361 results about "Bulk drug" patented technology

The invention provides a solid-phase synthesis method of semeglutide, and belongs to the technical field of synthesis of medical intermediates, and the method specifically comprises the following steps: segmenting a semeglutide main chain into three shorter polypeptide fragments, namely a fragment 4, a fragment 5 and a fragment 2, which are 7-14 sites, 15-22 sites and 23-37 sites; and respectively synthesizing and then assembling fragments to obtain a target product. The method specifically comprises the following steps: a) synthesizing a 7-14 peptide fragment and a 15-22 peptide fragment, and assembling the 7-14 peptide fragment and the 15-22 peptide fragment into a 7-22 peptide fragment, namely a fragment 1; b) synthesizing a 23-37 peptide fragment, selectively removing a protecting group A11oc on Lys26, and connecting with a side chain to form a fragment 3; c) connecting the peptide fragment 7-22 with the peptide fragment 23-37, and removing a protecting group to obtain a crude product; and d) separating and purifying to obtain a finished product. According to the invention, the purpose of high-purity, high-yield and low-cost synthesis of the semeglutide bulk drug can be achieved.

The invention relates to the field of pharmaceutical analytical chemistry, in particular to a method for determining tandospirone and salt intermediates thereof, high performance liquid chromatography is adopted, and chromatographic conditions include that a chromatographic column with octadecylsilane chemically bonded silica as a filler is adopted, and gradient elution is performed by a mobile phase A and a mobile phase B; wherein the mobile phase A consists of a first water phase and acetonitrile; the mobile phase B is composed of a second water phase and acetonitrile; the first water phase is a water solution containing monopotassium phosphate and sodium hexanesulfonate, and the pH value of the first water phase is 3.0-3.8; the second water phase is an aqueous solution containing monopotassium phosphate and sodium hexanesulfonate, and the pH value of the second water phase is 1.8-2.6. The testing method disclosed by the invention has good specificity, accuracy and repeatability, and can be used for monitoring the quality of the tandospirone raw material medicine.

The bulk drug freeze-drying plate layer structure comprises a main body plate layer and a bent plate layer and further comprises a connecting block, the bent plate layer comprises a horizontal part and an inclined part which is connected with the horizontal part and is arranged obliquely upwards, an upper panel and a lower panel of the horizontal part are parallel, an upper panel and a lower panel of the inclined part are parallel, the length of the main body plate layer is a, the length of the horizontal part is b, a is larger than b, and a is larger than b. One side of the connecting block is welded with the main body plate layer, and the opposite other side is welded with the horizontal part. The processing method comprises the following steps: S1, respectively processing the main body plate layer and the bent plate layer; s2, welding the main body plate layer and the bent plate layer; s3, the welded main body plate layer and the bent plate layer are leveled, and then the horizontal part of the bent plate layer is leveled; s4, fourth sealing blocks on the edges of the bent plate layers are assembled and welded, leveling is conducted after welding is completed, and the fourth sealing blocks and the connecting blocks are oppositely arranged; and S5, the welded main body plate layer and the bent plate layer are leveled again, and then the horizontal part of the bent plate layer is leveled.

The invention provides a preparation method of fusidic acid emulsifiable paste, and relates to the field of pharmaceutical preparations, and the preparation method comprises the following steps: step 1, preparation of fusidic acid nanoparticles, step 2, preparation of an oil phase of the emulsifiable paste, step 3, preparation of a water phase of the emulsifiable paste, step 4, emulsification, and step 5, mixing. According to the fusidic acid nanoparticles, firstly, a composite carrier is prepared, then fusidic acid, PLGA, the composite carrier and absolute ethyl alcohol are mixed, a nanoparticle oil phase is obtained, then PVA, PVP, sodium dodecyl glucoside sulfonate and dipotassium ethylenediaminetetraacetate are mixed with deionized water, a nanoparticle water phase is obtained, and finally a nanoparticle suspension is obtained through mixing. The fusidic acid emulsifiable paste prepared by the method can effectively solve the problems that the traditional emulsifiable paste bulk drugs are easy to agglomerate, the drug molecule particle size is large and the like, and the transdermal absorption rate and bioavailability of fusidic acid are improved, so that the antibacterial effect is enhanced.

