Tricine|CAS:5704-04-1| is an excellent amphoteric biological good's buffer. CN108653204B introduces the application of Tricine in the field of pharmaceutical preparations. The polyene phosphatidylcholine injection composition in this patent can be used for the treatment of various acute and chronic liver diseases, and its components and preparation steps are as follows:

The polyene phosphatidyl choline injection composition contains the following components per 10L injection: polyene phosphatidyl choline: 300-900 g; methoxy polyethylene glycol-phosphatidyl ethanolamine: 20-25 g; cholesterol: 20-40g ; Tricine: 35-50g; Arginine: 10-15g; Water for injection: 1-6L; Soybean oil: 2-4L; Antioxidant: 0.5-5g; The inventor found in the research that the addition of Tricine and arginine in a specific ratio is very important for solving the technical problem of the present invention, and turbidity is easy to occur when one of them is diluted; and the weight ratio of arginine to Tricine is in the range of 1:1-1:6 is more suitable, and turbidity will occur when diluted beyond this range.

After mixing the polyene phosphatidylcholine, methoxy polyethylene glycol-phosphatidylethanolamine, cholesterol, soybean oil, and antioxidant in the recipe quantity, dissolve them with ultrasonic waves, control the solution temperature below 40°C, and then add the recipe quantity. Tricine, arginine and water for injection containing 40% of the total dosage, stir until a clear liquid, coarsely filter with activated carbon for needles, add water to a sufficient amount, stir evenly, filter through a microporous membrane, and after passing the inspection, fill in In ampoules, nitrogen-filled, melt-sealed, and sterilized.

The polyene phosphatidylcholine injection pharmaceutical composition and preparation method provided by the present invention have the following advantages:

1. The prepared polyene phosphatidylcholine injection pharmaceutical composition has good clarity and high stability, when diluted with water for injection or 5% glucose solution, no turbidity occurs, and clinical use is safer;

2. The whole preparation process does not need nitrogen protection, the production process is simple and easy, and it is easy to realize industrialization.

References

CN108653204B A kind of polyene phosphatidyl choline injection pharmaceutical composition and preparation method thereof.