CN105125598A - Traditional Chinese medicine composition for treatment of nephritic syndromes and chronic renal failure and preparation method of traditional Chinese medicine composition - Google Patents
Traditional Chinese medicine composition for treatment of nephritic syndromes and chronic renal failure and preparation method of traditional Chinese medicine composition Download PDFInfo
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Abstract
The invention relates to traditional Chinese medicine composition for treatment of nephritic syndromes and chronic renal failure and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is composed of, by weight, 1-70 parts of fermented cordyceps sinensis powder and 1-60 parts of abelmoschus manihot extracts. Effective components of the traditional Chinese medicine composition are dissolved out by a reasonable extraction method, effect enhancement is realized, and bioavailability is improved. Furthermore, the traditional Chinese medicine composition has specific treatment effects on the nephritic syndromes, chronic renal failure and the like caused by various pathological types and various reasons including glomerulus diseases, secondary systemic diseases, diabetic complications and the like.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly a kind of Chinese medicine composition and preparation method for the treatment of the nephrotic syndrome and chronic renal failure.
Background technology
The nephrotic syndrome is caused by various diseases, increases with glomerular filtration membrane permeability, and a large amount of plasma protein becomes one group of main syndrome from glomerulopathy such as losss grade in urinating.Patients with clinical manifestations is High-grade Proteinuria, hypoalbuminemia, hypercholesterolemia, obviously edema etc.General have that High-grade Proteinuria is greater than 3.5g/d, low plasma protein is less than 30g/L, have obvious edema clinically, and hyperlipemia (serum cholesterol) is greater than the characteristic persons such as 6.5mmol/L, can be diagnosed as the nephrotic syndrome.The nephrotic syndrome belongs to " edema ", " chronic consumptive disease " of Chinese medicine.According to incomplete statistics, the Levels in Nephrotic Syndrome Patients of China is more than 6,000 ten thousand people.
Along with the sickness rate be on the increase and prevalence, chronic renal failure is one of modal chronic disease.Early stage renal hypertrophy, the extracellular matrix accumulation between glomerule and renal tubular interstitium, finally occur with glomerular sclerosis, kidney region fibrosis and renal tubules atrophy are the renal failure of main morphological features.Renal failure proceeds to whole latter stage, and renal function can not maintain the excretion activity of normal life, just means and needs to carry out hemodialysis or renal transplantation, bring heavy financial burden to patient.
Therefore, find effective ways and the active drug of preventing and treating the nephrotic syndrome and chronic renal failure, be current an urgent demand, there is profound significance and great social value.The object of this invention is to provide a kind of Chinese medicine composition, be different from the mechanism of action that general Western medicine is single, unilateral, but regulated by Mutiple Targets, too many levels and multipath, for the nephrotic syndrome and chronic renal failure, there is remarkable result, and this Chinese medicine composition toxic and side effects is little, safety is high.
Summary of the invention
The present invention relates to the Chinese medicine composition that one treats the nephrotic syndrome (mainly comprise secondary glomerulonephritis, diabetic nephropathy, renal amyloidosis etc. to increase with glomerular basement membrane permeability, show as one group of clinical syndrome of High-grade Proteinuria, hypoproteinemia, treating serious edema caused, hyperlipemia) and chronic renal failure.This medicine is easy to use, and has no side effect, and by certain preparation technology, improves the bioavailability of this Chinese medicine composition, and make the applicable dosage form that can carry and change new Chinese medicine composition.
A kind of Chinese medicine composition being used for the treatment of the nephrotic syndrome and chronic renal failure of the present invention, be by crude drug be Chinese caterpillar fungus fermentation mycopowder 1 ~ 70 part, Flos abelmoschi manihot extract 1 ~ 60 part makes.Wherein Chinese caterpillar fungus fermentation mycopowder can be selected from peacilomyce hepiahi
(Paecilomyceshepialid)cs-4 or Hirsutlla sinensis
(Hirsutellasinensis)zymophyte powder.
The Chinese medicine composition of the described treatment nephrotic syndrome and chronic renal failure, the weight proportion of each raw material components of this compound medicine is: Chinese caterpillar fungus fermentation mycopowder 10 ~ 40 parts, Flos abelmoschi manihot extract 5 ~ 40 parts.
