CN1736440A - Application of peru apple in preparation of medicine - Google Patents
Application of peru apple in preparation of medicine Download PDFInfo
- Publication number
- CN1736440A CN1736440A CN 200410011052 CN200410011052A CN1736440A CN 1736440 A CN1736440 A CN 1736440A CN 200410011052 CN200410011052 CN 200410011052 CN 200410011052 A CN200410011052 A CN 200410011052A CN 1736440 A CN1736440 A CN 1736440A
- Authority
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- China
- Prior art keywords
- administration
- nicandrae physaloidis
- herba nicandrae
- medicine
- mice
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Abstract
The invention relates to the use of Nicandra physalodes in preparing medicament for treating kidney diseases, which has the advantages of stronger pharmacological action, low price, low toxicity and simple process for manufacturing. The medicament can be made into the dosage forms of oral tablets or injections.
Description
Technical field:
The present invention relates to the purposes of Herba Nicandrae Physaloidis, particularly relate to the application of Herba Nicandrae Physaloidis in preparation treatment nephropathy medicine, relate in particular to the purposes in pharmaceutical field.
Background technology:
Herba Nicandrae Physaloidis is the herb of eggplant Nicandra plant Herba Nicandrae Physaloidis, different name is quartzy bean jelly (" a Guizhou Chinese herbal medicine register "), Herba hemipharagmatis heterophylli (" Kunming medical herbs commonly used among the people "), ice powder (" choosing of Yunnan Chinese herbal medicine "), big thousand living, Tian Zhu (" Yunnan Chinese herbal medicine "), bitter cowherb (" Guangxi medicinal plants register ").Herb contains Herba Nicandrae Physaloidis element (Herba Nicandrae Physaloidis glycoside bitter principle Nicandrin) 0.65%.Leaf contains Nicandrenone (Nicandrenone) and examines Herba Nicandrae Physaloidis element (Withanicandrin) Wei, and leaf contains paddy alcohol steroid, campesterol, isofucosterol, cholesterol, stigmasterol 24-methylene cholesterol, cloud tongue sterol.From the water extract of leaf, decompose 17 compound N ic
1-17, Nic wherein
1,2,3,7,10,11,12,17Structure determined
[3-7]Nic is a Nicandrenone.Root contains tropinone (Tropinone) hygrine (Hygrine).Get Flos Daturae lactone 2 (aturalactone2) from seed and get the plain B (NicandrinB of chemical compound Herba Nicandrae Physaloidis from defatted seed
[8], C28H38O6) (1) is new C28-steroidal lactone
[9]
Seed oil-containing 18.6%, satisfied fatty acid 11.1% linoleic acid 20.8% wherein, oleic acid 64.4% ， Bu Sudsization thing (stigmasterol, sitosterol) 0.83%
[1]Knownly can be used for food compound or thickening agent.
Summary of the invention:
The object of the present invention is to provide a kind of new purposes of Herba Nicandrae Physaloidis, i.e. new application in pharmacy.
In fact the present invention relates to Herba Nicandrae Physaloidis as the application in the medicine of preparation treatment or prevention nephritis.
The invention still further relates to Herba Nicandrae Physaloidis as the application in preparation treatment or the prevention renal failure medicine.
The invention still further relates to Herba Nicandrae Physaloidis as the application in preparation treatment or the prevention uremia.
In order to understand essence of the present invention better, the pharmacological tests with Herba Nicandrae Physaloidis illustrates its new purposes in pharmaceutical field below.Its structural formula is:
One, acute toxicity test in mice
Summary: (5.2g crude drug/ml) concentrates 40ml/kg to give mouse stomach Herba Nicandrae Physaloidis extract, 1 time on the 1st or 2 times on the 1st, accumulated dose is respectively 208g crude drug/kg or 416g crude drug/kg), or subcutaneous injection administration 104g crude drug/kg observes the internal organs heart with sovereign right, liver, spleen, lung, kidney and all do not have obvious pathological change.Calculating gastric infusion by kg body weight, quite clinical (adult is by 70 kilograms of calculating, dosage is 25g crude drug/day for each person) 582 times or 164 times of dosage, 291 times of the suitable clinical dosage of subcutaneous injection administration, be far longer than clinical consumption, can think that Herba Nicandrae Physaloidis gastric infusion or subcutaneous injection administration toxicity are lower.