The invention provides semeglutide, which is synthesized by adopting the following method, and the specific steps are as follows: 1) segmenting the main chain of semeglutide into three polypeptide fragments: 7-14 sites, 15-22 sites and 23-37 sites; (2) respectively preparing the 7-14-site fragments, the 15-22-site fragments and the 23-37-site fragments through solid-phase synthesis; 3) connecting the 7-14-site fragment with the 15-22-site fragment to form a 7-22-site fragment, and activating the C end of the fragment into active ester; (4) selectively removing an Alloc protecting group of Lys26 in the 23-37-site fragment, and then carrying out fatty acid modification to obtain a modified 23-37-site fragment; 5) in a liquid phase system, coupling the activated 7-22-site fragment and the modified 23-37-site fragment according to a molar ratio of 1: (0.6-1.4) to form a complete polypeptide chain; and 6) removing the protecting group and purifying to obtain a semaglutide finished product. The method provided by the invention can effectively realize high-purity, high-yield and low-cost synthesis of the semeglutide bulk drug.

The invention relates to a method for detecting residual solvent benzene in a ziprasidone hydrochloride bulk drug. According to the detection method, dimethyl sulfoxide is used as a diluent, a 2.8 mol / L potassium hydroxide solution is used as a cosolvent, and a dimethyl sulfoxide solution of high-concentration ziprasidone hydrochloride can be completely dissolved under a high-temperature heating condition, so that the sensitivity of benzene meets the requirement; and detecting the benzene in the ziprasidone hydrochloride bulk drug by using a gas chromatograph (GC-FID headspace sampling) connected with a hydrogen flame ionization detector. The detection method can be used for quantitatively detecting benzene higher than 0.4 ppm in ziprasidone hydrochloride bulk drugs. The method is high in sensitivity and practicability, and the detection process is simple and rapid.

< TableDetails number = '0001' > < Title / > < tbl: tgroup cool = '2' > < tbl: colspec cool = 'c001' cool = '46%' / > < tbl: colspec cool = 'c002' cool = '54%' / > < tbl: cool > < tbl: cool = '1' > impurity < / tbl: cool > < tbl: cool = '1' > HPLC percentage content < / tbl The mobile phase B is a 8mmol / L ammonium acetate solution, and the solvent is a mixed solvent of acetonitrile and water in a volume ratio of 95: 5; and carrying out gradient elution at a flow rate of 1.0 ml / min.

The invention relates to the technical field of biology, in particular to an inducer, a reagent combination and application of the inducer in preparation of anisodamine. The inducing agent comprises silver nitrate, acetylsalicylic acid and methyl jasmonate, the components of the inducing agent cooperate with one another, compatibility is high, synergistic interaction can be achieved, and the efficiency of the inducing agent for rapidly converting hyoscyamine into anisodamine is further improved. According to the invention, a suspension cell culture technology is adopted, and an optimized callus culture medium, a precursor substance hyoscyamine and an inducer are combined, so that compared with an initial material anisodamine tanguticum used by an existing anisodamine hydrobromide raw material medicine, the anisodamine hydrobromide raw material medicine has the advantages of short growth cycle, stable content and components, environmental protection and no damage to natural resources; the invention provides a new approach for obtaining a starting material for the production of an anisodamine hydrobromide bulk drug, and is suitable for popularization and application.

The invention discloses a methotrexate-cationic polypeptide conjugate as well as a preparation method and application thereof, and belongs to the technical field of medicinal chemistry. According to the conjugate, MTX and cationic polypeptide with the amino acid sequence shown as SEQ ID NO: 1 are connected through chemical bonding, the membrane binding characteristic of oligomeric lysine and the transmembrane capacity of TAT cell-penetrating peptide are creatively fused, and a polypeptide carrier system with efficient cell penetrating capacity is constructed; mTX obtains amphipathy and electropositivity through peptide fragment modification, stable nanoparticles can be spontaneously formed, and the problems of poor water solubility and instable acidity of raw material medicines are effectively improved; according to the conjugate, the accumulation efficiency of the medicine at a diseased region is remarkably improved by utilizing the targeting characteristic of the polypeptide carrier, the action time of the medicine is prolonged through a precise delivery mechanism, and meanwhile, the system toxicity is reduced. The preparation method adopts mild coupling reaction conditions, and the product is high in purity and excellent in stability; the compound is suitable for treating immune-mediated inflammatory diseases and specific malignant tumors, and provides an innovative solution thought for treating related diseases.

