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Sulfamidine is a kind of sulfanilamide antibacterial drug. It is white or yellowish crystalline powder, odorless and slightly bitter. Slightly soluble in water, slightly soluble in ethanol, easily soluble in boiling water, acetone, methanol and dilute inorganic acids.

Sulfamidine is one of the early antibiotics used for intestinal infection, which can treat all kinds of bacillary dysentery and enteritis, and can also be used to prevent bacterial infection before intestinal surgery. At the same time, sulfamide is the first choice for the treatment of leprosy, which is suitable for the treatment of various types of leprosy and can improve the clinical symptoms. It can also be used to treat herpetic dermatitis, lupus erythematosus, psoriasis, foot mycosis and malaria.

The invention relates to an inclusion complex formed by the inclusion of drug sulfaamidine with sulfobutyl beta cyclodextrin sodium with different degrees of substitution, and a powder injection preparation formed by the corresponding inclusion complex. The powder injection preparation comprises a sulfonamide gland, different substituted sulfobutyl beta cyclodextrin and a drug excipient. The invention improves the water solubility of sulfamidine and realizes the expansion goal of preparing the corresponding water solution dosage form and powder injection dosage form of sulfamidine.

Betadex sulfobutyl ether sodium is also known as sulfobutyl ether beta cyclodextrin sodium salt. Betadex sulfobutyl ether sodium is the sulfonated modified sodium salt of beta cyclodextrin, also known as thiobutyl ether beta cyclodextrin sodium salt. It is an anionic high water-soluble cyclodextrin derivative, which can well form non covalent complex with drug molecules, thus improving the stability, water solubility, safety and stability of drugs It can reduce nephrotoxicity, alleviate drug hemolysis, control drug release rate and cover up bad smell.

Accurately weigh 0.2mol of sulfamidine API, dissolve it in boiling water to get the spare solution; weigh 0.1mol of Betadex sulfobutyl ether sodium with 1 degree of substitution according to the molar ratio of inclusion compound, and dissolve it in distilled water. Add the aqueous solution containing the drug into the above spare solution slowly, dilute 200ml with steaming water, adjust the ultrasonic frequency to 25kHz and the temperature to 60 ℃, After ultrasonic inclusion for 45 minutes, the mixture was cooled and frozen in a refrigerator at - 28 ℃ for 48 hours, and then freeze-dried in a freeze dryer to obtain a fluffy yellowish solid, i.e. sulfamidine Betadex sulfobutyl ether sodium inclusion complex with a molar ratio of 2:1.