CN1899384A - Medicinal composition for treating nephritis and its preparing method and use - Google Patents
Medicinal composition for treating nephritis and its preparing method and use Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention discloses a kind of medicinal composition for treating nephritis and its preparation process. The medicine composition is prepared with motherwort 80-1800 weight portions, leech 70-1500 weight portions, and Japanese milkwort 110-2400 weight portions, and may be tablet, capsule, bolus and other orally taken preparation forms, It has the functions of promoting blood circulation to disperse blood clots and inducing diuresis to alleviate edema, and is used in treating nephritis, especially chronic nephritis.
Description
Technical field
The present invention relates to drug world, relate in particular to pharmaceutical composition of treatment nephritis and its production and application.
Background technology
Nephritis is that pathogenic microorganism is invaded matter and the caused struvite pathological changes of excess of the kidney matter between renal pelvis, kidney.In general, the common sympton of nephritis have that foam increases in edema, the urine, hematuria, waist are ached, hypertension etc.Nephritis is divided into acute and chronic two kinds: acute nephritis, but be the most common patient with the women of child-bearing age, cardinal symptom comprise hyperpyrexia, shiver with cold, lumbago, inappetence, feel sick, vomiting etc., and individual patient can have middle upper abdomen or abdomen pain entirely; Chronic nephritis generally surpasses the course of disease half a year or 1 year person and happyly is chronic nephritis, and shape is light than acute stage, can show as silent urine sometimes.
So far, treatment nephritis is mainly based on immunosuppressant class medicine.Used Chinese patent medicine, for example the patent No. is 98101633.2 Chinese patent, and it discloses a kind of medicine of mainly being made up of Chinese herbal medicine such as GULONG, HUOXUEDAN, Radix Paeoniae Rubra, Ramulus Sambuci Williamsii, Cortex Sapii Radicis, SHIZHUHUA, Radix Et Rhizoma Rhei, Herba Adonidis, Testis et Pentiss for the treatment of nephritis and kidney disease.The Chinese patent medicine that all things considered is used for treating nephritis still is fewer.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of nephritis.
The present invention also aims to provide the preparation method and the application of aforementioned pharmaceutical compositions.
Pharmaceutical composition of the present invention mainly is that the original medical material by following weight proportion is prepared from: Herba Leonuri 80-1800 part, Hirudo 70-1500 part, Herba Polygalae Japonicae 110-2400 part; Be preferably: Herba Leonuri 100-1200 part, Hirudo 90-1100 part, Herba Polygalae Japonicae 180-1500 part; More preferably: Herba Leonuri 300-500 part, Hirudo 250-450 part, Herba Polygalae Japonicae 500-650 part; Most preferably be: 443 parts of Herba Leonuris, 358 parts of Hirudos, 586 parts of Herba Polygalae Japonicae.
Aforementioned pharmaceutical compositions can be made conventional oral formulations, for example tablet, capsule, pill, drop pill, soft capsule, powder, granule, solution etc.Certainly when the concrete preparation of preparation, can add various adjuvants according to the concrete needs of every kind of preparation, for example, filler is as lactose, sucrose, dextrin, Icing Sugar etc.; Wetting agent is as distilled water, ethanol etc.; Binding agent is as syrup, hydroxypropyl cellulose, starch slurry etc.; Lubricant is as magnesium stearate etc.; Suspending agent is as vegetable oil, wax etc.
The present invention has also improved the preparation method of aforementioned pharmaceutical compositions, and wherein a kind of method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, granulate with syrup, drying, the adding magnesium stearate, granulate, tabletting promptly get tablet.
The present invention has also improved the preparation method of aforementioned pharmaceutical compositions, and another kind of method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, with the syrup granulation, drying behind the granulate, incapsulates, promptly.
The present invention has also improved the preparation method of aforementioned pharmaceutical compositions, and another kind of method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mix, after the drying, be ground into fine powder, be binding agent with water, make pill by agitation procedure, promptly.
