Stilbene glucoside medical composition and preparation method thereof
A technology of stilbene glycosides and compositions, which is applied in the field of medicine, can solve problems such as obstacles to the development of finished medicines and difficulties in pharmaceutical compositions, and achieve the effects of convenient and feasible preparation methods and improved stability
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Embodiment 1
[0028] Example 1 Effect of Carbohydrates on the Stability of Stilbene Glycoside Pharmaceutical Compositions
[0029] Six batches of stilbene glycoside freeze-dried powder were prepared according to the following method with stilbene glycoside as the active ingredient (content: 99.46%).
[0030] 5.0 g of stilbene glycosides, 0.1 g of sodium bisulfite, 0.1 g of disodium edetate, and 50.0 g of lactose were dissolved in 500 ml of water for injection to form a uniform solution. The 500ml solution is divided into 5 equal parts, that is, sample 1 to sample 5, 100ml / part, sample 1 does not add pH regulator hydrochloric acid, and sample 2 to sample 5 uses 1N hydrochloric acid to adjust the pH value to 6.0, 5.0, 4.0, 3.0 respectively.
[0031] 1.0 g of stilbene glycoside, 0.02 g of sodium bisulfite, and 0.02 g of disodium edetate were dissolved in 100 ml of water for injection, and the pH value was adjusted to 4.0 with 1N hydrochloric acid, which was sample 6.
[0032] Each batch of sa...
Embodiment 2
[0037] Example 2 The influence of pH value on the stability of the stilbene glycoside pharmaceutical composition
[0038] With stilbene glycoside as the active ingredient (content 99.46%), 5 batches of stilbene glycoside freeze-dried powder were prepared according to the following method.
[0039] 5.0 g of stilbene glycosides, 0.1 g of sodium bisulfite, 0.1 g of calcium sodium edetate, and 30.0 g of mannitol were dissolved in 500 ml of water for injection to form a uniform solution. 500ml solution is divided into 5 equal parts, i.e. sample 1 to sample 5, 100ml / part, adjust the pH value to 5.5, 5.0, 4.5, 4.0, 3.5 with 10% phosphoric acid and 10% sodium phosphate solution respectively.
[0040] Each batch of solutions was divided into 10ml vials (2ml / bottle), freeze-dried by a freeze dryer, filled with nitrogen, and capped.
[0041] The prepared freeze-dried sample was subjected to an accelerated test at 40±2°C and RH75%±5%. After 60 days, the properties of the sample were obse...
Embodiment 3
[0045] Example 3 Effects of antioxidants and metal complexes on the stability of the stilbene glycoside pharmaceutical composition
[0046] Using stilbene glycoside as the active ingredient (content 99.46%), 4 batches of stilbene glycoside freeze-dried powder injections were prepared as follows.
[0047] 3.0 g of stilbene glycosides, 0.3 g of vitamin C, 0.3 g of calcium sodium edetate, and 30.0 g of lactose were dissolved in 300 ml of water for injection to form a uniform solution. The 300ml solution was equally divided into 3 equal parts, that is, sample 1 to sample 3, 100ml / part, and the pH value was adjusted to 5.0, 4.5, 4.0 with 10% citric acid and 10% sodium citrate solution respectively.
[0048] 1.0 g of stilbene glycosides and 10.0 g of lactose were dissolved in 100 ml of water for injection, and the pH value was adjusted to 4.5 with 10% citric acid and 10% sodium citrate solution, which was sample 4.
[0049] Each batch of solutions was divided into 10ml vials (2ml / b...
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