CN109223992A - It is a kind of prevent and treat albuminuria Chinese medicine composition and its application - Google Patents

Abstract

The invention discloses a kind of Chinese medicine compositions for preventing and treating albuminuria, are made of following raw material medicine: 1~20 part of silkworm cocoon, 1~20 part of corn stigma, 0 ~ 20 part of Radix Astragali, 0 ~ 20 part of Radix Salviae Miltiorrhizae, 0 ~ 20 part of Rhizoma Chuanxiong.In addition, the invention also discloses the Chinese medicine compositions to be used to prepare the application in the drug and health care product for preventing and treating albuminuria.The present invention shows through zoopery and clinical test verifying, safety is good, curative effect is good, can be to albuminuria caused by the different pathogenies such as reduction diabetic nephropathy, membranous nephropathy, Primary Nephritis, IgA nephrosis, purpura nephritis, lupus nephritis, hypertensive nephropathy, gouty nephropathy, chronic renal failure, chronic nephritis, nephrotic syndrome, lupus nephritis, urinary tract infections.The Chinese medicine composition is that one kind can improve that clinical symptoms effect is good, and toxic side effect is small, has good potential applicability in clinical practice, and extraction process is simple, easily prepared, reduces preparation cost.

Description

It is a kind of prevent and treat albuminuria Chinese medicine composition and its application

Technical field

The present invention relates to technical field of traditional Chinese medicine, and in particular to a kind of Chinese medicine composition for preventing and treating albuminuria and It is applied.

Background technique

In the world, chronic kidney disease (Chronic KidneyDisease, CKD) has been considered to be a kind of Main public health problem.According to statistics, in Asia, Europe, Australia and the U.S., 10%~16% people suffers from different degrees of Chronic kidney disease.Since the patient of most of chronic kidney disease needs several years time just can gradually be converted to chronic kidney not Therefore the full terminal phase delays even to reverse the change of Patients with Chronic Kidney Disease Renal Paphology very necessary.When kidney illness, Glomerular filtration membrane permeability increases, it may appear that albuminuria (proteinuria)；When reabsorption dysfunction, kidney Protein reabsorption in bead filtrate is reduced, and also results in albuminuria.Albuminuria is common between glomerulus caused by a variety of causes Matter disease, such as diabetic nephropathy, pyelonephritis, antalgesic nephrosis, nephropathy due to antibiotics, heavy metal poisoning, congenital polycystic kidney And various congenital renal tubular diseases etc..Albuminuria is widely considered that Renal Paphology changes the mark of light and heavy degree Object, and can be with the reduction of predicting long-term glomerular filtration rate and the development of kidney failure terminal phase.Importantly, albuminuria Reduce can the decline significantly to High-grade Proteinuria renal function of patients play a protective effect, and think urine protein reducing Treatment can maximumlly protect kidney.Therefore, how to control, reduce albuminuria conduct protection renal function, delay renal damage The important research direction of progress.

In long-term clinical practice, doctor trained in Western medicine is there has been no the drug for being directed to albuminuria, and western medicine is primarily directed to the cause of disease Treatment, common drug: cortex hormone of aadrenaline, immunosuppressive drug, angiotensin converting enzyme inhibitor and angiotensins n Receptor antagonist etc. has certain side effect although having certain effect, is not easy patient's long-term use.In " albuminuria " There is no corresponding title in doctor, albuminuria belongs to the composition portion of " precise and tiny " described in theory of traditional Chinese medical science " yin essence " " vital essence " Point.It is bright to wear first gift " key to Diagnosis and Treatment " cloud: " three disappear long and urine is not smelly, counter to make sweet gas, rolling is gushed in drowning, more have it is floating drown, face is such as Lard, this essence be can't help, and true strength exhausts " " for example dense oil of color, above there is epistasis " " shape of small turbid urine leaching such as cream " that proposes " have it is floating drown, face Such as lard " be all human body cereal nutrient, be equivalent to the albumen of modern medicine, be the material base of body activities, transported by taste Digesting and absorbing the essence of foodstuff it is precise and tiny, the defeated vital organs of the human body that are distributed in are into the essence of five ZANG-organs and six FU-organs, and to maintain the physiological function of internal organs, the person of being full of is by kidney Envelope hiding, preferably hiding should not let out.These " cereal nutrients " lose in Feng Zang, excrete with urine, can form albuminuria.Chinese medicine thinks Store essential substances, precise and tiny bet, spleen deficiency do not take the photograph essence to kidney, and clean air is sunk, and general in foul smell, not main gas of lung etc. is current Chinese medicine bound pair albumen The generally acknowledged mechanism of urine.The pathogenesis of albuminuria is asthenia in origin and asthenia in superficiality, based on this void, has exogenous disease ailment said due to cold or exposure, the resistance of damp and hot and hemostasis concurrently It is stagnant etc., and can influence each other.And traditional Chinese medicine have in terms for the treatment of albumen urine treating both manifestation and root cause of disease, improve symptom, side effect it is smaller and The advantages such as uneasy to recur.

