Sodium hyaluronate gel injection for bone joint cavity and preparation method thereof
A technology of sodium hyaluronate and cross-linked hyaluronic acid, which is applied in the fields of anti-inflammatory agents, bone diseases, aerosol delivery, etc., and can solve the problem of unconfirmed cross-linking agent residues and residual BDDE in cross-linked sodium hyaluronate Detection, BDDE cannot be removed and other problems, to achieve the effect of improving the cross-linking reaction rate and conversion rate, no residual cross-linking agent, and slow degradation speed
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Embodiment 1）
[0058] The reagents used in this example are all pharmaceutical grade.
[0059] The preparation method of the sodium hyaluronate gel injection for bone and joint cavity of the present embodiment comprises the following steps:
[0060] ① Preparation of cross-linked sodium hyaluronate gel.
[0061] a. To a certain weight of white sodium hyaluronate (structural formula such as figure 1 As shown) add 500mL of a mixed solution consisting of 15wt% sodium hydroxide aqueous solution and acetone to the dry powder, or add a certain weight of white hyaluronic acid to 500mL of a mixed solution composed of 15wt% sodium hydroxide aqueous solution and acetone sodium hyaluronate dry powder; the average molecular weight of the sodium hyaluronate is 500,000 to 1.6 million Daltons (1.5 million Daltons in this example); stirring to evenly disperse the sodium hyaluronate to obtain a sodium hyaluronate base Suspension, that is, sodium hyaluronate is partially dissolved in a mixed solution of sod...
Embodiment 2）
[0114] The preparation method of the sodium hyaluronate gel injection for bone and joint cavity of the present embodiment comprises the following steps:
[0115] ① Preparation of cross-linked sodium hyaluronate dry powder.
[0116] a. To a certain weight of white sodium hyaluronate (structural formula such as figure 1 As shown) add 500mL of a mixed solution consisting of 15wt% sodium hydroxide aqueous solution and acetone to the dry powder, or add a certain weight of white hyaluronic acid to 500mL of a mixed solution composed of 15wt% sodium hydroxide aqueous solution and acetone sodium hyaluronate dry powder; the average molecular weight of the sodium hyaluronate is 500,000 to 1.6 million Daltons (1.5 million Daltons in this example); stirring to evenly disperse the sodium hyaluronate to obtain a sodium hyaluronate base Then add 11.1mL of cross-linking agent 1,4-butanediol diglycidyl ether (BDDE) to the sodium hyaluronate alkaline suspension, and mix well to obtain the reac...
Embodiment 3）
[0132] The rest of the preparation method of the sodium hyaluronate gel injection for bone and joint cavity is the same as that of Example 1, except that:
[0133] In step ③, the cross-linked sodium hyaluronate gel obtained by the method of step ① is 28.8g, and the sodium hyaluronate gel prepared by the method of step ② is 19.2g. The mass ratio of the two is 6:4.
[0134] In vitro cytotoxicity test, enzyme resistance test and rheological index test were carried out on the sodium hyaluronate gel injection prepared in this example.
[0135] (1) In vitro cytotoxicity test. According to the method for in vitro cytotoxicity detection in Example 1, the measured RCR is 87.5%, and the cytotoxicity is low.
[0136] (2) Enzyme resistance test. According to the method for detecting enzyme resistance in Example 1, a / b=0.46 was measured.
[0137] (3) Detection of heavy metal content in the gel. According to the detection method of heavy metal content in Example 1, the heavy metal cont...
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