星点设计-效应面法优化枸杞多糖含片的处方并考察其免疫调节作用

管庆霞; 张雪; 邹淑君; 王艳宏; 张喜武; 赵宇巍; 张悦; 张伟兵; 冯宇飞

doi:10.13422/j.cnki.syfjx.20191551

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星点设计-效应面法优化枸杞多糖含片的处方并考察其免疫调节作用

药剂与炮制 | 更新时间：2021-02-09

- 星点设计-效应面法优化枸杞多糖含片的处方并考察其免疫调节作用
- Optimization of Prescription of Lycii Fructus Polysaccharide Buccal Tablets by Central Composite Design-response Surface Methodology and Investigation of Its Immunomodulatory Effect
- 中国实验方剂学杂志 2019年25卷第24期页码：65-72
- 作者机构：
  
  黑龙江中医药大学，哈尔滨　 150040
- 作者简介：
  
  管庆霞，博士，副教授，从事中药纳米递药系统及中药新药开发研究，Tel：0451-87266893，E-mail：546105832@qq.com
  冯宇飞，博士，副教授，从事中药新技术与新剂型、方剂药效物质基础研究，Tel：0451-87266893，E-mail：fuf-002@163.com
- 基金信息：
  
  黑龙江省自然科学基金面上项目(H2016076);黑龙江省教育厅科学技术研究项目(12531624);哈尔滨市应用技术研究与开发项目（青年后备人才A类）(2017RAQXJ090)
- DOI：10.13422/j.cnki.syfjx.20191551
  中图分类号： R22; R28; R392; C37; R96; R94
- 纸质出版日期：2019-12-20，
  
  网络出版日期：2019-04-18，
  
  收稿日期：2019-02-04，
- 稿件说明：
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管庆霞, 张雪, 邹淑君, 等. 星点设计-效应面法优化枸杞多糖含片的处方并考察其免疫调节作用[J]. 中国实验方剂学杂志, 2019,25(24):65-72.

Qing-xia GUAN, Xue ZHANG, Shu-jun ZOU, et al. Optimization of Prescription of Lycii Fructus Polysaccharide Buccal Tablets by Central Composite Design-response Surface Methodology and Investigation of Its Immunomodulatory Effect[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2019,25(24):65-72.
管庆霞, 张雪, 邹淑君, 等. 星点设计-效应面法优化枸杞多糖含片的处方并考察其免疫调节作用[J]. 中国实验方剂学杂志, 2019,25(24):65-72. DOI： 10.13422/j.cnki.syfjx.20191551.

Qing-xia GUAN, Xue ZHANG, Shu-jun ZOU, et al. Optimization of Prescription of Lycii Fructus Polysaccharide Buccal Tablets by Central Composite Design-response Surface Methodology and Investigation of Its Immunomodulatory Effect[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2019,25(24):65-72. DOI： 10.13422/j.cnki.syfjx.20191551.

摘要

目的：

制备枸杞多糖(LBP)含片，并考察其免疫调节作用。

方法：

以含片的外观、口感、硬度、崩解时限为综合评价指标，采用单因素试验考察LBP提取物用量、填充剂、润湿剂、矫味剂、香精、崩解剂、润滑剂对LBP含片质量的影响，结合星点设计-效应面法优化LBP含片的处方。昆明种小鼠随机分为5组，即LBP含片低(100 mg·kg

