Method for manufacturing Parenteral formulation using bamboo salt

• Main Authors: KIM HYUNG HOI, HWANG YE JIN, KIM HYEONG SOO, PYO JAE SUNG, PARK MIN HI, KANG JAE SEON, KIM HEON WOO
• Format: Patent
• Language: English; Korean
• Published: 05.01.2023
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The present invention relates to a method of manufacturing a preparation for parenteral administration using bamboo salt and, more specifically, to a method of manufacturing a preparation for parenteral administration using bamboo salt, comprising the steps of: mixing bamboo salt, basic amino acid, and purified water, adjusting the pH of the mixture to 7.0 to 9.0, and then performing a first sterilized bamboo salt solution by perform high-pressure steam sterilization for the mixture; performing purification for aseptically filtering the first sterilized bamboo salt solution to remove precipitates; mixing an ionic preservative with purified water and then performing high-pressure steam sterilization for the mixture to prepare a preservative mixture; preparing a second sterilized bamboo salt solution by aseptically mixing the purified first sterilized bamboo salt solution and the preservative mixture; and aseptically sealing the second sterilized bamboo salt solution. The stability for the preparation for parenteral administration can be enhanced. 본 발명은 죽염을 이용한 비경구투여용 제제의 제조방법에 관한 것으로, 보다 구체적으로는, 죽염, 염기성 아미노산 및 정제수를 혼합하고 pH를 7.0~9.0으로 조절한 후, 고압증기멸균하여 제1 멸균죽염액을 제조하는 단계; 상기 제1 멸균죽염액을 무균적으로 여과하여 침전물을 제거하는 정제단계; 이온성 보존제와 정제수를 혼합한 후, 고압증기멸균하여 보존제혼합액을 제조하는 단계; 상기 정제된 제1 멸균죽염액과 보존제 혼합액을 무균적으로 혼합하여 제2 멸균죽염액을 제조하는 단계; 및 상기 제2 멸균죽염액을 무균적으로 밀봉하는 단계를 포함하여 이루어지는, 죽염을 이용한 비경구투여용 제제의 제조방법을 개시한다.