复方党参颗粒制备工艺优化及4种成分的同时测定

doi:10.5246/jcps.2023.08.055

中国药学(英文版) ›› 2023, Vol. 32 ›› Issue (8): 665-676.DOI: 10.5246/jcps.2023.08.055

复方党参颗粒制备工艺优化及4种成分的同时测定

杨杰¹^,², 景彩芳¹^,², 李少创¹^,², 刘思彤¹^,², 李董明¹^,², 李钦青¹^,²^,^*(), 贺文彬¹^,²^,^*()

1. 山西中医药大学国家级分子中医药学国际联合研究中心, 山西太原 030024
2. 山西中医药大学中医脑病学山西省重点实验室, 山西太原 030024

收稿日期:2023-01-28 修回日期:2023-02-18 接受日期:2023-04-06 出版日期:2023-08-31 发布日期:2023-08-31
通讯作者: 李钦青, 贺文彬
作者简介:
+ Tel.: +86-351-3179855, E-mail: Liqq@sxtcm.edu.cn
+ E-mail: hewb@sxtcm.edu.cn
基金资助:
The State Administration of Traditional Chinese Medicine Young Qihuang Scholars Support Project (Approval Document No.: National Traditional Chinese Medicine [2020] No. 7); Key Research and Development Program of Shanxi Province (International Science and Technology Cooperation) Major Regional Innovation Cooperation Project (Grant No. 201803D421006); Shanxi University of Traditional Chinese Medicine, Postgraduate Innovation and Entrepreneurship Project (Grant No. 2021CX046); Shanxi University of Traditional Chinese Medicine, Science and Technology Innovation Ability Cultivation Project (Grant No. 2020PY-YC-35, 2021PY-QN-10).

Preparation optimiztion of compound Codonopsis Radix granules and simultaneous determination of its four components

Jie Yang¹^,², Caifang Jing¹^,², Shaochuang Li¹^,², Sitong Liu¹^,², Dongming Li¹^,², Qinqing Li¹^,²^,^*(), Wenbin He¹^,²^,^*()

1 National International Joint Research Center of Molecular Chinese Medicine, Shanxi University of Traditional Chinese Medicine, Taiyuan 030024, Shanxi, China
2 Shanxi Key Laboratory of Chinese Brain Diseases, Shanxi University of Traditional Chinese Medicine, Taiyuan 030024, Shanxi, China

Received:2023-01-28 Revised:2023-02-18 Accepted:2023-04-06 Online:2023-08-31 Published:2023-08-31
Contact: Qinqing Li, Wenbin He

摘要/Abstract

摘要：

本研究采用单因素试验和响应面法优化复方党参颗粒喷雾干燥工艺, 获得最佳的喷雾干燥工艺参数; 以成型率和吸湿率为指标考察辅料的配比用量; 建立高效液相色谱(HPLC)法同时测定党参炔苷、阿魏酸、毛蕊异黄酮葡萄糖苷、甘草苷的含量。当喷雾干燥的进风温度为145 oC, 进风速率为75%, 进料速率为8%, 助干剂为5%, 喷雾干燥得粉率最高; 辅料用量为糊精: 糖粉为2:1时, 颗粒成型率和吸湿率均较好, 有效优化了复方党参颗粒的喷雾干燥工艺和辅料配比用量, 为复方党参颗粒的生产制备提供参考; HPLC同时测定复方党参颗粒中党参炔苷、阿魏酸、甘草苷、毛蕊异黄酮葡萄糖苷的含量分别为0.38 mg/g, 0.22 mg/g, 0.45 mg/g和0.25 mg/g, 为复方党参颗粒质量控制方法的建立奠定基础。

关键词: 复方党参颗粒, 响应面优化, 喷雾干燥, 高效液相色谱法

Abstract:

In the present study a single-factor experiment and response surface methodology were utilized to optimize the spray-drying process of compound Codonopsis Radix granules and determine the optimal spray-drying process parameters. The proportions of excipients were examined using indicators of molding rate and moisture absorption rate. High-performance liquid chromatography (HPLC) was established to simultaneously determine the contents of lobetyolin, ferulic acid, calycosin-7-O-β-D-glucoside (CG), and glycyrrhizin in the compound Codonopsis Radix granules. The findings indicated that the highest spray-drying yield was achieved when the inlet temperature of spray drying was set at 145 oC, the inlet air velocity at 75%, the feed rate at 8%, and the drying aid at 5%. A ratio of paste starch to powdered sugar at 2:1 resulted in a good particle molding rate and moisture absorption rate. By effectively optimizing the spray-drying process of compound Codonopsis Radix granules and excipient dosage this study provides a valuable reference for the production and preparation of these granules. The contents of lobetyolin, ferulic acid, glycyrrhizin, and CG in the compound Codonopsis Radix granules were found to be 0.38, 0.22, 0.45, and 0.25 mg/g, respectively. These results provided a foundation for establishing a quality control method for compound Codonopsis Radix granules.

