RESUMO
The physicochemical properties (pH and osmolarity), ingredients, and impurities containing in compound glycyrrhizin injections (eight items) marketed in China were compared with those in bland-name drug (Stronger Neo-Minophagen C injection). Glycyrrhizin (GZ), glycine (Gly), and l-cysteine (CysH) as the ingredients, moreover, glycyrrhetinic acid (GA), 3-monoglucuronyl-glycyrrhetinic acid (MGGA), and l-cystine (CysS) as the impurity were determined by HPLC. The pH and osmolarity were different every each pharmaceutical product, but the variation between batch was very small. On the other hand, although the contents of GZ, Gly, and CysH in bland-name drug were approximately 100% of the label claim, the contents of GZ in generic drugs were the range of 91.8-100.9%, indicating the GZ contents in four products were clearly less than value indicated in label (<97%). The remarkable difference was not accepted by impurities content such as GA and MGGA. The contents of CysH in generic drugs were the range of 79.9-100.4%, and CysS was determined in all generic drugs, suggesting that CysH may decompose to be CysS depending on the pH of injections in generic drug only. Because the variation of the ingredient content was big and products with a little quantity for the ingredients were recognized, establishment of the preparation that can maintain the prescribed ingredient content and the severity of the assay will be required.
RESUMO
A 71-year-old man suffering from epigastric discomfort and dizziness was admitted to our hospital and diagnosed with advanced gastric cancer with bulky lymph node metastases and liver metastasis. We thought a complete resection would be difficult, so he was treated with neo-adjuvant immunochemotherapy in combination with S-1 80 mg/m2 (2 weeks administration and 2-week rest), paclitaxel (PTX) 50 mg/m2 (day 1, 8, 15) and Lentinan (LNT) 2 mg/body (day 1, 8, 15). After 5 courses of this treatment, swollen lymph nodes decreased in size and the metastatic liver tumor disappeared. Total gastrectomy with lymph node dissection was performed. The histological diagnosis was pT2 pN0, Stage I B. Histological effects of primary tumor and lymphnodes were judged to be grade 2 and grade 3, respectively. We considered that the combination of S-1, PTX and LNT can be effective and safe for advanced gastric cancer.