The Chinese medicine composition of the described treatment nephrotic syndrome and chronic renal failure, the weight proportion of each raw material components of this compound medicine is: Chinese caterpillar fungus fermentation mycopowder 35 parts, Flos abelmoschi manihot extract 27 parts.
The preparation method of Flos abelmoschi manihot extract is:
A, by Flos abelmoschi manihot co-grinding to 10-80 order, by the flooding 1 ~ 4 time of 5-20 times amount, temperature is 30 ~ 100 DEG C, and each extraction time is 1 ~ 3 hour, filters, obtains Aqueous extracts.Filtering residue continuation concentration is alcohol reflux 1-4 time of 55% ~ 95%, and temperature is 30 ~ 100 DEG C, and each extraction time is 1 ~ 3 hour, filters, obtains alcohol extract;
B, by step a Aqueous extracts and alcohol extract, be evaporated to the extractum of proportion 1.1 ~ 1.35 respectively, be Aqueous extracts extractum and alcohol extract extractum; 1:1 ~ 1:10 the mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum, dry, make Chinese medicine preparation after adding pharmaceutic adjuvant.
Flos abelmoschi manihot extract, is characterized in that the 1:2 mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum.
The above-mentioned nephrotic syndrome refers to that secondary glomerulonephritis, diabetic nephropathy, renal amyloidosis etc. increase with glomerular basement membrane permeability, shows as one group of clinical syndrome of High-grade Proteinuria, hypoproteinemia, treating serious edema caused, hyperlipemia.
Detailed description of the invention
Below will the invention will be further described by specific embodiment, these describe not is further restriction to content of the present invention, neither unique elaboration of the present invention, and can be conventional, known, also can be that the present invention uses first time.Related personnel it should be understood that the equivalent replacement done content technologies feature of the present invention, or corresponding improvement etc., still belong to protection scope of the present invention.
Embodiment 1
A, Flos abelmoschi manihot 60 parts is crushed to 70 orders, by 80 DEG C of floodings 4 times of 20 times amount, each extraction time is 3 hours, filters, obtains Aqueous extracts.Filtering residue continues the alcohol reflux 3 times with 20 times 95%, and each extraction time is 2 hours;
B, by the Aqueous extracts that obtains in step a and alcohol extract, be evaporated to the extractum of proportion 1.1 ~ 1.35 respectively, filter, be Aqueous extracts extractum and alcohol extract extractum; The 1:1 mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum, with temperature 80 DEG C of vacuum dryings 48 hours, obtains dry extract, pulverizes, add peacilomyce hepiahi
(Paecilomyceshepialid)cs-4 zymophyte powder 40 parts, adds the conventional adjuvant be applicable to, makes hard capsule preparation.
Embodiment 2
A, by Flos abelmoschi manihot 36 parts of co-grinding to 60 orders, by 95 DEG C of floodings 3 times of 5 times amount, each extraction time is 1 hour, filters, obtains Aqueous extracts.Filtering residue continues the alcohol reflux 3 times with 15 times 95%, and each extraction time is 1 hour;
B, by the Aqueous extracts that obtains in step a and alcohol extract, be evaporated to the extractum of proportion 1.1 ~ 1.35 respectively, filter, be Aqueous extracts extractum and alcohol extract extractum; The 1:2 mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum, with temperature 60 C vacuum drying 48 hours, obtains dry extract, pulverizes, add Hirsutlla sinensis
(Hirsutellasinensis)zymophyte powder 25 parts, adds applicable conventional adjuvant, makes granule.
Embodiment 3
A, by Flos abelmoschi manihot 7 parts of co-grinding to 40 orders, by 40 DEG C of floodings 1 time of 10 times amount, each extraction time is 2 hours, filters, obtains Aqueous extracts.Filtering residue continues the alcohol reflux 4 times with 10 times 95%, and each extraction time is 2 hours;
B, by the Aqueous extracts that obtains in step a and alcohol extract, be evaporated to the extractum of proportion 1.1 ~ 1.25 respectively, filter, be Aqueous extracts extractum and alcohol extract extractum; The 2:3 mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum, with temperature 30 DEG C of vacuum dryings 48 hours, obtains dry extract, pulverizes, add peacilomyce hepiahi
(Paecilomyceshepialid)cs-4 zymophyte powder 5 parts, adds applicable conventional adjuvant, makes tablet.