Experiment purpose: very low according to this poison of drug of preliminary experiment, can not survey LD50, so do once or irritated stomach on the 1st or a subcutaneous injection maximum dosage-feeding is measured, observe the acute toxicity of Herba Nicandrae Physaloidis.
Experiment material:
1, medicine: the Herba Nicandrae Physaloidis extracting solution, 1.0g crude drug/ml is concentrated into 5.2g crude drug/ml (Cmax) before the test in water bath with thermostatic control, put 4 ℃ of refrigerators and preserve standby.
2, animal: Kunming kind white mice, body weight 19-21g, male and female half and half, available from Changchun institute of Biological Products animal housing, mice quality certification 10-1001.
Method and result:
1, once irritating the stomach maximum dosage-feeding measures: 40 of mices, fasting be can't help water 16 hours, press 40ml/kg and irritate stomach Herba Nicandrae Physaloidis concentrated solution 208g crude drug/kg, matched group gives with the volume distilled water, observes mice outward appearance in 7 days, ingests, drinking-water, feces, fur glossiness and nose, eye, oral cavity have or not the abnormal secretion thing.Claimed body weight, food ration and an amount of drinking water in per 2 days simultaneously.Put to death animal on the 8th, dissect, the perusal heart, liver, spleen, lung, kidney have or not obvious tissue pathologies change, the results are shown in Table 1-5, Fig. 1-5.
Table 1. Herba Nicandrae Physaloidis is once irritated the stomach maximum dosage-feeding to the influence of mice TBW (n=20, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 19.6±0.75 19.3±1.72 20.0±1.95 20.5±1.99 20.1±2.22 | 19.6±0.68 19.1±1.12 19.6±1.31 20.0±1.81 19.4±1.98 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Table 2. Herba Nicandrae Physaloidis is once irritated the stomach maximum dosage-feeding to the influence of male mice body weight (n=10, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 19.9±0.74 19.5±1.35 20.0±1.41 20.0±1.49 19.9±2.08 | 19.9±0.74 19.2±1.40 19.2±1.48 19.3±2.11 18.7±2.21 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Table 3. Herba Nicandrae Physaloidis is once irritated the stomach maximum dosage-feeding to the influence of female mice body weight (n=10, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 19.3±0.68 19.1±2.08 20.0±2.45 21.0±2.36 20.3±2.45 | 19.3±0.48 19.0±0.82 20.0±1.05 20.7±1.16 20.1±1.52 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Table 4. Herba Nicandrae Physaloidis is once irritated the influence (n=10, g//day) of stomach maximum dosage-feeding to the total food ration of mice
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 0.44 0.49 0.5 0.49 0.52 | 0.34 0.38 0.42 0.46 0.50 |
Table 5. Herba Nicandrae Physaloidis is once irritated the influence (n=10, ml//day) of stomach maximum dosage-feeding to the total amount of drinking water of mice
| Time (inferior) | Matched group | The |
| 1 2 3 4 | 0.65 0.40 0.5 0.48 | 0.55 0.30 0.48 0.46 |
| 5 | 0.48 | 0.50 |
Take medicine and observe as seen in back 7 days, quiet few moving, perpendicular hair phenomenon appears in about 2 minutes individual animal after the mice administration, can recover normal about 30 minutes, and all the other animal appearance, activity, fur glossiness etc. are generally in order, nose, eye, the no abnormal secretions in oral cavity do not have dead.By showing 1-5 and Fig. 1-5 result as seen, mice TBW, male mice body weight, total food ration, total amount of drinking water slightly reduce, but do not have obvious significant difference, and all the other are all normal, and the perusal heart, liver, spleen, lung, kidney have or not obvious pathological change.Because of drug level and administration volume restrictions fail to measure LD50, so mouse stomach administration LD50＞208g crude drug/kg.As seen, calculate 582 times of being equivalent to clinical (adult is by 70 kilograms of calculating) dosage by kg body weight and do not see obvious influence.Show that Herba Nicandrae Physaloidis filling stomach toxicity is lower.
