374 results about "Pharmacopoeia" patented technology

The invention discloses a traditional Chinese medicine decoction piece finished product quality detection and analysis method and system, and belongs to the field of medicines.The method comprises the steps that S1, a compound component database is built, the database integrates pharmacopoeia standards, clinical composition structures, medicinal material source attributes and pharmacodynamic related parameters, and a standard model is built in a multi-level structuring mode; s2, collecting multi-modal map data of the traditional Chinese medicine decoction piece samples; s3, encoding the collected atlas data by adopting a heterogeneous feature extraction algorithm to generate a fusion structure feature vector; s4, inputting the fusion structure feature vector into a multi-channel evaluation model, and carrying out weight comparison, classification judgment and threshold evaluation; and S5, generating a quality detection report. The method has the beneficial effects that high-precision quality detection combining multi-modal fusion, intelligent discrimination and traceability visualization is realized, and the quality consistency evaluation and risk identification capability of the traditional Chinese medicine decoction pieces is effectively improved.

The invention belongs to the technical field of in-vitro cultivation of calculus bovis, and particularly relates to a method for in-vitro cultivation of calculus bovis. According to the invention, firstly, the escherichia coli is subjected to bile domestication and ray induced mutation, a high-activity oxgall-resistant bezoar production engineering bacterium E.coli-NH01 is obtained through screening, a method for in-vitro cultivation of bezoar by using the engineering bacterium E.coli-NH01 is provided, the prepared bezoar meets the pharmacopoeia standard, the production efficiency of in-vitro cultivation of bezoar is improved, and the production cost is reduced. And the production cost is reduced, the overall forming period is shortened, and the key that precious traditional Chinese medicinal materials are popular can be achieved.

The invention provides a chemically modified tetanus toxin C fragment as well as preparation and application thereof. The method for chemically modifying the tetanus toxin C fragment comprises the following steps: 1) reacting the tetanus toxin C fragment with a reducing agent to reduce a disulfide bond in the tetanus toxin C fragment; and 2) carrying out a reaction on the reduced tetanus toxin C fragment and an alkylation reagent, and carrying out modification. The recombinant tetanus toxin C fragment prepared by the method disclosed by the invention not only meets the quality standard required by pharmacopeia, but also has the advantages of stable conformation, high yield, easiness in amplification and low cost, and has a wide application prospect in the preparation of human vaccines, veterinary vaccines and antibody drugs and the development process of in-vitro diagnostic reagents.

The invention belongs to the technical field of mineral processing, and particularly relates to a preparation method of a diatomite filter aid. The preparation method of the diatomite filter aid comprises the following steps: (1) calcining diatomite raw ore to obtain primary diatomite; (2) carrying out acid leaching treatment on the first-grade diatomite, and washing the first-grade diatomite subjected to acid leaching to obtain refined diatomite; and (3) calcining the refined diatomite in an acid atmosphere to obtain the diatomite filter aid. The diatomite filter aid has the beneficial effects that the diatomite filter aid meets the requirements of United States Pharmacopoeia and Chinese Pharmacopoeia.

The invention discloses a CLIP-guided multi-modal fusion microscopic identification method, relates to the field of microscopic image analysis, and aims to solve the problem of difficulty in microscopic identification of component characteristics of Chinese patent medicines. Microscopic identification is used for authenticity identification and quality evaluation by identifying microstructure characteristics of medicinal materials, and a traditional method depends on manual analysis and is low in efficiency and high in subjectivity. Although the automation performance is improved by deep learning, the problems of dependence on labeled data, inaccurate feature positioning, large domain difference, insufficient utilization of professional knowledge and the like still exist, and the misjudgment risk is increased. Therefore, the invention provides a CLIP-guided multi-modal fusion microscopic identification method which is used for classifying medicinal plants. Experiments show that the method can accurately position the key feature area of the microscopic image under the condition of no label data, the feature extraction capability is enhanced through professional knowledge in pharmacopoeia, and the features have fine-grained local texture information and associated information containing the identification point position relation through a dynamic feature fusion module. The method is suitable for authenticity identification and quality detection of the Chinese patent medicine.

