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The Validity and Safety Study on Doxorubicin Hydrochloride Liposome Injection

Author: LiuBaoFeng
Tutor: LiuZhaoPing
School: Shandong University
Course: Pharmaceutical Engineering
Keywords: Doxorubicin hydrochloride Liposomes Effectiveness of Security
CLC: R965.3
Type: Master's thesis
Year: 2010
Downloads: 166
Quote: 0
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Abstract


The subject from the in vivo efficacy, pharmacokinetics and toxicity of doxorubicin hydrochloride liposome injection with reference preparations Kai Lai compared to the consistency to verify the effectiveness of metabolic processes in the body, as well as security, doxorubicin hydrochloride liposome injection for clinical trials and listed to carry out the necessary pre-clinical pharmacology and toxicology studies. 1. In vivo pharmacodynamic studies in vivo anti-metastatic ovarian cancer efficacy of the role of the results showed that 10 and 20 mg · m-2 dose administration of doxorubicin hydrochloride liposome injection with Kai Lai the relative tumor value-added rate lt; 40 %, both in vivo tumor suppressor activity, and therefore, it is recommended that reference Kai Lai Dosage clinical dosing regimen of doxorubicin hydrochloride liposome injection. 2 animal pharmacokinetic Kinetics of intravenous infusion of Beagle dogs after administration plasma concentration - time curve measurement test results show that doxorubicin hydrochloride liposome injection and reference preparations Kai Lai phase, the doxorubicin The main pharmacokinetic parameters AUC, Cmax and Tmax was no significant difference between the two formulations are bioequivalent. Tumor-bearing mice in vivo tissue distribution of test results showed that doxorubicin hydrochloride liposome injection with reference preparations Kai Lai tissue distribution trends, 1h after distribution of the body, hour after administration of the organizations in the distribution pattern roughly : kidney gt; liver gt; ovarian gt; heart gt; muscle gt; stomach gt; the spleen gt; the small intestine gt; skin gt; tumor gt; fat gt; lung gt; brain, they are bioequivalent. 3 safety study BALB / c mice intravenous dose acute toxicity test results show that given a single intravenous injection of doxorubicin hydrochloride liposome injection and Kai Lai after mice were decreased locomotor activity, lying curled, vertical hair, listlessness, tremors, and even death, calculated by the method of Bliss, doxorubicin hydrochloride liposome injection intravenous injection in mice LD50 13.582 mg · kg-1, Kai Lai mice injected intravenously LD50 13.283 mg · kg-1. Who is basically the same. Wistar rats were administered three cycles repeated intravenous dose toxicity test results show that doxorubicin hydrochloride liposome injection and Kai Lai toxicity basically the same performance can be seriously affected animal weight gain and feed consumption, animal drug in locomotor activity, reduced hair dull, lying curled, twisted body, the individual animal hind limb weakness and other symptoms, clinical indicators examination showed to reduce the proportion of bone marrow suppression, WBC and bone marrow granulocyte red blood cells, abnormal liver function, pathological examination showed animals thymus and male animal testicles, epididymis organ wet weight decreased only see Sertoli cells in the seminiferous tubules of the testis, reduction in spermatogenic cells, stromal hyperplasia. The above results show that injection of doxorubicin hydrochloride liposome as the reference to the foreign products listed Kai Levin developed similar preparation, its pharmacological effects in vivo metabolic processes in vivo drug safety Kai Lekkil the same, as alternative or complementary products in clinical use.

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CLC: > Medicine, health > Pharmacy > Pharmacology > Experimental Pharmacology > Safety of the drug test
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