Preclinical Development Of Qigui Capsule

Objective Qigui capsule(QC) with hematogenesis and benefiting-vital-energy is developed due to the increasing number of patients with blood deficiency and weak vital energy led by the result that is more and more strain of life, work and study, and improving the human health index.Methods The extraction was optimized by the contents of astragolosideⅣ, Ferulic acid and volatile oils, and spray drying process was also so by average transinformation rate of astragolosideⅣand Ferulic acid, and moisture and yield of dry power, employing orthogonal test. The investigation of the HPLC determination of astragolosideⅣand Ferulic acid in QC and the TLC qualitative differentiation constructed the draft of quality standard. The action of haemostasis, analgesia, catharsis, hematogenesis and benefiting-vital-energy and immunological regulation in the models of which were blood deficiency induced by iron-deficiency or blood loss, bis-deficiency of blood and vital energy, and deficiency of vital energy, even and hemostasis, analgesis, catharsis, and the antagonism on smooth muscle contraction of uterus in the normal level or in the action of pitocin and primary dysmenorrheal were all investigated in thanks for the pharmacological evaluation. Meanwhile, the security tests were carried out, too.Results The orthogonal tests resulted in the optimal extraction under the condition of 11 folds water for 3 hours first time, and then 9 times water for 1.5 hours second time, and the optimal spray-drying process under the condition of the inlet temperature of 170℃, the relative density of 1.10g/ml extract, and the proportion 1: 0.30 between the theoretical dry weight of extract and the weight of adjuvant. In a capsule, the content of astragolosideⅣ(C41H68O14)was more than 1.0880mg, and the one of ferulic acid, more than 1.2179mg. It was essential for the TLC qualitative differentiation of radix codonopsitis and red jujube. The formulation variously recovered the experimental animals in the models of blood deficiency induced by iron-deficiency or blood loss, bis-deficiency of blood and vital energy, and deficiency of vital energy, increasing the content of hemoglobin, erythrocyte, and serum iron in the experimental animals. It also antagonized the smooth muscle contraction of uterus in the normal level or in the action of pitocin and primary dysmenorrheal. Its hemostasis, analgesis, and catharsis were much effective too. The acute toxicity test led to no LD50, no adverse reaction, no abnormal change of tissues and organs, and 65.5117 g/kg (equal to the 80 times normal daily dose in human) of the maximum daily dose in mice. The long-term toxicity test also did to no flaccid toxicity.Conclusion The preparation process of QC with the controllable quality is simple. QC can significantly nourish blood, benefit vital energy, regulate menstruation and immunology, relieve pain, and loose the bowel. So it is proper to treat bis-deficiency of blood and vital energy due to the good safety, high effectiveness and practical controllability.