33 results about "Ranitidine hcl" patented technology

Solid oral dosage formulations, such as tablet, mini-tab, multiparticulates or osmotic delivery systems, are coated with a mucoadhesive polymeric coating or formed of a mucoadhesive polymer to increase oral bioavailability of Biopharmaceutical Classification System (BCS) Class I drugs. Representative BCS I drugs include valacyclovir, gabapentin, furosemide, levodopa, metformin, and ranitidine HCl. The inclusion of mucoadhesives in the solid oral dosage form brings the dosage form into close proximity with the target epithelium and facilitates diffusion of drug into intestinal tissue. The mucoadhesive polymer may be either dispersed in the matrix of the tablet or applied as a direct compressed coating to the solid oral dosage form. Preferred mucoadhesive polymers include poly(adipic)anhydride “P(AA)” and poly(fumaric-co-sebacic)anhydride “P(FA:SA)”. Other preferred mucoadhesive polymers include non-erodable polymers such as DOPA-maleic anhydride co polymer; isopthalic anhydride polymer; DOPA-methacrylate polymers; and DOPA-cellulosic based polymers.

The invention provides a ranitidine hydrochloride lipidosome capsule and new application thereof. Particularly, certain amounts of yolk lecithin, cholesterin, natrium glycocholicum, tween 80 and an active ingredient ranitidine hydrochloride are combined and are prepared into ranitidine hydrochloride lipidosome by film dispersion technology, and the ranitidine hydrochloride lipidosome is mixed with the general accessories of medicine to prepare the capsule. The ranitidine hydrochloride lipidosome capsule better solves the problems of easy deliquescence, moisture absorption, color change and poor stability of the ranitidine hydrochloride, increases preparation medical effect and biological availability and can be used for treating herpetic stomatitis of childrem.

The invention belongs to the technical field of medical inspection, and specifically relates to a method for checking total number of aerobic bacteria of ranitidine hydrochloride capsules. The methodcomprises the following process: taking 10 g of ranitidine hydrochloride capsules in a sterile conical flask, adding a sterile sodium chloride peptone buffer of pH7.0 to dilute to 100 ml, shaking theconical flask to disperse the solution evenly, preparing a test solution of 1:10, placing the full amount of 1:10 test solution of the conical flask on a large volume side of a special bag with a homogenizer with filtering function, conducting fully tapping for 30 seconds in a tapping instrument, taking the test solution on the small volume side after filtration as the test solution of 1:10 for coarse filtration, taking 20 ml of the test solution of 1:10 for coarse filtration to be diluted to 100 ml by using the sterile sodium chloride peptone buffer of pH7.0, preparing a test solution of 1:50, adding 1 ml of the test solution of 1: 50 into a plate, injecting 15-20 ml of trypsin soybean pepton agar culture medium immediately, conducting mixing evenly, solidifying, and incubating at 30-35 DEG C for 3-5 days, and determining the number of colonies. According to the present invention, the operation steps of the method are simple, and the inspection results are stable and reliable.

The invention relates to a ranitidine hydrochloride composition freeze-dried powder injection for treating stomach illness and belongs to the technical field of medicine. The composition freeze-dried powder injection is prepared from ranitidine hydrochloride and an excipient. The excipient is mycose, the ranitidine hydrochloride is a new crystal form compound, and is ranitidine hydrochloride different from what is reported in the prior art by an X ray power diffraction pattern as shown in picuture 1 by using Cu-Kalpha ray measurement, through test, the new crystal form compound is high in purity, good in mobility and stability, low in impurity content and safe and reliable in clinical use, and does not easily absorb humidity, and the freeze-dried powder injection prepared by the new crystal form compound is good in stability after being matched with a solvent, extremely low in insoluble particle content and very suitable for clinical use.

The invention discloses a ranitidine hydrochloride composition dry suspension for treating gastric ulcer, and belongs to the technical field of medicine. A composition is composed of ranitidine hydrochloride, sucrose, sodium carboxymethylcellulose, sodium alginate, pectin, polyethylene glycol and stevioside; the ranitidine hydrochloride is a new crystal form compound, is measured with a Cu-Ka ray to obtain an X-ray powder diffraction pattern and is different from ranitidine hydrochloride reported by the prior art, wherein the X-ray powder diffraction pattern is as shown in figure 1. Experiments find that the dry suspension prepared with the ranitidine hydrochloride-new crystal form compound solves the problem that the ranitidine hydrochloride is extremely prone to being deliquesced, moisture is prone to being absorbed, color is prone to being changed, and the stability is poor, the components are simple, adverse reactions are greatly prevented from occurring, and the stability, medicine effects and bioavailability of the dry suspension are improved.