Key words: Compound Codonopsis Radix granules, Response surface optimization, Spray drying, High-performance liquid chromatography

Supporting:

杨杰, 景彩芳, 李少创, 刘思彤, 李董明, 李钦青, 贺文彬. 复方党参颗粒制备工艺优化及4种成分的同时测定[J]. 中国药学(英文版), 2023, 32(8): 665-676.

Jie Yang, Caifang Jing, Shaochuang Li, Sitong Liu, Dongming Li, Qinqing Li, Wenbin He. Preparation optimiztion of compound Codonopsis Radix granules and simultaneous determination of its four components[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(8): 665-676.

图/表 7

Table 1. Factor levels of spray drying experiments.

Table 2. Design and results of compound Codonopsis Radix granules spray drying response surface test (n = 3).

Table 3. Screening results of excipient ratio (n = 3).

Figure 1. HPLC chromatogram. Note: (a) Mixed reference solution; (b) Test solution; (c) Negative test solution of lacking Codonopsis Radix; (d) Negative test solution of lacking Astragali Radix; (e) Negative test solution of lacking Angelicae Sinensis Radix; (f) Negative test solution of lacking Glycyrrhizae Radix et Rhizoma. 1. Calycosin-7-O-β-D-glucoside (CG); 2. Glycyrrhizin; 3. Ferulic acid; 4. Lobetyolin.

Table 4. Results of methodological investigation (n = 6).

Table 5. Test results of sample recovery rate of each component (n = 6).

Table 6. Determination results of each component content (mg/g, n = 6).

