含有丁酸处理蛋壳和补骨脂素的新型泡腾剂治疗骨质疏松症

IF 2.7 4区医学 Q2 PHARMACOLOGY & PHARMACY

Journal of Pharmaceutical Innovation Pub Date : 2025-04-25 DOI:10.1007/s12247-025-09993-4

Maithilee Mande, Mayuri Kale, Dyandevi Mathure, Ravindra Kulkarni, Deepa Mandlik, Vaibhav Shinde

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引用次数: 0

摘要

目的开发含有补骨脂素和蛋壳提取物丁酸钙（ECB）协同混合物的泡腾颗粒，作为治疗骨质疏松症的新型口服制剂。方法采用湿法制粒法制备泡腾颗粒，补骨脂素溶于乙醇并通过涡旋混合作为制粒剂。用丁酸处理蛋壳粉，得到可溶性丁酸钙（ECB）。将补骨脂素和可溶性丁酸钙与含有柠檬酸、碳酸氢钠和甘露醇的泡腾碱混合。在 7.1.6 版设计专家软件中使用中心复合设计对配方进行了优化。通过糖皮质激素诱导的雌性wistar大鼠骨质疏松症模型研究了优化配方的抗骨质疏松症活性。结果优化后的配方溶解迅速，90%以上的补骨脂素和钙在30分钟内释放，表明生物利用度提高。结果显示，泡腾颗粒能明显改善骨质疏松症动物体内的碱性磷酸酶活性和钙水平；组织病理学分析证实骨结构得到了改善。结论补骨脂素和ECB泡腾颗粒（PECB-EG）是一种长期治疗骨质疏松症的有效方法。

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Novel Effervescent Formulation Containing Butyric Acid Treated Egg Shell and Psoralen for Manamegent of Osteoporosis

Background

Current treatments available for osteoporosis involve high risk and severe adverse effects hence, can’t be used in prolonged treatment.

Purpose

Development of effervescent granules containing a synergistic blend of psoralen and eggshell derived calcium butyrate (ECB) as a novel oral formulation for osteoporosis treatment.

Methods

Wet granulation method was used for preparation of effervescent granules, Psoralen dissolved in ethanol by vortex mixing was used as granulating agent. The eggshell powder was treated with butyric acid to get soluble calcium butyrate (ECB). Both psoralen and ECB were mixed with the effervescent base containing citric acid, sodium bicarbonate and mannitol. The formulation was optimized by using central composite design in design expert software version 7.1.6. Anti-osteoporotic activity of optimized formulation was studied by glucocorticoid induced osteoporosis model in female wistar rats.

Results

The optimized formulation demonstrated rapid dissolution, with over 90% of psoralen and calcium released within 30 min, indicating enhanced bioavailability. Results revealed that the effervescent granules significantly improved alkaline phosphatase activity and calcium levels in osteoporotic animals; histopathological analysis confirmed improved bone architecture. These findings underscore the potential of this dual-action formulation for enhancing bone health and warrant further investigation into its clinical applications in osteoporosis management.

Conclusion

Psoralen and ECB effervescent granules (PECB-EG) are an effective treatment option for long term treatment of osteoporosis.

Graphical Abstract

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来源期刊

Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-

CiteScore

3.70

自引率

3.80%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.