Embodiment 4
A, by Flos abelmoschi manihot 60 parts of co-grinding to 70 orders, by 55 DEG C of floodings 3 times of times amount, each extraction time is 2 hours, filters, obtains Aqueous extracts.Filtering residue continues the alcohol reflux 4 times with 20 times 85%, and each extraction time is 2 hours;
B, by the Aqueous extracts that obtains in step a and alcohol extract, be evaporated to the extractum of proportion 1.1 ~ 1.25 respectively, filter, be Aqueous extracts extractum and alcohol extract extractum; The 1:3 mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum, with temperature 65 DEG C of vacuum dryings 24 hours, obtains dry extract, pulverizes, add Hirsutlla sinensis
(Hirsutellasinensis)zymophyte powder 40 parts, adds pure water, then adds applicable conventional adjuvant, makes oral formulations.
Embodiment 5
The Chinese medicine composition of the treatment nephrotic syndrome of the present invention and chronic renal failure is to the protective effect evaluating drug effect of the chronic renal failure rats that adenine is induced.
Wistar rat 84, male and female half and half, be divided into 7 groups at random by sex body weight, experimental result is as follows:
1, after modeling starts, rats in normal control group, hair color is glossy, activity is freely frequent, amount of drinking water is stablized, and body weight, in increasing progressively state, on average increases by 14.73% than the experiment initial stage, the intensely dark pool of the visible chaeta of modeling rat outward appearance, activity less and back arch, amount of drinking water showed increased, body weight increasess slowly, about there is the Mus of half to occur the situation of weight loss, on average decline 9.12%; During Drug therapy, model group rats body weight increases slowly, rate of increase 19.95%, each gavage treatment group rat compares model group, the weight of animals increases very fast, increases by 22.65%, 23.79% than at the end of firm modeling, 20.18%, 32.72%, 37.90%, and apparent condition has certain alleviation, each group of experimental session average weight (see table 1), wherein composition of medicine of the present invention two various dose group body weight increase more obvious compared with other groups.Compared with Radix seu folium abelmoschi moschati-JINSHUIBAO group, the body weight rate of increase of present composition high and low dose group reaches 37.90% and 32.72% respectively, and the body weight rate of increase of Radix seu folium abelmoschi moschati-JINSHUIBAO group is 20.18%.
Table 1 is tested and is started, and modeling terminates and respectively organizes body weight at the end for the treatment of
| Group | Dosage (g/kg) | Body weight (g) before modeling | Body weight (g) after modeling | Body weight rate of increase (%) | Treatment terminates body weight (g) | Body weight rate of increase (%) |
| Normal group | - | 217.63 ±12.30 | 249.68 ±15.36 | 14.73 | 295.84 ±20.31 | 18.50 |
| Model group | - | 218.57 ±13.37 | 191.22 ±17.75** | -12.51 | 229.37 ±17.46 | 19.95 |
| Huang Kui capsule group | 6 | 221.56 ±19.18 | 204.33 ±21.35** | -7.78 | 250.63 ±24.10 | 22.65 |
| Paecilomyces hepiall chen group | 2.5 | 225.36 ±15.36 | 205.84 ±20.31** | -8.66 | 254.81 ±21.55 | 23.79 |
| Radix seu folium abelmoschi moschati-JINSHUIBAO group | 6(Huang Kui capsule)+2.5(paecilomyces hepiall chen) | 219.87 ±18.46 | 207.56 ±21.66** | -5.60 | 249.46 ±19.62 | 20.18 |
| The present composition | 0.75 | 223.76 ±15.36 | 201.14 ±13.81** | -10.11 | 266.97 ±24.61 | 32.72 |
| The present composition | 1.5 | 219.36 ±20.77 | 196.74 ±16.89** | -10.31 | 271.30 ±21.03 | 37.90 |
* P
0.05, * * P
0.01 compared with normal group;
#p
0.05,
##p
0.01 compared with model group
2, the present composition is on the impact of chronic renal failure rats kidney weight coefficient
As shown in table 2, the kidney weight coefficient (33.5 of model group rats at the end of modeling
1.8) with Normal group (6.7
0.3) significantly (P is increased
0.01); Model group rats still increases in treatment the 14th day and 28 days Kidney coefficients, and renal hypertrophy is (P obviously
0.01), treat each group of rat kidney weight coefficient and than significantly increase (P with normal group
0.01), wherein the present composition was treatment the 28th day, and Kidney coefficients decreases compared with model control group.
