The invention discloses
human body simulation fasting gastric juice and a preparation method thereof, and belongs to the technical field of in-vitro
dissolution experiments of pharmaceutical preparations. The invention aims to solve the problems that in the prior art, simulated gastric juice has significant differences with real empty gastric juice of a
human body in the aspects of
surface tension,
osmotic pressure and buffer capacity, so that an in-vitro
evaluation result of a
dissolution behavior of a pharmaceutical preparation is inaccurate, and scientificity and reliability of an in-vitro
dissolution experiment of a
drug are influenced. The
human body simulated fasting gastric juice comprises the following components: 2 to 30 mg / mL of
bovine serum albumin, 0 to 7.517 E-05 mol / L of
glycocholic acid or glycocholate, 0 to 7.421 E-05 mol / L of glycochenodeoxycholic acid or glycochenodeoxycholate, 0 to 8.369 E-04 mol / L of
taurocholic acid or taurocholate, 0 to 9.005 E-04 mol / L of
taurochenodeoxycholic acid or taurochenodeoxycholate, 0.025 to 0.138 g / L of
calcium chloride, 0.478 to 1.12 g / L of
potassium chloride, 0.015 to 0.063 g / L of
magnesium chloride, 2.05 to 5.26 g / L of
sodium chloride, 0.037 to 0.411 g / L of
sodium dihydrogen
phosphate and a pH
regulator. The method can be used for evaluating the dissolution behavior of the pharmaceutical preparation
in vitro, and is suitable for the fields of
drug development,
quality control and the like.