The invention relates to the field of computer vision, in particular to an intelligent identifying and sorting method and system for traditional Chinese medicinal materials. Based on a multispectral and microscopic vision fusion engine, millisecond-level authenticity identification of traditional Chinese medicinal materials is realized through sub-pixel-level feature extraction and cross-modal knowledge distillation, and similar medicinal material confusion is thoroughly eliminated by combining PointRend point cloud segmentation and pharmacopoeia map confrontation verification; a rotary YOLO-MoE multi-angle defect detection mechanism is innovated, a zero-adulteration quality control closed loop with zero manual intervention is achieved under the assistance of a self-adaptive guide execution unit, and a map database is continuously upgraded synchronously through a dynamic federated learning mechanism. The technical bottleneck that an existing traditional Chinese medicine identification system depends on artificial experience and is weak in authenticity identification capability is broken through, and the key problems of confusion of medicinal materials with similar forms caused by single dimension of semi-automatic pharmacy visual identification, missing detection of defective products caused by no quality control mechanism and the like are thoroughly solved; and the medicinal material identifying and sorting process is improved to a stable, reliable, self-adaptive and cooperative intelligent level.

The invention discloses a human albumin binding peptide 1E3 and application of the human albumin binding peptide 1E3 in promoting purification of human albumin, and belongs to the technical field of polypeptides. The human albumin binding peptide comprises an amino acid sequence as shown in SEQ ID NO. 1; and / or an amino acid sequence of a fusion protein with the same function, which is obtained by connecting tag protein to the N terminal and / or C terminal of the amino acid sequence as shown in SEQ ID NO.1. The human albumin binding peptide has extremely high affinity with human albumin and can be used for separating and purifying a human albumin solution, and the purity of the purified human albumin far exceeds the pharmacopoeia standard and can reach 99.99% or above. The method is good in safety and stable in process, and has a wide application prospect in the aspect of separation and purification of the human albumin.

The invention provides a cellobiose epimerase mutant E250Q, an engineering bacterium and application of the cellobiose epimerase mutant E250Q, and belongs to the technical field of genetic engineering. According to the invention, glutamic acid at the 250th site of an amino acid sequence of wild cellobiose epimerase is mutated into glutamine, so that the cellobiose epimerase mutant E250Q is obtained. The amino acid sequence of the cellobiose epimerase mutant disclosed by the invention is shown as any one of SEQ ID NO.1-6. The invention further discloses a preparation method of the cellobiose epimerase mutant. According to the method, recombinant bacteria or cellobiose epimerase mutant E250Q is used as a catalyst, lactose is used as a substrate, the conversion rate of converting lactose to lactulose reaches 67.1%, the yield of brepinose is only 4.0-5.7% and is lower than the by-product proportion permitted by Chinese Pharmacopoeia, and the method has extremely high application value in industrial production of lactulose.

The invention belongs to the technical field of separation of drug intermediates, and particularly relates to a control method for a process impurity 2-ethyl valeric acid (EP-B) in preparation of valproic acid or sodium valproate by a diethyl malonate method. According to the method disclosed by the invention, the content of 2-ethyl-2-propylmalonic acid process impurities in dipropylmalonic acid is controlled, so that the content of 2-ethylvaleric acid (EP-B) which is a process impurity in valproic acid or sodium valproate is accurately controlled; adding a polar solvent into the dipropylmalonic acid crude product, heating, pulping for a certain time, cooling, filtering and drying to obtain a high-purity dipropylmalonic acid refined product; high-purity valproic acid (RRT is equal to 1.00) is prepared through decarboxylation of the dipropyl malonic acid fine product, and the purity is 99.779%; 0.020% of 2-ethyl valeric acid (RRT is equal to 0.90); and valeric acid (RRT = 0.77), 0.039%. The valproic acid product quality meets the requirements of European Pharmacopoeia. According to the method, the problems of quality control and process evaluation of valproic acid or sodium valproate prepared by a diethyl malonate method are solved.