The present invention has also improved the preparation method of aforementioned pharmaceutical compositions, and another kind of method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, adding drop pill substrate behind the heating and melting, splashes in the condensed fluid, after the cooling, sort out, drying, promptly.
The present invention has also improved the preparation method of aforementioned pharmaceutical compositions, and another kind of method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, after the drying, crushing screening, with soybean oil and Cera Flava, mixing, colloid mill, prepare rubber with gelatin, G ﹠ W, make soft capsule by pressing, promptly.
Perhaps this method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, add the excipient that suits, for example sucrose, dextrin etc. are made granule, after the drying, granulate, packing, promptly.
Raw materials used medical material and adjuvant can be buied at regular pharmacy.Used Herba Leonuri, Hirudo and Herba Polygalae Japonicae weight dry decoction pieces weight to buy at pharmacy.
In the pharmaceutical composition of the present invention, Herba Leonuri, hardship is let out hot loosing, the master goes into blood system, is good at the blood circulation promoting and blood stasis dispelling regulating menstruation, and the energy inducing diuresis to remove edema shows as and can improve and increase the renal blood flow amount, make the pathological changes of glomerule or renal tubules obtain repairing and regeneration, renal fibrosis is reversed,, recover renal function to eliminate albumen in inflammatory lesion and the urine; Hirudo wherein contains the hirudin that can suppress blood coagulation, thereby has effects such as removing blood stasis, removing blood stasis; Herba Polygalae Japonicae has antitussive, reduces phlegm, invigorates blood circulation, stops blooding, calms the nerves, effect such as detoxifcation.The main pharmaceutical composition of being made by Herba Leonuri, Hirudo and Herba Polygalae Japonicae has the effect of blood circulation promoting and blood stasis dispelling, inducing diuresis to remove edema, can treat nephritis, especially edema that (chronic) nephritis caused, lumbago, albuminuria, giddy, symptom such as weak can be improved and alleviate to chronic nephritis.
Patient and anemia of pregnant woman hemorrhage and menstrual period prohibit clothes pharmaceutical composition of the present invention.The instructions of taking of pharmaceutical composition of the present invention is as follows: every day 3 times, each dosage is in 5～7g raw medicinal material.
The specific embodiment
Further describe the present invention below in conjunction with specific embodiment, characteristics of the present invention and advantage will be clearer.These illustrative embodiment only be used for illustrating of the present invention; to protection scope of the present invention without any restriction; it will be understood by those skilled in the art that the substitutions and modifications of doing according to spirit of the present invention any of equal value all fall within the scope of protection of the present invention.
Embodiment 1
1) takes by weighing Herba Leonuri 443g, Hirudo 358g, Herba Polygalae Japonicae 586g;
2) with Hirudo with the alcohol dipping of 2000ml 75% 2 hours, filter, obtain filtrate and filtering residue (Hirudo after the alcohol dipping), in filtrate, add distilled water and make wherein that ethanol content is 15%, with the filtering residue vacuum drying, pulverize, cross 100 mesh sieves, the gained fine powder is standby, the gained coarse powder flooded 2 hours with above-mentioned gained filtrate according to the percolation under fluid extract and the extractum item (2000 editions first appendix IO of Chinese Pharmacopoeia), and the ethanol of reuse 15% is that solvent carries out percolation, collected percolate, decompression recycling ethanol, being concentrated into relative density is the clear paste of 1.05 (60 ℃):
3) Herba Leonuri and Herba Polygalae Japonicae are used 12000ml water retting 2.5 hours, decocted 1.5 hours, filter, repeat above-mentioned dipping, decoction and filtering operation again, merging filtrate, being evaporated to relative density is the clear paste of 1.10 (60 ℃), add ethanol and make wherein that ethanol content is 75%, left standstill 24 hours, filter, decompression filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.15 (60 ℃):
4) with two kinds of clear paste mix homogeneously of above-mentioned gained, drying is pulverized, again with above-mentioned gained fine powder mix homogeneously, cross 100 mesh sieves, granulate,, add the 28g magnesium stearate 80 ℃ of dryings with the syrup of 70ml 60%, granulate is pressed into tablet, altogether 1000, the bag film-coat gets final product.