Chinese invention patent application CN201810007858.9 disclose a kind for the treatment of albumen urine Chinese medicine composition and its Preparation method and purposes, the Chinese medicine composition include silkworm cocoon polypeptide and corn silk polysaccharide.Since silkworm cocoon is more in the patent Peptide and corn silk polysaccharide are the fractions of active ingredient of silkworm cocoon and corn stigma, but the extraction process of polysaccharide and polypeptide is complicated, And quality control is more difficult, causes cost relatively high in this way.

Summary of the invention

One of the technical problem to be solved in the present invention is to provide a kind of Chinese medicine composition for preventing and treating albuminuria.

The second technical problem to be solved by the present invention is to provide a kind of purposes of Chinese medicine composition.

In one aspect of the invention, a kind of Chinese medicine composition for preventing and treating albuminuria is provided, by the bulk pharmaceutical chemicals of following parts by weight It is made: 1~20 part of silkworm cocoon, 1~20 part of corn stigma, 0 ~ 20 part of Radix Astragali, 0 ~ 20 part of Radix Salviae Miltiorrhizae, 0 ~ 20 part of Rhizoma Chuanxiong.

The traditional chinese medicine composition of the invention can be formed by 1~20 part and 1~20 part of corn stigma of silkworm cocoon；Or by silk cocoon 1~20 part of shell, 1~20 part of corn stigma, 1 ~ 20 part of Radix Astragali composition, or by 1~20 part of silkworm cocoon, 1~20 part of corn stigma, 1 ~ 20 part of Radix Salviae Miltiorrhizae composition, or be made of 1~20 part of silkworm cocoon, 1~20 part of corn stigma, 1 ~ 20 part of Rhizoma Chuanxiong.

As currently preferred technical solution, the traditional chinese medicine composition of the invention is made by the bulk pharmaceutical chemicals of following parts by weight: silkworm 15-20 parts of cocoon shell, 15-20 parts of corn stigma, 1-5 parts of Radix Astragali, 1-5 parts of Radix Salviae Miltiorrhizae, 1-5 parts of Rhizoma Chuanxiong.Wherein, most preferred parts by weight are matched Than are as follows: 15 parts of silkworm cocoon, 15 parts of corn stigma, 5 parts of Radix Astragali, 3 parts of Radix Salviae Miltiorrhizae, 3 parts of Rhizoma Chuanxiong.

Chinese Herbs of the present invention are definite, securely and reliably, significant in efficacy.Wherein silkworm cocoon is Bombycidae insect man The cocoon shell of silkworm moth (Bombyx mori L.), alias: silkworm cocoon, cocoon Huang, continuous silkworm, silkworm cocoon.It is sweet in flavor, warm-natured.With stopping blooding, quench the thirst With the effect of detoxification sore treatment.Corn stigma is for the style and column cap of gramineae plant maize (Zea mays L.).In many Have the record of corn stigma in medical ancient books and records, corn stigma hide it is sweet, light, it is mild-natured.Radix Salviae Miltiorrhizae is that " Chinese Pharmacopoeia " (2015 editions) are recorded Lamiaceae plant Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge. dry root and rhizome.Radix Astragali is " Chinese Pharmacopoeia " (2015 Version) documented by leguminous plant Mongolia Huang seedling Astragalus membranaceus (Fisch.) Bge. var. Mongholicus (Bge.) Hsiao's or film Radix Astragali Astragalus membranaceus (Fisch.) Bge. is dry Dry.Rhizoma Chuanxiong is umbelliferae Rhizoma Chuanxiong (scientific name: Ligusticum documented by " Chinese Pharmacopoeia " (2015 editions) Chuanxiong hort) dry rhizome.

