Production method for a suspension drug
A production method and suspension technology, applied in drug combination, pharmaceutical formula, liquid delivery, etc., can solve problems such as drug hardening
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Embodiment 1
[0028] Embodiment 1: the preparation of iodother amylamine suspension
[0029] The formula of iodoxanamide suspension is: every 100L suspension drug contains 2kg iodoxanamide (oral grade, CASNO.22662-39-1), 225g sodium alginate (analytical pure, CAS NO.9005- 38-3), 10kg Tween-80 (analytical grade, CASNO.9005-65-6), 100g citric acid (oral grade, CAS NO.77-92-9), 100g sodium citrate (oral grade, CASNO. 68-04-2), 3L soybean oil (food grade, CAS NO.8001-22-7), 7L dimethyl silicone oil (food grade, CASNO.9006-65-9), 1000ml benzyl alcohol (analytical grade, CAS NO.100-51-6), the balance is water (distilled water or water for injection). The sodium alginate used in this program is a polymer material, and it is necessary to check the viscosity of sodium alginate according to the requirements of "GB 1886.243-2016 National Food Safety Standard Food Additive Sodium Alginate". The viscosity of sodium alginate can be used in this formula if the viscosity is between 600-800 .
[0030] Th...
Embodiment 2
[0037] Example 2 is basically the same as Example 1, except that the formula components are changed (as shown in Table 1), and when making the sodium alginate solution, 70°C water is used to swell the sodium alginate for 2 hours. Embodiment 3-Embodiment 5 are basically the same as Embodiment 1, the difference lies in the adjustment of formula and process parameters, see Table 1 for details.
[0038] Comparative Example 1-Comparative Example 5 are basically the same as Example 1, the difference lies in the adjustment of formula and process parameters, see Table 2 for details. In comparative example 1-comparative example 5, the suspension agent (thickening agent) such as sodium carboxymethyl cellulose, xanthan gum (combined with dextran-70), starch (coordinated with dextran-20), polyethylene glycol and dextran The dosages are the optimal dosages obtained after many experiments and tests.
experiment example 1
[0048] Sedimentation volume ratio: Refer to the detection method of sedimentation volume ratio in "Chinese Veterinary Pharmacopoeia" 2015 Edition 0111 Oral Solution, Oral Suspension, and Oral Emulsion to detect the sedimentation volume of Examples 1-5 and Comparative Examples 1-12 ratio (each embodiment or comparative example is provided with 10 repetitions, n=10), the sedimentation volume ratio of specified settling time (this experimental example adopts 3h, 24h, 48h and 7 days, four kinds of settling time) is bigger, shows that mixed The better the suspension effect and the more stable the suspension, the experimental results are shown in Table 4-Table 6.
[0049] Detection of redispersion: get the suspension 500ml in the above-mentioned embodiment and comparative example, place in the sample bottle (do not set repeated experiment), let stand for three months (all appear different degrees of stratification), then turn the sample bottle upside down , observe how many times th...
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