59 results about "Penehyclidine hydrochloride" patented technology

The invention discloses a process for preparing a penehyclidine hydrochloride injection and belongs to the field of medicines. The specific preparation process of the injection is as follows: (1) treating inner packaging materials with acid in advance, then washing the inner packaging materials with purified water and water for injection and then pasteurizing and drying the inner packaging materials for standby application; (2) weighing penehyclidine hydrochloride based on the prescription dose, adding a defined amount of water for injection to dissolve penehyclidine hydrochloride, then adding water for injection to reach the total amount and stirring the liquid medicine uniformly; and (3) measuring the pH value and the content, filtering the liquid medicine after the pH value and the content are qualified, filling and sealing the filtrate in the inner packaging materials for standby application and carrying out pasteurization, thus obtaining the penehyclidine hydrochloride injection. The process has the following beneficial effects: not only can the pH value and content of the penehyclidine hydrochloride injection product obtained by the process be more stable, but also the product quality is more easily ensured; and meanwhile, the final product is proved to be safe and effective by animal long-term toxicity tests and pharmacodynamics tests.

The invention discloses a method for preparing a penehyclidine hydrochloride injection and belongs to the field of medicines. The specific preparation process of the injection is as follows: (1) washing inner packaging materials with purified water and water for injection and then pasteurizing and drying the inner packaging materials for standby application; (2) weighing penehyclidine hydrochloride based on the prescription dose, adding a defined amount of water for injection to dissolve penehyclidine hydrochloride, regulating the pH value of the liquid medicine to 4.6-4.8 with a pH regulator, then adding water for injection to reach the total amount and stirring the liquid medicine uniformly; and (3) measuring the pH value and the content, filtering the liquid medicine after the pH valueand the content are qualified, filling and sealing the filtrate in the inner packaging materials for standby application and carrying out pasteurization, thus obtaining the penehyclidine hydrochloride injection. The method has the following beneficial effects: not only can the pH value and content of the penehyclidine hydrochloride injection product obtained by the method be more stable, but alsothe product quality is more easily ensured; and meanwhile, the final product is proved to be safe and effective by animal long-term toxicity tests and pharmacodynamics tests.

The invention provides a method for purifying 3-(2-cyclopentyl-2-hydroxy-2-phenylethoxy) quinuclidine and preparing penehyclidine hydrochloride. The method comprises the following steps: (1) mixing 3-quinuclidinol with a dimethyl sulfoxide solution, and reacting with sodium hydride and a 1,1-phenyl amyl oxirane solution; (2) adding purified water and ethyl acetate to carry out extraction, collecting the organic phase, washing, carrying out back extraction with a hydrochloric acid solution, and collecting the water layer; (3) adjusting the pH value of the water layer to 5-7, washing the water layer by ethyl acetate, adjusting the pH value to 9-12 again, extracting the water layer by ethyl acetate, and collecting the organic phase; and (4) filtering, and carrying out reduced pressure concentration to obtain 3-(2-cyclopentyl-2-hydroxy-2-phenylethoxy) quinuclidine oil. According to the method, by separating and purifying 3-(2-cyclopentyl-2-hydroxy-2-phenylethoxy) quinuclidine, the yield and quality of a target product are improved, and a penehyclidine hydrochloride finished product with a high yield and high purity is obtained through one-step salifying crystallization.

The invention discloses a novel method for preparing a penehyclidine hydrochloride injection and belongs to the field of medical drugs. The preparation process of the injection comprises the following steps: (1) performing acid treatment on an inner package in advance, washing with pure water and water for injection, performing high-temperature sterilization and drying for later use; (2) weighing penehyclidine hydrochloride according to the prescription amount, adding a proper amount of water for injection for dissolving, regulating the pH of the liquid medicine to be 4.6-4.8 by using a pH regulator, adding the water for injection to the total amount, and uniformly stirring; (3) measuring the pH value and the content, filtering and encapsulating the water in the spare inner package after the water is qualified, and sterilizing at a high temperature to obtain the injection. The penehyclidine hydrochloride injection product prepared by the process method is stable in pH and content, and the product quality is easily guaranteed; meanwhile, the long-term animal toxicity test and pharmacodynamic test prove that the final product is safe and effective.

