摘要：【中文】本发明提供了一种卡巴他赛注射液，按质量计，包括以下组分：卡巴他赛10份、聚山梨酯80 200‑270份、聚乙二醇400‑500份和乙醇定容至1000份。产品稳定性良好，易过滤灌装，且在临床中使用方便。 【EN】The invention provides a cabazitaxel injection which comprises the following components in parts by mass: 10 parts of cabazitaxel, 270 parts of polysorbate 80200-. The product has good stability, is easy to filter and fill, and is convenient to use in clinic.

摘要：【中文】本发明公开了一种注射用卡非佐米冻干制剂的生产工艺，包括如下步骤：在室温下，向配液罐中加入注射用水，再加入150~200重量份磺丁基‑β‑环糊精，搅拌至溶解；加入2.5~4重量份无水枸橼酸，搅拌至溶解，对溶液充入氮气；在搅拌的条件下加入3~4重量份原料药，搅拌并超声至溶解，降低药液温度至2~8℃；缓慢加入NaOH溶液调节pH值，用注射用水定容至1000重量份；配液完成后，立即将药液预过滤至一缓冲罐中，并顶空充氮保压；除菌过滤，无菌灌装，冻干，氮气复压、卸料轧盖，制得成品。通过对工艺工序中对氧气、配液温度和工艺时限的控制，生产的产品内毒素低，杂质低，稳定性好。 【EN】The invention discloses a production process of a carfilzomib freeze-dried preparation for injection, which comprises the following steps of adding water for injection into a liquid preparation tank at room temperature, adding 150-200 parts by weight of sulfobutyl- β -cyclodextrin, stirring until the mixture is dissolved, adding 2.5-4 parts by weight of anhydrous citric acid, stirring until the mixture is dissolved, filling nitrogen into the solution, adding 3-4 parts by weight of raw material medicines under the stirring condition, stirring and ultrasonically dissolving, reducing the temperature of the liquid medicine to 2-8 ℃, slowly adding NaOH solution to adjust the pH value, fixing the volume to 1000 parts by weight by using water for injection, immediately pre-filtering the liquid medicine into a buffer tank after liquid preparation is completed, filling nitrogen into the buffer tank at the top, keeping the pressure, sterilizing, filtering, aseptically filling, freeze-drying, re-pressing nitrogen, discharging and capping, and preparing a finished product.

摘要：【中文】本发明公开了一种阿糖胞苷注射液，按质量计，包括阿糖胞苷10‑30份、苯甲醇5‑10份、氯化钠1‑5份、碳酸氢钠1‑5份和注射用水定容至1000份。通过加入渗透调节剂，并优化制剂制备开发工艺，可以有效的预防注射过程中存在的安全风险，且生产出产品稳定性优于原研品的产品。 【EN】The invention discloses an cytarabine injection which comprises, by mass, 10-30 parts of cytarabine, 5-10 parts of benzyl alcohol, 1-5 parts of sodium chloride, 1-5 parts of sodium bicarbonate and water for injection with the constant volume of 1000 parts. By adding the osmotic adjusting agent and optimizing the preparation and development process of the preparation, the safety risk in the injection process can be effectively prevented, and the product with the product stability superior to that of the original product is produced.

摘要：【中文】本发明公开了一种注射用盐酸美法仑冻干制剂，按质量计，包括以下组分：盐酸美法仑25‑30份、聚维酮8‑12份、枸橼酸0.5‑0.7份、盐酸4‑6份和注射用水定溶至1000份。还提供了注射用盐酸美法仑冻干制剂的制备方法，显著加快产品的复溶时间，减小给药风险。 【EN】The invention discloses a melphalan hydrochloride freeze-dried preparation for injection, which comprises the following components in parts by mass: 25-30 parts of melphalan hydrochloride, 8-12 parts of povidone, 0.5-0.7 part of citric acid, 4-6 parts of hydrochloric acid and 1000 parts of water for injection. Also provides a preparation method of the melphalan hydrochloride freeze-dried preparation for injection, which remarkably accelerates the redissolution time of the product and reduces the administration risk.

摘要：【中文】本发明公开了一种注射用达托霉素冻干粉针，按质量计，包括达托霉素70‑100份、有机溶剂5‑15份和注射用水定容至1000份。通过加入少量有机溶剂，产品稳定性高、外观均一且复溶时间短。 【EN】The invention discloses a daptomycin freeze-dried powder injection for injection, which comprises 70-100 parts of daptomycin, 5-15 parts of organic solvent and water for injection with constant volume of 1000 parts by mass. By adding a small amount of organic solvent, the product has high stability, uniform appearance and short redissolution time.

摘要：【中文】本发明公开了一种注射用盐酸托泊替康冻干制剂的制备方法，包括如下步骤：准备10000重量份的注射用水，并充入氮气；向注射用水中加入288重量份的甘露醇，搅拌至溶解；再加入120重量份的酒石酸，搅拌至溶解；加入26重量份的盐酸托泊替康，搅拌至溶解；调节药液pH值，用注射用水定容至12000重量份的药液；将药液预过滤至一缓冲罐中，并顶空充氮保压；除菌过滤、无菌灌装，上料、冻干；氮气复压、卸料轧盖，制得成品。提高了药液稳定性，延长了药液存放时限。进而可以扩大单批生产批量，降低产品单支成本，让更多的患者用得上，更可及。 【EN】The invention discloses a preparation method of a topotecan hydrochloride freeze-dried preparation for injection, which comprises the following steps: 10000 parts by weight of water for injection are prepared and nitrogen is filled; 288 parts by weight of mannitol is added into the water for injection and stirred until the mannitol is dissolved; adding 120 parts by weight of tartaric acid, and stirring until the tartaric acid is dissolved; adding 26 parts by weight of topotecan hydrochloride, and stirring until the topotecan hydrochloride is dissolved; adjusting the pH value of the liquid medicine, and fixing the volume to 12000 parts by weight of the liquid medicine by using water for injection; pre-filtering the liquid medicine into a buffer tank, and filling nitrogen into the headspace for pressure maintaining; sterilizing, filtering, aseptic filling, loading and freeze-drying; and (4) carrying out nitrogen repression, discharging and capping to obtain a finished product. The stability of the liquid medicine is improved, and the storage time limit of the liquid medicine is prolonged. Further, the batch production of single batch can be enlarged, the cost of single product is reduced, and more patients can use the product more conveniently.