The invention discloses a ranitidine and a preparation method thereof, as well as a ranitidine preparation, a compound preparation and a preparation method thereof. Among them, ranitidine has low impurity content, high stability and simple preparation method; the ranitidine preparation and compound preparation prepared therefrom have high bioavailability and safety. The ranitidine, the ranitidine preparation and the compound preparation provided by the invention can effectively treat and maintain the treatment of erosive esophagitis.

The invention discloses a novel synthesis method for high-stability ranitidine bismuth citrate. The method includes the steps of: 1) preparing a raw material solution; 2) performing a reaction to prepare ranitidine; 3) purifying the ranitidine; 4) performing a salt forming reaction; 5) discolorizing and sterilizing a product; and 6) producing a ranitidine bismuth citrate finish product. The novel synthesis method, through reasonable process design, can increase the quality and stability of ranitidine, thereby improving the pharmacologic property and stability of the ranitidine bismuth citrate. The novel synthesis method is low in raw material cost, has gentle process conditions, is good in controllability and yield, and is suitable for industrial production.

The invention relates to the field of drug detection, in particular to a method for determining related substances of ranitidine hydrochloride by high performance liquid chromatography. The method of the present invention adopts octadecylsilane bonded silica gel as a packing agent; Mobile phase comprises mobile phase A and mobile phase B, and described mobile phase A and mobile phase B are modified phosphate buffer saline and acetonitrile For the mixed solution, the pH value of the modified phosphate buffer solution is 6.70±0.05; the flow rate of the mobile phase is 1.1-1.3ml / min; gradient elution is adopted. The method of the invention can separate the related substances of ranitidine hydrochloride in the high-performance liquid chromatogram; and through optimizing the conditions, the sensitivity and accuracy of detecting each component are further improved. The method can better control the quality of ranitidine hydrochloride, and at the same time, the analysis speed is fast, the specificity is good, and the reproducibility is high. Security promotion and application.

The invention relates to the technical field of separation and purification of fine chemicals, more specifically, to a method for refining ranitidine base. In the present invention, by using a mixed solvent composed of a strong polar solvent and a weak polar solvent, there is a large difference in the solubility of ranitidine base and the impurities therein in this solvent, thereby making ranitidine base in the crystallization process Butyrine and impurities can be effectively separated, and the refined product obtained has high purity and stable properties. The ranitidine base refined by the method of the present invention is analyzed by a liquid chromatograph, and the purity of the ranitidine base is more than 99.9%, the total impurities are not more than 0.15%, and the individual impurities are not more than 0.05%. The ranitidine hydrochloride product obtained by preparing the purified ranitidine base and then salting it with the method provided by the invention has a purity reaching or better than the quality level of the original drug, thereby further improving the safety of the drug during use .

The invention discloses a ranitidine hydrochloride sample pretreatment method, which comprises: S1, weighing a ranitidine hydrochloride sample, the ranitidine hydrochloride sample containing an impurity N-nitrosodimethylamine; s2, preparing a ranitidine hydrochloride test solution, and enabling the concentration of N-nitrosodimethylamine in the ranitidine hydrochloride test solution to reach the detection limit of the high performance liquid chromatography; s3, adding an alkaline solution into the ranitidine hydrochloride test solution, and enabling the alkaline solution to completely react with hydrochloric acid in ranitidine hydrochloride to obtain a ranitidine neutralization solution; s4, a silver ion solution is added into the ranitidine neutralization solution, silver ions and secondary amino groups in ranitidine are subjected to a complex reaction completely, and precipitates are generated. According to the method, the ranitidine precipitate in the high-concentration ranitidine test sample is removed, a by-product NDMA is not generated, meanwhile, the NDMA in the sample is reserved, the NDMA detection sensitivity is greatly improved, and the mass spectrum detection requirements of various models are met.