Pyridostigmine bromide syrup and preparation method thereof
A technology of pyridostigmine bromide and syrup, which is applied in the field of medicine, can solve problems such as susceptibility to diabetes, inattention, and decreased digestive function, and achieve the effect of ensuring quality stability, clear and transparent products, and easy swallowing and taking
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Embodiment 1
[0027] The preparation of embodiment 1 pyridostigmine bromide syrup of the present invention
[0028] 1. Preparation of 80% (g / mL) sucrose simple syrup: Weigh sucrose and add freshly prepared sterilized water, place in a water bath at 90°C, stir quickly with a glass rod until fully dissolved, wait for it to cool to room temperature, and mix evenly by ultrasonic , that is. Store in a refrigerator at 4°C and dilute with water when used.
[0029] 2. Preparation of 20% (g / mL) sodium benzoate solution and 20% (g / mL) citric acid solution: weigh sodium benzoate, add fresh sterilized water, fully dissolve, add water to the mark, and dilute to 20% Sodium benzoate solution. A 20% citric acid solution was prepared in the same way, and the two were prepared and stored at 4°C for future use.
[0030] 3. Preparation of pyridostigmine bromide syrup: Accurately weigh 7.5 g of PB (pyridostigmine bromide) crude drug in a beaker, add water to dissolve, add water to make up to 25 mL.
[0031]...
Embodiment 2
[0033] The screening of embodiment 2 auxiliary material of the present invention
[0034] 1. Preparation of stock solutions of various excipients
[0035] 1. Preparation of pyridostigmine stock solution: Weigh 7.5g of pyridostigmine crude drug, accurately weigh it, put it in a 25ml sterilized volumetric flask, add an appropriate amount of newly prepared sterilized water to dissolve, add water to the mark, and set Allow. The final concentration is 300mg / ml.
[0036] 2. Preparation of simple syrup: Weigh 400.0g of sucrose into a 500ml sterilized beaker, add an appropriate amount of freshly prepared sterilized water, place in a water bath at 90°C, stir quickly with a glass rod until fully dissolved, and transfer to a 500ml volumetric flask , wait for it to cool to room temperature, add water to dilute the scale mark, and ultrasonically mix to obtain 80% (g / ml) simple syrup, and its relative density (25° C.) is measured to be 1.308, which meets the requirements.
[0037] 3. The...
experiment example 1
[0067] Experimental example 1 stability experiment of pyridostigmine bromide syrup of the present invention
[0068] The syrup prepared according to Example 1 was placed at 4°C for 6 months, and its stability was investigated from aspects such as appearance, pH, and content. The results are shown in Table 1:
[0069] time
[0070] Experimental results: After the pyridostigmine bromide syrup of the present invention was placed at 4°C for 6 months, it became clear and transparent, and the appearance, color, pH and content of the main drug did not change significantly, indicating that its quality was stable.
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