Method for drying hydrocortisone sodium succinate asepsis powder

Abstract

The invention discloses a method for drying hydrocortisone sodium succinate asepsis powder, which comprises the following steps: delivering filtered hydrocortisone sodium succinate water solution into a temperature control tank, delivering the water solution after passing through a second precision filter into a spray drying tower, atomizing the water solution through an atomizer, and contacting the water solution with hot aseptic air to be dried. The top inside the spray drying tower is provided with a hot air distributor which comprises an inner pipe and an air deflector, the lower part of the air deflector is bent to one side, the outer surface of the tower wall of the spray drying tower is provided with a tower wall shaking device, one end of a dust discharge pipe is connected with an air hammer chamber, the other end of the dust discharge pipe is arranged outside a sterile room, the air hammer chamber is hermetically connected with the tower wall of the spray drying tower, and the dried hydrocortisone sodium succinate asepsis powder is discharged from a discharge hole at the bottom of the spray drying tower and collected by a cyclone separator. The method strictly ensures asepsis of liquid medicine, ensures even drying of materials, avoids dust pollution, and strictly ensures the cleanliness of the sterile room.

Description

technical field [0001] The invention belongs to the field of preparation of chemicals, in particular to a method for drying hydrocortisone sodium succinate sterile powder. Background technique [0002] The hydrocortisone sodium succinate aqueous solution prepared by chemical synthesis can be prepared into hydrocortisone sodium succinate sterile powder by several methods. Such as the vacuum freeze-drying method, the method is to freeze-dry a certain concentration of hydrocortisone sodium succinate solution to obtain solid block-shaped hydrocortisone sodium succinate, and then pulverize and screen to obtain a powder product. This method has the following disadvantages in the production process: (1) the production process requires high-power refrigeration equipment to cool down the liquid medicine in the freezer, which consumes a lot of energy, and the production cost is high, and the drying time is long and the drying efficiency is low. (2) Since the weight loss on drying of ...

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Problems solved by technology

This method has the following disadvantages in the production process: (1) the production process requires high-power refrigeration equipment to cool down the liquid medicine in the freezer, which consumes a lot of energy, and the production cost is high, and the drying time is long and the drying efficiency is low. (2) Since the weight loss on drying of hydrocortisone sodium succinate itself is ≤1%, and the hygroscopicity is relatively high, the pulverization process may cause the phenomenon that the moisture content increases, and it is easy to be contaminated with bacteria, so it is difficult to ensure sterility and no heat Therefore, the requirements for the environment are quite strict, and a sterile environment with extremely low humidity must be guaranteed.

(3) For secondary crushing, the use of mechanical power transmission will cause the increase of related substances, resulting in a decline in product quality, and the entire production process is discontinuous

[0004] At present, there are several deficiencies in the spray drying of sterile drugs. First, the initial material is filtered before entering the atomizer. During the filtering process, the material is easily affected by the ambient temperature, resulting in unstable physical and chemical properties.

The second is that the air deflector of the hot air distributor of the general spray drying tower is a straight plate setting. This air deflector can cause heat concentration in the hot air, and the material will be partially overheated and cause partial coking. At the same time, some products have excessive moisture content. affect product quality

The third is that the air hammer chamber of the tower wall vibration device outside the drying tower is connected to the tower wall. When the air hammer swings in the air hammer chamber and hits the tower wall, the formed air flow drives the vibrating iron dust through the air hammer chamber and the tower wall. The air outlets between them diffuse into the aseptic room, causing dust pollution to the aseptic production environment, resulting in a decrease in the cleanliness of the aseptic environment

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