36 results about "Pharmacopoeia" patented technology

This invention provides a method for preparing rocuronium bromide injection. By optimizing the conventional moist heat sterilization process, specifically by increasing the initial temperature of the heating process and decreasing the initial temperature of the cooling process, the overall exposure time of the injection to high temperatures is significantly shortened while maintaining the sterilization time at 121°C, thus significantly improving the quality stability of rocuronium bromide injection. Multiple batches of samples from this invention have met the related substance limits for rocuronium bromide injection as specified in the Chinese Pharmacopoeia, after accelerated stability and long-term stability studies.

This invention discloses a method for refining and desalting belladonna fluid extract, relating to the field of traditional Chinese medicine pharmaceuticals. Belladonna grass is pulverized through a 24-mesh sieve to form coarse powder. The powder is percolated using ethanol as a solvent to obtain a primary belladonna extract. The ethanol is recovered from the primary extract, and the extract is cooled to room temperature. Chlorophyll is removed by separation using a ceramic membrane. The extract is then filtered, and the filtrate is concentrated using an organic nanofiltration membrane to remove salts. The membrane filtrate is further concentrated under reduced pressure to a thick paste. Seven times the volume of ethanol is added and stirred until homogeneous. The mixture is allowed to stand until complete precipitation. The supernatant is collected, and the ethanol is recovered and concentrated to a thick paste. Based on the content determined in the thick paste, an appropriate amount of 85% ethanol is added, and the mixture is diluted with water to prepare a finished belladonna fluid extract product conforming to pharmacopoeia standards. This method is stable and reliable, avoids high-temperature degradation of the active ingredients, effectively removes impurities from the belladonna fluid extract, and prevents salt precipitation in the finished product. This ensures its efficacy and medication safety, and has broad market application prospects.

The application discloses a method for improving the chromatographic separation degree of impurities A and B in acetylcysteine raw materials, and is characterized by the following steps: controlling the column temperature of a chromatographic column within a specific low temperature range of 15 DEG C plus or minus 2 DEG C, and using the difference between the distribution behaviors of impurities A and B between a stationary phase and a mobile phase at different temperatures to significantly improve the separation degree of the two impurities. When the column temperature is 15 DEG C, the separation degree of impurities A and B can reach 2.06, which is much higher than the pharmacopoeia standard, and the separation degrees under the conditions of 30 DEG C, 35 DEG C and 40 DEG C all fail to meet the standard. The application does not need to replace the chromatographic column, is simple and convenient to operate, low in cost, can stably meet the accurate quantification requirements of related substances in acetylcysteine raw materials, and has good popularization and application value.

This invention discloses the contents of a Tibetan Artemisia capillaris capsule, which is prepared from the following raw and excipient materials in weight percentages: 55%–59% filler, 3%–6% flow aid, and the remainder being Tibetan Artemisia capillaris extract; the Tibetan Artemisia capillaris extract is an alcoholic extract of Tibetan Artemisia capillaris. The Tibetan Artemisia capillaris granules of this invention not only meet the quality requirements of the pharmacopoeia but also have low cost, making them suitable for large-scale industrial production.

The application belongs to the technical field of compound synthesis, and particularly relates to a preparation method of dipyrone with controlled content of 4-N methylene sulfonic acid sodium dipyrone impurity, which comprises the following steps: dissolving 4-formylaminoantipyrine in water, and then adding dimethyl sulfate and lye to react to obtain a methylation liquor; the obtained methylation liquor is hydrolyzed and neutralized, and then is left to stand and separate into layers, the upper 4-methylaminoantipyrine oil is cooled and crystallized to obtain 4-methylaminoantipyrine solid; the obtained 4-methylaminoantipyrine solid, ethanol, sodium pyrosulfite, activated carbon and formaldehyde are mixed to react to obtain dipyrone; the mass percentage of 4-aminoantipyrine in the 4-formylaminoantipyrine is not more than 1.5%. The content of 4-N methylene sulfonic acid sodium dipyrone (unknown impurity) in the prepared dipyrone is less than or equal to 0.05%, which meets the requirements of the European Pharmacopoeia.

This invention provides an in vitro cultured bezoar, its preparation method, and its application, belonging to the field of traditional Chinese medicine preparation technology. The preparation method of this invention involves obtaining a bile-resistant, high-β-glucuronidase-active *Escherichia coli* strain through bile gradient acclimation, which is then combined with *Enterococcus faecalis* to form a functional bacterial community. This community is then cultured in vitro through a three-stage process of proliferation, transformation, and crystallization, followed by gradient calcium ion-induced crystallization and vacuum freeze-drying to obtain in vitro cultured bezoar. This invention aims to solve the problems of low conversion efficiency, uneven crystallization, insufficient content of effective components, and unstable product quality in existing technologies. The obtained in vitro cultured bezoar product has significantly higher bilirubin and conjugated bile acid contents than the standards of the *Chinese Pharmacopoeia*, and the process is stable, controllable, and suitable for industrialization.

