| Objective:Lycium has been approved by the Ministry of Health as food and drug,both in clinical medicine or health food development has broad prospects.Lycium barbarum polysaccharide(LBP)is the main active ingredient of Lycium which has immune regulation and other effects.In this study,we used LBP as the LBP buccal tablets to establish the quality standard of LBP buccal tablets,and to explore the effect of LBP immunoregulation.Method:1.The LBP extraction method was optimized by the single factor method and the star point design-response surface method.The LBP content was evaluated by the method of phenol sulfuric acid.2.On the basis of single factor study,the LBP buccal tablets forming process was optimized by the method of response point method,and the appearance,taste,hardness and disintegration time of the tablet were taken as comprehensive evaluation indexes to determine the best prescription.3.According to the relevant provisions of the "China Pharmacopoeia" 2015 Edition four tablets,the establishment of quality standards,including the appearance of the film,TLC identification,tablet weight difference,hardness,fragility,disintegration time,stability test,and determination of polysaccharide content in LBP buccal tablets.4.The immunoregulatory activity of LBP was evaluated in a normal mouse animal model,by measuring the weight of the thymus and spleen and calculating the thymus,spleen index,The phagocytic index of monocytes and macrophages in normal mice was determined by carbon particle clearance test,detection of serum hemolysin antibody content,and the effect of late-type hypersensitivity(DTH),and the effect of LBP on the immunoregulatory function of mice was studied preliminarily.Results:1.In this experiment,LBP was extracted by ultrasonic extraction,the best extraction process is:the ratio of material to liquid is 44 mg·mL-1,the temperature is 51℃,the time is 27min,the power is 166 W,the extraction are two times.2.The optimal formulation of LBP buccal tablets was 80%for LBP extract,11.5%for dextrin/mannitol(1.2 g·g-1),1%for cyclamate/malic acid(1 g·g-1),Creamy flavors 0.5%,CMS-Na6.5%,magnesium stearate acid 0.5%,wetting agent for 80%ethanol.3.LBP buccal tablets are yellowish brown triangular tablets.The color is even.The tablet is complete and smooth which has a sweet and sour taste with cream aroma;TLC identification results show that the spots clearly visible,negative without interference;each piece of LBP containing polysaccharide The content of not less than 200mg;tablet weight difference,hardness,fragility,disintegration time and other projects in line with "Chinese Pharmacopoeia" 2015 Edition four tablets under the rules of the relevant provisions of the rules.4.Using the immune mice animal models to evaluate the regulation function of LBP,the experimental results show that the 200 mg·kg-1·d-1 LBP can significantly increase the thymus and spleen index and phagocyte coefficient;prove that LBP can enhance the immune function of mice,the phagocyte function of macrophages through incentive,to strengthen the non-specific immune function;100 mg·kg-1·d-1 LBP low middle and high dose could significantly increase the blood serum levels in mice,mice that consolidate humeral immunity.The high dose of LBP at 300 mg·kg-1·d-1 can significantly improve the cellular immunity of mice and improve the cellular immunity of mice.Conclusion:Extraction of LBP by ultrasonic extraction has a high extraction rate,low effective component destruction,convenient operation,saving time,high efficiency and energy saving.LBP tablets prescription design is reasonable,and the preparation process is feasible,can be applied to large-scale production requirements,quality control;LBP buccal tablets with in vivo immune activity,LBP buccal tablets can improve the immune function of normal mice.This study has opened up new ideas for increasing the comprehensive utilization value of Lycium.and LBP in order to further develop its scientific value,and it is the basis for the clinical application and supply. |
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