2, irritating the stomach maximum dosage-feeding on the 1st measures: 40 of mices, fasting be can't help water 16 hours, irritate the stomach Herba Nicandrae Physaloidis concentrated solution (40ml/kg of 5.2g crude drug/ml), administration is 2 times in 24 hours, minor tick 6h, daily dose is 416g crude drug/kg, and matched group gives with the volume distilled water, observes mice outward appearance in 7 days, ingests, drinks water, activity, feces, fur glossiness and nose, eye, oral cavity have or not the abnormal secretion thing.Claimed body weight, food ration and an amount of drinking water in per 2 days simultaneously.Put to death animal on the 8th, dissect, the perusal heart, liver, spleen, lung, kidney have or not obvious tectology to change, and the results are shown in Table 6-table 10, Fig. 6-Figure 10.
Table 6. Herba Nicandrae Physaloidis one day is irritated the stomach maximum dosage-feeding to the influence of mice TBW (n=20, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 | 19.2±0.42 19.3±1.42 | 19.3±0.48 19.4±1.17 |
| 3 4 5 | 20.0±1.63 20.6±2.12 19.9±2.77 | 19.9±1.85 20.0±1.83 19.6±1.84 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Table 7. Herba Nicandrae Physaloidis one day is irritated the stomach maximum dosage-feeding to the influence of male mice body weight (n=10, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 19.9±0.70 19.6±1.40 20.4±1.20 21.2±1.80 20.5±2.0 | 19.8±0.90 19.6±1.30 20.1±1.10 21.1±1.20 20.3±1.60 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Table 8. Herba Nicandrae Physaloidis one day is irritated the stomach maximum dosage-feeding to the influence of female mice body weight (n=20, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 19.2±0.42 19.3±1.42 20.0±1.63 20.6±2.12 19.9±2.77 | 19.3±0.48 19.4±1.17 19.9±1.85 20.0±1.83 19.6±1.84 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Table 9. Herba Nicandrae Physaloidis was irritated the influence (n=20, g//day) of stomach maximum dosage-feeding to the total food ration of mice on the 1st
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 0.43 0.47 0.45 0.46 0.45 | 0.42 0.46 0.48 0.48 0.48 |
Table 10. Herba Nicandrae Physaloidis was irritated the influence (n=20, ml//day) of stomach maximum dosage-feeding to the total amount of drinking water of mice on the 1st
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 0.65 0.55 0.58 0.52 0.55 | 0.68 0.38 0.55 0.65 0.50 |
Take medicine and observe as seen in back 7 days, quiet few moving, perpendicular hair phenomenon appears in about 2 minutes individual animal after the mice administration, can recover normal about 30 minutes, and all the other animal appearance, activity, fur glossiness etc. are generally in order, nose, eye, the no abnormal secretions in oral cavity do not have dead.By showing 6-10 and Fig. 6-10 result as seen, the weight of animals, food ration, amount of drinking water are all normal after the administration, and the perusal heart, liver, spleen, lung, kidney have or not obvious pathological change.Because of drug level and administration volume restrictions fail to measure LD50, so mouse stomach administration LD50＞416g crude drug/kg.As seen, calculate 1164 times of being equivalent to clinical (adult is by 70 kilograms of calculating) dosage by kg body weight and do not see obvious influence.Show that Herba Nicandrae Physaloidis filling stomach toxicity is very low.