参考文献 27

[1]	Li, P.; Wu, H. Treatment of chemotherapy-induced leukopenia in 66 cases with Angelica sinensis blood tonic soup. Shaanxi J. Tradit. Chin. Med. 2008, 320, 951–952.
[2]	Chen, K.L.; Xu, D.M.; Wang, L.S. Clinical efficacy of self-made Angelica sinensis blood tonic soup with added ingredients in the treatment of postoperative anemia in lower limb fractures. Inn. Mongolia J. Tradit. Chin. Med. 2015, 34, 32–33.
[3]	Liu, Y.; Tang, M.L.; Cai, W.; Shang, F.F.; Li, D.J.; Duan, Z.H. Preparation of yam and hawthorn solid beverage by spray-drying method. Food Ind. 2021, 42, 103–107.
[4]	National Pharmacopoeia Commission. Pharmacopoeia of the People’s Republic of China:The first part of 2020 edition. Beijing: China Medical Science and Technology Press. 2020.
[5]	Chen, G.Y.; Rao, Z.; Qu, H.Y.; Xie, M.Z.; He, Q. Optimization of juice granule prescription and its hygroscopicity. Chin. Patent Med. 2021, 43, 2157–2160.
[6]	Sun, M.J.; Dai, X.W.; Zou, Q. Optimization of prescription and determination of hygroscopicity. Chin. Patent Med. 2021, 43, 177–181.
[7]	Wang, Z.D.; Bai, W.R.; Liu, S.J.; Fan, Y.W.; Gao, R.Y. Preparation of Poria cocos yam barbary wolfberry solid beverage. Food Ferment. Ind. 2022, 48, 211–217.
[8]	Zhao, X.; Chen, L.F.; Li, R.M.; Zhou, Z.; Pan, S.K. Research on the spray drying process of instant soybean powder with response surface optimization. Food Res. Dev. 2021, 42, 81–88.
[9]	Liu, Y.; Shang, F.F.; Li, D.J.; Cai, W.; Tang, X.X.; Zhang, Q.; Duan, Z.H. Optimization of spray drying process of Chinese yam solid beverage. Food Res. Dev. 2019, 40, 107–112.
[10]	Xu, Y.Q.; Li, B.Y.; Guo, L.; Liu, Y.; Kan, H.; Fan, F.Y. Study on spray drying process of passion passion powder. Preserva. Proce. 2020, 20, 156–161.
[11]	Jiang, Y.P.; Liu, Y.F.; Guo, Q.L.; Jiang, Z.B.; Xu, C.B.; Zhu, C.G.; Yang, Y.C.; Lin, S.; Shi, J.G. C₁₄-polyacetylene glucosides from Codonopsis pilosula. J. Asian Nat. Prod. Res. 2015, 17, 601–614.
[12]	Song, D.; Wang, Z.T.; Li, L.Y.; Zhong, G.Y. Study on the protective effect of Parthenoxyside on gastric mucosal injury in gastric ulcer model. Chin. Med. Emerg. 2008, 123, 963–964, 986.
[13]	Zhang, L. HPLC and BBD response surface method. Food Add. China. 2021, 32, 107–114.
[14]	Li, J.; Han, L.; Ma, Y.F.; Huang, Y.F. Inhibition effect of Astragalus 3 ingredients on oxidative stress in Chang Liver cells. Chin. J. Tradit. Chin. Med. 2015, 40, 318–323.
[15]	Chen, L.Y.; Li, Z.X.; Tang, Y.H.; Cui, X.L.; Luo, R.H.; Guo, S.S.; Zheng, Y.T.; Huang, C.G. Isolation, identification and antiviral activities of metabolites of calycosin-7-O-β-D-glucopyranoside. J. Pharm. Biomed. Anal. 2011, 56, 382–389.
[16]	Zhang, D.M. Effect of mornoisone-7-O-β-D-, glucoside on apoptosis and Bcl-2/Bax expression in human cervical cancer HeLa cells. Chin. herbal Med. 2015, 46, 1498–1502.
[17]	Yang, Z.C.; Zhang, F.M.; Sun C H.; Zhang, K.J.; Chen, Y.; Zhang, Y.B.; E, X.H. Study on the optimized infiltration process of Astragalus membranaceus based on HPLC-DAD-ELSD and response surface design. Chin. herbal Med. 2020, 51, 6196–6204.
[18]	Wang, Y.F. Advances in ferulic acid derivatives. West. Leather. 2020, 42, 105
[19]	Yang, Y.; Yu, C.Q.; Guo, Z.X.; Wang, M.Y.; Li, X.B. 2 Research on the quality characteristics of angelica in different producing areas based on HPLC fingerprint and multi-index composition. Chin. herbal Med. 2021, 52, 4666–4674.
[20]	Kao, T.C.; Wu, C.H.; Yen, G.C. Bioactivity and potential health benefits of licorice. J. Agric. Food Chem. 2014, 62, 542–553.
[21]	Cui, Y.; Wang, J.N.; Fan, Z.Y.; Tang, X.M.; Ma, B.; Guan, J.; Zhu, H.Y. The content of glycyrrhizin and glycyrrhizin decoction was measured simultaneously by UFLC. J. Jilin Univ. Med. 2022, 43, 168–170.
[22]	Liao, J.M.; Li, L.Y.; Qu, Y.A.; Yang, X.F.; Yang, J.X. Study on chemical stability of dangshen ynyside, the active ingredient of Dangshen medicinal materials. Res. Dev. Nat. Prod. 2020, 32, 385–388, 434.
[23]	Zhang, Y.B.; Jiang, R.W.; Li, S.L.; Qiao, C.F.; Han, Q.B.; Xu, H.X.; Huang, J.L.; Bi, P.X.; Shao, P.Z. Chemical and molecular characterization of Hong Dangshen, a unique medicinal material for diarrhea in Hong Kong. J. Chin. Pharm. Sci. 2007, 16, 202–207.
[24]	Wang, Q.; Lai, H.; Chen, L.; Li, J.; Mi, X.Q.; Zhao, F.L. Determination of astragaloside and malanlavone glucoside content in three dosage forms of astragalus by high performance liquid chromatography. China Pharm. Comp. 2019, 28, 23–26.
[25]	Wang, P.; Wang, Y.H.; Gao, J.; Lai, P.H.; Liu, Y.Q. The content of puerarin and ferulic acid and danphenolic acid B in Tongmai dropping pills was determined simultaneously by HPLC. Med. Herald. 2018, 37, 731–734.
[26]	Yang, H.M.; Xu, J.Q.; Gong, S.Z.; Yu, J. Simultermination of glycyrrhizin and glycyrrhizin. Daily Chem. Ind. 2021, 51, 250–255.
[27]	Meng, L.L.; Li, Z.; Chen, Y.G.; Fu, X.T.; Zhang, Y.T.; Guo, H.Z. Simultaneous determination of five major components of Glycyrrhizae Radix et Rhizoma in Xiaoer Zhike Tangjiang with standardized reference extract. J. Chin. Pharm. Sci. 2015, 24, 449–457.

复方党参颗粒制备工艺优化及4种成分的同时测定

Preparation optimiztion of compound Codonopsis Radix granules and simultaneous determination of its four components

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