Description:Summary
Acute kidney injury was induced using Gentamycin in Wistar rats.
Silybin is widely present in seeds extract of Silybum marium, but its oral bioavailability
was not enough to be included in clinical application alone or in extract form, So to
improve its bioavailability, we have synthesized silver nanoformulations of silybin from
seeds extract . Acute kidney injury was induced using Gentamycin in Wistar rats.
Preclinical Findings confirmed that oral administration of Silybin. Nano formulations at
two different doses (10 mg/kg and 20 mg/kg, body weight) exhibited significant
protection on proximal tubule tissues of kidney in compared to Toxic control
group. Further Silybin NF showed better lipid peroxidation and antioxidant defense
system in GEN-induced toxic group in compared to silybin treated group. Furthermore,
Prepared NFs did not show any sign of toxicity at a particular dose revealed by
histopathological examination of all vital organs. This study revealed that ecofriendly
NFs can be a promising preventive measure could be useful for clinical application to
patients on long term antibiotic therapy for chronic infections.
Polyherbal formulation as Nephroprotectant for Kidney disorders

Description
Kidney is the vital organ responsible for maintain the Haemostasis and other physiology of the body. Exposure of kidney to very high dose of nephrotoxic drugs like aminoglycosides, results in develop toxicity in the kidney and show acute kidney Injury (AKI), if untreated leads to renal
failure and would finally destroy the basic units of kidney called

nephrotoxicity. In present scenario in an alternative way, antibiotics are being prescribed frequently which have negative effects on kidneys.
Till date, there is no specific pharmacological therapy available for prevention or treatment of Acute kidney Injury. There are many mechanical
devices which may provide temporarily relief from the existing kidney

conditions by Dialysis or haemodialysis. However, such mechanical devices have certain limitations, for example high cost, and limited time period, therefore not suitable for long approach. In another instance, Haem dialysis has its own complications like altered blood pressure, fluid
15 overload, Anemia which again is not a convenient method to get 100%

patient compliance.

The problem is solved by the features listed in claim 1.

The purpose of the invention is achieved by providing a formulation comprising an extract from a part of an herbal plant and silver nitrate. The

herbal plant is silybum marium, and the part thereof is seed. The formulation is a nanoemulsion. The formulation is suitable for providing significant protection to kidney. The dosage amount of the formulation varies between 10 and 20 mg/kg. No toxicity has been determined during
5 experimentation for the dosage range of the formulation. The formulation is

administered orally. The formulation has no odour. Evaluation of the formulation is carried out using Aminoglycoside induced acute kidney injury in rhodent model.
The present invention also discloses a method for preparing the

10 aforementioned formulation. The method involves coarsely powdering

seeds of silybum marium. The extraction is done using deionized water in (50-700 C) for 30 minutes heating. The method further involves adding 1mM silver nitrite dropwise to 20 ml of the extract. The silver nitrate is added into the extract drop wise. After few hours, the solution turned into
15 dark brown in colour indicating formation of silver nanoparticles.

Evaluation of renoprotective effect was carried out in Gentamycin induced Acute kidney injury in Sprague Dawley rats. All animals were divided in to five groups each containing four rats. To induce nephrotoxicity gentamicin 100 mg/kg was injected i.p. in toxic, T1 (10mg/Kg NF) and T2 (20mg/Kg)
20 groups. T1 and T2 were treatment groups where gentamicin was co-

administered with the prepared formulation.

At the end of study rats were weighed, blood samples were collected for biochemical estimations and after that, kidneys were isolated for evaluation of antioxidant and histopathological evaluations.

Groups Serum Creatinine (mg/dL) Blood Urea Nitrogen (mg/dL) Total Protein (g/dL)
Normal Control (NC) 0.45 ± 0.03 25.33 ± 1.43 3.80 ± 0.15
Toxic Control (TC) 1.11 ± 0.07 # 104.03 ± 4.08 # 6.95 ± 0.03 #
NF1 0.677 ± 0.02 *** 34.43 ± 0.33 *** 6.00 ± 0.06 ***
NF2 0.587 ± 0.02 *** 27.51 ± 1.33 *** 4.71 ± 0.06 ***
Perse 0.523 ± 0.03 25.84 ± 0.16 4.14 ± 0.08
5

All values are expressed as Mean ± SEM. # (p<0.0001) indicates TC compared to NC.
*** (p<0.0001) indicates treatment groups NF1 compared to TC.

*** (p<0.0001) indicates treatment groups NF2 compared to TC. The

10 comparison was done by ANOVA followed by Dunnett’s test.

Groups TBARS

(nmol/g) Superoxide dismutase (U/mg) Catalase (U/mg)
Normal Control (NC) 10.50 ± 0.31 3.09 ± 0.15 43.40 ± 0.61
Toxic Control (TC) 18.02 ± 0.43 # 1.23 ± 0.13 # 22.77 ± 0.69#
NF1 13.00 ± 0.23 *** 1.91 ± 0.07 ** 30.89 ± 0.40 ***
NF2 11.90 ± 0.21 *** 2.38 ± 0.14 *** 35.60 ± 0.38 ***
Perse 10.78 ± 0.31 3.02 ± 0.08 41.50 ± 0.37

All values are expressed as Mean ± SEM. # (p<0.0001) indicates TC compared to NC.
*** (p<0.0001) indicates treatment groups compared to TC,

5 ** (p<0.05) indicates treatment group compared to TC. The comparison

was done by ANOVA followed by Dunnett’s test.

, Claims:Claims

1. A herbal formulation for treatment of acute kidney injury characterized in that the formulation comprises an extract from a part of a herbal plant comprising silybum marium and
additional excipients.

2. The herbal formulation for treatment of acute kidney injury according to claim 1,
characterized in that the part of the herbal plant is seed.

3. The herbal formulation for treatment of acute kidney injury according to claim 1,
characterized in that the additional excipient is silver nitrate.

4. The herbal formulation for treatment of acute kidney injury according to claim 1,
characterized in that the formulation comprising the seed extract and the silver nitrate in 2:8 wt.

5. The herbal formulation for treatment of acute kidney injury according to claim 1,
characterized in that the formulation is Nano emulsion.

6. The herbal formulation for treatment of acute kidney injury according to claim 1,
characterized in that the formulation has dosage amount varying between 10 and 20 mg/kg.

7. The herbal formulation for treatment of acute kidney injury according to claim 1,
characterized in that the extract of the seeds is in coarsely powdered form.