3, once subcutaneous maximum dosage-feeding is measured: 40 of mices, press 20ml/kg subcutaneous injection Herba Nicandrae Physaloidis concentrated solution 104g crude drug/kg, matched group gives with the volume normal saline, observes mice outward appearance in 7 days, ingests, drinks water, activity, feces, fur glossiness and nose, eye, oral cavity have or not the abnormal secretion thing.Claimed body weight, food ration and an amount of drinking water in per 2 days simultaneously.Put to death animal on the 8th, dissect, the perusal heart, liver, spleen, lung, kidney have or not obvious tissue pathologies change, the results are shown in Table 11-table 15, Figure 11-Figure 15.
Subcutaneous administration amount of table 11. Herba Nicandrae Physaloidis is to the influence of mice TBW (n=20, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 18.9±0.97 18.8±1.10 20.1±1.95 19.7±2.1 19.7±2.03 | 19.0±1.03 18.9±0.79 19.4±1.56 19.3±2.08 19.4±1.6 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Subcutaneous administration amount of table 12. Herba Nicandrae Physaloidis is to the influence of male mice body weight (n=10, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 19.3±0.68 18.8±1.14 20.1±2.13 19.7±2.16 19.6±2.22 | 19.3±0.68 18.7±0.82 19.6±1.84 19.2±1.93 19.4±1.17 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Subcutaneous administration of table 13. Herba Nicandrae Physaloidis is to the influence of female mice body weight (n=10, g, x ± s)
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 19.4±0.70 19.4±0.97 19.5±2.01 19.8±2.20 19.8±1.93 | 19.5±0.71 19.1±0.74 19.1±1.29 19.4±2.32 19.4±2.01 |
Annotate: matched group is * P＜0.05 relatively; * P＜0.01; * * P＜0.001.
Subcutaneous administration of table 14. Herba Nicandrae Physaloidis is to the influence (n=20, g//day) of the total food ration of mice
| Time (inferior) | Matched group | The |
| 1 2 3 | 0.36 0.44 0.45 | 0.40 0.43 0.48 |
| 4 5 | 0.38 0.44 | 0.42 0.44 |
Subcutaneous administration of table 15. Herba Nicandrae Physaloidis is to the influence (n=20, ml//day) of the total amount of drinking water of mice
| Time (inferior) | Matched group | The |
| 1 2 3 4 5 | 0.55 0.50 0.50 0.42 0.48 | 0.60 0.58 0.48 0.42 0.45 |
Take medicine and observe as seen in back 7 days, quiet few moving, perpendicular hair phenomenon appears in about 2 minutes individual animal after the mice administration, can recover normal about 30 minutes, and all the other animal appearance, activity, fur glossiness etc. are generally in order, nose, eye, the no abnormal secretions in oral cavity do not have dead.By showing 11-15 and Figure 11-15 result as seen, the weight of animals, food ration, amount of drinking water are all normal after the administration, and the perusal heart, liver, spleen, lung, kidney have or not obvious pathological change.Because of drug level and administration volume restrictions fail to measure LD50, so mouse stomach administration LD50＞104g crude drug/kg.As seen, calculate 291 times of being equivalent to clinical (adult is by 70 kilograms of calculating) dosage by kg body weight and do not see obvious influence.Show that Herba Nicandrae Physaloidis filling stomach toxicity is lower.
Conclusion: experimental result shows, (40ml/kg of 5.2g crude drug/ml), 1 time on the 1st or 2 times on the 1st, accumulated dose is respectively 208g crude drug/kg or 416g crude drug/kg), or a subcutaneous injection administration 104g crude drug/kg observed 7 to give mouse stomach Herba Nicandrae Physaloidis concentrated solution.Mice outward appearance, activity, ingest, drinking-water, body weight, feces, fur glossiness etc. are normal substantially, nose, eye, the no abnormal secretions in oral cavity, no overt toxicity reaction does not have dead.Put to death animal, dissect, the perusal heart, liver, spleen, lung, kidney all do not have obvious pathological change.The individual animal activity reduces, erects the hair phenomenon after rarely seen administration, but this irritates 582 times or 1164 times of stomach dosage quite clinical (adult is by 70 kilograms of calculating) dosage, or 291 times of the suitable clinical dosage of subcutaneous injection dosage, and be far longer than clinical consumption, so can think that Herba Nicandrae Physaloidis gastric infusion or subcutaneous injection administration toxicity are lower.