Embodiment 2
Take by weighing Herba Leonuri 320g, Hirudo 430g, Herba Polygalae Japonicae 650g;
By with embodiment 1 in 2), 3) identical method handles Hirudo, Herba Leonuri and Herba Polygalae Japonicae, then two kinds of clear paste of gained are mixed, dry, pulverize, mixes with the gained fine powder then, with 60% syrup 70-80ml granulation, drying behind the granulate, incapsulates, promptly.
Embodiment 3
Take by weighing Herba Leonuri 500g, Hirudo 250g, Herba Polygalae Japonicae 500g;
By with embodiment 1 in 2), 3) identical method handles Hirudo, Herba Leonuri and Herba Polygalae Japonicae, then two kinds of clear paste of gained are mixed, dry, pulverize, mix with the gained fine powder then, after the drying, being ground into 120 order fine powders, is binding agent with water, make pill by agitation procedure, promptly
Embodiment 4
Take by weighing Herba Leonuri 100g, Hirudo 90g, Herba Polygalae Japonicae 1500g;
By with embodiment 1 in 2), 3) identical method handles Hirudo, Herba Leonuri and Herba Polygalae Japonicae, then two kinds of clear paste of gained are mixed, dry, pulverize, mixes adding drop pill substrate (as PEG etc.) then with the gained fine powder, behind the heating and melting, splash in the condensed fluid, after the cooling, sort out, drying, promptly.
Embodiment 5
Take by weighing Herba Leonuri 1200g, Hirudo 90g, Herba Polygalae Japonicae 180g;
By with embodiment 1 in 2), 3) identical method handles Hirudo, Herba Leonuri and Herba Polygalae Japonicae, with two kinds of clear paste mixing of gained, dry, pulverizing, mix with middle gained fine powder then, after the drying then, pulverized 120 mesh sieves, with soybean oil 344g, Cera Flava 6g, mixing, cross colloid mill 3 times, with gelatin: glycerol: 100: 35: 95 formulation rubber of water, make soft capsule by pressing, promptly.
Embodiment 6
Take by weighing Herba Leonuri 1800g, Hirudo 70g, Herba Polygalae Japonicae 2400g;
By with embodiment 1 in 2), 3) identical method handles Hirudo, Herba Leonuri and Herba Polygalae Japonicae, then two kinds of clear paste of gained are mixed, dry, pulverize, mixes with middle gained fine powder then, adding excipient dextrin is made granule, after the drying, granulate, packing, promptly.
The test example
Use pharmaceutical composition tablet in treatment primary nephrotic syndrome of the present invention (PN) case 67 examples of the embodiment of the invention 1 gained, the result is as follows.
Data and method
1. the object of observation: PNS patient's 132 examples of being in hospital, diagnostic criteria is with reference to the academic meeting revised standard of second nephropathy in the whole nation in 1985.Wherein male 94 examples, women 38 examples; 2.5 years old～56 years old age, average (41 ± 12.7) year; Medical history 1～56 month, average (23 ± 11.2) moon.Be divided into two groups at random, 67 examples are organized in treatment, matched group 65 examples.Including case in all gets rid of the Secondary cases nephrotic syndrome and merges other kidney diseases.All accompany edema clinically, urine protein is qualitative +～+++.Hypertension person 12 examples in the treatment group, companion hematuria person 61 examples; Serum albumin (36.5 ± 8.2) g/L; Triglyceride (2.7 ± 1.86) mmol/L.Hypertension person 11 examples in the matched group, companion hematuria person 58 examples; Serum albumin (37.6 ± 7.4) g/L; Serum cholesterol (7.9 ± 1.8) mmol/L; Triglyceride (2,9 ± 1,32) mmol/L.Patient age, sex, the course of disease and the state of an illness are similar between two groups, have comparability.
