Method for preparing bendamustine hydrochloride freeze-dried powder injection
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A technology of bendamustine hydrochloride, freeze-dried powder injection, applied in the field of preparation of bendamustine hydrochloride freeze-dried powder injection, can solve the problems of high toxicity, increased production cost, poor safety, etc., and reach the content of related substances Low cost, save testing cost, reduce production cost
Inactive Publication Date: 2010-09-22
PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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[0003] The freeze-dried powder injection of bendamustine hydrochloride for injection listed in the United States and Germany is prepared according to its unstable properties in water. Chinese patent CN101119708A discloses the preparation method of freeze-dried powder injection of bendamustine hydrochloride According to the unstable properties of bendamustine hydrochloride in water, the
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Embodiment 1
[0063] Add bendamustine hydrochloride and lyophilized excipients into water for injection at 30°C, dissolve, quickly add water for injection at 10°C, mix well, turn on the cooling system, cool the liquid rapidly at 10°C, adjust the pH value, pH When the value is 2.0, add activated carbon, stir, filter out the activated carbon, filter, fill, freeze-dry, and obtain.
Embodiment 2
[0065] Add bendamustine hydrochloride and lyophilized excipients into water for injection at 50°C, dissolve, quickly add water for injection at 0°C, mix well, turn on the cooling system, quickly cool the liquid to 0°C, and adjust the pH value, pH When the value is 2.0, add activated carbon, stir, filter out the activated carbon, filter, fill, freeze-dry, and obtain.
Embodiment 3
[0067] Add bendamustine hydrochloride and freeze-dried excipients into water for injection at 30°C, dissolve, quickly add water for injection at 0°C, mix well, turn on the cooling system, quickly cool the liquid to 0°C, and adjust the pH value, pH When the value is 2.0, add activated carbon, stir, filter out the activated carbon, filter, fill, freeze-dry, and obtain.
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Abstract
The invention discloses a method for preparing bendamustine hydrochloride freeze-dried powder injection, which is characterized by comprising the following steps of: adding the bendamustine hydrochloride and a freeze-dried excipient into water for injection with the temperature of between 30 and 50 DEG C, dissolving, and rapidly adding the water for injection with the temperature of between 0 and10 DEG C; mixing uniformly, starting a cooling system, and rapidly cooling the liquid medicament to the temperature of between 0 and 10 DEG C; adjusting the pH value to between 2.0 and 3.0, adding active carbon, stirring, filtering the active carbon, filtering, filling, and freeze-drying to obtain the freeze-dried powder injection. In the technical method, organic solvents are not added and only water is used as the solvent; the pH value and temperature are controlled; and the preparation-related substance has low content.
Description
technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of bendamustine hydrochloride freeze-dried powder injection. Background technique [0002] Bendamustine hydrochloride is a bifunctional alkylating agent. Its pharmacological effect is to cross-link DNA single-strand and double-strand through alkylation, interfere with DNA function and DNA synthesis, and thus play an anti-tumor effect. Bendamustine hydrochloride can be used to treat various malignant tumors such as Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, chronic lymphocytic leukemia (CLL) and breast cancer. The effective rates of non-Hodgkin's lymphoma treatment are 61%-97% and 41%-48%, respectively, and can be used alone or in combination: in the cyclophosphamide / vincristine / prednisone regimen, bendamole Stine replaces cyclophosphamide, and has similar curative effect on the development of non-Hodgkin's lymphoma with low toxicity; for p...
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IPC IPC(8): A61K9/19A61K31/4184A61K47/10A61P35/00
Inventor 顾群金治刚孙学伟徐春霞王东孙德杰
Owner PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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