Two, Herba Nicandrae Physaloidis is to the clinical research of acute and chronic renal failure: 38 similar substantially routine acute and chronic renal failure patients of the cause of disease, the state of an illness are divided into treatment at random organize 18 examples, matched group 20 examples are treated, observing treatment organizes patient's urine amount of 18 examples, serum creatinine, serum creatinine clearance rate, urine sodium and renal failure index all there were significant differences before and after medication, two groups of patients obviously are better than matched group in aspect treatment groups such as shortening oliguria stage, raising dialysance and cure rate, illustrate that Herba Nicandrae Physaloidis of the present invention has remarkable efficacy to reversing acute and chronic renal failure.
Therapeutic Method: the Herba Nicandrae Physaloidis all herbal medicine is fried in shallow oil after the soup for oral administration, main consumption and usage are got root 4.5-7.5 gram, fruit 11.5-12.5 gram, neck 19-23 gram every day and are mixed and be used as medicine, and add clear water and decoct, and boil at twice, boiled 40 minutes for the first time, and be 30 minutes for the second time; Obey day and get final product for 3-4 time.Be 15 days the course of treatment, and after slight patient took medicine 12-15 days, the state of an illness began to take a turn for the better, and patient's part index number begins to descend individual.Slight uremic patient can be fully recovered in 3-6 month, took the patient with severe symptoms for a long time and also can fully recover.
Treatment group and treatment of control group result are relatively
| Oliguria stage | Dialysance | The renal failure reversion rate | |
| The treatment group | 2.1+0.3 | 0/18(0) | 18/18(100％ |
| Matched group | 8.3+6.7 | 16/20(80％) | 15/20(75％) |
| The P value | P＜0.01 | P＜0.05 | P＜0.05 |
38 routine patients are taken Herba Nicandrae Physaloidis therapeutic effect such as following table after 15 days simultaneously:
| Index name | Super normal reference value number before the treatment | Treat effective situation after 15 days | |
| Effective situation | Effective percentage (%) | ||
| Serum creatinine | 38 | 26 | 69 |
| Blood urea nitrogen | 38 | 38 | 100 |
| Urine protein | 38 | 27 | 71 |
| Hematuria | 27 | 21 | 80 |
| Uric acid | 35 | 35 | 100 |
| Hematochrome | 38 | 18 | 48 |
| Blood pressure | 38 | 30 | 80 |
| Heart rate | 36 | 27 | 75 |
| Urinary system is not smooth | 38 | 25 | 64 |
| Edema | 38 | 38 | 100 |
38 routine patients are taken Herba Nicandrae Physaloidis 30 therapeutic effect such as following table simultaneously:
| Index name | Super normal reference value number before the | Treat | 30 days effective situations | ||
| Effective situation | Effective percentage (%) | ||||
| Serum creatinine | 38 | 38 | 100 |
| Blood urea nitrogen | 38 | 38 | 100 |
| Urine protein | 38 | 38 | 100 |
| Hematuria | 27 | 27 | 100 |
| Uric acid | 35 | 35 | 100 |
| Hematochrome | 38 | 38 | 100 |
| Blood pressure | 38 | 38 | 100 |
| Heart rate | 36 | 36 | 100 |
| Urinary system is not smooth | 38 | 38 | 100 |
| Edema | 38 | 38 | 100 |
Above result, can draw good effect of the present invention and be: the present invention has excavated new medical application to known Herba Nicandrae Physaloidis; Its safety non-toxic, pharmacological action is strong, and good prospect in medicine is arranged; Have low price, toxicity is little.Preparation technology is simple, and can make peroral dosage form, injection type, tablet etc., and is easy to use, no dependence.