This invention belongs to the field of pharmaceutical synthesis, specifically relating to a method for preparing etorizine hydrochloride and its intermediates. Specifically, it involves reacting propionyl chloride and ethylbenzene at -80 to -50°C to obtain p-ethylphenylacetone, which is then reacted with piperidine and paraformaldehyde to form a salt, yielding etorizine hydrochloride. The method for preparing p-ethylphenylacetone provided by this invention can obtain a product with a low content of compound II. Using this as a raw material to prepare etorizine hydrochloride simplifies post-processing, improves yield, and ensures that the content of compound III meets pharmacopoeia standards, making it suitable for industrial production.

The application discloses a method for reducing vanadium element impurities in heparin sodium bulk drug and heparin sodium fine product obtained by the method, and belongs to the technical field of bulk drug preparation. The method comprises the following steps: dissolving heparin sodium crude product in purified water, performing enzymolysis, oxidizing under weak acid condition, precipitating with ethanol under strong alkaline condition, performing microfiltration and dehydration, and performing freeze drying. The vanadium element impurities in the obtained heparin sodium fine product are always kept at a low limit under the premise of guaranteeing other quality indexes, the residual amount meets the requirements of pharmacopoeia and the industry, and there is no risk of exceeding the standard.

This invention discloses a food-medicine composition with the effects of clearing the lungs, resolving phlegm, dispersing blood stasis, and eliminating nodules, belonging to the fields of functional food therapy and traditional Chinese medicine lung conditioning technology. This invention completely abandons the defects of traditional low-dose health care formulas. All raw materials are strictly formulated according to the legally prescribed therapeutic doses in the Chinese Pharmacopoeia and the conventional dosages in traditional Chinese medicine clinical prescriptions for pulmonary nodules. It uses high doses of Houttuynia cordata and fresh Imperata cylindrica root as the core heat-clearing and nodule-dispersing principal herbs, combined with sufficient amounts of Platycodon grandiflorus, Citrus reticulata peel, and Citrus reticulata peel to clear the lungs and resolve phlegm; a high proportion of Lilium brownii, Polygonatum odoratum, and Ophiopogon japonicus to nourish yin and protect the lungs; and Prunus persica to invigorate blood and disperse blood stasis, constructing a three-level pharmacopoeia-compliant dosage system. This invention features a rigorous formulation, a balanced combination of hot and cold properties of the medicinal ingredients, and sufficient potency. It breaks through the technical bottleneck of traditional dietary therapy formulas that cannot deeply disperse stagnation. It can effectively intervene in the phlegm and blood stasis in the lungs, improve pulmonary nodules, and eliminate long-term symptoms of lung heat and excessive phlegm, chest tightness, and dry throat. Its efficacy can be verified through multiple dimensions, including human trials, animal pharmacology experiments, and real clinical cases. The technology is innovative and practical, and it can be used as a high-end conditioning food for sub-healthy lungs in the general public, as well as a long-term standardized dietary intervention program for people with pulmonary nodules. It has extremely high value for industrialization and promotion.

This invention discloses a method and system for quality testing and analysis of finished traditional Chinese medicine (TCM) decoction pieces, belonging to the pharmaceutical field. The method includes the following steps: S1. Constructing a compound component database, which integrates pharmacopoeia standards, clinical prescription structures, medicinal material source attributes, and efficacy-related parameters, and establishes a standard model in a multi-level structured manner; S2. Collecting multimodal spectral data of TCM decoction piece samples; S3. Encoding the collected spectral data using a heterogeneous feature extraction algorithm to generate a fused structural feature vector; S4. Inputting the fused structural feature vector into a multi-channel evaluation model for weight comparison, classification judgment, and threshold assessment; S5. Generating a quality testing report. Beneficial effects: This method achieves high-precision quality testing combining multimodal fusion, intelligent discrimination, and traceability visualization, effectively improving the quality consistency assessment and risk identification capabilities of TCM decoction pieces.

