Children are a specific population of drug use and there exist obvious differences in anatomy， physiology and psycholo gy between children and adults. The development of child-appropriate oral dosage forms faces many challenges. Few types and specifications of oral dosage forms suitable for pediatric use lead to failure to meet the clinical need for pediatric dosing. In recent years， some child-appropriate new dosage forms， such as orodispersible mini-tablets， micro-tablets， oral dispersible films， oral multi-particulate dosage forms， oral powder， and chewable capsules， have been approved for marketing and further exhibit obvious clinical advantages. Meanwhile， other new pediatric oral preparations， such as drug-containing oral jelly， drug-containing milk powder， oral gel， preservative-free single-dose oral liquid preparations， and single-dose oral solid preparations that need to be reconstituted into liquid before use， may become an important supplement to pediatric oral preparations in the future. Additionally， the emergence of some new pediatric oral dosing devices will also provide a strong guarantee for convenient and accurate dosing in children.

The pharmacodynamics of prostaglandin E1 (PGE1) administered by different routes to rats was investigated in this paper. The hypotensive effect of PGE1 was used as an index of drug efficacy, pharmacodynamic parameters such as time to reach peak effect (Tmax), maximal percentage of blood pressure decrease (Emax, %), duration of effect (Td), and the area determined after PGE1 given to rats intranasally, sublingually, intraperitoneally (ip),and intramuscularly (im), separately, and compared with those obtained from intravenous (iv) administration. Similar to iv route, the pharmacodynamic parameters of PGE1 from the other administration routes, Emax, Td and in particular AUC values were all increased with increasing doses, showing dose-efficacy relationship. Tmax was found to be approximately 3-4 min for nasal route, 3-8 min for im, 6-8 min for ip and 12-30 min for sublingual route, separately. Thus, the order of magnitude of absorption rate of the drug was as follows: nasal≈im＞ip＞sublingual. If the pharmacological bioavailability (PF) for each administration route was used as a tentative measure of drug absorption extent, the order of magnitude of absolute bioavailability appeared as follows: nasal＞im≈ip＞sublingual. Furthermore, the interindividual difference was found to be larger for im and ip route than that for nasal and sublingual route. These results indicate nasal and sublingual routes are two promising routes for the systemic delivery of PGE1 in clinical applications.

OBJECTIVE: To prepare the inclusion compound of diclofenac sodium (DFS)-β-cyclodextrin (β-CD) and investigate its properties. METHOD: The inclusion compound of DFS-β-CD was prepared by the co-precipitation method. RESULTS: The inclusion compound of DFS-β-CD was confirmed by UV absorption spectrum, IR absorption spectroscopy, differential scanning calorimetry (DSC) and phase solubility diagram. Meanwhile, the content analysis of the inclusion compound showed that the molecular ratio of DFS to β-CD was 1∶1. CONCLUSION: The soluability and dissolution rate of DFS were increased and its irritation to stomach was reduced when the drug was included by β-CD.