Bromocriptine composition sustained-release preparation and preparation method thereof
A technology for sustained-release preparations and compositions is applied in the field of sustained-release preparations of bromocriptine compositions and their preparation, and can solve the problems of uncontrollable drug release, fibrosis of bromocriptine, fluctuation of blood drug concentration and the like
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Embodiment 1
[0129] Example 1 Screening of Bromocriptine Composition Sustained Release Formulation
[0130] In order to obtain sustained-release preparations with better release uniformity and stability, screening tests were carried out on the types of sustained-release materials, diluents, binders and lubricants. The performance of the obtained bromocriptine composition tablet was evaluated with the sustained-release effect as a reference index.
[0131] Dissolution measurement method: refer to the second method of appendix XC of the 2010 edition of "Chinese Pharmacopoeia", carried out in an automatic dissolution apparatus, the dissolution medium is a phosphate buffer solution with a pH of 6.8, and the temperature of the dissolution medium is 37 ° C ± 5 ° C, The rotation speed is 100rpm / min, and sampling is performed at 10 time points. At the specified sampling time point, absorb 5mL of the solution and filter it, and replenish the same volume of dissolution medium at a temperature of 37°...
Embodiment 2
[0147] Example 2 Preparation of Bromocriptine Composition Sustained Release Tablets
[0148] Preparation of tablets with a strength of 0.7 mg:
[0149] Take the raw and auxiliary materials according to the following formula (according to 1000 preparation units):
[0150]
[0151]Get principal agent bromocriptine, pulverize, cross 40 mesh sieves, obtain fine powder, standby; Get hypromellose (sustained-release material), ethyl cellulose, starch, microcrystalline cellulose and magnesium stearate, Crush them separately and pass through a 40-mesh sieve. Bromocriptine obtained after sieving is evenly divided into 20 equal parts by mass; hypromellose is evenly divided into 20 equal parts by mass; starch is evenly divided into 20 equal parts by mass; Divide into 20 equal portions and set aside. Firstly take 8 parts out of 20 parts obtained by equally dividing bromocriptine, hypromellose, starch and microcrystalline cellulose, mix them, shake at a frequency of 20 times / second fo...
Embodiment 3
[0152] Example 3 Preparation of Bromocriptine Composition Sustained Release Tablets
[0153] Preparation of tablets with a strength of 3.5 mg:
[0154] Take the raw and auxiliary materials according to the following formula (according to 1000 preparation units):
[0155]
[0156]
[0157] Take the main drug bromocriptine, pulverize it, and pass through a 40-mesh sieve to obtain a fine powder for subsequent use; take chitosan, sodium carboxymethylcellulose, pregelatinized starch and calcium stearate, pulverize respectively, and pass through a 40-mesh sieve . The bromocriptine obtained after sieving is evenly divided into 20 equal parts according to the mass; the chitosan is evenly divided into 20 equal parts according to the mass; First take bromocriptine, chitosan and 9 parts of the 20 parts obtained by pregelatinized starch, mix, and mix evenly with a frequency of 20 times / second for 10 minutes; then add bromocriptine, chitosan 5 parts in the 20 parts of pregelatiniz...
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