The invention provides a quantifiable staphylococcus aureus fresh culture bacterial liquid which is different from a traditional culture medium and is obtained by limiting growth of staphylococcus aureus through vitamin C and a preparation method of the quantifiable staphylococcus aureus fresh culture bacterial liquid. The staphylococcus aureus fresh culture bacterial liquid comprises a bacterial strain, a nitrogen source, a carbon source, inorganic salt and a limiting factor. On the basis of reducing components of a carbon source, a nitrogen source and an energy source, a limiting factor vitamin C is added into the culture medium, and the growth trend of the staphylococcus aureus can be accurately controlled by controlling the concentration of the vitamin C, so that a staphylococcus aureus fresh culture bacterium solution with the strain concentration of less than or equal to 1000cfu / 100mu L is accurately and efficiently obtained; therefore, the requirements of Chinese pharmacopoeia are met, the requirement that the generations of working strains do not exceed 5 generations is met, and a fresh culture with the colony count meeting the specification of the pharmacopoeia can be obtained.

The invention discloses a method for determining the content of bis (2-aminophenyl) disulfide in 2-aminothiophenol. The method comprises the following steps: preparing an acetonitrile solution of citric acid as a diluent; preparing a system applicability solution, a reference solution and a test solution by using a diluent; a diluent, a system applicability solution, a reference substance solution and a test solution are sequentially injected by adopting a liquid chromatography, and the content of bis (2-aminophenyl) disulfide in a 2-aminothiophenol sample is determined by adopting an external standard method. The antioxidant citric acid is added into the diluent, so that the generation of the disulfide compound is inhibited, the existing disulfide compound is not damaged, the solution stability is high, the operation is simple, the system applicability, specificity, accuracy, precision and durability completely accord with the guidance principle verified by the Chinese pharmacopoeia method, and the method is suitable for industrial production. The method can be used for quality control of 2-aminothiophenol.

The invention belongs to the technical field of separation of drug intermediates, and particularly relates to a method for preparing a high-purity dipropylmalonic acid refined product by adding a polar solvent into a dipropylmalonic acid crude product, heating, pulping for a certain time, cooling, filtering and drying. Decarboxylating the refined dipropylmalonic acid product to obtain high-purity valproic acid; distilling the filtrate to recover the polar solvent to obtain 2-methyl-2-propylmalonic acid, and carrying out decarboxylation on the 2-methyl-2-propylmalonic acid to obtain 2-methylpentanoic acid; 2-methylvaleric acid is used as a perfume additive. According to the method disclosed by the invention, the process impurity 2-methyl-2-propylmalonic acid in dipropylmalonic acid is separated, and the process impurity 2-methylvaleric acid (EP-L) in valproic acid or sodium valproate is precisely separated; the quality of the valproic acid product prepared by the method disclosed by the invention meets the requirements of European Pharmacopoeia EP-11 (2023). According to the invention, the problems of quality control and process evaluation of valproic acid or sodium valproate prepared by a dimethyl malonate method are solved.

The invention provides a traditional Chinese medicine decoction piece quality evaluation method based on big data, and relates to the technical field of data processing, and the method comprises the steps: extracting texture direction consistency data from texture dense region detection points of a central region, and extracting structural symmetry data from wrinkle region detection points; comparing the color gradient change data with a preset standard color gradient threshold to generate a first difference index, comparing the texture direction consistency data with a historical qualified batch texture direction distribution range to generate a second difference index, and comparing the structural symmetry data with a pharmacopoeia form standard to generate a third difference index; and calculating a quality evaluation value based on the first difference index, the second difference index and the third difference index in combination with the initial quality deviation risk value, and obtaining a quality grade judgment result of the traditional Chinese medicine decoction pieces according to an interval matching relationship between the quality evaluation value and a preset risk threshold. According to the invention, the evaluation accuracy can be improved.

