Potassium citrate slow-release micro pill and preparation method thereof
A technology of slow-release pellets and potassium citrate, which is applied in the directions of bulk delivery, metabolic diseases, drug combination, etc., can solve the problems of improving the processing properties of pellets without surfactants, such as potassium citrate slow-release pellets, etc. To achieve the effect of low friability, high yield and controllable quality
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Embodiment 1
[0081] Embodiment 1: the main factor that affects the forming of pill core containing medicine
[0082] In this embodiment, in the case of the selected drug, the solubility of the active ingredient (vitamin C (0.2g / ml, easily soluble), potassium citrate (0.02g / ml, slightly soluble)), the excipient (microcrystalline cellulose), wetting agent (20% ethanol), surfactant (polysorbate 80), wetting time of soft material (min), extrusion frequency (HZ), sieve aperture (mm), 9 variables such as spheronization time (min), drying temperature (°C), and 2 dummy variables (Dummy) were designed in P-B experiment (N=12) to investigate the main factors affecting the formation of drug-containing pellet cores. Wherein, the amount of the active ingredient is the weight ratio of the active ingredient to (the sum of the active ingredient and the excipient), and the amount of the excipient is the weight ratio of the excipient to the (the sum of the active ingredient and the excipient). The amount o...
Embodiment 2
[0095] Embodiment 2: Surfactant is to the influence of important procedure in the processing of core containing pill
[0096] In this embodiment, vitamin C (easy to dissolve), taurine (dissolved), and bromamide hydrochloride (slightly soluble) were respectively used as active ingredients with microcrystalline cellulose (excipient), 20% ethanol (moisturized wet agent) to form the basic formula, adding and (active substance+excipient) weight percent is 0, 1, 2, 3, 4, 6, 7% surfactant (polysorbate 80 ) to form a series of formulas (the active ingredient of formula 1 is vitamin C, the active ingredient of formula 2 is taurine, and the active ingredient of formula 3 is bromamide hydrochloride), according to the "preparation method" and "process parameters" in the "example description" Prepare the bar, observe and calculate the shape of the bar and the yield per unit time, and drop the bar naturally into a 1-meter square plate, shake it gently and transfer it to an electric blast dr...
Embodiment 3
[0111] Containing pill core formula: parts by weight
[0112] Active ingredient: Potassium citrate 79.5 parts
[0113] Excipient 1: 20 parts of microcrystalline cellulose
[0114] Excipient 2: 0.5 parts of hypromellose
[0115] Surfactant: 2.5 parts of polyoxyethylene (40) hydrogenated castor oil
[0116]Wetting agent: 20 parts of 20% ethanol
[0117] Coating solution formula (taking the pill core as 100 parts by weight):
[0118] 10% Surelease 100 parts of water dispersion
[0119] Note: 10% Surelease The water dispersion is ethyl cellulose water dispersion (the same below).
[0120] Preparation process: Prepare three batches of micropills according to the "Example Description" and the above formula. The quality evaluation results are shown in Table 6 below, and the properties of the micropills are shown in Table 6. diagram 2-1 , 2-2 , 2-3.
[0121] Table 6: Ball core quality evaluation
[0122] Evaluation index / batch
[0123] Yield (Yd)
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