Chinese medicine of the present invention is the silkworm cocoon benefit in side according to theory of traditional Chinese medical science reasonable formula, clinical application effective Chinese medicine compound prescription Kidney replenishing essence, corn stigma can have the inducing diuresis to remove edema to be；Radix Astragali energy invigorating qi for consolidating superficies, Radix Salviae Miltiorrhizae and Rhizoma Chuanxiong can promoting blood circulations.Perfect square is combined energy Enriching kidney essence, benefiting qi and removing blood stasis are used for the disease of the kidney essence deficiency deficiency of vital energy, have good efficacy to clinical proteinuria.We are based on Chinese medicine The compound of theoretical direction is an organic whole, and the performance of curative effect is also not an ingredient or certain a herb institute can be complete Substitute entirely, and experimental study show we as a whole when its curative effect it is best, have significantly than simple using effect Synergy effect.

Chinese medicine composition of the present invention can be pressed after direct or extracted processing with pharmaceutically acceptable pharmaceutical carrier Various oral medicinal herb conventional doses are made for preventing and treating albuminuria in the conventional method of this field.Work is processed in the extraction Traditional Chinese medicine extraction method known in the art, such as, but not limited to steam distillation, solvent extraction method (packet can be used in skill Include and be not limited to methanol, ethyl alcohol, acetone etc.), sublimed method, supercritical extraction etc..

The pharmaceutical preparation form can be any pharmaceutical dosage form, these dosage forms include: tablet, sugar coated tablet, Film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral solution, mouth containing agent, granule, electuary, ball Agent, powder, paste, sublimed preparation, suspension, pulvis, solution, injection, suppository, ointment, emplastrum, creme, spray, drop Agent, patch；It is preferred that peroral dosage form, such as: capsule, tablet, oral solution, granule, pill, powder, sublimed preparation, paste.It is described Peroral dosage form can contain common excipient, such as adhesive, filler, diluent, tablet agent, lubricant, disintegrating agent, Toner, flavoring agent and wetting agent when necessary can be coated tablet.Suitable filler includes cellulose, mannitol, cream It is sugared with other similar fillers；Suitable disintegrating agent includes starch, polyvinylpyrrolidone and starch derivatives, such as hydroxyl Amylcose acetate sodium；Suitable lubricant includes, such as magnesium stearate.Suitable pharmaceutically acceptable wetting agent includes dodecyl Sodium sulphate etc..

Drug and health care of the second aspect of the present invention there is provided the Chinese medicine composition in preparation prevention and treatment albuminuria Application in product.The albuminuria be include diabetic nephropathy, membranous nephropathy, Primary Nephritis, IgA nephrosis, purpuric kidney Inflammation, lupus nephritis, hypertensive nephropathy, gouty nephropathy, chronic renal failure, chronic nephritis, nephrotic syndrome, systemic lupus erythematosus Albuminuria caused by the various diseases such as ephritis, urinary tract infections.

The results show, Chinese medicine composition of the invention have apparent treatment albumen urine effect.The present invention is through animal Experiment and clinical test verifying show that safety is good, and curative effect is good, can effectively treat albuminuria, and the traditional chinese medicine composition of the invention is A kind of improvement clinical symptoms effect is good, and toxic side effect is small, the Chinese medicine with good potential applicability in clinical practice.Test example 1 shows this Component compound is got well than therapeutic effect effect of the simple to diabetic nephropathy rats albuminuria, prompts each taste Chinese medicine in the compound With synergistic function.Comparison of the different ratio Chinese medicine composition of the present invention of test example 2 to diabetic nephropathy rats albuminuria Research has shown that, in a first aspect, different ratio Chinese medicine composition of the present invention can significantly reduce diabetic nephropathy rats albuminuria Proteinuria level, wherein most preferred weight are as follows: 15 parts of silkworm cocoon, 15 parts of corn stigma, 5 parts of Radix Astragali, 3 parts of Radix Salviae Miltiorrhizae, 3 parts of Rhizoma Chuanxiong.Second aspect, it was demonstrated that silkworm cocoon and corn stigma composition Traditional Chinese medicine compound composition are better than silkworm cocoon polypeptide and corn stigma The extract (extracting method reference Chinese invention patent application CN201810007858.9) of polysaccharide (1:1), hypoglycemic level, UAE and BUN significantly lower (P < 0.05), and extraction process is simple, it is easily prepared, preparation cost is reduced, has reached pre- Technical effect unexpectedly.The third aspect, three taste medicines combine (compound H, compound I, compound J), four traditional Chinese medicine combines (Compound B, compound C), five kinds of Chinese medicine combination (compound D, compound E) is superior to two taste medicine combined effects, has significant difference (P < 0.05), and table Bright three taste, four tastes, five kinds of Chinese medicine all have synergistic function.3 clinical research of test example proves, can by the traditional chinese medicine composition of the invention To treat diabetic nephropathy high protein urine disease, treated effect 76.7%.Test example 4 demonstrates, and the traditional chinese medicine composition of the invention can To treat membranous nephropathy high protein urine disease.In conclusion the traditional chinese medicine composition of the invention can be effectively reduced caused by chronic kidney disease Albuminuria.