The invention discloses a processing method of wine-processed rhizoma polygonati, which belongs to the technical field of traditional Chinese medicine processing, and comprises the following steps: selecting rhizoma polygonati, cleaning, slicing and drying; spraying an acidic compound solution, steaming for the first time, preserving heat, moistening, and collecting a steaming solution; after finishing and slicing, spraying catalytic compound liquid prepared from steaming liquid and auxiliary materials, steaming for the second time, and preserving heat and moistening; then steaming at normal pressure for the third time; and finally, pre-drying at low temperature, heating and finally drying, and inspecting to obtain a wine rhizoma polygonati finished product. According to the invention, a segmented precise regulation and control system is constructed, so that the used functional additive can be completely removed, and the purity and safety of the product are guaranteed; the compound liquid proportion, spraying parameters and steaming key indexes are defined, systematic control standards are formed, the problem of quality fluctuation of traditional processing is solved, the product appearance and taste are better, the key indexes stably exceed the pharmacopoeia standard, and upgrading from experience and technology to standardized production is achieved.

The present invention provides a non-distillation injection water preparation system, the non-distillation injection water preparation system comprises a pure water production system and an injection water production system connected to each other, the pure water production system comprises a purification module, a first treatment module and a first storage module, untreated raw material water in an external feed source is purified by the purification module and the first treatment module and then enters the first storage module, the injection water production system comprises a second treatment module, a filtering module and a second storage module, and purified water purified by the pure water production system flows out of the first storage module; and the water enters the second storage module through the second processing module and the filtering module. According to the non-distillation injection water preparation system, purified water and injection water can be produced at the same time through a short non-distillation process, the process preparation standard of pharmacopeia is met, the water using process at the rear end of production can be effectively simplified, and the investment cost and the operation cost of the whole system are reduced.

The invention discloses a method for preparing vitamin D2 with high conversion rate and high selectivity, and belongs to the technical field of organic photosynthesis reaction.The method comprises the steps that an ergosterol solution passes through a first-stage illumination reactor, the illumination wavelength is controlled to be 254 nm, the illumination time is 20-25 min, and an ergosterol ring-opening product reaction solution is obtained through a first photoreaction; the ergosterol ring-opening product reaction liquid passes through a second-stage illumination reactor, the illumination wavelength is controlled to be 365-415 nm, the illumination time is 30-35 min, and a VD2 precursor reaction liquid is obtained through a second photoreaction; the VD2 precursor reaction liquid is heated and converted into VD2 converted oil; and carrying out esterification, crystallization, hydrolysis and recrystallization on the VD2 conversion oil to obtain a VD2 finished product. According to the method, the conversion rate of ergosterol and the selectivity of a target product can be remarkably improved, the purity of a VD2 finished product is improved, the impurity content is reduced, and the VD2 impurity limit requirement specified by European Pharmacopoeia is met.

The invention provides a mesenchymal stem cell injection, a preparation process and application of the mesenchymal stem cell injection to treatment of autoimmune diseases, and belongs to the technical field of biological medicines. The mesenchymal stem cell injection provided by the invention is prepared from a complete culture solution 1, a complete culture solution 2 and a complete culture solution 3 under specific culture conditions. The mesenchymal stem cell working bank used for preparing the mesenchymal stem cell injection is good in cell safety, has better cell proliferation ability, highly expresses CD73, CD90 and CD105, does not express CD19, CD34, CD45, CD11b and HLA-DR, and has osteogenesis and adipogenesis differentiation ability and better biological efficacy. The mesenchymal stem cell injection provided by the invention meets the pharmacopoeia standard, has high HGF and sTNFR1 contents, and can play a role in preventing and treating autoimmune diseases.

