Pharmaceutical composition and preparation method of homogenate hydrobromide powder for injection
A technology of urine hydrobromide and water for injection, which is applied in the direction of drug combination, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve the technical difficulties of freeze-dried powder injections and other problems
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preparation example 1
[0101] Preparation example 1, preparation of the powder injection comprising homogenine hydrobromide
[0102] formula:
[0103] Urine hydrobromide 4 mg, Mannitol 20mg, pH regulator to pH6.0,
[0104] Water for Injection Appropriate amount, add to 1ml.
[0105] Preparation:
[0106] (1) Weigh urine hydrobromide, mannitol, and another specified amount of sodium citrate (to obtain powder injections containing different amounts of sodium citrate) in the prescription in the above table, and place them in a stainless steel bucket , add water for injection of about 80% of the prescription amount to dissolve each component, then add 0.1% (w / v) activated carbon according to the volume of the solution, stir for 30 minutes, filter and decarbonize, and add water for injection to nearly the full amount of the prescription.
[0107] (2) Take a sample of the filtrate, measure the pH value, adjust it to the specified value with a pH regulator...
preparation example 2
[0112] Preparation example 2, preparation of the powder injection comprising homogenine hydrobromide
[0113] Recipe: 4 mg of uricine hydrobromide, specified amount of mannitol, 20 mg of sodium citrate, pH regulator to pH 6.0, appropriate amount of water for injection, added to 1 ml.
[0114] Preparation:
[0115] (1) Weigh urine hydrobromide, sodium citrate, and other specified amount of mannitol (to obtain powder injections containing different amounts of mannitol) in the above prescription, put them in a stainless steel bucket, add About 80% of the water for injection in the prescription is used to dissolve the components, and then add 0.1% (w / v) activated carbon according to the volume of the solution, stir for 30 minutes, filter and decarbonize, and add water for injection to nearly the full amount of the prescription.
[0116] (2) Take a sample of the filtrate, measure the pH value, adjust it to the specified value with a pH regulator if necessary, and then add water ...
preparation example 3
[0124] Preparation example 3, preparation of the powder injection comprising homogenine hydrobromide
[0125] Recipe: On the basis of Ex105 in Preparation Example 1, additionally add a specified amount of disodium edetate, 20 mg of sodium citrate, a pH regulator to pH 6.0, and an appropriate amount of water for injection to 1 ml. The dosages of disodium edetate in different batches were 0mg, 0.1mg, 0.2mg, 0.5mg, 1mg, 1.5mg respectively, and 6 batches of powder injections obtained were Ex301, Ex302, Ex303, Ex304, Ex305, Ex306 . The pH values of these 6 powder injections in their initial states were measured (the pH value when they were dissolved in water for injection into a solution containing 4 mg / ml of homogenate hydrobromide), and the results showed that they were all within the range of pH 5.93-6.11.
[0126] These 6 powder injections were tested for stability at 45° C. for 4 months as described herein. For each batch of powder injections, measure their pH (pHa) after ...
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