Specific embodiment

Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention Rather than it limits the scope of the invention.In the following examples, the experimental methods for specific conditions are not specified, usually according to conventional strip Part or according to the normal condition proposed by manufacturer.Unless otherwise stated, otherwise all percentage, ratio, ratio or number is pressed Poidometer.

Embodiment 1: oral solution

Raw material is taken by following weight proportion: 300 grams of silkworm cocoon, 300 grams of corn stigma, 100 grams of Radix Astragali, 60 grams of Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong 60 Gram.Above 5 taste adds water to cook 2 times, and from boiling timing, 1 hour every time, 10 times of amount water, second plus 8 times of amount water were decocted for the first time After boiling, merge decoction liquor twice, let cool 3000rpm and be centrifuged 10 minutes, remove supernatant, be concentrated, add proper auxiliary materials, Oral solution 1L is made according to existing known method, by every bottle of 10ml packing to get daily 3 times, every time 1 bottle oral.

Embodiment 2: granule

Raw material is taken by following weight proportion: 300 grams of silkworm cocoon, 300 grams of corn stigma, 100 grams of Radix Astragali, 60 grams of Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong 60 Gram.Above 5 taste adds water to cook 2 times, and from boiling timing, 1 hour every time, 10 times of amount water, second plus 8 times of amount water were decocted for the first time After boiling, merge decoction liquor twice, let cool 3000rpm and be centrifuged 10 minutes, remove supernatant, is concentrated into the leaching that specific gravity is 1.35 Cream adds appropriate dextrin and Icing Sugar, and after 70 DEG C dry, 1000 g of particle granulation is made, by every bag of 5 g packing to get daily It is 3 times, every time 1 bag oral.

Sugar-free particle extracting method is identical as there is sugared particle, and after extract is prepared into 1.35 medicinal extract, appropriate paste is added Essence and microcrystalline cellulose and polyvinylpyrrolidone alcoholic solution are pelletized.After drying, 1000 g of particle granulation is made, by every bag 5 G packing to get, daily oral 3 times, 1 bag, as sugar type granules every time.

Embodiment 3: tablet

Raw material is taken by following weight proportion: 300 grams of silkworm cocoon, 300 grams of corn stigma, 100 grams of Radix Astragali, 60 grams of Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong 60 Gram.Above 5 taste adds water to cook 2 times, and from boiling timing, 1 hour every time, 10 times of amount water, second plus 8 times of amount water were decocted for the first time After boiling, merge decoction liquor twice, lets cool 3000rpm and be centrifuged 10 minutes, take supernatant, subtract and be concentrated into dry cream, then by existing There is method well known to technology that tablet is made, every 0.3 gram, daily 3 times oral, 3 tablets once.

Embodiment 4: pill

Raw material is taken by following weight proportion: 300 grams of silkworm cocoon, 300 grams of corn stigma, 100 grams of Radix Astragali, 60 grams of Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong 60 Gram.Add suitable quantity of water to decoct 2 times, from boiling timing, 1 hour every time, after decoction, merges decoction liquor twice, be concentrated into dry cream Suitable auxiliary material is added in powder.Water-honeyed pill 1000 are made by method known in the art again, 0.5 gram every, takes orally 3 daily It is secondary, 5 tablets each time.It is daily 3 times oral, 5 tablets each time.