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a composition of piveronium bromide and a cherokee rose fruit extract, a preparation process and application. The tablet is composed of piveronium bromide, a rosa laevigata michx extract, a disintegrating agent, a lubricant and a filler, and pharmacological experiments of rats find that the tablet has a significant treatment effect on diarrhea-type irritable bowel syndrome, can be completely dissolved out within 15 min, has low content of related substances, is higher than the requirements of pharmacopeia, and is suitable for further industrial mass production.

The application discloses a preparation method of fenbendazole impurity C, wherein the fenbendazole impurity C is impurity C in the European Pharmacopoeia (EP), and the compound has a molecular formula of C 27 H 23 N5O2S2, the application takes 2-nitro-5-phenylmercaptoaniline as raw material, realizes the preparation of the fenbendazole impurity C through a four-step reaction in the following route, the preparation method of the impurity compound is easy to obtain raw materials, simple to operate, reasonable in process design, relatively mild in reaction condition, high in yield, and can realize industrial production, the prepared fenbendazole impurity C can be used as a control sample for qualitative and quantitative research of impurity C in fenbendazole quality research, the content of the fenbendazole impurity C is controlled, so that the quality of the crude drug is ensured.

The invention discloses a quality detection method of an infantile poria cocos and coix seed paste, the detection method sequentially comprises the steps of preparation of the infantile poria cocos and coix seed paste, thin-layer identification, finished product inspection and content determination, and according to inspection items (general rule 0183) under oral thick paste items of four parts of Chinese Pharmacopoeia of 2020 edition, inspection items of characters, relative density, insoluble substances and water content are studied; identifying poria cocos, semen euryales and semen coicis in the root-benefiting conditioning paste by adopting a thin layer chromatography (TLC); according to the method, the content of pachymic acid serving as an effective component in the poria cocos and coix seed paste for children is measured and researched by adopting an HPLC (High Performance Liquid Chromatography) method, so that a basis is provided for quality control of the product, and the method is good in reproducibility, good in durability, simple and convenient, and capable of effectively controlling the quality of the poria cocos and coix seed paste for children.

The invention relates to an under-forest mountain ginseng and garden ginseng identification method based on a ginsenoside proportion, and belongs to the field of traditional Chinese medicinal material identification methods. The method specifically comprises the following steps: determining the contents of ginsenosides Rg1, Re and Rb1 of ginseng monomers by adopting a high performance liquid chromatography, calculating the Rb1 / (Rg1 + Re) proportion characteristic, and identifying the understory ginseng and the garden ginseng. The method has the advantages of being small in sample dosage, simple, high in method precision and repeatability and the like, the contents of the three kinds of ginseng monomer saponin specified by the 2020 edition Chinese Pharmacopoeia are measured, the proportion of the three kinds of ginseng monomer saponin can be calculated to serve as an identification index of the understory ginseng and the garden ginseng, and it is stipulated that the proportion Rb1 / (Rg1 + Re) of the ginseng monomer saponin in the understory ginseng is larger than 0.6, and the proportion Rb1 / (Rg1 + Re) of the ginseng monomer saponin in the garden ginseng is smaller than 0.6.

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 discloses a method for detecting related substances in an amoxicillin raw material and a preparation thereof, and relates to the technical field of pharmaceutical analysis, HPLC conditions are as follows: the elution gradient is 0-5 min: 100% mobile phase A; in 5-25 min, 100%-94% of the mobile phase A and 0-6% of the mobile phase B are adopted; 25-40 min, 94%-84% of the mobile phase A and 6%-16% of the mobile phase B are adopted; 40-50 minutes: 84% of the mobile phase A and 16% of the mobile phase B; 50-51min: 84% of the mobile phase A, 100% of the mobile phase A and 16-0% of the mobile phase B; and in 51-60 min, 100% of the mobile phase A is adopted. The method for detecting the related substances of the amoxicillin related varieties, which is recorded and published by various Chinese pharmacopoeias and literatures, is confirmed, and a set of more effective high performance liquid chromatography is established and verified by screening and optimizing liquid phase conditions such as chromatographic columns and mobile phases, particularly chromatographic column brands, fillers, models and the like; the quality control can be simultaneously carried out on process impurities, degradation impurities, polymers and other organic impurities of amoxicillin raw materials and preparations thereof, so that the occurrence of adverse reactions such as anaphylaxis and the like is reduced, and the safety and effectiveness of medication are ensured.

