36 results about "Dexrazoxane" patented technology

The present invention provides a method of treating conditions associated with iron and calcium overload comprising administering an effective amount of dexrazoxane or a non-dexrazoxane compound of formula (IA), (IB), or (IC) or a pharmaceutically acceptable salt, tautomer, or stereoisomer thereof.

This disclosure provides methods and pharmaceutical compositions for reducing or eliminating cardiotoxicity, particularly cardiotoxicity induced by a cancer treatment or other therapy. In some cases, the methods and compositions prevent or reduce cardiotoxicity caused by anthracycline treatment. The methods provided herein often comprise administering a protective agent such as myricetin, tricetin, robinetin, ficetin, vitexin, quercetin, dihydrorobinetin, kaempferol, 7,3′,4′,5′-tetrahydroxyflavone, and myricitrin in conjunction with the administration of a cancer drug or other treatment. They may comprise administering a protective agent in combination with dexrazoxane. The compositions provided herein include co-formulations of a protective agent with a different protective agent or with a cancer treatment (e.g., anthracycline drug).

A high performance liquid chromatography method used for dexrazoxane-related substances is provided, and in the method, a low-density bonding reversed-phase C18 chromatographic column resistant to pure water is employed; a gradient elution is carried out with mobile phase A and mobile phase B as eluents, the mobile phase A being a buffer, and the mobile phase B being an organic solvent; the volume percent of mobile phase A in eluents in a first stage of the gradient elution is not lower than 90%, and the duration of the first stage of the gradient elution ranges from 15˜30 minutes. By means of the analytical method, dexrazoxane is effectively separated from main impurities, and the qualities of the active pharmaceutical ingredients of dexrazoxane and the preparations thereof could be better controlled.

The invention relates to a dexrazoxane freeze-dried powder injection and the preparation method. The preparation is used for resisting the cardiac toxicity which is induced by the cumulate quantity of adriamycin. The dexrazoxane freeze-dried powder injection contains the active components of the dexrazoxane and hydrochloric acid, the weight proportion of which is 1 to 0.05 to 0.5, and the preferential proportion is 1 to 0.2 to 0.5. The preparation method is that the hydrochloric acid is put into an aseptic vessel; the water for injecting is added till 80 percent of the preparation quantity, and the temperature is reduced and kept at 2 to 6 DEG C; the dexrazoxane is added to be mixed, and the hydrochloric acid of 1.0mol/L is dripped slowly into the solution to be solved while mixing the solution; the water for injecting is added till the full quantity; active carbon of 0.3 percent is added for absorbing for thirty minutes, and then the solution is decarbonized; after the medium body content is mensurated as being eligible, the solution is filtered by a 0.22 micron-micropore filtering filer; the filtrate is filled into a 25ml cillin bottle according to the filling quantity of 10ml each bottle, and the bottles are partially plugged by buna plugs and filled onto a plate to be sent into a freeze-drying box; a temperature probe is inserted, and the box door is closed; the filtrate is warmed, sublimed and dried be stages; nitrogen is puffed; the plugs are pressed; the filtrate is taken out from the box for rolling the openings, detecting the quality and packaging and the preparation can be obtained.

The invention relates to the field of medicine, in particular relates to the fields of preparation and application of dexrazoxane, and more particularly relates to a dexrazoxane-containing composition and a preparation method thereof, and a dexrazoxane freeze-drying preparation and a redissolving solvent thereof. The dexrazoxane-containing composition is a solution consisting of dexrazoxane, hydrochloric acid, water and tertiary butanol, wherein the dexrazoxane concentration of the composition is 20 to 30 mg/mL. The dexrazoxane freeze-drying preparation provided by the invention has excellent stability and the preparation method is easy to industrialize.

Disclosed is an anticancer slow release agent which comprises slow release microspheres and dissolvent, wherein the slow release microballoons comprise anti-cancer active constituents and slow release auxiliary materials, the dissolvent being specific dissolvent containing suspension adjuvant. The anticancer antibiotics are selected from Idarubicin, Valtaxin, Pirarubicin and Mitoxantrone, The anti-metabolite drugs are selected from Pemetrexed, Carmustine, Tegafur, Zalcitabine, Emtritabine, Galocitabine, Ibacitabine, Ancitabine, Decitabine, Flurocitabine, Enocitabine, Imidazoletabine, Capecittabine, Gemcitabine, Fludrarbine, Raltitrexed, Dexrazoxane, Cladribine, Nolatrexed and folic acid, The slow release auxiliary materials are selected from EVAc, Polifeprosan, sebacylic acid copolymer, lactic acid, the viscosity of the suspension adjuvant is 100-3000cp (at 25-30 deg C), and is selected from sodium carboxymethylcellulose. The slow release microspheres can also be prepared into slow release implanting agent for injection or placement in or around tumor.

A freeze dried composition containing dexrazoxane is disclosed. Its preparing process is also disclosed, which features use of antioxidizing agent to make its product have high antioxidizing stability.

The present invention provides for use of an anthracycline, such as doxorubicin, alone or in combination with a protective agent, such as dexrazoxane, for treating multiple sclerosis.

