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A technology of dexamethasone sodium phosphate and freeze-dried powder injection, applied in the field of biomedicine, can solve the problems of intractable drug concentration, obvious systemic side effects, etc., achieve good therapeutic effect, and reduce the interaction, types and uses of drugs. small amount of effect
Active Publication Date: 2021-03-19
和舆(苏州)医药科技有限公司
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Problems solved by technology
However, for the treatment of inner ear diseases, the main problems in the traditional systemic administration mode (oral, intravenous): firstly, the existence of the blood-labyrinth barrier makes it difficult for the drug to reach the therapeutic concentration in the inner ear; secondly, the systemic side effects are obvious
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Embodiment 1
[0112] Example 1 Formulation and preparation method of sodium phosphate injection
[0113] Table 2
[0114]
[0115] Preparation:
[0116] (1) Water dissolves the phosphate buffer of pH 8.0 in injection of 90% of the amount of phosphate sodium hydrogen phosphate and sodium phosphate.
[0117] (2) Sodium dexamethasone phosphate, EDTA-2NAcA is added to (1), and the pH is stirred, and the pH is determined, and the pH is adjusted to 8.0 ± .005;
[0118] (3) Set to 50mL in the bottle, shake well;
[0119] (4) Filter the chemical solution, dispensed into a 3ml Willlin bottle, 1 mL per bottle, to apply a freeze-drying technology to a sterile powder, ie
[0120] (5) The obtained sterilized powder is a white loose block;
[0121] (6) The full control temperature during the preparation is room temperature.
Embodiment 2
[0122] Example 2 Formulation and preparation method of sodium sodium phosphate injection
[0123] table 3
[0124]
[0125] Preparation:
[0126] (1) Cooling water in the injection to room temperature;
[0127] (2) Sodium dexamethasone phosphate, EDTA-2NAcA is dissolved with water, and the pH adjusting agent is adjusted to 8.0 ± 0.05;
[0128] (3) Set to full amount, shake well;
[0129] (4) Compositilory Silter filtration, use freeze-drying technology to make the liquid into a sterile powder, dispensed into a 3ml Willin bottle, 1ml per bottle,
[0130] (5) The obtained sterilized powder is a white loose block;
[0131] (6) The full control temperature during the preparation is room temperature.
Embodiment 3
[0132] Example 3 Formulation and preparation method of sodium sodium phosphate injection
[0133] Table 4
[0134]
[0135] Preparation:
[0136] (1) Water dissolved with water injection of sodium dexamethasone phosphate and excipients;
[0137] (2) Adjust the drug solution PH to 8.0 ± 0.05 with 0.1 M HCl;
[0138] (3) Filter filtration, dispensed into 3ml Willlin bottle, 1 mL per bottle, to apply freeze-drying technology to a sterile powder, ie
[0139] (4) The resulting sterile powder is a white loose block;
[0140] (5) The full control temperature during the preparation is room temperature.
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Abstract
The invention belongs to the field of biological medicine, and relates to a freeze-dried powder injection containing dexamethasone medicine. The freeze-dried powder injection provided by the inventionis a dexamethasone drug freeze-dried powder injection which does not contain a freeze-drying supporting agent or an excipient or a bracket agent. Through intratympanic administration of the freeze-dried powder injection, on one hand, the toxic and side effects of oral administration on the whole body can be reduced, and the injection plays a role in focus parts; and on the other hand, compared with common hydro-acupuncture, the injection can effectively prevent medicine hydrolysis, and the bioavailability of the medicine is improved. The freeze-dried powder injection provided by the inventiondoes not need a bracket agent, and has osmotic pressure more suitable than that of a commercially available dexamethasone sodium phosphate injection, deposition of excessive auxiliary materials in middle ears and damage of hypertonic fluid to local tissues are avoided, and the safety of intratympanic administration can be improved. Besides, the variety and dosage of auxiliary materials required by the freeze-dried powder preparation prepared by the invention are both small, which reduces the mutual action of the medicines, and guarantees good safety in industrial production and clinical medication.
Description
[0001] The application date of the application for this apartment is June 15, 2020, and the application number is 20,2010,543814.5, and the invention is "a dexamethasone phosphate sodium phosphate." Technical field [0002] The invention belongs to the field of biopharmaceutical, involving a lyophilized powder injection containing dexamethasone drug. Background technique [0003] In recent years, glucocorticoids have been widely used in the treatment of various inner ear diseases, such as deafness, Meisi disease and acute meningitis. The sudden deafness is a sudden non-volatile sensible neurological deafness, which is inhautive, fast, can lead to sudden decline in patient hearing within minutes, hours, or 3 days. Common accompanying symptoms are mainly tinnitus and dizziness. The cause of sudden deafness has not been completely clear, the main causes are: internal ear microcirculation, specific infection, immunogenic factors and mental psychological factors. Acute deafness is simi...
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