Development of Standard Operating Procedures (SOPs) of a Polyherbal Formulation Qurṣ-i Muṣaffī Recommended for the Treatment of Skin Diseases

Abstract

Background: Despite increasing acceptability and effectiveness, Unani Medicine has been widely criticized for lack of quality assurance and poor presentation. Therefore, in order to ensure the production of high-quality drugs, good manufacturing practices and the development of scientifically Standard Operating Procedures (SOPs) are necessary. The purpose of this study was to create SOPs for a polyherbal formulation Qurṣ-i Muṣaffī (QM) regarding its binder, temperature and duration of drying, as well as an assessment of its Mizāj (temperament).Materials and Methods: 18 batches of QM were prepared under different conditions (binder, temperature and duration of drying). Powder of particle sizes 150 μm, gum acacia mucilage (10%, 15% and 20% w/w) were used as a binder, at 60°C temperature for 20 and 30 min during the process of granulation and after compression 20 min only.Results: Data of the study revealed that the final batch of QM with particle size 150 μm, gum acacia (20 %) as the binder, temperature 60°C for 30 min for granules and 20 min after compression were found appropriate. The temperament (Mizāj) of the QM was assessed through method described by renowned Unani scholar Al-Kindῑ and found to be moderate degree in hot property and second degree in dry property.Conclusion: The obtained results of final batches of QM can be adopted as the SOPs for future references in terms of process standardization and reproducibility of the drug.

Keywords: Mizāj; Quality Control; Qurṣ-i Muṣaffī; SOPs; Unani System of Medicine