The application discloses a preparation method of a triptolide sesquiterpene alkaloid purity standard sample, and belongs to the technical field of natural product separation and purification and standard substance preparation. The method comprises the following steps: obtaining total alkaloid crude products through ethanol extraction and acid-dissolution alkalinization extraction, enriching the total alkaloid crude products through methanol grading, pre-separating the total alkaloid crude products through a specific two-phase system of petroleum ether (60-90 DEG C)-ethyl acetate-isopropyl alcohol-water HSCCC, and finally obtaining monomer products with purity greater than or equal to 99.0% through reverse-phase preparation HPLC refining and low-temperature multiple recrystallization. The obtained standard sample has water content less than or equal to 0.5%, residual solvents meet the requirements of ICH Q3C and the Chinese Pharmacopoeia, and the impurity spectrum fingerprint similarity is greater than or equal to 0.98 under different raw material batches and amplification conditions, so that the batch consistency, traceability and storage stability are significantly improved, and the strict requirements of standard substances in quality control and analytical detection are met.

This application discloses a method for preparing bilastin and its impurities. The method for preparing bilastin includes a reaction step using a compound of formula (I) and / or a salt of a compound of formula (I) as an intermediate, wherein the content of the compound of formula (II) in the intermediate product is not higher than 0.1 wt%. The method of this application yields bilastin with a purity higher than 99.5%, and the content of a single impurity is not more than 0.1%. The purity of the bilastin product meets the quality standards specified in the pharmacopoeia, with a high product qualification rate, which is conducive to large-scale production.

The application provides a preparation method of a test sample in a content determination method of Astragalus membranaceus, which comprises the following steps: a, taking Astragalus membranaceus medicinal material powder, and sieving; b, placing the powder into a stoppered conical flask, adding 20-100 ml of 1-6 % ammonia solution-methanol solution (4 ml of ammonia solution is taken, 50 % methanol is added to 100 ml, and shaking is performed), weighing, ultrasonic extraction (250 W, 40 kHz) is performed for 10-90 min, cooling, weighing again, supplementing the lost weight with 1-6 % ammonia solution-methanol solution, shaking, filtering, and taking the filtrate, so that the test sample is obtained. The application further provides a content determination method of calycosin-7-glucoside in Astragalus membranaceus. The optimized method is stable and feasible, simple in operation, high in extraction efficiency, short in analysis time, low in detection cost, and accurate in determination, and can provide a scientific basis for improving the content determination method of calycosin-7-glucoside in Astragalus membranaceus in Chinese Pharmacopoeia.

This invention discloses a method for processing the traditional Chinese medicine Pinellia ternata. The method involves processing the raw Pinellia ternata in a phosphate solution under sealed conditions, followed by slicing into thick pieces and drying to obtain the processed product. The medicinal material is Pinellia ternata or Arisaema heterophyllum. The method of this invention uses phosphate solution to soak Pinellia ternata, which significantly reduces its irritant properties. Toxicological experiments have shown that the processed Pinellia ternata is non-irritating and does not cause a numbing sensation on the tongue. This invention does not use alum, thus avoiding the use of residual Al from alum as a processing excipient in pharmacopoeia methods. 3+ The toxicity to the human nervous system is minimal, ensuring safe and effective clinical use. Compared with traditional processing methods, phosphate-processed Pinellia ternata has the advantages of quantifiable process indicators, simple operation, and no introduction of hazards. It provides a reference for the processing technology of phosphate-processed Pinellia ternata, lays the foundation for the quality stability of phosphate-processed Pinellia ternata, and ensures the safety and efficacy of traditional Chinese medicine.

This invention relates to a 30 mg bilayer biphasic-release tablet containing merogabarine or a pharmaceutically acceptable salt thereof, and a method for preparing the same. The tablet is a bilayer tablet consisting of an immediate-release layer and a sustained-release layer, wherein the immediate-release layer accounts for 20%–35% of the total drug content, and the sustained-release layer accounts for 65%–80% of the total drug content. The sustained-release layer contains hydroxypropyl methylcellulose K15M or hydroxypropyl methylcellulose K100M and ethylcellulose. Under the conditions of the second method for release determination in the current edition of the Chinese Pharmacopoeia, the tablet has a predetermined 24-hour release window in any of the media selected from pH 1.2, pH 4.5, and pH 6.8, and maintains a small difference in media values ​​at 8 hours and 12 hours, making it suitable for development into an oral sustained-release formulation for once-daily administration.

This invention discloses a porcine circovirus vaccine filling device, relating to the field of vaccine filling technology. The device includes a filling assembly comprising a base, a support frame on top of the base, the support frame being L-shaped, a servo motor at the top of the support frame, and a connecting frame fixedly mounted on the bottom telescopic end of the servo motor through the support frame. The connecting frame has several sets of mounting holes arranged sequentially, through which connecting pipes are installed. This invention, by setting up the filling assembly, can effectively buffer the filling process. The sieve plate provides effective buffering and defoaming, solving the problem of air bubbles easily generated during filling in existing devices. It avoids the problem of large differences in drug dosage due to air bubbles, ensuring the product complies with veterinary pharmacopoeia regulations. Simultaneously, it prevents oxygen in the air bubbles from accelerating the oxidative denaturation of vaccine antigen proteins, ensuring the drug's efficacy and preventing immunization failure.