Table 2 present composition is on the impact of chronic renal failure rats kidney weight coefficient
| Group | Dosage (g/kg) | Treat the 14th day kidney weight coefficient (g/kg) | Treat the 28th day kidney weight coefficient (g/kg) |
| Normal group | - | 7.3 ±0.3 | 6.3 ±0.5 |
| Model group | - | 18.7 ±0.4** | 14.5 ±1.1** |
| Huang Kui capsule group | 6 | 13.9 ±1.1** | 12.9 ±1.4** |
| Paecilomyces hepiall chen group | 2.5 | 17.6 ±0.6** | 14.0 ±1.6** |
| Radix seu folium abelmoschi moschati-JINSHUIBAO group | 6(Huang Kui capsule)+2.5(paecilomyces hepiall chen) | 17.1 ±1.5** | 13.3 ±0.9** # |
| The present composition | 0.75 | 14.9 ±1.5** | 10.3 ±1.1** ## |
| The present composition | 1.5 | 16.1 ±1.0** | 11.4 ±1.3** ## |
* P
0.05, * * P
0.01 compared with normal group;
#p
0.05,
##p
0.01 compared with model group
3, the present composition is on the impact of chronic renal failure rats renal function index
As shown in Table 3, model group rats all declines than the modeling initial stage at the serum creatinine (Scr) of the 14th day and the content of blood urea nitrogen (BUN), but is significantly higher than normal group (P
0.05, P
0.01); Treat each group and more all show decline to a certain degree with model group, the Scr content of the present composition declines particularly evident (P
0.01).Model group rats continues to decline at the blood serum Bun of the 28th day and BUN content, but still apparently higher than normal group (P
0.01).Compared with model group, each treatment group blood serum Bun and BUN content have decline, wherein the action effect of the present composition extremely significantly (P
0.01).
Table 3 present composition is on the impact of chronic renal failure rats blood serum Bun and SUN
| Group | Dosage (g/kg) | Treat the 14th day Scr(μm of ol/L) | Treat the 14th day BUN(mmol/L) | Treat the 28th day Scr(μm of ol/L) | Treat the 28th day BUN(mmol/L) |
| Normal group | - | 54.31 ±3.96 | 7.95 ±1.06 | 65.84 ±8.31 | 6.50 ±0.66 |
| Model group | - | 96.55 ±6.37** | 16.65 ±0.35** | 89.37 ±7.46** | 12.95 ±0.69** |
| Huang Kui capsule group | 6 | 90.56 ±6.18 | 14.33 ±0.33** # | 85.63 ±4.10** | 9.27 ±1.13** # |
| Paecilomyces hepiall chen group | 2.5 | 85.36 ±5.36 # | 15.84 ±0.31** | 84.81 ±4.55** | 8.60 ±1.52 # |
| Radix seu folium abelmoschi moschati-JINSHUIBAO group | 6(Huang Kui capsule)+2.5(paecilomyces hepiall chen) | 89.87 ±8.46 | 17.56 ±0.56** # | 80.46 ±6.62* # | 8.18 ±0.96 ## |
| The present composition | 0.75 | 80.36 ±5.36 # | 12.14 ±0.71** ## | 66.97 ±4.61 ## | 7.72 ±1.13 ## |
| The present composition | 1.5 | 85.60 ±6.77 # | 13.74 ±0.49** ## | 71.30 ±6.03 ## | 7.90 ±1.16 ## |
* P
0.05, * * P
0.01 compared with normal group;
#p
0.05,
##p
0.01 compared with model group
4, the present composition is on the impact of chronic renal failure rats nephridial tissue oxidation resistance
As shown in Table 4, model group rats T-SOD and GSH-Px in the nephridial tissue of the 14th day is active significantly lower than normal group (P
0.05, P
0.01); Compare with model group, wherein active and Radix seu folium abelmoschi moschati-JINSHUIBAO group and present composition group the GSH-Px activity of the T-SOD of present composition group all significantly raises (P
0.05).Model group T-SOD and GSH-Px activity in the nephridial tissue of the 28th day is still remarkable in normal group (P
0.01); Compared with model group, treating each group of T-SOD all has remarkable rising, and the GSH-Px activity of Radix seu folium abelmoschi moschati-JINSHUIBAO group and present composition group all has remarkable rising, and vigor is suitable.