Embodiment 5: decoction

By table 1 provide ten kinds for the treatment of albumens urine Traditional Chinese medicine compound composition weight proportion weigh raw material, separately constitute compound A, Ten kinds of Compound B, compound C, compound D, compound E, compound F, compound G, compound H, compound I and compound J Traditional Chinese medicine compound compositions, match Square table is shown in Table 1, in table 1,100 grams of every part of dosage.Suitable quantity of water is added to decoct 2 times, from boiling timing, 1 hour every time, decoction was finished Afterwards, merge decoction liquor twice, instructions of taking are as follows: take in two times in one day.

1. 5 kinds of Traditional Chinese medicine compound composition tables of table

The drug effect of the traditional chinese medicine composition of the invention is proved with test example below:

Test example 1: the traditional chinese medicine composition of the invention imitates comparative studies to rat protein uroflowmetry

Raw material is taken by following weight proportion: 300 grams of silkworm cocoon, 300 grams of corn stigma, 100 grams of Radix Astragali, 60 grams of Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong 60 Gram.Add suitable quantity of water to decoct 2 times, from boiling timing, 1 hour every time, after decoction, merge decoction liquor twice, be concentrated under reduced pressure, It is freeze-dried again and freeze-dried powder is made, it is spare as composition (ZHW)；In addition, take respectively 400 grams of silkworm cocoon, 400 grams of corn stigma, 100 grams of Radix Astragali, 60 grams of Radix Salviae Miltiorrhizae, 60 grams of Rhizoma Chuanxiong press preparation method of composition, freeze-dried powder is made after decocting and concentrating respectively, makes respectively Obtain silk cocoon shell extract (CJK), Corn silk P.E (YMX), Astragalus Root P.E (HQ), Salvia root P.E (DS), Rhizoma Chuanxiong extraction Object (CX), it is spare.

SD rat is bought, adaptable fed 7 days, have a blood test sugared normal, Urine proteins qualitative test feminine gender, animal health condition were good It is good, start to test.Two groups are randomly divided by weight, i.e., only, early stage model group is only for blank control group (blank group).Experiment starts each Group early stage rat gives high sugared, high fat diet (adding 20% sucrose, 10% lard, 2.5% cholesterol in conventional feed), and blank control Organize normal diet of then freely ingesting, two groups of equal free waters.After 8 weeks after early diabetic nephropathy group Rat Fast, intraperitoneal injection 10% chloraldurate solution 3.5ml/kg, is anaesthetized, and injection capacity is 0.3ml/100g weight.After confirmation anesthesia, row left side kidney Dirty resection: rat prone position is fixed on operating table, depilation, exposed skin, conventional iodophor disinfection, from left side backbone with help Skin and muscle layer, exposure kidney and circumrenal adipose capsule are cut at the angle of bone, are ligatured at the hilus renalis, are completely extractd left kidney, It checks without after bleeding profusely, sutures muscle layer and skin.2 weeks after operation, after 18 h of each group Rat Fast, chain is given by 50mg/kg Urea helps the intraperitoneal injection of rhzomorph (STZ)-secondary property, i.e., specific dosage is that (use, citrate buffer dissolve weight before use, dense Spend the citrate buffer of blank control group injection equivalent.After injecting STZ 72h, tail vein blood surveys blood glucose, and stays and urinate for 24 hours. It is positive and is stablized 5 days with blood glucose level >=16.7mmol/L, glucose in urine, and survey urine protein positive after 2 weeks, as early animal Model foundation standard is included in observation object.The successful rat of modeling is randomly divided into group by Urine proteins and blood glucose value: model comparison Group (abbreviation model group) and benazepril hydrochloride group (abbreviation positive drug group), silk cocoon shell extract (CJK) group, Corn silk P.E (YMX) group, Astragalus Root P.E (HQ) group, Salvia root P.E (DS) group, Rhizoma Chuanxiong extract group (CX) and composition (ZHW) group, Every group each 12, single cage is raised after every group #, between each group rat blood glucose and Urine proteins it is more not statistically significant (P > 0.05).

After modelling, CJK, YMX, HQ, DS, ZHW and benazepril hydrochloride (positive drug group) are treated respectively. Each group dosage is respectively 50mg/kg/ days, and positive drug group dosage is 0.9mg/kg/ days, gastric infusion.Normal group and model Group gives the distilled water of equivalent respectively, starts to terminate after being administered to the experiment of 4 weekends.

