Rani Seema, Rahman Khaleequr, Younis Peerzada Mohammad
Department of Ilmul Saidla, National Institute of Unani Medicine, Bengaluru, Karnataka, India.
Ayu. 2015 Jan-Mar;36(1):83-90. doi: 10.4103/0974-8520.169007.
Sufoofe Sailan (SS) is a polyherbal powder preparation used in Unani medicine to treat gynecological diseases. It is observed that SS degrade early as it is in the form of powder; however, the stability study of SS was not carried out till date.
To evaluate the accelerated stability of SS.
Finished formulation of SS was packed in three airtight transparent polyethylene terephthalate containers. One pack was analyzed just after manufacturing and remaining two packs were kept in stability chamber at 40°C ± 2°C/75% ± 5% RH, of which one pack was analyzed after the completion of three and another after 6 months. Organoleptic, physico-chemical, microbiological parameters along with high-performance thin layer chromatography (HPTLC) fingerprinting were carried out.
Organoleptic characters showed no significant change in accelerated stability condition. All physico-chemical parameters showed changes <5%, HPTLC fingerprinting showed minimum changes and microbial studies were in confirmation to the World Health Organization guidelines.
SS confirmed to the International Conference on Harmonization Guideline for accelerated testing of the pharmaceutical product on said parameters and as per the Grimm's statement the shelf life of SS may last 20 months.
苏富菲·赛兰（SS）是一种用于尤纳尼医学治疗妇科疾病的多草药散剂制剂。据观察，由于SS为散剂形式，其降解较早；然而，迄今为止尚未对SS进行稳定性研究。
评估SS的加速稳定性。
将SS成品制剂包装在三个气密透明聚对苯二甲酸乙二酯容器中。一包在生产后立即进行分析，其余两包置于40°C ± 2°C/75% ± 5%相对湿度的稳定性试验箱中，其中一包在三个月结束后分析，另一包在六个月后分析。进行了感官、物理化学、微生物参数以及高效薄层色谱（HPTLC）指纹图谱分析。
在加速稳定性条件下，感官特性未显示出显著变化。所有物理化学参数的变化<5%，HPTLC指纹图谱显示变化最小，微生物研究符合世界卫生组织指南。
SS在上述参数方面符合国际协调会议药品加速试验指南，并且根据格林姆的说法，SS的保质期可能为20个月。