The impact that table 4 present composition is lived on chronic renal failure rats nephridial tissue T-SOD and GSH-Px enzyme
| Group | Dosage (g/kg) | Treat the 14th day T-SOD(U/mg) | Treat the 14th day GSH-Px(U/mg) | Treat the 28th day T-SOD(U/mg) | Treat the 28th day GSH-Px(U/mg) |
| Normal group | - | 411.31 ±2.66 | 243.85±12.06 | 430.71±13.60 | 285.72±17.35 |
| Model group | - | 264.55±16.31** | 200.65±18.75* | 229.68±13.69** | 237.65±15.68** |
| Huang Kui capsule group | 6 | 299.25±8.55** # | 214.33±4.73* # | 299.64±183.33** ## | 249.77±14.11* |
| Paecilomyces hepiall chen group | 2.5 | 285.36±5.36** | 215.84±6.31* | 295.34±13.65** ## | 251.03±16.44 |
| Radix seu folium abelmoschi moschati-JINSHUIBAO group | 6(Huang Kui capsule)+2.5(paecilomyces hepiall chen) | 300.37±6.11** # | 228.45±8.56 ## | 308.87±16.22** ## | 264.90±14.36 ## |
| The present composition | 0.75 | 311.62±5.36* ## | 231.59±7.16 ## | 355.41±15.58** ## | 264.48±11.32 ## |
| The present composition | 1.5 | 340.25±9.85* ## | 223.69±6.49 ## | 357.16±19.23** ## | 277.63±16.30 ## |
5, combined therapy of the present invention impact that renal failure model group rats renal tissues pathology is changed
In normal group, all renal tissue sample excess of the kidney matter rules, renal cells queueing discipline is complete, and the glomus of composition glomerule is normal.There is larger gap in model group excess of the kidney matter, visible a large amount of brown adenine crystalline deposit thing in nephridial tissue, be positioned at renal tubules and interstitial, renal cells distortion or downright bad, interstitial chronic inflammatory cell infiltration, and being attended by fibrosis hypertrophy, glomerule blister cavities expands, and bead mesentery slightly thickens.Treat each group compared with model group, kidney substantial damage alleviates, and metabolism crystal reduces, and wherein effect is evident as present composition group high and low dose group most, is secondly Radix seu folium abelmoschi moschati-JINSHUIBAO group.
Embodiment 6 investigates the therapeutic effect of Chinese medicine composition of the present invention to the nephrotic syndrome by clinical trial
See " new Chinese medicine guideline of clinical investigations ", accept Levels in Nephrotic Syndrome Patients 93 example for medical treatment in xx city xx nephropathy Comprehensive Treatment hospital, wherein male 64 people, women 29 people.26 ~ 64 years old age, average 40.1 years old, the course of disease 3 ~ 8 years.
Diagnostic criteria: glomerular proteinuria, companion or do not accompany glomerule source property hematuria, has or without hypertension and edema.
Inclusive criteria: the diagnostic criteria meeting chronic nephritis, the age, twenty-four-hour urine protein quantification 3g, signed Informed Consent Form person in 18 ~ 65 one full year of life.
Therapeutic Method: on the basis of general treatment, gives the medicine of embodiment 1, every day 3 times, each 3.Observe 8 weeks.
Result shows, in 93 examples, and effective 26 examples (27.96%), effective 54 examples (58.06%), invalid 13 examples (13.98%), total effective rate 86.02%.