Experimental result is shown in Table 2, table 3 and table 4.The experimental results showed that compared with being given with blank, model group and each treatment group's blood glucose With the significant raising of microdose urine protein (UAE), show modeling success.After treatment, positive drug group, HQ group, DS group, CX group To blood glucose without remarkable effect, and CJK group, YMX group and ZHW group can significantly reduce blood glucose to a certain degree, and reduce journey with ZHW group Degree is most significant, shows that ZHW plays the role of collaboration and reduces blood glucose.In addition, positive drug group, HQ group, CX group and DS group are micro white to urinating Albumen (UAE) has certain reduction effect, but is not so good as CJK group, YMX group and ZHW group, and ZHW group was in treatment 2 weeks and 4 Effect highly significant, more significant than independent CJK group and independent YMX group effect when all, shows that ZHW group has collaboration to reduce urine egg White effect.In addition, and CJK group, YMX group and ZHW group can also reduce serum creatinine (Scr) and urea nitrogen (BUN) is horizontal.It is comprehensive and Speech, ZHW can improve the symptom effect of diabetic nephropathy, more obvious than each drug effect fruit is used alone.

2 each group rat of table, 0,2,4 weekend blood glucose compare ()

Note: P < 0.01 compared with ZHW * P < 0.01 compared with model group, #

3 each group of table treatment different time microdose urine protein (UAE) compare ()

Note: P < 0.01 compared with * P < 0.01 compared with model group, # and ZHW group

At the end of table 4 is tested each group serum creatinine (Scr) and urea nitrogen (BUN) compare ()

Note: P < 0.01 compared with model group *；P < 0.01 compared with ZHW group #

Test example 2: the Chinese medicine composition of different ratio of the invention relatively grinds the proteinuria efficacy and blood glucose of diabetic nephropathy Study carefully

It takes six kinds of compound A prepared by " embodiment 5 ", Compound B, compound C, compound D, compound E, compound F, compound G, compound H, answer Square I replicates Diabetic Nephropathy model according to the method that " test example 1 " uses as experimental subjects.

After modelling, compound A, Compound B, compound C, compound D, compound E, compound F, compound G, compound are given respectively H, compound I, benazepril hydrochloride (one group of positive drug), corn silk polysaccharide and two groups of positive drug of silkworm cocoon polypeptide extract 1:1(, Extracting method is referring to number of patent application 201810007858.9) it is treated.Dosage is 50mg/kg/ days, positive drug One group of dosage is 0.9mg/kg/ days, gastric infusion.Normal group and model group give the distilled water of equivalent respectively, start to Terminate after medicine to the experiment of 4 weekends.

Experimental result is shown in Table 5, the results showed that, compared with being given with blank, model group and each treatment group's blood glucose and urine Microalbunin White (UAE) is significant to be increased, and shows modeling success.After treatment, one group of positive drug to blood glucose without remarkable effect, and compound A, Compound B, compound C, compound D, compound E, compound F, compound G, compound H, compound I can significantly reduce blood glucose, UAE, BUN to a certain degree Acted on Scr, and it is most significant with compound D group reduction degree, this result shows that the Chinese medicine compound prescription of different proportion all have it is good The proteinuria efficacy of diabetogenous nephrosis is reduced, and compound D effect is best.Meanwhile we study and also found, compound G is significantly better than sun Property two groups of medicine, i.e. the Traditional Chinese medicine compound composition of silkworm cocoon and corn stigma composition is better than silkworm cocoon polypeptide and corn silk polysaccharide extract (1:1), hypoglycemic horizontal, UAE and BUN significantly lower (P < 0.05), and extraction process is simple, and it is easily prepared, it reduces Preparation cost, has reached unexpected technical effect.Also, three taste medicines share (compound H, compound I, compound J), four traditional Chinese medicine Share (Compound B, compound C), five kinds of Chinese medicine shares (compound D, compound E) and is superior to two taste medicines and shares effect, have significant difference (P < 0.05), and further prove that three tastes, four tastes, five kinds of Chinese medicine all have synergistic function.

