[Translation] A single-center, open-label, randomized, four-period, two-sequence repeated crossover bioequivalence study of a single oral dose of cyclosporine soft capsules in Chinese healthy volunteers under fasting and fed conditions

主要研究目的：研究中国健康受试者在空腹和餐后条件下单次口服受试制剂环孢素软胶囊（50mg）与参比制剂Neoral®（50mg）的药代动力学行为，评价空腹和餐后条件口服两种制剂的生物等效性。次要研究目的：评价受试制剂环孢素软胶囊（50mg）与参比制剂Neoral®（50mg）在健康人群中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic behavior of the test preparation cyclosporine soft capsule (50 mg) and the reference preparation Neoral® (50 mg) in Chinese healthy subjects after a single oral administration under fasting and postprandial conditions, and to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions. Secondary purpose of the study is to evaluate the safety of the test preparation cyclosporine soft capsule (50 mg) and the reference preparation Neoral® (50 mg) in healthy people.

Start Date26 Feb 2024

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Zhejiang Ruibang Laboratories

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Zhongguo Kangshengsu Zazhi

Optimization of fermentation media for hypocrellin production by Shiraia bambusicola CGMCC 2201

Author: Bu Guang-ming ; Yang Hai-long

Objective To enhance the hypocrellin production by optimizing the fermentation media of Shiraia bambusicola CGMCC 2201.Methods The key components of fermentation media were firstly determined by onefactor-at-a-time experiment, and then the concentrations of key components were optimized by the central composite design and the response surface anal.Moreover, the effects of plant oils on the hypocrellin biosynthesis were also investigated to obtain the optimal fermentation medium formula for hypocrellin production by submerged culture of S. bambusicola CGMCC 2201.Results Four key components of fermentation media were selected, which were glucose, ammonium sulfate, potassium dihydrogen phosphate, and magnesium sulfate, and soybean oil significantly enhanced the biosynthesis of hypocrellin.The components of the optimized fermentation media(g/L) were: glucose 47.33, ammonium sulfate 2.14, potassium dihydrogen phosphate 2.87, magnesium sulfate 1.68, and soybean oil 10.The hypocrellin yield reached 257.66 mg/L in the optimal media, 141.25% higher than that in the initial media.Conclusion Media components were the important factors in the biosynthesis of hypocrellin in S. bambusicola CGMCC 2201, and the hypocrellin production was significantly increased by the optimization of fermentation media.

Shenyang Yaoke Daxue Xuebao

Extraction and purification of lovastatin using macroporous adsorption resin

Author: Kang, Ning ; Bu, Guang-ming

The objective is to isolate and purify lovastatin from fermentation broth of Aspergillus terreus by macroporous adsorptive resins.Six resins were screened for isolation and purification of lovastatin from the fermentation broth.The optimum pH value for releasing lovastatin from the fermentation broth was 11; HZ-818 was selected as the adsorbent for isolating lovastatin from the filtered fermentation broth.The optimum conditions for the column chromatog. were as follows: the flow rate for adsorption is 1/40 resin bed volume/min^-1 and the column were eluted with 1% NaOH in 75% ethanol at a flow rate of 1/100 resin bed volume/min^-1.The yield of lovastatin can be increased to 70% under the optimal condition, and the quality of the final product meets that required in USP 27.

Zhongguo Kangshengsu Zazhi

Isolation and purification of lovastatin by macroreticular ion exchange resin method

Author: Bu, Guangming ; Chen, Tongxin

Macroreticular ion exchange resin method replacing solvent extraction method was used in isolation and purification of lovastatin.Macroreticular anion ion exchange resin D-273 was used as adsorbent at flow rate of 1/30 (BV/min), and 75% ethanol containing 4% NaOH was used as desorption agent at flow rate of 1/100 (BV/min).The recovery rate of lovastatin was above 68%, and the quality was in accordance with requires of US Pharmacopeia (USP) 27.In conclusion, macroreticular ion exchange resin method is better than solvent extraction method at cost and safety aspects, which shall be popularized in industrial production

100 Deals associated with Zhejiang Ruibang Laboratories

100 Translational Medicine associated with Zhejiang Ruibang Laboratories

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