Hydrochlorothiazide/Irbesartan

Investigate the effect of Tripterygium wilfordii polyglycoside tablets on serum inflammatory factors and T cells in patients with chronic nephritis.

A total of 89 patients with chronic nephritis were randomly divided into a control group (44 cases, treated with irbesartan hydrochlorothiazide combined with dipyridamole) and an observation group (45 cases, treated with Tripterygium wilfordii polyglycoside tablets based on irbesartan hydrochlorothiazide and dipyridamole like the control group). Patients in both groups were treated for two months. The renal function, inflammatory factors, the proportion of T lymphocyte subsets, and 24 h urinary protein quantification (24 h Upro) of patients with hemodialysis were compared between the two groups before and after treatment. The occurrence of adverse reactions was recorded.

SCR, BUN levels, 24 h Upro, serum hs-CRP, TNF-α, and IL-8 levels in the two groups after treatment were lower than those before treatment, and those of the observation group were lower than those of the control group (all P<0.05). After treatment, the CD4+ ratio and CD4+/CD8+ ratio of the two groups of patients increased, while the CD8+ ratio decreased. The changes in the observation group were greater than those in the control group (all P<0.05). There was no significant difference in the incidence of total adverse reactions between the two groups during treatment (P>0.05).

Treatment combined with Tripterygium wilfordii polyglycosides can significantly alleviate the inflammatory state of patients with chronic glomerulonephritis, reduce the level of proteinuria, and improve renal function. Tripterygium wilfordii polyglycosides can improve immune function of the body and has high safety.

Avalide(@), a medication used for the treatment of hypertension, is a combination of Irbesartan, and Hydrochlorothiazide. Irbesartan, one of the active pharmaceutical ingredients (API) in Avalide products, exists in two neat crystalline forms: Form A and Form B. Irbesartan Form A is the API form used in a wet granulation for the preparation of Avalide tablets. The presence of the less soluble Irbesartan Form B in Avalide tablets may result in the slower dissolution. In this paper, we have presented our work on the method development, verification and challenges of quantitatively detecting, via NIR and ssNMR, very small amounts of Irbesartan Form B in Avalide tablets. As part of the NIR method development and qualification, limit of detection, linearity and accuracy were examined. In addition, a limited study of the robustness of the method was conducted and a bias in the level of Form B was correlated to the ambient humidity. ssNMR, a primary method for the determination of polymorphic composition, was successfully used as an orthogonal technique to verify the accuracy of the NIR method and added to the confidence in the NIR method. The speed and efficiency of the NIR method make it a suitable and convenient tool for routine analysis of Avalide tablets for Form B in a QC environment.