The invention provides a preparation method of an edaravone and dextroborneol injection, the injection comprises edaravone, dextroborneol, propylene glycol and sodium pyrosulfite, in the preparation process, the propylene glycol accounting for 60%-85% of the prescription dosage and water accounting for 5%-25% of the prescription dosage are injected into a liquid preparation tank according to the volume ratio, the mixture is heated to 50-60 DEG C, edaravone is added and stirred to be dissolved, and the edaravone and dextroborneol injection is prepared. The preparation method comprises the following steps: dissolving propylene glycol in the remaining prescription dosage, adding dextroborneol which is dissolved by propylene glycol in the remaining prescription dosage in advance, uniformly stirring, adding water which is close to a constant volume, cooling to 25 DEG C or below, adding sodium pyrosulfite, adjusting the pH value to 4.0-5.0, and fixing the volume to a full volume. According to the preparation method of the edaravone dextroborneol injection, auxiliary materials in a specific proportion are matched with the preparation steps, the problem that raw material medicines are extremely easy to separate out in the preparation process is solved, the requirement of the preparation process for an industrial liquid preparation tank is low, industrial operation is convenient, and the preparation cost is low.

The invention relates to the technical field of spectrum on-line detection, and discloses a raw material medicine purity on-line detection method based on spectrum data fusion, which comprises the following steps: arranging two spectrum probes of the same type on a pipeline at an interval; a time sequence self-adaptive calibration mechanism is constructed, cross-correlation peak value tracking is adopted in the mechanism when signals can be tracked, and instantaneous thermal pulses are actively applied for calibration when the signals cannot be tracked, so that accurate transit time is obtained; according to the method, through space-time difference self-calibration, dependence on multi-spectrometer hardware is eliminated, high suppression of physical noise is achieved by using a single type of spectrometer, the principle is clear, and the method is suitable for large-scale popularization and application. And through active thermal pulse calibration, the problem of cross-correlation failure under homogeneous fluid is solved.

The invention provides a UPLC-MS / MS (Ultra Performance Liquid Chromatography-Mass Spectrometry / Mass Spectrometry) detection method for N-nitroso landiolol in a landiolol hydrochloride bulk drug. The method comprises the step of carrying out qualitative detection or quantitative analysis on a potential nitrosamine impurity-N-nitroso landiolol in a landiolol hydrochloride bulk drug by adopting an ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS), wherein the structural formula of the N-nitroso landiolol is shown as a formula I in the specification. The detection method disclosed by the invention is high in sensitivity, strong in specificity and good in repeatability, can be used for rapidly and effectively detecting N-nitroso landiolol in the landiolol hydrochloride bulk drug, and has important significance on quality control of the landiolol hydrochloride bulk drug. ; formula I.

The invention belongs to the technical field of medicine detection, and particularly discloses a method for detecting related substances in sinomenine hydrochloride raw material medicine and application, and the method comprises the following steps: preparing a test solution; preparing a contrast solution; preparing a mixed impurity reference substance solution; according to the determination method, the five known impurities in the sinomenine hydrochloride raw material can be accurately and quantitatively analyzed, the impurity content of the sinomenine hydrochloride raw material can be more accurately and comprehensively reflected, and the quality of sinomenine hydrochloride can be better controlled.

The application discloses a preparation method of enciferstat bulk drug and belongs to the field of drug synthesis. 9,10-dimethoxy-2-(2,4,6-trimethylphenylimino)-3,4,6,7-tetrahydro-2H-pyrimido[6,1-a]isoquinolin-4-one (SM) is used as a raw material, and the raw material is reacted with cyclohexylamine under alkaline conditions, and the reaction is washed with water, dried, and concentrated to obtain an intermediate I; the intermediate I is reacted with urea under pressurized heating conditions to prepare an enciferstat drug molecule, the two-step yield is more than 67%, and the purity is more than 99%, the method has a simple operation process, the product is easy to purify, the yield is high, the product purity is high, and a new method for preparing enciferstat bulk drug is provided.

The invention relates to the technical field of drug analysis and detection, in particular to a method for detecting related substances in moxifloxacin hydrochloride bulk drugs. According to the detection method provided by the invention, the separation efficiency of the known impurity (impurity F) can be improved, and the separation degree between the main component and the adjacent impurity can reach 1.5 or above; in addition, a solvent formula is optimized, so that a test sample is more stable, and the detection method is more accurate; the detection accuracy is improved, and the recovery rate is controlled within the range of 93-102%.