The application belongs to the technical field of medicine synthesis, and particularly relates to a preparation method of methoxychlorpromazine monohydrochloride monohydrate. The method comprises the following steps: step 1, methoxychlorpromazine base is dissolved in a polar solvent, and hydrochloric acid is added to obtain a mixed solution; step 2, a poor solvent of methoxychlorpromazine monohydrochloride monohydrate is added to the mixed solution, crystallization is carried out, and separation is performed, and methoxychlorpromazine monohydrochloride monohydrate is obtained; the poor solvent is selected from one or a mixture of two or more of isopropyl alcohol, n-butyl alcohol, acetone, butanone, ethyl acetate, butyl acetate, dichloromethane, trichloromethane, toluene, methyl tert-butyl ether, isopropyl ether and diethyl ether. The method has the advantages of simple process, good repeatability, easy operation, high yield, product purity of more than 99.8%, complete compliance with the requirements of European Pharmacopoeia 9.0 and US Pharmacopoeia USP43, and suitability for industrial production.

The traditional Chinese medicine comprises the following raw materials in parts by weight: 15g of codonopsis pilosula, 10g of rhizoma acori graminei, 10g of processed polygala tenuifolia, 15g of rhizoma smilacis glabrae, 12g of raw dens draconis, 10g of astragalus membranaceus, 9g of divaricate saposhnikovia root, 10g of bighead atractylodes rhizome, 6g of raw liquorice, 9g of ephedra, 9g of almond, 15g of gypsum, 9g of cassia twig, 9g of rhizoma alismatis, 10g of radix bupleuri, 6g of scutellaria baicalensis, 9g of ginger processed pinellia, 9g of ginger, 9g of aster tataricus, 9g of flos farfarae, 9g of blackberry lily, 3g of asarum, 10g of parched white peony root, 9g of immature bitter orange and 9g of pericarpium citri reticulatae. According to the traditional Chinese medicine for detoxifying and clearing away the lung-heat and the decocting method thereof, the prescription medicine is designed from integrity, prevention and treatment are carried out at the same time, all the prescription medicines adopt non-toxic and harmless top-grade traditional Chinese medicine raw materials recorded in Pharmacopoeia, medicinal materials with bitter, cold and severe nature and taste are reduced as much as possible, damage to yang qi in a body is avoided, and the traditional Chinese medicine is safe and reliable. Therefore, the traditional Chinese medicine composition can meet the requirements of preventing and treating pneumonia in the aspects of safety, reasonability and effectiveness.

The invention belongs to the technical field of liquid phase detection, and particularly relates to a quality control and detection method for lumbricus soaked with liquorice. According to the method, methanol water is used as a mobile phase, the content of hypoxanthine and inosine in the lumbricus glycyrrhiza is detected by high performance liquid chromatography, and the method has important significance on quality control of a lumbricus glycyrrhiza product. The detection method disclosed by the invention is good in system applicability, precision, reproducibility, recovery rate and stability, and meets the requirements of Chinese Pharmacopoeia, Chinese Pharmacopoeia, appendix of Chinese Pharmacopoeia, Chinese appendix of Chinese Pharmacopoeia, Chinese Pharmacopoeia, Chinese

