Guduchi (Tinospora cordifolia [Willd.] Miers) is a flagship rejuvenating herb of Ayurveda with reported anti-diabetic potential. In the present study, different dosage forms of Guduchi stem (growing on neem tree) were developed by adopting Ayurvedic pharmaceutical process of Bhavana (levigation). Guduchi Churna (GC) was subjected to 07 times Bhavana separately with its own extracted juice, decoction and potable water, and dosage forms namely Svarasa Bhavita Guduchi Churna (SBGC), Kwatha Bhavita Guduchi Churna (KBGC), and Jala Bhavita Guduchi Churna (JBGC) were prepared. The present study was aimed to evaluate the role of Bhavana on the potentiation of therapeutic properties of Guduchi. Sequential solvent extracts (5, 10, 15 and 25%) of GC, SBGC, KBGC and JBGC were prepared in different solvents [phosphate buffer, hexane, dichloromethane (DCM), chloroform] and screened for the α-amylase and α-glucosidase inhibitory activity. The results revealed that phosphate buffer and DCM extracts of SBGC exhibited strong α-amylase inhibitory potential (>80% inhibition at 25% concentration) followed by KBGC, JBGC and GC with reference to the standard acarbose. In α-glucosidase inhibitory activity, maximum inhibition was observed in DCM and chloroform extracts of SBGC (>85% inhibition at 25% concentration), followed by KBGC (>80% inhibition at 25% concentration), JBGC and GC. In vivo anti-hyperglycemic studies were carried out by oral glucose tolerance test in Swiss albino mice. Test drugs (JBGC, KBGC, SBGC) treated groups showed marginal decrease of blood glucose levels in normo glycemic mice. However, the blood glucose level in test drug JBGC, KBGC and SBGC treated groups was still within normal range in overnight fasted mice. In oral glucose tolerance test, among all dosage forms SBGC (51.08%) produced pronounced anti-hyperglycemic effect followed by KBGC (42.57%) at a dose of 520 mg/kg. The GC, JBGC, KBGC and SBGC samples were also standardized using berberine (a well established anti-diabetic compound) as a marker compound by HPTLC fingerprint analysis. Findings of the present study indicate that SBGC and KBGC can be used in the treatment of diabetes mellitus and gives supporting evidence to Ayurvedic claims that the Bhavana process has pharmaceutico-therapeutic significance in Ayurvedic drug development.
Objective: To establish a noticeable and a justifiable identification system to assess the impact of shodhana (processing) on various levels of Baliospermum montanum (Danti) root samples obtained through shodhana (processing technique) in quality agreement based on near-infrared-spectroscopy.Methods: Authenticated raw Danti (R. D) root and various Danti root samples obtained after shodhana (processing) such as water processed Danti root (WPDR), Kusha processed Danti root (KPDR) and classical processed Danti root (CPDR), were dried, pulverized and shifted through eighty meshes. The samples were subjected to NIR spectral detection from 750 to 2500 nm at the interval of 1 nm. The multivariate analysis, principal component analysis (PCA) and hierarchical cluster analysis (HCA) analyzed with the help of Unscrambler and Matlab software.Results: Direct spectral analysis indicated the existence of significant numerical and graphical differences between Danti root samples containing different treatments during processing in respect to CH, OH and NH functional groups. The multivariate PCA algorithom plot allowed a clear segregation of the Danti root samples after various data preprocessing technique onto the hotelling T2 95% confidence limit for principal component 1 and 2. The cluster analysis had shown the extra information on the metabolite profiling of the complex purificatory environment. Conclusion:The present study demonstrates a generic, non-destructive solution to discriminate qualitatively in the sample matrix all the differently pretreated samples in favor of the NIR-sensitive functional group.
Objective: The combination between the stem bark powder of Chirabilva and Veerataru is used ethno folklore for the management of anticonvulsion by tribal people. To standardise the evidently used polyherbal formulation in a systemic way for supporting the identity, quality, purity, safety and efficacy concern with modern technique. Methods:Microscopic anatomical examination and powder microscopy were performed fresh and dried plant materials respectively. The compound polyherbal formulation is processed by organoleptic characterization, macro-microscopic evaluation, physicochemical, phytochemical testing, DNA fingerprinting and high-performance thin-layer chromatography (HPTLC) profiling employing a standard methodology. Chromatographic fingerprinting after visualisation the data are exploited by multivariate chemometric technique. Results:Results of the experiment provided diagnostic characteristics to identify quality and purity and standardise the polyherbal formulation along with respective ingredients. The RAPD analysis of Dichrostachys cinerea and Holoptelea integrin folia showed some similar bands at the same base pair indicate the presence of genetical identity may take into consideration of the control the ingredients. HPTLC technique utilised to distinguish the ingredient and polyherbal formulation based on the presence or absence of certain target phytochemical (flavonoid, polyphenol, etc.) constituents, manifested as peaks or bands from the chemical fingerprint profiles. Visualized chromatographic profile of polyherbal formulation along with its constituents applying the multivariate chemometric technique is easily discriminated of respective retardation factor in principal component score space. Conclusion:The findings from this study will provide systemic evaluation for this anticonvulsant formulation and also serve as a master document to control the quality of polyherbal formulation.
Question-based Review (QbR) is a format proposed by United States Food and Drug Administration (US FDA) enhancing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's Common Technical Document (ICH CTD) format to streamline the submission process. It is a question-answer format applied to Quality Overall Summary section of the submission. The format includes putting up questions under every section, so the applicant can submit precise and accurate data for approval of the respective application. The QbR format can be applied to NDA, ANDA, and Type II DMF applications. The companion document available with Manual of Policy and Procedures 5015.10 (MaPP 5015.10) allows the reviewer to inspect the critical information in the data provided. It encourages applicants to encompass Quality by Design (QbD) in their development process. QbR gives a structure through which the data collected by applying QbD can be presented. For effective application of QbR format, the submission should be backed with thorough scientific knowledge, risk assessment data, and data integrity. The questions asked compel the applicant to provide justification for the various decisions made in the development phase. Also, questions regarding quality target product profile, critical quality attributes, critical material attributes, critical process parameters and design of experiment are covered under the QbR format. MaPP 5015.10 finalized by US FDA in 2014 clarifies the concept of QbR. There is MicroQbR available which includes questions confirming the sterility of the product. QbR is a step towards speeding up the review process with an intention to motivate the applicants to implement QbD to the project.
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