The present application relates to the technical field of pharmaceutical chemistry, and particularly relates to a preparation method of fenofibrate and impurities thereof. The present application carries out Friedel-Crafts acylation reaction on 4-chlorobenzoyl chloride, anisole, Lewis acid and benzene solvent, then carries out demethylation reaction, and then separates and purifies to obtain compound II, impurity compound IV and impurity compound V; the compound II (or impurity compound IV), 2-bromoisobutyric acid isopropyl ester, an alkaline reagent and an alcohol solvent are mixed to carry out etherification reaction, and then separated and purified to obtain fenofibrate (or impurity compound VI). The preparation method provided by the present application has high yield and high purity of fenofibrate, can realize identification of impurities in the preparation process of fenofibrate, and provides a convenient condition for quality control of bulk drug. Moreover, the raw materials and solvents used are widely sourced, low in cost and small in danger, the preparation method is high in safety factor, simple in operation, and suitable for large-scale industrial production.

The invention discloses a continuous preparation method of a platinum bulk drug, which comprises the following steps: by taking chloroplatinite as a starting material, in a reaction environment of taking water as a solvent, replacing the starting material with iodized salt to obtain iodoplatinite, and then adding an amine ligand to quickly react to generate an intermediate-cis-diiodo-platinum-amine complex; introducing the solid-liquid mixed system containing the intermediate into a filtering and washing device, filtering and washing, directly discharging the solid into a reaction kettle, adding silver salt and water, reacting completely, and filtering; and concentrating the filtrate to obtain a crude product of the target product, and recrystallizing the crude product to obtain the platinum bulk drug. Or reacting the filtrate with a leaving group (or a salt formed by the leaving group) of the target compound, concentrating, filtering and washing to obtain a crude product of the target product, and recrystallizing the crude product to obtain the platinum bulk drug. The production efficiency and quality consistency of the product can be improved, the process amplification flow is simplified, the production cost and material consumption are reduced, green manufacturing is realized, and the method is an optimal choice for industrial production of platinum bulk drugs.

The invention belongs to the technical field of medicine synthesis, and discloses a preparation method of a sodium nitroprusside raw material medicine. According to the method, weak acid is adopted for catalysis, the effect of remarkably reducing generation of toxic substances such as cyanide and nitrogen dioxide is achieved by controlling the material dripping speed and the dripping pH, the reaction is mild, the technological operation is safe and controllable, and industrial production of the sodium nitroprusside raw material medicine is facilitated. According to the preparation method of some examples, silica gel filtration is used for post-treatment, the residual risk of impurities such as sodium ferricyanide, ferric ferrocyanide and ferric ferricyanide is reduced, and the purity of the raw material medicine is larger than or equal to 99.9% and is far superior to the requirements of pharmacopoeia of various countries.

The invention relates to the technical field of pharmaceutical analysis, and provides a method for identifying the structure of an impurity in a meropenem bulk drug, which is used for identifying the structure of the impurity in the meropenem bulk drug by liquid chromatography-mass spectrometry. In the chromatographic conditions of the liquid chromatography-mass spectrometry, a mobile phase comprises a mobile phase A and a mobile phase B, and the mobile phase A is a formic acid aqueous solution with the mass fraction of 0.1%-0.3%; and the mobile phase B is an acetonitrile solution containing formic acid with the mass fraction of 0.1-0.3%. By means of the technical scheme, the problems that in the related technology, the variety of structure identification of impurities of meropenem raw material medicine is few, and the accuracy and the like are not high when an existing detection method is used for identification are solved.

The invention discloses a method for detecting phosphate impurities, namely diethyl phosphoacetic acid and diethyl phosphate, in afatinib, and establishes a simple and sensitive ion chromatography detection method based on the hydrolysis property of a phosphate compound under an alkaline condition. Sodium hydroxide or potassium hydroxide solution-water is used as a mobile phase for isocratic or gradient elution, and a conductivity detector is used for detection. According to the present invention, the accurate quantification of the impurities in the afatinib is achieved, the detection speed is fast, the cost is low, the operation is simple, and the good specificity, the sensitivity, the precision and the accuracy are provided, such that the product quality of the afatinib maleate bulk drug synthesized by using the diethyl phosphoacetic acid as the starting material and the related preparation can be further ensured.