The mixture of the different compounds of table 5. to diabetic nephropathy rats blood glucose and Microalbuminuria ()

Test example 3: the traditional chinese medicine composition of the invention treats the clinical research of diabetic nephropathy high protein urine disease

In order to show clinical efficacy of the invention, we screened Diabetic Nephropathy patients 60, according to Traditional Chinese Medicine association in 2007 Nephrosis branch " diabetic nephropathy diagnosis, differentiation of symptoms and signs for classification of syndrome and efficacy assessment standard (tentative program) ":

1. there is exact diabetes medical history, the course of disease is often at 6~10 years or more；2. meeting the diagnosis point of Mogensen diabetic nephropathy Phase standard belongs to the diabetic nephropathy III phase, i.e. lasting albuminuria, urinary albumin-creatinine ratio ratio > 300ug/mg or urinary albumin Excretion rate > 200ug/min or urinary albumin be quantitative > 300mg/24h or quantity of proteinuria > 0.5g/24h.Exclude serious liver kidney function Can be abnormal, pregnant woman, breast feeding women.It is divided into observation group (sugar free granule of " embodiment 2 " preparation, abbreviation ZHW) to control with basis Treatment group (melbine+depressor treatment group), every group 30.It is separately simulated by SAS statistical package and generates the table of random numbers, according to grinding Study carefully scheme and be included in exclusion criteria and enter a group case, subject sequentially enters treatment according to the successive of research is included in, by random number serial number Group and control group.Treatment group: using the sugar free granule of " embodiment 2 " of the invention preparation, agent is by every bag of 5 g packing to get often Day is 3 times, every time 1 bag oral.Primary Care group: melbine+depressor treatment, specification 10mg/ piece is a piece of daily, night Clothes.Two groups of the course for the treatment of is 2 weeks.

Efficacy determination was with reference to nephrosis branch of China Association of Traditional Chinese Medicine " diabetic nephropathy diagnosis and efficacy evaluation mark in 2007 Quasi- (tentative) " publication the formulation of efficacy on diabetic nephropathy evaluation criteria.(see Table 6)

6 Comprehensive Assessment scalar quantization table of table

Test result is shown in Table 7 and table 8, and clinical test results show that the traditional chinese medicine composition of the invention can significantly reduce diabetic nephropathy Urine albumen amount for 24 hours (Pro for 24 hours), the microdose urine protein (mALB) of patient have the improvement result of highly significant, have to renal function aobvious Writing improves, and has a degree of improvement result to blood glucose level.In short, ZHW is significantly improved diabetogenous nephrosis disease symptoms. Concrete outcome is as follows:

(1) albuminuria interpretation of result

After treating, the urine albumen amount for 24 hours (Pro for 24 hours) and microdose urine protein (mALB) numerical value of Primary Care group patient compared with It is substantially reduced before treatment, and ZHW has the drop for having highly significant to urine albumen amount for 24 hours (Pro for 24 hours) and microdose urine protein (mALB) Low (P < 0.01), (see Table 7).

The different treatment histonurias of table 7 compare ()

* compared with before treatment, there is significant difference in P < 0.05；For * compared with before treatment, there is highly significant difference in P < 0.01

(2) renal function interpretation of result

After treating, Primary Care group is significantly improved effect, serum urea nitrogen (BUN) to glomerular filtration rate (eGFR) There are also increase for kept stable and serum creatinine (Scr)；And ZHW group creatinine, urea nitrogen, glomerular filtration rate are aobvious Writing improves, and prompts to improvement renal function significant effect (see Table 8).

The different treatment group's renal functions of table 8 compare ()

* compared with before treatment, statistically significant P < 0.05 of difference.

(3) blood sugar effects are analyzed

It after treating, is significantly improved in terms of Primary Care group fasting blood-glucose (FBG) and 2h postprandial blood sugar (PBG), ZHW group is empty It is significantly improved in terms of abdomen blood glucose (FBG) and 2h postprandial blood sugar (PBG), relative extent is not so good as Primary Care group, there is statistics Meaning (P < 0.05) (see Table 9).

Patient's FBG and PBG situation of change table after the different therapeutic modalities of table 9 ()

* compared with before treatment, statistically significant P < 0.05 of difference.

(4) it is formulated according to the efficacy on diabetic nephropathy evaluation criteria of table 6, the treated effect of ZHW group is 76.7% significant Higher than control, concluding is shown in Table 10.Show that ZHW group has good curative effect.

