Tarannum Asira, Shamsi Shariq, Zaman Roohi
Department of Ilmul Saidla (Unani Pharmacy), National Institute of Unani Medicine, Bangalore, Karnataka, India.
J Ayurveda Integr Med. 2013 Jul;4(3):147-51. doi: 10.4103/0975-9476.118687.
Unani medicines are being used since antiquity. However, in spite of their efficacy, they have been widely criticized due to lack of standardization and poor quality presentation. For this reason, application of good manufacturing practices and development of standard operating procedures (SOPs) in the manufacture of herbal medicines became an essential tool to assure their quality.
Therefore, the objective of the study was to develop the SOP of Habbe Shifa (HS) regarding the particle size (PS), binder, temperature of drying, and duration of drying.
In this study, 24 batches of HS were prepared according to the instructions given in formulary to develop SOP. Three particle sizes (i.e., 80, 100, and 120 No. Mesh sieve), were taken for preparation of pills. Water and Samaghe Arabi (Gum Acacia mucilage [GAM]) were used as binder for preparing the lubdi (mass) in different batches. Different temperature and duration of drying were used to dry the pills in hot air oven to get satisfactory results. All the batches were assessed three times for hardness, friability, and disintegration time and mean regarded as standard parameter value.
The batch with 150 μm PS (100 mesh sieve), 5% w/w GAM used as a binder, dried at 90°C for 120 min showed hardness 3.50 ± 0.00 kg/cm, friability 0.02 ± 0.003%, and disintegration time 25.00 ± 0.57 min, which showed most appropriate result among all batches and considered as final batch. Its SOP may be used for future reference which can help in setting up regulatory limit to assure the quality of Unani medicines.
尤纳尼医学自古以来就被使用。然而，尽管其具有疗效，但由于缺乏标准化和质量呈现不佳，一直受到广泛批评。因此，在草药制造中应用良好生产规范和制定标准操作规程（SOP）成为确保其质量的重要工具。
因此，本研究的目的是制定关于哈贝希法（HS）在粒度（PS）、黏合剂、干燥温度和干燥持续时间方面的标准操作规程。
在本研究中，根据药典中的说明制备了24批HS以制定标准操作规程。制备药丸时采用了三种粒度（即80目、100目和120目筛网）。在不同批次中，用水和阿拉伯树胶黏液（GAM）作为黏合剂来制备鲁布迪（团块）。在热风烘箱中使用不同的干燥温度和持续时间来干燥药丸以获得满意的结果。对所有批次的硬度、脆碎度和崩解时间进行了三次评估，并将平均值视为标准参数值。
粒度为150μm（100目筛网）、使用5% w/w的GAM作为黏合剂、在90°C下干燥120分钟的批次，其硬度为3.50±0.00 kg/cm，脆碎度为0.02±0.003%，崩解时间为25.00±0.57分钟，在所有批次中显示出最合适的结果，并被视为最终批次。其标准操作规程可供未来参考，有助于设定监管限度以确保尤纳尼医学的质量。