Description of drawings:
Fig. 1 is the influence curve figure of Herba Nicandrae Physaloidis single administration of the present invention to the mice body weight;
Fig. 2 is the influence curve figure of Herba Nicandrae Physaloidis single administration of the present invention to the male mice body weight;
Fig. 3 is the influence curve figure of Herba Nicandrae Physaloidis single administration of the present invention to the female mice body weight;
Fig. 4 is the influence curve figure of Herba Nicandrae Physaloidis single administration of the present invention to the mice food ration;
Fig. 5 is the influence curve figure of Herba Nicandrae Physaloidis single administration of the present invention to the mice amount of drinking water;
Fig. 6 is the influence curve figure of Herba Nicandrae Physaloidis of the present invention administration on the one to the mice body weight;
Fig. 7 is the influence curve figure of Herba Nicandrae Physaloidis of the present invention administration on the one to the male mice body weight;
Fig. 8 is the influence curve figure of Herba Nicandrae Physaloidis of the present invention maximum administration on the one to the mice amount of drinking water;
Fig. 9 is the influence curve figure of Herba Nicandrae Physaloidis of the present invention administration on the one to the mice food ration;
Figure 10 is the influence curve figure of Herba Nicandrae Physaloidis of the present invention administration on the one to the mice amount of drinking water;
Figure 11 is the influence curve figure of subcutaneous administration of Herba Nicandrae Physaloidis of the present invention to the mice body weight;
Figure 12 is the influence curve figure of Herba Nicandrae Physaloidis subcutaneous administration of the present invention to the male mice body weight;
Figure 13 is the influence curve figure of Herba Nicandrae Physaloidis subcutaneous administration of the present invention to the female mice body weight;
Figure 14 is the influence curve figure of Herba Nicandrae Physaloidis subcutaneous administration of the present invention to the mice food ration;
Figure 15 is the influence curve figure of Herba Nicandrae Physaloidis subcutaneous administration of the present invention to the mice amount of drinking water;
The specific embodiment:
The present invention will be further described below in conjunction with embodiment:
Embodiment 1:
The Herba Nicandrae Physaloidis all herbal medicine being fried in shallow oil after the soup for oral administration, got root 7.5 grams, fruit 12.5 grams, neck 20 grams and mix and be used as medicine, add clear water and decoct, boil at twice, boiled 40 minutes for the first time, is 30 minutes for the second time; Obey day and get final product for 3-4 time.Be 15 days the course of treatment, and after slight patient took medicine 12-15 days, the state of an illness began to take a turn for the better, and patient's part index number begins to descend individual.Slight uremic patient can be fully recovered in 3-6 month, took the patient with severe symptoms for a long time and also can fully recover.
Embodiment 2:
Getting root 9.5 gram, fruit 11.5 grams, neck 19 grams and mix and be used as medicine, add clear water and decoct, boil at twice, boiled 40 minutes for the first time, is 30 minutes for the second time; Obey day and get final product for 3-4 time.
Embodiment 3:
Getting root 6.5 gram, fruit 10.5 grams, neck 23 grams and mix and be used as medicine, add clear water and decoct, boil at twice, boiled 40 minutes for the first time, is 30 minutes for the second time; Obey day and get final product for 3-4 time.
Embodiment 4:
Getting root 4.5 gram, fruit 13.5 grams, neck 22 grams and mix and be used as medicine, add clear water and decoct, boil at twice, boiled 40 minutes for the first time, is 30 minutes for the second time; Obey day and get final product for 3-4 time.
Embodiment 5:
Get root 7.5 gram, fruit 12.5 grams, neck 20 grams and mix and be used as medicine, make tablet by known tabletting technology.
Claims (4)
1, Herba Nicandrae Physaloidis is as the application in the medicine of preparation treatment or prevention nephritis.
2, Herba Nicandrae Physaloidis is as the application in preparation treatment or the prevention renal failure medicine.
3, Herba Nicandrae Physaloidis is as the application in preparation treatment or the prevention uremia.
4, comprise peroral dosage form, injection type, tablet according to claim 1,2,3 described Herba Nicandrae Physaloidis as the medicine of preparation treatment or prevention nephropathy.
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