2. Therapeutic Method: two groups of all oral persantin 25mg of patient, 3 times on the 1st; Look the state of an illness and use urokinase (5 ± 2) ten thousand u intravenous drips, 1 time on the 1st.The treatment group adds the tablet 2-4 sheet with embodiment 1,3 times on the 1st; Take Chinese herbal medicine decoction treatment (by what open behind the symptom Chinese medical discrimination) behind the conventional Chinese medical discrimination of matched group.Two groups all do not add with adrenal gland's glucocorticoid and other immunosuppressant.Stipulate that 12 weeks were 1 course of treatment.
3. observation index: in the drug administration process, two groups of patient's measuring blood pressures in equal morning every day 1 time, the liquid 1 time of having urine examined weekly, the biochemical indicator 1 time of having a blood test in per 2 weeks.All case finishes back 6 months follow-up observation change of illness state situations 1 course of treatment.
4. statistical method: measurement data is so that (x ± s) expression adopts the t check, and enumeration data result adopts the x2 check in the literary composition.
The result
1. curative effect determinate standard
Produce effects: clinical symptoms and sign disappear, and urine detection feminine gender, biochemical analysis index be all in normal range, and renal function is normal and follow up a case by regular visits to not recurrence in 6 months; Effectively: clinical symptoms and sign disappear, urine protein ±, biochemical analysis is normal substantially, changes though follow up a case by regular visits to 6 months observation index, but still before being better than treatment; Invalid: with compare that aforementioned index does not have obvious change and/or clinical symptoms increases the weight of before the treatment.
2. after two groups of curative effects relatively finished the course of treatment, clinical symptoms and sign disappeared in the treatment group, total effective rate 95.5% (64/67), the number of days 18～54d that is in hospital, average 28d; Matched group total effective rate 69.2% (45/65), the number of days 21～57d that is in hospital, average 33d.Treatment group and matched group be P＜0.01 relatively.The biochemical all indexs of blood contrast respectively before and after the treatment, all have clear improvement.
Discuss
Nephrotic syndrome mainly is the imbalance of spleen renal function according to theory of Chinese medical science, with the passing of time causes spleen, lung, kidney all empty, because the patient immune function is low, blood flow is in hypercoagulability, and it is not smooth to circulate, the change of clinical and biochemical analysis aspect that to cause that water humidity hysteresis in the body stays etc. a series of.Pharmaceutical composition of the present invention mainly forms by pure Chinese medicine extraction such as Herba Polygalae Japonicae, Herba Leonuri, Hirudo are refining, shows that through pharmaceutical research Herba Polygalae Japonicae includes seven kinds of mucin and derivant thereof, and it has certain effect to recovering glomerule filter membrane purification function.The another kind of main component Hirudo of pharmaceutical composition of the present invention has stronger blood coagulation resisting function, therefore, the prescription of pharmaceutical composition of the present invention has blood circulation promoting and blood stasis dispelling, blood viscosity lowering, can effectively prevent and alleviate blood clotting material adventitious deposit on filter membrane, can improve the circulation of body inner blood preferably, reach the purpose of eliminating edema.Clinical trial shows, self contrasts the variation tool significant difference (P＜0.01) of the biochemical all indexs of blood before and after the treatment group is taken medicine; And compare with matched group, all better improved (P＜0.01) after finishing the course of treatment.Result of study demonstrates pharmaceutical composition of the present invention eliminating clinical symptoms, correct albuminuria, alleviating aspects such as hematuria, particularly effectively improves PNS patients serum albumin level, and its effect is better than matched group.It is worthy of note that this paper treatment group is not used glucocorticoid and other immunosuppressant, thereby also avoided the toxic and side effects of this type of medicine.It is low to take this medicine PNS healing back relapse rate, does not see obvious adverse reaction in the therapeutic process, is that pharmaceutical composition of the present invention is compared one of unique advantage with other drug.