The invention belongs to chemical synthesis pharmacy technology field, the invention provides a preparation method of medicine dexrazoxane which has a function of antitumor, the process includes: N,N-dichloroacetyl imine (II) is prepared by chloroacetonitrile in the presence of acid, then the (+)- dexrazoxane (I) is obtained by condensation of the N,N-dichloroacetyl imine (II) and the (+)-1,2-propanediamine (III), the obtained dexrazoxane is made into pharmaceutically acceptable salt. The method according to the invention has advantages of simple route, convenient operation, easy industrialization and short period, and the obtained product has high purity. Route of the process is shown in the upper right.

The invention provides a separation and detection method of a dexrazodone intermediate and impurities. The method comprises the following steps: (1) diluting dexrazodone containing the intermediates and the impurities by using a diluent to obtain a sample solution; and (2) detecting the sample solution by using a high performance liquid chromatograph, wherein a chromatographic column of the high performance liquid chromatograph is a CAPCELL PAK ADME chromatographic column. According to the separation and detection method disclosed by the invention, the dexrazodone intermediate M2, the intermediate M1, the impurity A, the impurity B, the impurity C, the impurity D, the impurity E and the impurity F can be effectively separated, good base line separation can be realized among peaks, when the flow velocity of a mobile phase or the column temperature of a chromatographic column is properly controlled, the peak separation degrees of most of the intermediates and the impurities are greater than 3.0, and an overall separation degree is high so that the quality of dexrazoxane and the intermediates thereof can be effectively controlled.

The present invention relates to a method of refining preparation of the right razoxane. The method comprises the mixing and stirring of the right razoxane crude and the C_1-3 alkyl alcohol of the weight of 2 to 20 times; the chloride hydrogen or the solution is added to adjust the pH value to be between 0.5 and 5; the solution is then filtered; the filter cake and the C_1-3 alkyl alcohol of the weight of 2 to 20 times are then mixed and stirred; the triethylamine is used to adjust the pH value to be between 7 and 10; the solution is then filtered; the C_1-3 alkyl alcohol is used to wash; the solution is filtered to be dry; the fine product of the right razoxane can be got after vacuum drying at the temperature between 30 and 60 DEG C. The refining method can effectively remove the color of the crude, and has the high product purity, the simple operation, the short production cycle, the high collection rate and the easiness for the industrial production.

The invention discloses a method for detecting dexrazodone and related substances thereof, dexrazodone and/or related substances in dexrazodone or a preparation thereof are qualitatively or/and quantitatively detected by adopting a high performance liquid chromatography method, and the detection conditions of liquid chromatography are as follows: a chromatographic column is C18 or an equivalent chromatographic column; and mobile phases comprise a mobile phase A and a mobile phase B, the mobile phase A is a phosphoric acid buffer solution, the mobile phase B is a mixed solution of the phosphoric acid buffer solution and acetonitrile in a volume ratio of (80-90): (10-20), and gradient elution is carried out. By adopting the method disclosed by the invention, the dexrazolone and nine related substances in the dexrazolone can be effectively detected at the same time, and verification experiments of system applicability, specificity, accuracy, precision, linear range, quantitation limit detection limit and durability show that the method can achieve the purpose of accurate quantitative analysis, and is beneficial to more strict quality control on the dexrazolone.

The invention discloses dexrazoxane related substances and a detection method thereof, and provides four new oxidation impurities of dexrazoxane: an oxidation impurity 1, an oxidation impurity 2, a chromogenic impurity 1 and a chromogenic impurity 2; the related substances are qualitatively or/and quantitatively detected by adopting a high performance liquid chromatography method; the detection conditions of the liquid chromatography comprise that a chromatographic column is C18 or an equivalent chromatographic column; mobile phases comprise a mobile phase A and a mobile phase B, wherein the mobile phase A is a phosphoric acid buffer solution, the mobile phase B is a mixed solution of the phosphoric acid buffer solution and acetonitrile in a volume ratio of (80-90):(10-20), and gradient elution is carried out. By adopting the method disclosed by the invention, nine related substances of dexrazoxane can be effectively detected at the same time, and verification experiments of system applicability, specificity, accuracy, precision, linear range, quantitation limit detection limit and durability show that the method can achieve the purpose of accurate quantitative analysis, and more strict quality control of dexrazoxane is facilitated.

The invention discloses a dexrazoxane preparation method. According to the preparation method, (S)-1,2-diaminopropane-tetraacetate and alkali metal salt thereof are used as raw materials, and ammoniumsalt is used as an ammonium source to prepare dexrazoxane. By the adoption of the preparation method, tedious technological operation is avoided, the technological operation is easier and more convenient, and therefore the preparation method is more adaptive to industrial amplifying production.

The invention discloses a lyophilized preparation containing dexrazodone and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. A solution for preparing the dexrazoxane freeze-dried preparation is composed of dexrazoxane, hydrochloric acid and water according to a certain proportion, the concentration of dexrazoxane is 30-40 mg/mL, and the pH value of the solution is 1.6-2.0. The invention further provides a method for preparing the dexrazoxane freeze-dried preparation, the dexrazoxane freeze-dried preparation is kept at the temperature of-55 DEG C to-60 DEG C for 4-5 hours, then a vacuum pump is started, the vacuum degree is reduced to be below 0.2 mbar, primary drying is carried out at the temperature of-25 DEG C to 15 DEG C, the primary drying time is 60-70 hours, finally, desorption drying is continued at the temperature of 0.15 mbar and the temperature of 25-35 DEG C, and the drying time is 5-10 hours. The prepared freeze-dried product has water content of less than 1%, has good stability and can be stored at room temperature.