The utility model relates to the technical field of bulk drugs, in particular to a bulk drug centrifugal machine which comprises a centrifugal machine body, a buffer plate is arranged on the outer wall of the centrifugal machine body, a buffer assembly is arranged at the bottom of the centrifugal machine body, and a sealing mechanism is arranged in the centrifugal machine body. According to the centrifugal machine for the raw medicine, through the arrangement of the first fixing plate, the first sealing plate, the bolts, the limiting plate, the second sealing plate, a sealing ring and a second fixing plate, when the centrifugal machine conducts centrifugal treatment on the raw medicine, the internal structure of the centrifugal machine can be effectively protected, and the influence of vibration and impact force generated by high-speed rotation on equipment is reduced; by means of the structural design, the sealing mechanism can ensure that in the operation process of the centrifugal machine, raw material medicine in the centrifugal machine cannot leak, meanwhile, the interior of the centrifugal machine is protected against external pollution, and cleanliness and safety in the centrifugal process are guaranteed.

The utility model discloses a bulk drug separation and purification device which comprises a supporting frame, a bottom plate is fixedly connected to the upper surface of the supporting frame, an outer cylinder and an inner cylinder are fixedly connected to the upper surface of the bottom plate, a stirring device is arranged in the inner cylinder, a collecting box is arranged in the outer cylinder and the inner cylinder, and the collecting box is communicated with the inner cylinder through a purification mechanism. A component detector is arranged on the collecting box, a top plate is fixedly connected to the upper surface of the outer cylinder, a water tank is fixedly connected to the upper surface of the top plate, a liquid pump is fixedly connected to the side surface of the water tank, the liquid pump communicates with the outer cylinder through a water inlet pipe, and a refrigerator is arranged on the water inlet pipe; the side surface of one side, far away from the liquid pump, of the water tank is fixedly connected with a water outlet pipe, the water outlet pipe is communicated with the outer cylinder, and through the structure, when some toxic raw material medicines are separated and purified, the situation that the toxic raw material medicines are leaked due to damage of the device, and the surrounding environment and personnel are harmed can be avoided.

The present invention discloses a preparation method of Molnupiravir, comprising the following steps: (1) reacting a solution of a compound of formula 2 with an acid solution in a microchannel reactor; (2) neutralizing the reaction product of step (1) with a base to obtain Molnupiravir; (3) post-treatment; wherein the solvent used in the reaction is selected from at least one of 2-methyltetrahydrofuran, dichloromethane, ethyl acetate, isopropyl acetate, acetone, and n-butanol, and the ratio of the flow rate of the solution of the compound of formula 2 to the inner diameter of the microchannel reactor is 5 to 150,000. This preparation method can simplify the operation, has high reaction efficiency, high throughput, low by-product content, controllable product quality, and simple subsequent purification treatment; the conversion rate of the starting material is as high as over 95%, the product yield is as high as over 80%, and the product purity is as high as over 99%, meeting the standards of bulk drugs; it has wide applicability and covers small-scale, pilot-scale, and industrial-scale preparations.

The invention provides a crystal form VI of an acrylamide compound, and the acrylamide compound is (S)-N-(5-((6-(2-(7, 7-dimethyl-1-oxo-1, 3, 4, 6, 7, 8-hexahydro-2H-cyclopentane [4, 5] pyrrolo [1, 2-a] pyrazine-2-yl)-3-(hydroxymethyl) pyridine-4-yl)-4-methyl-3-oxo-3, 3, 4-triazolo [1, 2-a] pyrazine-2-yl)-3-(hydroxymethyl) pyridine-4-yl)-4-methyl-3-oxo-3, 3, 4-triazolo [1, 2-a] pyrazine-2-yl)-3-(2, 3, 4-triazolo [1, 2-a] pyrazine-2-yl)-4- The crystal form VI is a 2-(2, 4-dihydropyrazine-2-yl) amino)-2-(2-methyl-4-(tetrahydro-2H-pyran-4-yl) piperazine-1-yl) 5phenyl) acrylamide compound, and an X-ray powder diffraction pattern of the crystal form VI comprises diffraction peaks with the following 2 theta angle values: 8-3 + / -0.2 degrees, 13.2 + / -0.2 degrees and 18.9 + / -0.2 degrees. The crystal form VI has the advantages of good stability and low hygroscopicity, and is suitable for industrial production of bulk drugs and development of preparation prescriptions.

