Study On Human Tolerance Of Chaihu Nasal Spray

Purpose:To observe the tolerance on the Bupleurum nasal spray,determine the safe dose,find out the adverse reactions under the dosage,formulate dosage regimen and provide a safe dosage range for phase Ⅱ trials.Material and method:40 eases in the single dose group by Bupleurum nasal spray,16 cases in successive administration group.The dosages of the single dose group are divided into six groups(0.2 ml、0.4 ml、0.6 ml、0.8 ml、1.0 ml、1.2 ml),the case in each group were four,eight,eight,eight,eight and six respectively,each ease will only accept an appropriate dose.The trial will start with small dose and start with next dose after the end of the observation with small dose.The successive administration group has 16 cases.One shed and new one ease is bring into this group.Then 16 eases complete the test.The dosages of the single dose group are divided into two groups(1.0 ml、1.2 ml),the ease in each group were eight and eight respectively.The first group:1.0 ml,5 times/day/person for seven days.The other group: 1.2 ml,6 times/day/person for seven days.Subjects were observed in vital signs, laboratory parameters, ECG and symptoms and signs of each system.The data were analyzed by SAS9.1.3 software. Measurement data are expressed in mean ± standard deviation.Count data were described by frequency statistics.Results: 1、Nine patients had abnormal,7 cases belong to the single dose group,2 cases belong to successive administration group.The laboratory examination results of remaining cases were within normal range. 2、7 cases of the single dose group with abnormal degree of 1 moderate cases, mild in 6 cases;And 2 cases of adverse reactions may be related to drugs,others may not.3、2 cases of the successive administration group all with abnormal degree of moderate case,and adverse reactions may not be related to drugs. Conclusion: Through this study, 1.the recommended phase II clinical trial: a single phase of each side of nasal drug delivery can not be carried out continuously 2 spray and spray operation 2 above, that is, each side nasal spray spray each 1, each 0.1 ml; 2.It is appropriate to apply the drug Less than or equal to 3 times,and the time interval between every two medication more than 10 should be suitable;The daily maximum dosage for participants better within 1.2 ml;Treatment has good tolerance within 7 days. 3.The main adverse reaction of Bupleurum nasal spray is nasal irritation and dizziness.