Claims (5)
1. be used for the treatment of a Chinese medicine composition for the nephrotic syndrome and chronic renal failure, it is characterized in that the component comprising following weight proportion: Chinese caterpillar fungus fermentation mycopowder 1 ~ 70 part, Flos abelmoschi manihot extract 1 ~ 60 part, wherein Chinese caterpillar fungus fermentation mycopowder can be selected from peacilomyce hepiahi
(Paecilomyceshepialid)cs-4 or Hirsutlla sinensis (
hirsutellasinensis) zymophyte powder.
2. treat the Chinese medicine composition of the nephrotic syndrome and chronic renal failure according to claim 1, the weight proportion of each raw material components of this compound medicine is: Chinese caterpillar fungus fermentation mycopowder 10 ~ 40 parts, Flos abelmoschi manihot extract 5 ~ 40 parts.
3. treat the Chinese medicine composition of the nephrotic syndrome and chronic renal failure according to claim 2, the weight proportion of each raw material components of this compound medicine is: Chinese caterpillar fungus fermentation mycopowder 35 parts, Flos abelmoschi manihot extract 27 parts.
4. the treatment nephrotic syndrome according to claim 1,2 or 3 and the Chinese medicine composition of chronic renal failure, is characterized in that the preparation method of Flos abelmoschi manihot extract is:
A, by Flos abelmoschi manihot co-grinding to 10-80 order, by the flooding 1 ~ 4 time of 5-20 times amount, temperature is 30 ~ 100 DEG C, and each extraction time is 1 ~ 3 hour, filters, obtains Aqueous extracts; Filtering residue continuation concentration is alcohol reflux 1-4 time of 55% ~ 95%, and temperature is 30 ~ 100 DEG C, and each extraction time is 1 ~ 3 hour, filters, obtains alcohol extract;
B, by step a Aqueous extracts and alcohol extract, be evaporated to the extractum of proportion 1.1 ~ 1.35 respectively, be Aqueous extracts extractum and alcohol extract extractum; 1:1 ~ 1:10 the mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum, dry, make Chinese medicine preparation after adding pharmaceutic adjuvant.
5. the Flos abelmoschi manihot extract described in claim 4, is characterized in that the 1:2 mixing in mass ratio of Aqueous extracts extractum and alcohol extract extractum.
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| CN116421634A (en) * | 2023-06-12 | 2023-07-14 | 江西金水宝制药有限公司 | Cs-4 cordyceps sinensis powder extract and preparation method and application thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106310146A (en) * | 2016-11-24 | 2017-01-11 | 南京中医药大学 | Traditional Chinese medicine composition having efficacy of preventing and treating chronic renal failure and preparation method and application thereof |
| CN106310146B (en) * | 2016-11-24 | 2019-07-09 | 南京中医药大学 | Have effects that prevent and treat the Chinese medicine composition and the preparation method and application thereof of chronic kidney hypofunction |
| CN116421634A (en) * | 2023-06-12 | 2023-07-14 | 江西金水宝制药有限公司 | Cs-4 cordyceps sinensis powder extract and preparation method and application thereof |
| CN116421634B (en) * | 2023-06-12 | 2023-09-12 | 江西金水宝制药有限公司 | Cs-4 cordyceps sinensis powder extract and preparation method and application thereof |
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Inventor after: Xu Zhenghong Inventor after: Shi Jinsong Inventor after: Lu Zhenming Inventor after: Ren Yilin Inventor after: Tang Haitao Inventor after: Tang Renmao Inventor before: Xu Zhenghong Inventor before: Shi Jinsong Inventor before: Lu Zhenming Inventor before: Ren Yilin Inventor before: Tang Haitao Inventor before: Xu Baiyi Inventor before: Zhu Shanyi Inventor before: Cong Xudong |
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Effective date of registration: 20160128 Address after: No. 1800 road 214122 Jiangsu Lihu Binhu District City of Wuxi Province Applicant after: Jiangnan University Applicant after: Jiangsu SZYY Group Pharmaceutical Limited Address before: No. 1800 road 214122 Jiangsu Lihu Binhu District City of Wuxi Province Applicant before: Jiangnan University |
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Application publication date: 20151209 |