The invention relates to the technical field of pharmaceutical analysis, in particular to a chromatographic method for determining optical isomers in a carbidopa raw material medicine and a preparation thereof by using an HPLC (High Performance Liquid Chromatography) method. The detection method is simple, convenient, rapid and accurate to operate, and specifically comprises the following steps: dissolving a proper amount of a sample with a solvent, diluting to a certain concentration, taking a certain volume of the sample, carrying out isocratic elution at a certain column temperature by adopting a high performance liquid chromatography, using a hand-type chromatographic column, a mobile phase A and a mobile phase B, and carrying out quantitative analysis by adopting a self-control method with correction factors. And calculating the isomer in the test solution. The method is good in specificity, solution stability, linearity, repeatability, intermediate precision and durability, and the detection result is accurate and reliable through verification.

The utility model relates to pantoprazole sodium bulk drug processing technical field discloses a kind of crushing devices for pantoprazole sodium bulk drug processing, including crushing box, the crushing box outer circle one side is connected with feed hopper and is fixedly connected to be penetrated, the crushing box outer circle top is fixedly connected with first motor, the first motor output end is connected with second rotating shaft and is fixedly connected to be penetrated, the second rotating shaft outer circle top is fixedly connected with two first scrapers, the first rotating shaft is rotatably connected with first rotating shaft in the top of the inner wall of two first scrapers and is penetrated, the first rotating shaft and second rotating shaft outer circle are fixedly connected with the uniformly distributed crushing knife of second rotating shaft, the second rotating shaft bottom end is fixedly connected with spiral blanking bar. In the utility model, first motor drives second rotating shaft and first scraper rotation, second rotating shaft and first rotating shaft drive crushing knife rotation, under the location of first gear, first rotating shaft and crushing knife autorotation, improve crushing effect.

The utility model belongs to the technical field of medicine detection, and particularly relates to a sampler for detecting a bifonazole raw material medicine, which comprises a base, the top of the base is fixedly connected with a fixing frame. The top of the fixing frame is fixedly connected with an electric push rod. The end part of the electric push rod is fixedly connected with a fixed plate; a water suction pump is fixedly connected to the bottom of the fixed plate; the output end of the water suction pump communicates with a water outlet pipe; the side wall of the water outlet pipe is fixedly connected with a sealing cover; the input end of the water suction pump communicates with a water inlet pipe; a first clamping groove is formed in the top of the base; a second clamping groove is formed in the top of the base; through the structure, the electric push rod is arranged to connect the water suction pump with the water outlet pipe and the water inlet pipe, and the liquid storage tank and the sampling bottle are matched for use, so that a solution can be pumped into the sampling bottle through the water suction pump during sampling, and sampling can be completed only by replacing different sampling bottles, and the situation that the solution needs to be pumped out and guided into a container in multiple sampling processes can be reduced; and the operation process is tedious.

The invention relates to a compound as well as a preparation method and application thereof. The preparation method comprises the following steps: taking a compound 1 as an initial raw material, and sequentially carrying out condensation with thiourea, alkaline hydrolysis and oxidative coupling with pentafluoropentanethiol to obtain the compound 1, the raw materials are easy to obtain, the reaction conditions are mild, the post-treatment process is effectively simplified through an optimized pulping purification technology, the purity of the final product is up to 98.5% or above, and the method is suitable for industrial production. And a key material basis is provided for quality research of fulvestrant bulk drugs.

The invention provides a preparation method of a choltheophylline bulk drug with high yield and high purity. The method mainly comprises the following steps: firstly, dissolving theophylline in a first solvent, adding trimethylamine after cooling treatment, and carrying out heat preservation and stirring at a certain temperature; then adding a base catalyst, cooling again, then adding chloroethanol, continuously stirring and slowly heating; filtering while the solution is hot, slowly cooling filtrate, adding a second solvent for crystallization, and filtering to obtain a crude cholintheophylline product; and then, dissolving the crude cholintheophylline in a third solvent, heating and stirring for a period of time, filtering while hot, cooling filtrate for crystallization, and finally, carrying out suction filtration and vacuum drying to obtain a cholintheophylline finished product. The choltheophylline bulk drug prepared by the method has excellent yield and purity, and is suitable for industrial production.