The invention discloses the application of penehyclidine hydrochloride in the treatment of septic shock in which microcirculation disturbance still exists after comprehensive treatment measures such as replenishing blood volume. Infection toxic shock referred to in the present invention refers to the shock caused by bacterial attack, and the effect of the present invention is proved by the effect of penhyclidine hydrochloride aqueous solution on microcirculation disorder caused by infectious toxic shock in rabbits.

The invention relates to a penhyclidine hydrochloride impurity and a preparation method thereof, belonging to the technical field of medicine. The penehyclidine impurity provided by the present invention is shown in formula I, and the impurity reference substance 3-(2-cyclopentyl-2-hydroxyl-2-phenylethoxy) quinine-1-oxide synthesis method provided , the synthetic raw materials are easy to obtain, the operation is simple and convenient, the cost is low, and it has good economic value.

The invention discloses an evaluation method of influences of penehyclidine hydrochloride to calcium ions in dysmenorrhea animal model cells. The method comprises the following steps: obtaining a blank cell suspension; adding oxytocin into the blank cell suspension, and mixing for acting for 5 to 15 minutes so as to obtain an animal model cell suspension; dividing the animal model cell suspension into three groups, and adding reagents in equal volume into three groups of animal model cell suspension, wherein one group is a positive control group in which a contrast reagent is added and acts for 10 to 20 minutes, one group is an experimental group in which penehyclidine hydrochloride in different doses is added and acts for the same time with the positive control group, and one group is a model group without adding the reagent; and contrasting differences of the concentration of the calcium ions in the cells of the experimental group with the concentration of the calcium ions in the cells of the model group and the positive control group. The embodiment of the invention can reveal the influences of penehyclidine hydrochloride to the concentration of the calcium ions in the dysmenorrhea animal model cells, and can ensure that the efficacy of penehyclidine hydrochloride in different concentrations is evaluated by contrasting the concentration of the calcium ions in the cells of the experimental group with the concentration of the calcium ions in the cells of the positive control group and the model group.

The invention discloses a detection method for determining two impurities in penehyclidine hydrochloride. In the method, high performance liquid chromatography (HPLC) is employed. Acetonitrile and 20 mmol / L monopotassium phosphate (containing 0.5% of triethylamine with the pH being adjusted to 3.0 through diluted phosphoric acid) are employed as a mobile phase. The contents of the impurities are determined through gradient elute. During determination, a solvent is prepared according to an initial mobile phase proportion, namely, the acetonitrile : the 20 mmol / L monopotassium phosphate (containing 0.5% of triethylamine with the pH being adjusted to 3.0 through diluted phosphoric acid) is 32:68. The penehyclidine hydrochloride is prepared into a sample solution through the solvent and an impurity referent substance solution is prepared through the same method to obtain the impurity referent substance solution. The sample solution, the impurity referent substance solution are injected directly. A chromatogram is collected and the contents of the impurities are calculated according to an external standard method according to the areas of peaks. The method is simple in operation, is high in sensitivity, can be used in quantitative determination, is high in accuracy and is good in reproducibility so that product quality of the penehyclidine hydrochloride can be effectively controlled and clinical medication is ensured to be safe and effective.

The invention provides an industrial production method of penehyclidine hydrochloride injection, wherein the penehyclidine hydrochloride injection is prepared by steps of adjusting pH to be not less than 4.0 and less than 4.6 by using an acid, filling and sterilizing. The industrial production method of penehyclidine hydrochloride injection provided by the invention is strong in industrialization operability; and the obtained injection is good in stability, and capable of effectively avoiding the quality changes of pH, related substances, content, related indexes and the like after being stored for a long time without the need of special storage conditions, thus bringing an effective guarantee for the safety and the clinical efficacy of the product.