Product Testing and Preclinical work

We extend Research Support Services to AYUSH industry to enhance the public acceptability of their drugs as well as better compliance with regulatory requirements by detailed testing and characterization of the drugs using modern scientific methods. We support them in all aspects of preclinical studies of new drugs and formulations, including animal studies, with all the required documentation practices.

Our Laboratory has been approved by the Ministry of AYUSH, Govt. of India, to provide such services, and we have a number of reputed clients from all over the country (click here for our client list).

Some of the Research Studies and Testing Services offered by us

  1. Fingerprinting and Chemical Screening
  2. Routine biological screening assays
  3. Routine Enzyme assays for anti diabetes and antioxidant activity
  4. Specialized Screening Assays
  5. Toxicity studies
  6. Imaging solutions
  7. Pharmacological assays (In vivo- animal model studies)
  8. Shelf life studies
  9. Pesticide residue analysis (Qualitative and Quantitative)
  10. Aflatoxin analysis (Quantitative and Qualitative)
  11. Heavy Metal Analysis using ICP-MS
  12. Customised Mechanistic Investigations.
Some details of these are given below.
A. Fingerprinting and Chemical Screening:

We offer chemical profiling services for herbal extracts to ensure quality control of the products and as an authentication of purity of the preparation by its unique chemical fingerprint.

The chemical analysis include:
  1. Fingerprinting & Quantification of marker compounds using HPLC, HPTLC
  2. Phyto-chemical Analysis using TLC
  3. Isolation of lead compounds
  4. Heavy metal & trace metal analysis
  5. Quantitative determination of ash & moisture content
  6. Determination of Foreign matters
  7. Microscopic and Macroscopic
  8. Alcohol & Water Extractive
  9. Viscosity
  10. Saponification value

B. Routine biological screening assays

  1. Antimicrobial assay
  2. Total heterotrophic bacterial count
  3. Presence of pathogens in herbal products
  4. Viability Assays
  5. Proliferation Assays

C. Routine Enzyme assays for anti diabetes and antioxidant activity

  1. Anti diabetes
    1. α- Glucosidase inhibition assay ( Type 2 diabetes)
    2. α - Amylase inhibition assay (post-prandial hyperglycemia)
  2. Anti-oxidant assay:
    1. DPPH Method
    2. Total Phenol estimation
    3. β Carotene Bleaching assay

D. Specialized Screening Assays

Specialized screening services at the AU-KBC Centre offer wide spectrum of in vitro analysis to understand ISM formulations and natural products. This includes,

  1. Target Specific assays:
    1. Anticancer assay
    2. Anti diabetic assay
    3. Anti migraine
    4. Wound healing assay
    5. Assays for Cardiovascular diseases
  2. Electrophysiological Analysis:
  3. Distribution of ions across cells defines cardiac and neuronal functions. Therefore, cardio or neuro modulatory formulations are expected to work through these proteins known as ion channels. The Ion Channel Biology unit of the centre equipped with single/dual patch clamp set up, epifluorescence measuring microscope, and associated accessories offers specialized ion-channel based assays to identify ion channel targets for natural formulations. In addition, effects of these compounds on electrically-active cells (cardiomycetes & neurons) are also analysed. The set up offers wide range of services starting from screening to in-depth mechanistic analysis of cardio and neuro related ISM formulations

  4. Angiogenesis solutions:
  5. The Vascular Biology Unit of the centre offers specialized services to study the effect of ISM products on angiogenesis and vascular functions that is implicated in cancer, tumor, retinopathy, muscular degeneration, infractions, ischemia and wound healing by the following assays:

    1. Ex-vivo angiogenesis assays - Chick chorioallantoic membrane (CAM) assay
  6. Nitric Oxide and Oxidative Stress Assays:
  7. Nitric oxide is a core signaling molecule with diverse functions implicated in hypertension, angiogenesis, and wound healing and so on. Any ISM formulation offering solutions to such conditions can be studied using the following protocols:

