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Purpose: In accordance with the relevant provisions of the new drug research, completed doubly odd oral preclinical studies, including its preparation process, quality standards, stability evaluation, pharmacology, toxicology and other studies. Provide a scientific basis for the clinical application and mechanism of action of the two-odd oral solution. Methods: on the basis of the literature, according to the nature of the function Indications and prescription drugs ingredients, using ultrasonic extraction method to determine the preparation process. Flavonoids and saponins preparations were identified by thin-layer chromatography, spectrophotometry oral liquid polysaccharide content was measured to determine the oral liquid quality control methods. Preliminary stability studies of the drug, including traits, identification and determination. Toxicology, acute toxicological studies to evaluate its safety; pharmacodynamic tests, immunoassays and anti-aging test. Dual the odd oral liquid role in D-galactose induced aging model to detect serum superoxide dismutase (SOD), lipid peroxidation product malondialdehyde aldehyde (MDA), glutathione peroxidase (GSH-Px) indicators of change, and to explore its anti-aging mechanisms. Results: In the study of quality standards: flavonoids, saponins qualitative identification of the thin layer, dot separation, to prove that the selected method is specific; oral liquid content was measured by spectrophotometric determination of total polysaccharide content, the average recovery rate of 99.767% (RSD = 1.93%); total the polysaccharide average content of three batches of samples measured were 2.87,2.95,2.92 mg. ml-1; the drug preliminary stability study results show that the goods of light and heat better stability; the retention samples at room temperature three-month expedition, the indicators are in line with the regulations, no significant changes, indicating that the odd-odd oral stability of fluid preliminary. The acute toxicity test showed that the the doubly odd oral solution safe and non-toxic side effects; the doubly odd oral solution can increase the normal immune organ weights; the doubly odd oral solution significantly increased serum SOD (P lt; 0.01) and GSH-PX vitality (P lt; 0.01), to reduce the content of MDA in the serum (P lt; 0.01). Conclusion: In summary doubly odd oral liquid through pre-clinical pharmacy, pharmacology and toxicology, and other aspects of the study, results showed that the drug preparation process is feasible, the quality standards to control the quality of drugs, examine the drug's stability. Pharmacological experiments show that the drug can enhance immune function, improve the antioxidant capacity, has the role of aging.
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