Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

Span 80 was prepared in a combined process of etherification and esterification in succession, and the effects of material ratio, reaction temperature, and reaction time on several important indexes of Span 80 like acid value, hydroxyl value, saponification value and iodine value, etc. were studied.According to the results of study, the acid value of product is on-specification when the molar ratio of dehydrated sorbitan to oleic acid is 1:(1.2 - 1.4).When the reaction temperature is 200°C and the reaction time is 6 h, the hydroxyl value decreases gradually as the content of oleic acid increases as the material ratio is increased from 1:1.2 to 1:1.4.The iodine value is off specification when com. grade oleic acid is used as the material, and is on-specification when imported vegetable oil acid is used.

The sorbitol standards in different pharmacopeias, i.e., the Chinese pharmacopoeia, the European pharmacopoeia, the United States pharmacopoeia and the Japanese pharmacopoeia, were analyzed and discussed in this paper.The test methods and limitation of several main indicators in different pharmacopoeia were compared, such as content, acidity, reducing sugars, etc.As for the content of sorbitol, ChP 2010 was the strictest, which was not less than 98.0%.For acid value, the requirement in USP 32 was more general as pH value was required in the range of 3.5-7.0, while EP 7.0 was stricter requiring pH to be neutral.As for reducing sugar, the demand of EP 7.0 was more general requiring that the deoxidation product of cuprous oxide should be no more than 67 mg, while JP16 was stricter requiring no more than 13.6 mg.This research is supposed to be helpful for the preparation of high-quality sorbitol and the establishment of sorbitol quality standard

A review.Sorbitol is a fine chem. with wide usage.It can be used in many fields, such as cosmetics, food, medicine, etc.With its broadened application, more and more attention was paid on its safety, especial in pharmaceutical industry.This paper summarized the preparation methods of sorbitol, such as catalytic hydrogenation, electrochem. reduction, and fermentationAdvantages and disadvantages of these methods were also compared.Moreover, the possible residual impurity in each preparation method was analyzed.This review is supposed to be helpful for the preparing of high-quality sorbitol.