The present application belongs to the technical field of traditional Chinese medicine preparation, and particularly relates to a preparation process of Xiangtao Qingyou granules. Five-finger fig and clove are uniformly mixed, heated, reflux extracted, concentrated to form extract liquid, and then granulated together with any two of lactose, corn starch and beta-cyclodextrin. When the auxiliary materials are lactose-cyclodextrin (2:1) combination, the extract-mixed auxiliary materials are granulated in (1:4.8) or (1:4) combination, brown yellow uniform granules can be obtained, which can be completely dissolved in hot water within 5 min, the rest angle is 21.34° and 21.76° respectively, the forming rate is 98.13% and 98.33% respectively, and the moisture absorption rate within 24 h is 0.749% and 0.754% respectively. It is shown that the preparation process of the present application can obtain Xiangtao Qingyou granules with appearance and solubility meeting the requirements of pharmacopoeia, good fluidity, high forming rate and not easy to absorb moisture by using the above two combinations, and the preparation method is stable and feasible.

Provided in the present invention is a digital standard for verifying the accuracy of the metagenome biological information detection process. In the present invention, 24 viral genomes of particular concern to the Chinese Pharmacopoeia are selected, and a total of 100 samples are constructed. Each sample contains 24 different viral genome sequences. The abundance is randomly generated, and the viral abundance distribution of each sample is different. The digital standard of the present invention can be used for verifying the accuracy of the biological information process built on the basis of metagenome.

The application discloses a kind of to improve agarwood tetrol content's odd Nan multi-generation grafting cultivation method, belong to plant breeding and cultivation technical field.The application aims at solving the existing odd Nan agarwood agarwood tetrol content is far lower than pharmacopoeia standard, cannot satisfy medicinal demand, and the existing grafting technology breeding goal is single, does not form the problem of directional breeding system.The application carries out grafting with agarwood tree species as rootstock and odd Nan branch as scion, after cultivation management, induces to be fragrant, with agarwood tetrol content as core index to screen excellent single plant, then with excellent plant branch as scion repeats multi-generation cycle cultivation, finally obtains the odd Nan strain with high agarwood tetrol content.The application can realize the stable promotion of agarwood tetrol content generation by generation, retain the core advantage of odd Nan rapid fragrant formation simultaneously, is suitable for the large-scale directional cultivation of odd Nan medicinal variety.

A synthesis method for selamectin was developed, where doramectin is oxidized by manganese dioxide, oximated and de-sugared in one-step by an aqueous solution of hydroxylamine hydrochloride, and then selectively reduced in the presence of Wilkinson's catalyst and hydrogen to obtain selamectin. Doramectin is oxidized to a carbonyl group firstly, so that the generation of impurities during the subsequent reaction is reduced; t-butyl alcohol with a larger steric hindrance is used as a solvent, so that transesterification impurities are avoided; the hydrogenation is implemented in the final step, and the crude product is recrystallized before the hydrogenation reaction, so that the cost is greatly reduced. The method of the present application with an overall yield of 57%. The purity of product was 97.11%. All impurities meet the requirements of Pharmacopoeia. The present application is a simpler, more economical and more efficient synthesis method, and is suitable for industrial production.

The application discloses a preparation method of a pharmaceutical-grade disodium hydrogen phosphate, and belongs to the technical field of chemical raw medicine preparation. In the application, anhydrous sodium carbonate is used as an alkali source to react with phosphoric acid, no stirring device is arranged in the reaction process or only a basic rotating speed is used to maintain homogeneity of the system, and solid-liquid disturbance mixing is realized by using carbon dioxide gas generated in the reaction to escape; meanwhile, three-stage pH stepwise precise regulation and control are adopted to regulate and control the reaction process. The method can effectively avoid the generation of trisodium phosphate impurities caused by local over-alkalization, the content of trisodium phosphate in the finished product is less than or equal to 0.05%, the pH difference between batches of products is less than or equal to 0.1, the main content of anhydrous substance is 99.3% to 99.8%, and all indexes meet the pharmaceutical standards in the Chinese Pharmacopoeia. The energy consumption of concentration and evaporation in the process is 18% to 22% lower than that in the traditional sodium hydroxide method, the anhydrous sodium carbonate is not a dangerous chemical product, and the storage and transportation and compliance management costs are effectively reduced. The application has the advantages of simple process, strong stability and suitability for industrial large-scale production.