    1. Nitric oxide estimation (cells/tissue) using DAF, GRIESS assays & Ultra-sensitive NO electrode.
    2. Oxidative stress and redox biology
      1. Superoxide assay
      2. Glutathione assay.
E. Toxicity Assays:

  1. AMES Mutagenicity Assay
  2. MTT cytotoxicity assay
  3. Chromosomal aberration toxicity
  4. Artemia toxicity assay
F. Shelf life studies (Stability Chamber)

Stability of a drug/ and formulation can be defined as its ability in a specific container to remain within prescribed standards (label claim) of physical, chemical, therapeutic and toxicological specifications to ensure the identity strength and quality and purity of a formulation.
The following two types of stability testing is being carried out

  1. Real-time stability testing
  2. A product is stored at recommended storage conditions and monitored until it fails the specification.
  3. Accelerated stability testing
  4. A product is stored at elevated stress conditions (such as temperature, humidity, and pH). degradation at the recommended storage conditions can be predicted using known relationships between the acceleration factor and the degradation rate.
    The degradation is measured by different chromatographic techniques.

G. Pharmacological assays (animal models)

  1. Analgesic
  2. Anti inflammatory
  3. Anti obesity
  4. Anticancer
  5. Anti diabetic activity
  6. Central Nervous system depressant activity (CNS)
  7. Wound healing
  8. Anti aloepecia
  9. Hepato protective activity
  10. Anti Ulcer

H. Pesticide residue analysis (Quantitative) (Quantitative)

The following Organochlorine and Organophosphorous have been analysed in ISM drugs and formulations.

Organo Chlorine

  1. Aldrin (expressed as dieldrin
  2. Chlordane ( cis& trans)
  3. Chlorothalonil
  4. DDT (all isomers)
  5. Dicofol
  6. Dieldrin (see aldrin)
  7. Endosulphan (all isomers)
  8. Endrin
  9. HCH (alpha & beta)
  10. Heptachlor
  11. Lindane
Organophosphorous
  1. 4-bromo-2-chlorophenol
  2. Acephate
  3. Chlorfenvinphos
  4. Chlorpyriphos
  5. Chlorpyriphos-methyl
  6. Diazinon
  7. Dichlorvos
  8. Dimethoate (Including Omethoate)
  9. Ethion
  10. Etrimphos
  11. Fenitrothion
  12. Iprobenphos
  13. Malathion
  14. Methamidophos
  15. Monocrotophos
  16. Omethoate
  17. Oxydemeton-methyl
  18. Parathion ethyl
  19. Parathion-methyl
  20. Phorate
  21. Phosalone
  22. Phosphamidon
  23. Profenophos
  24. Quinalphos
  25. Triazophos

I. Aflatoxin study.

The qualitative and quantitative analysis of aflatoxin is being carried ot in ISM drugs and formulations. The following two types of aflatoxins are analyzed by using chromatography techniques.
Aflatoxin B1 and B2, produced by Aspergillus flavus and A. parasiticus
Aflatoxin G1 and G2, produced by Aspergillus parasiticus

J. Heavy Metal Analysis using ICP-MS

The quantitative and Qualitative analysis of harmful heavy Metals such as Lead, Mercury, Arsenic and cadmium is being analysed routinely in ISM drugs using ICP-MS.

K. Pharmacological assays (Cell lines & animal models)
  1. Analgesic
  2. Anti inflammatory
  3. Anti – obesity
  4. Anticancer
  5. Anti diabetic activity
  6. Central Nervous system depressant activity (CNS)
  7. Wound healing
  8. Anti alopecia
  9. Anti - Cholesterol
  10. Hepato protective activity
  11. Skin Toxicity
L. Customised Mechanistic Investigations

The following mechanistic studies are carried out:

Note: For our Certificates to be valid, please note that they should bear the signature and seal of the Director or Program Director of the AU-KBC Research Centre.
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