Curative effect compares between the different treatment groups of table 10

Test example 4: the traditional chinese medicine composition of the invention treats the experimental study of membranous nephropathy high protein urine disease

24 h urines will be collected after rat adaptable fed 1 week in metabolic cage, measure 24 h quantity of proteinuria (24 h- Upro) < 5 mg, are randomly divided into normal group (15) and modeling group (30).With positive ionization bovine serum albumin(BSA) (C-BSA) membranous nephropathy is induced, C-BSA30 mg is taken to be dissolved in 15 mL of physiological saline and equivalent incomplete Freund's adjuvant Mixing, it is fully emulsified.1 mL of emulsion is taken to carry out in the nape of the neck of modeling group rat, groin, the multiple point subcutaneous injections in oxter It is pre- immune, the next day 1 time, totally 3 times.Then it is formally immunized by 16 mg/kg/d tail vein injection C-BSA every time, weekly 3 times, continuous 4 weeks.24 h urines, measurement 24 h-UPro >, 20 mg prompt modeling success are collected in metabolic cage.Normal group The isometric physiological saline of each tail vein injection of rat.After modeling survival and through 24 h-UPro detect confirm modeling at The rat of function totally 24.24 rats are randomly divided into model group, composition group (ZHW group), every group 12.ZHW group is given The granule of group " embodiment 2 " preparation, dosage 50mg/kg, Normal group and model group give the distilled water of equivalent respectively, Start to terminate after being administered to the experiment of 4 weekends.

Experimental result is shown in Table 11, the results showed that, compared with blank group (i.e. Normal group), model group and each treatment group's blood Sugar and microdose urine protein (UAE) significant raising, show modeling success.After treatment, ZHW group can be significant to a certain degree Blood glucose, UAE, BUN and Scr effect are reduced, it should be the result shows that the albuminuria of membranous nephropathy high protein urine disease can be effectively reduced in ZHW group It is horizontal.

11. Traditional Chinese medicine compound composition of table to membranous nephropathy high protein urine disease indices influence ()

(note: there are significant differences, * * P < 0.01 significant differences in P < 0.05 * compared with model group).

Claims (9)

1. a kind of Chinese medicine composition for preventing and treating albuminuria, it is characterised in that: be made by the bulk pharmaceutical chemicals of following parts by weight: silkworm cocoon 1 ~20 parts, 1~20 part of corn stigma, 0 ~ 20 part of Radix Astragali, 0 ~ 20 part of Radix Salviae Miltiorrhizae, 0 ~ 20 part of Rhizoma Chuanxiong.

2. Chinese medicine composition according to claim 1, which is characterized in that be made by the bulk pharmaceutical chemicals of following parts by weight: silk cocoon 1~20 part of shell, 1~20 part of corn stigma.

3. Chinese medicine composition according to claim 1, which is characterized in that be made by the bulk pharmaceutical chemicals of following parts by weight: silk cocoon 1~20 part of shell, 1~20 part of corn stigma, 1 ~ 20 part of Radix Astragali.

4. Chinese medicine composition according to claim 1, which is characterized in that be made by the bulk pharmaceutical chemicals of following parts by weight: silk cocoon 1~20 part of shell, 1~20 part of corn stigma, 1 ~ 20 part of Radix Salviae Miltiorrhizae.

5. Chinese medicine composition according to claim 1, which is characterized in that be made by the bulk pharmaceutical chemicals of following parts by weight: silk cocoon 1~20 part of shell, 1~20 part of corn stigma, 1 ~ 20 part of Rhizoma Chuanxiong.

6. Chinese medicine composition according to claim 1, which is characterized in that be made of the bulk pharmaceutical chemicals of following parts by weight: silk cocoon 15-20 parts of shell, 15-20 parts of corn stigma, 1-5 parts of Radix Astragali, 1-5 parts of Radix Salviae Miltiorrhizae, 1-5 parts of Rhizoma Chuanxiong.

7. Chinese medicine composition according to claim 6, which is characterized in that be made of the bulk pharmaceutical chemicals of following parts by weight: silk cocoon 15 parts of shell, 15 parts of corn stigma, 5 parts of Radix Astragali, 3 parts of Radix Salviae Miltiorrhizae, 3 parts of Rhizoma Chuanxiong.

8. Chinese medicine composition according to claim 1-7 preparation prevention or treatment albumen urine disease drug or Application in health care product.

9. application according to claim 8, which is characterized in that the albuminuria be include diabetic nephropathy, film property kidney Disease, Primary Nephritis, IgA nephrosis, purpura nephritis, lupus nephritis, hypertensive nephropathy, gouty nephropathy, chronic kidney Albuminuria caused by failure, chronic nephritis, nephrotic syndrome, lupus nephritis, the various diseases of urinary tract infections.