| Phthalate esters (PAEs) is widely used plasticizer. often added to plastic drug packaging to increase the flexibility. Studies have shown that drugs in contact with the packaging material containing PAEs, PAEs would migrate to drugs, which is harm to human health. It is necessary to establish an accurate and easy method to analysis plastic packakging materials and preparations PAEs residue levels and pollution status, since China has not been the relevant standards for PAEs monitoring. And exploring the plastic drug packakging plasticizer migration to the formulation of the law is the basis for the development of appropriate limits for PAEs. Some Chinese herbal medicines in the place of origin with the roughing process the sulfur fumigation to corrosion and pest control result in SO2residual. It is of great significance to establish an accurate, simple, fast method for quantitative SO2to increase the supervision and coverage of Chinese herbal medicines. The main contents are as follows.1Established method for detection of PAEs residue in plastic drug packaging and corresponding preparationsThe study established a GC-MS method for detection22PAEs residue in plastic drug packaging and its corresponding preparations. The samples were extrated by n-hexane, and purificated by PSA and florisil. The established purification method comparative of the commonly used the SPE purification methods reported in many literature, the final choice of high recovery, low limit of detection and quantitation of PSA and the florisil associated with pre-treatment methods, and has been improved. The established purification method is simple, fast, and a small amount of organic reagents, lower costs and reduce environmental pollution, and the purification effect is significant, the substance capable of removing a large amount of pigment, lipids, sugars and other interference. The limits of quantitation and limits of detection established GC-MS method for PAEs were in the range of0.003-0.050μg/g and0.005-0.145μg/g.22PAEs in a certain concentration range of linear correlation coefficient greater than0.9965, the recovery in the range of86.4%-101.2%with RSD (n=9) was less than5.6%, RSD (n=9) of repeatability is less than6.2%, and RSD n=9) of precision was less than6.9%.2preliminary explorations the rule of plastic drug packaging PAEs migration to the preparationIn this section, we had preliminary explorated the rule of the migration of PAEs in plastic drug packaging to the preparations. With reference to EU Directive82/711/EC and Traditional Chinese Medicine Stability Test Requirements, migration test models had been established. A60%ethanol solution simulated the liquid preparation, homemade3different kinds of Baipian simulated solid preparation. The results showed that concentrations of DBP, DIBP, DEHP in samples increased as a function of storage time. A positive correlation between the amount of PAEs that migrated and storage time during the entire migration process was confirmed. The measured results are shown in a specific period of time within each plasticizer were1-2times the migration of the initial amount, and the migration velocity in the liquid preparation was significantly higher than the solid preparation.3Established rapid determination method for SO2residue in TCMEstablishing a rapid method for determination of sulfur dioxide residue in Chinese herbal medicine, realize the rapid qualitative and semi-quantitative of sulfur dioxide residues in Chinese herbal medicine by the rule of SFDA. In dilute hydrochloric acid, the active metal zinc can restore the sulfurous acid or sulfite to produce hydrogen sulfide, while hydrogen sulfide to allow wetting of the lead acetate test paper strips black.Using the principle, sulfur dioxide rapid determination device our laboratory invented (patent number:ZL201120254892.X) and lead acetate test paper strips, we had determined the3categories,6varieties,18batches of Chinese herbal medicines sulfur dioxide residue, and then used the Chinese Pharmacopoeia method to verify this experimental method. The results showed that more than60%samples were detected SO2residue, in which11samples SO2residue was over the limit of SFDA. This phenonmenon should receive further attention. |
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