Production method for suspension medicament
A production method and suspension technology, applied in drug combination, pharmaceutical formula, anti-infective drugs, etc., can solve problems such as drug hardening
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0028] Example 1: Preparation of Iodosulfamide suspension
[0029] The formula of iodlosamide suspension is as follows: every 100L of the suspension medicine contains 2kg iodoxamide (oral grade, CAS NO.22662-39-1), 225g sodium alginate (analytical grade, 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 dimethicone (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 scheme is a polymer material, and the viscosity of sodium alginate needs to be checked with reference to the requirements of "GB 1886.243-2016 National Food Safety Standard for Food Additives Sodium Alginate". The viscosity of sodium alginate can be used in this formula when the viscosity is between 600 and 800. .
...
Embodiment 2
[0037] Example 2 is basically the same as Example 1, except that the ingredients of the formula are changed (as shown in Table 1), and when making the sodium alginate solution, water at 70° C. is used to swell sodium alginate for 2 hours. Example 3-Example 5 are basically the same as Example 1, and the difference lies in the adjustment of formula and process parameters, as shown in Table 1 for details.
[0038] Comparative Example 1-Comparative Example 5 are basically the same as Example 1, and the difference lies in the adjustment of formula and process parameters, as shown in Table 2 for details. In Comparative Example 1-Comparative Example 5, suspending agents (thickeners) such as sodium carboxymethyl cellulose, xanthan gum (with dextran-70), starch (with dextran-20), polyglycol and dextran The dosage is the best dosage obtained after many experiments and tests.
experiment example 1
[0048] Sedimentation volume ratio: with reference to the detection method of sedimentation volume ratio in "Chinese Veterinary Pharmacopoeia" 2015 edition 0111 Oral Solution, Oral Suspension, Oral Emulsion, to detect the sedimentation volume of Examples 1-5 and Comparative Examples 1-12 Ratio (10 repetitions are set for each example or comparative example, n=10), the larger the sedimentation volume ratio of the specified sedimentation time (3h, 24h, 48h and 7 days, four sedimentation times are used in this experimental example), it means that the mixture is mixed. The better and more stable the suspension effect is, the experimental results are shown in Table 4-Table 6.
[0049] Detection of re-dispersion: take 500ml of the suspension in the above-mentioned embodiment and the comparative example, place it in a sample bottle (no repeat experiment is set), let stand for three months (all have different degrees of stratification), and then turn the sample bottle upside down. , ob...
PUM
Login to View More Abstract
Description
Claims
Application Information
Login to View More