ABOUT HEPAR-P
Quality Control

Special features of HEPAR-P™ capsule:

Standardised Phyllanthus niruri extract EPN 797 is a complex extract, which contains several active principals, and it is their combined activity that might be responsible for its polyvalent therapeutic actions, which are essential for treating disorders of multifactorial origin.

The polyvalent action of standardised Phyllanthus niruri extract EPN 797 depends upon combined expression of several pharmacological actions. The various active constituents of standardised Phyllanthus niruri extract EPN 797 would be expected to have different pharmacological actions when they are administered alone, as opposed to when they are administered together with other constituents of the extract.

The total standardised Phyllanthus niruri extract EPN 797 preparation seems essential for its therapeutic indications. And therefore no single constituent can mimic the effects of the total extract of Phyllanthus niruri standardised extract EPN 797.

 

It is the combined activity of the total extract that is therapeutically active!

 

To ensure that standardised Phyllanthus niruri extract EPN 797 produced possesses consistent and reproducible hepatitis B virus inhibiting and liver protective activities, we have developed a stringent quality evaluation protocol comprises of Chemical and Biological Standardization Methods, known as:

Nova-PhytoAssays Quality Control System

 

Why do we need to use Nova-PhytoAssays Quality Control System?

This is to ensure that every capsule of HEPAR-P produced possesses consistent:

i. Chemical composition, and

ii. Biological activities:

a) in vivo liver protective activity, and

b) in vitro HBsAg inhibitory activity.

 

This is a proprietary quality control protocol whereby both the chemical composition and the biological activities of HEPAR-P™ capsule are being monitored:

Chemical standardisation:

Biological standardisation:

 

Chemical standardisation:
1. Qualitative fingerprinting by TLC

TLC fingerprinting is used to establish the qualitative information of the chemical composition in HEPAR-P capsule.
The characteristic TLC fingerprint of HEPAR-P capsule as shown in the Diagram must exhibit the presence of corilagin, geraniin, phyllanthin, hypophyllanthin, brevifolin carboxylic acid, rutin, and gallic acid.

2. Qualitative fingerprinting by HPLC

HPLC fingerprinting is used to establish the qualitative information of the chemical composition in HEPAR-P capsule.
The characteristic HPLC fingerprint of HEPAR-P capsule as shown in the Diagram must exhibit the presence of corilagin, brevifolin carboxylic acid, rutin, and gallic acid.

3. Quantitative fingerprinting by HPLC to assay corilagin

The quantity of the active chemical compound, corilagin in HEPAR-P capsule is determined by HPLC assay.
Each capsule of HEPAR-P capsule must contain 10 mg of corilagin as shown in the Diagram.

4. Quantitative fingerprinting by UV spectrophotometric method to assay total Phyllanthus flavonoids.

The quantify of the total Phyllanthus flavonoids in HEPAR-P capsule is determined by UV spectrophotometry assay.
Each capsule of HEPAR-P capsule must contain 45 mg of total Phyllanthus flavonoids as shown in the Diagram.

 

Biological standardisation:

1. In vitro biological assay to evaluate HBsAg inhibitory activity of HEPAR-P™ capsule

Determine the in vitro HBsAg inhibitory activity of HEPAR-P™ capsule by measuring the binding activity of HEPAR-P™ to HBsAg.

Specification:
By using the test method described above, HEPAR-P™ must exhibit a mean % Inhibition of not less than 50% between hepatitis B virus surface antigen (HBsAg) with antibody (HBsAb) at statistically significant level of P 0.05


The rationale of using Nova-PhytoAssay for quality control of HEPAR-P capsule is to ensure that every batch of HEPAR-P manufactured has consistent chemical compositions and relevant biological activities.

2. In vivo biological assay to evaluate protective effect of HEPAR-P™ capsule against CCl4-induced liver injury in mice

Administer orally the test solution to at least six male ICR mice at dose of 240 mg of HEPAR-P™ per kg body weight per day for 6 consecutive days. A single dose of CCl4 is then adminsitered to cause liver injury in the control and HEPAR-P treatment groups. Serum levels of AST and ALT are measured.

Specification:
By using the test method described above, HEPAR-P™ must produce a protection Index of not less than 2.0, and mean serum level of SGPT of the HEPAR-P™ test sample group must be significantly lower than mean serum level of SGPT of the control group statistically at P 0.05


Cutting-edge analytical techniques and equipment are used to ensure that the quality of HEPAR-P is the best in the world and also complying to our stringent in-house specification.

 

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