－1

·d

－1

)，中(200 mg·kg

－1

·d

－1

)，高(300 mg·kg

－1

·d

－1

)剂量组，正常组(0.9%生理盐水，300 mg·kg

－1

·d

－1

)和阳性药组(赐能素组，300 mg·kg

－1

·d

－1

)，计算小鼠免疫器官指数、单核巨噬细胞吞噬指数、血清溶血素抗体水平及迟发型变态反应(DTH)的足趾厚度差，探讨LBP含片的免疫调节作用。

结果：

LBP含片最优处方为LBP提取物用量80%，糊精-甘露醇(1.2∶1)用量11.5%，甜蜜素-苹果酸(1∶1)用量1%，奶油香精用量0.5%，羧甲基淀粉钠(CMS-Na)用量6.5%，硬质酸镁用量0.5%，80%乙醇适量；在该最优条件下，LBP含片硬度11.83 kg，崩解时限13.21 min，均符合2015年版《中国药典》的相关规定，且制得的含片外观、口感均较好。与正常组比较，LBP含片中、高剂量组可显著增加小鼠胸腺指数、脾脏指数和吞噬指数(

0.05，

0.01)，LBP各剂量组均可显著增加小鼠血清溶血素抗体水平(

0.05，

0.01)，LBP含片高剂量组可显著提高小鼠DTH程度(

0.05)。

结论：

采用星点设计-效应面法优选所得的LBP含片处方工艺稳定可行，LBP含片可改善正常小鼠的免疫调节功能，为枸杞及LBP的开发利用、临床应用提供了实验依据。

Abstract

Objective:

To prepare Lycii Fructus polysaccharide buccal tablets and investigate its immunomodulatory effect.

Method:

Taking the appearance

taste

hardness and disintegration time of the tablets as comprehensive evaluation index

based on single factor tests

central composite design-response surface methodology was adopted to optimize the prescription of Lycii Fructus polysaccharide buccal tablets with mass ratio of dextrin to mannitol

mass ratio of cyclamate to malic acid and dosage of sodium carboxymethyl starch (CMS-Na) as factors. Kunming mice were randomly divided into 5 groups

namely the Lycii Fructus polysaccharide buccal tablets low (100 mg·kg

-1

·d

-1

)

medium (200 mg·kg

-1

·d

-1

) and high (300 mg·kg

-1

·d

-1

) dose groups

the normal group (0.9% normal saline

300 mg·kg

-1

·d

-1

) and the positive medicine group (Cinengsu group

300 mg·kg

-1

·d

-1

). The immunomodulatory effect of the buccal tablets were investigated by calculating immune organ index

monocyte-macrophage phagocytic index

serum hemolysin antibody level

and the voix pedis thickness difference of delayed hypersensitivity (DTH) of mice.

Result:

Optimal prescription for the buccal tablets was 80% of Lycii Fructus extract

11.5% of dextrin-mannitol (1.2∶1)

1% of cyclamate-malic acid (1∶1)

0.5% of cream essence

6.5% of CMS-Na

0.5% of magnesium stearate

and appropriate amount of 80% ethanol. Under the optimal condition

the hardness of the buccal tablets was 11.83 kg

its disintegration time was 13.21 min

both of which were in line with the relevant provisions of the 2015 edition of

Chinese Pharmacopoeia

and the buccal tablets had good appearance and taste. Compared with the normal group

medium and high dose groups of Lycii Fructus polysaccharide buccal tablets significantly increased thymus index

spleen index and phagocytic index of mice (

0.05

0.01)

serum hemolysin antibody level of mice was significantly increased in all Lycii Fructus polysaccharide buccal tablets groups (

0.05

0.01)

and DTH level of mice was significantly increased in high dose group of Lycii Fructus polysaccharide buccal tablets (

0.05).

Conclusion:

The formulation process of the buccal tablets optimized by central composite design-response surface methodology is stable and feasible

and Lycii Fructus polysaccharide buccal tablets can improve the immune regulation function of normal mice

and this study can provide experimental basis for the development

utilization and clinical application of Lycii Fructus and Lycii Fructus polysaccharides.

关键词

枸杞子枸杞多糖含片免疫调节作用崩解时限足跖增厚法星点设计-效应面法

Keywords

Lycii FructusLycii Fructus polysaccharidesbuccal tabletsimmunomodulatory effectdisintegration timevoix pedis thickening methodcentral composite design-response surface methodology

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