Claims (8)
1. pharmaceutical composition for the treatment of nephritis, it mainly is that original medical material by following weight proportion is prepared from: Herba Leonuri 80-1800 part, Hirudo 70-1500 part, Herba Polygalae Japonicae 110-2400 part.
2. pharmaceutical composition according to claim 1 is characterized in that, the weight proportion of raw materials used medical material is: Herba Leonuri 100-1200 part, Hirudo 90-1100 part, Herba Polygalae Japonicae 180-1500 part.
3. pharmaceutical composition according to claim 1 is characterized in that, the weight proportion of raw materials used medical material is: Herba Leonuri 300-500 part, Hirudo 250-450 part, Herba Polygalae Japonicae 500-650 part.
4. pharmaceutical composition according to claim 1 is characterized in that, the weight proportion of raw materials used medical material is: most preferably be: 443 parts of Herba Leonuris, 358 parts of Hirudos, 586 parts of Herba Polygalae Japonicae.
5. pharmaceutical composition according to claim 1 is characterized in that, this pharmaceutical composition is an oral formulations.
6. method for preparing the described pharmaceutical composition of claim 1, this method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, granulate with syrup, drying, the adding magnesium stearate, granulate, tabletting promptly get tablet;
Perhaps this method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, with the syrup granulation, drying behind the granulate, incapsulates, promptly.
Perhaps this method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mix, after the drying, be ground into fine powder, be binding agent with water, make pill by agitation procedure, promptly.
Perhaps this method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, adding drop pill substrate behind the heating and melting, splashes in the condensed fluid, after the cooling, sort out, drying, promptly.
Perhaps this method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, after the drying, crushing screening, with soybean oil, Cera Flava, mixing, colloid mill, prepare rubber with gelatin, G ﹠ W, make soft capsule by pressing, promptly.
Perhaps this method comprises: 1) with Herba Polygalae Japonicae and Herba Leonuri with water retting, decoction, filter then, filtrate is made clear paste; 2) Hirudo is used alcohol dipping, filtration, obtain filtrate and filtering residue, filtering residue is pulverized, obtain coarse powder and fine powder, coarse powder with above-mentioned filtrate percolation, is made clear paste; 3) two kinds of clear paste of gained are mixed, dry, pulverize, then with 2) in the gained fine powder mixes, add the excipient that suits, (as sucrose, dextrin) makes granule, after the drying, granulate, packing, promptly.
7. the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment nephritis.
8. purposes according to claim 7, wherein nephritis is chronic nephritis.
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| CN2006101035380A CN1899384B (en) | 2006-07-21 | 2006-07-21 | Medicinal composition for treating nephritis and its preparing method and use |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780199A (en) * | 2010-03-24 | 2010-07-21 | 安徽农业大学 | Traditional Chinese medicine breast perfusate for treating mastitis of dairy cattle and preparation method thereof |
| CN101953852A (en) * | 2010-09-16 | 2011-01-26 | 贵州信邦制药股份有限公司 | Antithrombin preparation and preparation method thereof |
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2006
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780199A (en) * | 2010-03-24 | 2010-07-21 | 安徽农业大学 | Traditional Chinese medicine breast perfusate for treating mastitis of dairy cattle and preparation method thereof |
| CN101780199B (en) * | 2010-03-24 | 2011-07-27 | 安徽农业大学 | Traditional Chinese medicine breast perfusate for treating mastitis of dairy cattle and preparation method thereof |
| CN101953852A (en) * | 2010-09-16 | 2011-01-26 | 贵州信邦制药股份有限公司 | Antithrombin preparation and preparation method thereof |
| CN101953852B (en) * | 2010-09-16 | 2014-09-24 | 贵州信邦制药股份有限公司 | Antithrombin preparation and preparation method thereof |
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| CN1899384B (en) | 2010-04-07 |
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