A kind of stable levoxiracetam sustained-release capsule and preparation method thereof
A sustained-release capsule and stable technology are applied in the field of stable levooxiracetam sustained-release capsules and their preparation, which can solve the requirements that the sustained-release preparation cannot be met, the release degree cannot be well controlled, and the product quality varies greatly, etc. The problem is that the preparation process is simple and feasible, the release speed is slow, and the number of doses is reduced.
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Embodiment 1
[0023] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:
[0024] Element Dosage Levoxiracetam 1 copy lactose 1.6 servings Hypromellose K4M 1.3 parts Hypromellose K15M 1.1 copies
[0025] carnauba wax 0.6 parts stearyl alcohol 0.12 parts 60% ethanol solution 2.0 copies
[0026] Make 1000 capsules
[0027] Preparation process:
[0028] 1. Pretreatment of raw and auxiliary materials: Take the main drug, slow-release matrix material and blocker in the prescription amount, mix and grind them into fine powder (the amount that can pass through the No. 5 sieve and the No. 6 sieve must not be less than the total 95% of the amount), sieved;
[0029] 2. Granulation: Add binder, mix and granulate with 18-mesh sieve, place the wet granules in a hot air oven, set the temperature at 40-60°C, dry until the moisture content of the granules is ≤3%, and g...
Embodiment 2
[0063] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:
[0064] Element Dosage Levoxiracetam 1 copy lactose 1.8 servings Carboxypropylmethylcellulose K4M 1.6 servings Carboxypropylmethylcellulose K15M 1.5 servings
[0065] carnauba wax 0.8 parts stearyl alcohol 0.16 parts 70% ethanol solution 2.3 servings
[0066] Make 1000 capsules
[0067] Preparation process: prepared according to the preparation process of Example 1. According to the test method of Example 1, the release measurement and the sample stability test were carried out respectively. The release measurement test results showed that levoxiracetam was released slowly, and the release time was as long as 12 hours. The release RSD of each sample at different time points Both are less than 5%, and the stability test results show that the quality of the sample is stable in June a...
Embodiment 3
[0069] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:
[0070] Element Dosage Levoxiracetam 1 copy lactose 1.7 servings Carboxypropylmethylcellulose K4M 1.5 servings Carboxypropylmethylcellulose K15M 1.3 parts carnauba wax 0.7 parts stearyl alcohol 0.13 parts 60% ethanol solution 2.1 parts
[0071] Make 1000 capsules
[0072] Preparation process: prepared according to the preparation process of Example 1. According to the test method of Example 1, the release measurement and the sample stability test were carried out respectively. The release measurement test results showed that levoxiracetam was released slowly, and the release time was as long as 12 hours. The release RSD of each sample at different time points Both are less than 5%, and the stability test results show that the quality of the sample is stable in June after acceleration, and th...
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