A kind of preparation method of sterile injectable material
A technology of hyaluronic acid and vitamins, applied in the field of preparation of sterile injectable materials, can solve problems such as affecting application and poor plasticity
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Embodiment 1
[0020] Example 1: Preparation of cross-linked hyaluronic acid gel
[0021] Take 3g of high-molecular-weight hyaluronic acid (1.0MDa) and 1g of low-molecular-weight hyaluronic acid (0.4MDa) and dissolve them in 50ml of an aqueous solution with a pH of 8.5, and add 1,4-butanediol glycidyl ether twice for cross-linking. , The final concentration of 4-butanediol glycidyl ether is 0.001M. The cross-linking process has two downward pressures and two horizontal forces for 10 minutes each. Then neutral physiological isotonic phosphate buffer is swollen to pH 7.2 under the condition of 4-8 DEG C to remove uncross-linked cross-linking agent, and the cross-linking degree of the cross-linked product is 2.5%. Homogenize at 4-8°C to form uniform cross-linked hyaluronic acid gel particles, which are then divided into four equal portions.
Embodiment 2
[0022] Example 2: Preparation of sterile injectable hyaluronic acid gel
[0023] Get 0.2g high molecular weight hyaluronic acid (1.6MDa) and dissolve in 5ml neutral physiological isotonic phosphate buffer to form free hyaluronic acid solution, add 250mg vitamin C magnesium phosphate (MAP). The prepared solution was added to a portion of the product of Example 1 at a ratio of 1:49, and then manually stirred and mixed. 130°C, 4min damp heat sterilization. The performance parameters of the hyaluronic acid gel prepared in Example 2 are shown in Table 1, wherein the pushing force is measured at a pushing speed of 10.5mm / min through a disposable syringe with a 30G needle.
[0024] Table 1.
[0025]
[0026]
Embodiment 3
[0027] Example 3: Preparation of sterile injectable hyaluronic acid gel
[0028] Take 0.1g high molecular weight hyaluronic acid (4.0MDa) and add 15ml neutral physiological isotonic phosphate buffer, add 15mg lipoic acid. The prepared solution was added to a part of the product of Example 1 at a ratio of 3:7, and then 1% dextran was added, and then manually stirred and mixed. 130°C, 4min damp heat sterilization. The performance parameters of the hyaluronic acid gel prepared in Example 3 are shown in Table 2, wherein the pushing force is measured at a pushing speed of 12.5mm / min through a disposable syringe with a 27G needle.
[0029] Table 2.
[0030]
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