The invention relates to a formula and a preparation method of compound desert cistanche granules, the compound desert cistanche granules are prepared by adding flavor on the basis of Qingzheng dialectical record yang-warming soup, the raw materials comprise desert cistanche, bighead atractylodes rhizome, monkshood, Chinese angelica, cynomorium songaricum, fried semen raphani and perillaseed, and the total weight of a single bag is 7g. The production process comprises the key steps of pretreatment of medicinal materials, independent first decoction of radix aconiti carmichaeli for detoxification, extraction of semen raphani and perillaseed volatile oil, inclusion of beta-cyclodextrin, combined decoction and concentration of all the medicinal materials, dry granulation and the like, and the technical effects that granules are instantly dissolved within 45 + / -5 seconds and the transfer rate of crude drugs is 91.2% are achieved by optimizing the proportion of auxiliary materials and process parameters. The quality of the finished product meets the requirements of Chinese Pharmacopoeia, the content of aconitine is less than or equal to 0.02%, the total number of microbial limit aerobic bacteria is less than or equal to 100 CFU / g, the problems that a traditional compound cistanche deserticola preparation is slow in dissolution speed, unstable in toxicity control and non-standard in production process are solved, and the method is suitable for large-scale industrial production.

The invention discloses a method for detecting 5 '(E)-VPA phosphoramidite monomer related substances, and belongs to the technical field of liquid chromatography detection. Related substances comprise 5 '-(E)-VP-2'-OMe-A (Bz), 5 '(Z)-VPA, 5'-(E)-VP-2 '-OMe-A-CE-P and 5' (E)-VPA-OX, and chromatographic detection conditions comprise that the column temperature is 23-27 DEG C, a stationary phase of a chromatographic column is octadecyl bonded silica gel, a mobile phase A is an ammonium acetate solution, a mobile phase B is acetonitrile, gradient elution is performed, and the like. According to the method, four related substances in the 5 '(E)-VPA phosphoramidite monomer are effectively separated through specific liquid chromatography conditions, the system adaptability, specificity, linearity and range, detection limit, quantitation limit and accuracy verification of the method all meet acceptable standards of pharmacopoeia, and detection of multiple related substances can be completed within a short time; and a reliable means is provided for detecting and controlling the quality of the 5 '(E)-VPA phosphoramidite monomer.

The invention provides a method for detecting the content of dextromethorphan hydrobromide and quinidine sulfate capsules, and provides a convenient, efficient and accurate detection method for solving the problem of detecting the impurity content of the dextromethorphan hydrobromide and quinidine sulfate capsules. The method can be used for detecting the contents of six main impurities in the dextromethorphan hydrobromide and quinidine sulfate capsule: impurity A, impurity B, impurity C, impurity D, hydroquinidine and cinchonine, so that the medication safety is effectively guaranteed, the quality control of the dextromethorphan hydrobromide and quinidine sulfate capsule is facilitated, and the method is convenient, efficient, accurate and suitable for industrial production. The method completely accords with the guidance principle verified by a Chinese pharmacopoeia method in the aspects of system applicability, detection limit, quantitation limit and linearity, and can be used for quality control of dextromethorphan hydrobromide quinidine sulfate capsules.

The invention relates to a preparation process for producing water for injection based on a hollow fiber deoxidation membrane, and belongs to the technical field of preparation of water for injection medicines. According to the preparation process of the water for injection, dissolved oxygen in a water body can be stably removed, reproduction of microorganisms, bacteria and the like in the water can be effectively restrained by strictly controlling the content of oxygen and carbon dioxide in the water, meanwhile, due to removal of carbon dioxide in the water body, the conductivity of the water body is further reduced, the pH value of the finished water is stabilized to be 6.5-7.5, and the water quality is improved. The related industrial standards of the water for injection are met, and the content of microorganisms and endotoxin meets the strict requirements of the 2025 edition pharmacopoeia. Compared with a traditional distillation method, the membrane method integration process does not need to consume a large amount of industrial steam, energy consumption can be remarkably reduced, and the operation cost is reduced; by optimizing the position of the hollow fiber deoxidation membrane device, the water quality and the storage stability of the water for injection can be improved, and the production cost and the maintenance cost can be reduced.