is pleomorphic type, and counting is greater than 10,000/ml, can be called pure blood urine.

1.3 differential diagnosis in tcm standards

" kidney yin and yang deficiency type " Case definition with reference to latent nephritis in " new Chinese medicine guideline of clinical investigations ": primary symptom: soreness of the waist and knees, fatigue and weak, dry mouth and throat, dysphoria in chestpalms-soles, edema, aversion to cold and preference for warmth, deep-thready pulse, tongue is red. Secondary disease: have a dizzy spell, yellowish or reddish urine, hectic fever night sweat, limb is cold, just quiet, and enuresis nocturna is long clearly, white,slippery and moist fur, and arteries and veins is thin.

1.4 include standard in

1. Informed Consent Form is signed

2. age 18～70 years old.

3. clinical diagnosis meets latent nephritis, and differential diagnosis in tcm meets " kidney yin and yang deficiency type " Case definition.

4. chronic kidney disease standard by stages: GFR >=90ml/min/1.73m2.

5. twenty-four-hour urine protein quantification < 1.0g/24h.

1.5 exclusion standard

1. primary glomerulopathy belongs to acute nephritis, radical property ephritis, chronic glomerulonephritis, nephrotic syndrome person.

2. spirit patient, can not co-worker.

3. serious brain, the heart, liver organ disease person is had to be associated with serious acute and chronic infection cancer patients.

4. gestation or lactating women and have in the recent period gestation plan patient.

1.6 cases are rejected and are come off standard

1. all cases not meeting the standard of including in and be strayed into should be rejected;

2. irregular observation measure or data not umbra ring observe judgement person should reject.

3. in observing, patient does not exit person voluntarily and should be considered as coming off;

4. occur that adverse events should not continue viewer and be considered as coming off in observing

1.7 methods for the treatment of

Adopt the embodiment of the present invention 1 medicine composite for curing, prescription is as follows: field grasswort 6g, Rhizome of Largeleaf Curculigo 6g, white butterfly flower 6g, the 6g that picks up the ears, white Dysosma versipellis 6g, Herba Balanophorae polyandrae 6g, thorn dragon tooth 6g, rattlesnake plantain 6g, root bark of tree peony 6g, rhizoma alismatis 6g, Radix Glycyrrhizae 6g, water decoction, day one dose, sooner or later sub-service, taking 7d as a course for the treatment of.

1.8 treatment fore-and-aft observing indexs

(1) laboratory examination: 1. red blood cell count(RBC) inspection in routine urinalysis. 2. urine protein is qualitative and 24 hours protein quantifications. 3. glomerular filtration rate(GFR (GFR).

(2) TCM syndrome integration: with reference to " new Chinese medicine clinical study medication guide principle ", according to nothing, gently, in, heavy, it is designated as 0,1,2,3 point respectively.

1.9 doctor trained in Western medicine therapeutic evaluatioies

Adopt urine protein therapeutic evaluation:

Cure: routine urianlysis albumen turns negative, or twenty-four-hour urine protein quantification is normal;

Effective: routine urianlysis albumen reduce 2 "+", or twenty-four-hour urine protein quantification reduce >=40%;

Effective: routine urianlysis albumen reduce 1 "+", or twenty-four-hour urine protein quantification reduce < 40%;

It is invalid: urine protein is without minimizing or increases.

1.10 TCM syndrome therapeutic evaluation

" new Chinese medicine clinical study medication guide principle " that evaluation criteria was promulgated with reference to 2002.

1. fully recovering: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%

2. effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%

3. effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%

4. invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.

Calculation formula: nimodipine method: integration × 100% before (before treatment integration after integration-treatment)/treatment.

1.11 statistical method

SPSS14.0 version statistical software is adopted to analyze. Measurement data adds with all numbers and subtracts standard deviation and represent, compares and adopts t inspection, represent that difference has statistical significance with P < 0.05 before and after treatment.

2. result

Before and after 2.1 treatments, lab index compares

After treatment, urine erythrocyte, 24 quantity of proteinurias obviously reduce before all relatively treating, and difference has statistical significance (P < 0.05), and after treatment, GFR obviously raises before relatively treating, and difference has statistical significance (P < 0.05), in table 1.

Table 1 is treated front and back lab index and is compared

Time	Urine erythrocyte counts	24h quantity of proteinuria	GFR
				Before treatment	18.92±4.23	0.89±0.15	99.13±11.45
After treatment	4.45±1.04	0.26±0.04	116.38±12.24
				T value	5.435	4.983	4.467
P value	0.016	0.023	0.026

2.3 doctor trained in Western medicine curative effects

150 example patients, cure 138 examples, effective 7 examples, effective 5 examples, invalid 0 example. Curative effect: curative ratio 92.0%, total obvious effective rate 96.7%, always has efficiency to be 100%.

TCM syndrome integration and TCM syndrome curative effect before and after 2.2 treatments

TCM syndrome total mark (4.98 ± 1.25) point after treatment, relatively (34.23 ± 6.56) point before treatment obviously reduce, and difference has statistical significance (t=5.365, P < 0.05); 150 example patient's TCM syndrome curative effects: cure 137 examples, effective 9 examples, effective 4 examples, invalid 0 example. Curative effect: curative ratio 91.3%, total obvious effective rate 97.3%, always has efficiency to be 100%.

2.3 safety analysis

Before and after treatment, patient's routine blood test, liver kidney merit and electrocardiogram(ECG are without considerable change, and drug safety is better.

Claims (3)

1. treat a pharmaceutical composition for the invisible glomerulonephritis of kidney yin and yang deficiency type, it be made up of the Chinese medicine of following weight part:

Field grasswort 4-8 part, Rhizome of Largeleaf Curculigo 4-8 part, white butterfly flower 4-8 part, 4-8 part of picking up the ears, white Dysosma versipellis 4-8 part, Herba Balanophorae polyandrae 4-8 part, thorn dragon tooth 4-8 part, rattlesnake plantain 4-8 part, root bark of tree peony 4-8 part, rhizoma alismatis 4-8 part, Radix Glycyrrhizae 4-8 part.

2. the pharmaceutical composition of the invisible glomerulonephritis for the treatment of kidney yin and yang deficiency type according to claim 1, it is characterised in that, it is made up of the Chinese medicine of following weight part:

Field grasswort 5-7 part, Rhizome of Largeleaf Curculigo 5-7 part, white butterfly flower 5-7 part, 5-7 part of picking up the ears, white Dysosma versipellis 5-7 part, Herba Balanophorae polyandrae 5-7 part, thorn dragon tooth 5-7 part, rattlesnake plantain 5-7 part, root bark of tree peony 5-7 part, rhizoma alismatis 5-7 part, Radix Glycyrrhizae 5-7 part.

3. the pharmaceutical composition of the invisible glomerulonephritis for the treatment of kidney yin and yang deficiency type according to claim 3, it is characterised in that, it is made up of the Chinese medicine of following weight part:

Field grasswort 6 parts, Rhizome of Largeleaf Curculigo 6 parts, white butterfly spend 6 parts, pick up the ears 6 parts, white Dysosma versipellis 6 parts, Herba Balanophorae polyandrae 6 parts, thorn dragon tooth 6 parts, rattlesnake plantain 6 parts, the root bark of tree peony 6 parts, rhizoma alismatis 6 parts, 6 parts, Radix Glycyrrhizae.