The present invention provides a solid oral pharmaceutical composition comprising a pharmaceutically effective amount of living microorganisms and one or more pharmaceutically acceptable water absorbing excipient(s), wherein the composition has a water content, determined according to European Pharmacopoeia 9.4, section 2.5.12., from 0.5 to 30% with respect the total weight of the composition.The invention also provides processes for its preparation as well as it use in therapy.The live-cell based composition of the invention is stable at mild conditions.

The present invention provides a solid oral pharmaceutical composition comprising a pharmaceutically effective amount of live microorganisms and one or more pharmaceutically acceptable water-absorbing excipients, wherein the water content of the composition is between 0.5% and 30% by weight of the total composition, as determined according to the European Pharmacopoeia 9.4 section 2.5.12. The present invention also provides a process for its preparation and its use in therapy. The live cell-based composition of the present invention is stable under mild conditions.

This invention discloses a preparation process for high-purity donkey-hide gelatin from black donkey skin, belonging to the field of traditional Chinese medicine extraction and refining technology. This process utilizes a multi-stage coupling technology involving ultrasound-assisted degreasing, directional depolymerization with compound enzymes, gradient membrane separation, low-temperature vacuum concentration, and supercritical CO₂ purification to achieve high-purity preparation of donkey-hide gelatin from black donkey skin. Specific steps include: black donkey skin selection and pretreatment, directional depolymerization with compound enzymes, gradient membrane separation and purification, low-temperature vacuum concentration, deep purification with supercritical CO₂, condensation and drying. The donkey-hide gelatin prepared by this invention has a dry-based protein purity ≥95%, with residual impurities such as proteins, fats, and heavy metals far below the standards of the Chinese Pharmacopoeia, and an active polypeptide retention rate ≥90%. Simultaneously, the process cycle is shortened by 60%, energy consumption is reduced by 40%, and batch-to-batch variation is ≤2%, making it suitable for continuous industrial production. This invention solves the technical problems of low purity, significant activity loss, low efficiency, and unstable quality in traditional donkey-hide gelatin preparation processes, significantly improving the quality of donkey-hide gelatin.

The application discloses a measurement method and system for heavy metal content of Chinese traditional medicine herba potentillae discoloris, and the measurement method comprises the following steps: pretreating the Chinese traditional medicine herba potentillae discoloris, and realizing effective enrichment and preliminary purification of target heavy metal ions in the herba potentillae discoloris by using a microwave digestion-turbid point extraction technology; determining optimal spectral experimental parameters of inductively coupled plasma atomic emission spectrometry by using a response surface method; investigating and eliminating ion interference and acid interference generated after microwave digestion-turbid point extraction of the herba potentillae discoloris sample; after removing the interference of the herba potentillae discoloris sample solution obtained by using the microwave digestion-turbid point extraction technology, the inductively coupled plasma atomic emission spectrometry is used to determine the target heavy metal content in the herba potentillae discoloris; and the accuracy of the metal content determination method is verified according to the Chinese Pharmacopoeia. The application improves the sensitivity and accuracy of the heavy metal content analysis method of the Chinese traditional medicine.

The application provides a process for preparing hydrocortisone sodium succinate, which uses succinic anhydride and hydrocortisone as raw materials to carry out a reaction, can solve the problem of residual acetone in the low-temperature acetone crystallization process, and can obtain a product with high quality (purity >= 99.5%) and meeting the requirements of pharmacopoeia standards and ICH guidelines in residual solvent, sodium content, and drying loss.

This invention relates to the field of Gastrodia elata cultivation technology, specifically to a method for producing and applying selenium-enriched Gastrodia elata. By using selenium-enriched Armillaria mellea spawn for Gastrodia elata cultivation, this invention significantly increases the selenium content in commercial Gastrodia elata, significantly improves its yield, and enhances the effective components specified in the Chinese Pharmacopoeia of Gastrodia elata. While increasing the selenium content, it also improves the yield and quality of Gastrodia elata.

The invention belongs to the field of veterinary drug preparations, and particularly relates to soluble powder and application thereof to treatment of avian coccidiosis, the soluble powder contains sulfachloropyrazine sodium, dimetridazole, catechin and other components, through auxiliary material component optimization, the final soluble powder is found through acceleration tests, and the content of the sulfachloropyrazine sodium, the dimetridazole, the catechin and the like in the soluble powder is increased. The dissolution rate and content of the product meet or are higher than the requirements of Chinese veterinary drug pharmacopoeia. Pharmacodynamic experiments show that the soluble powder product disclosed by the invention is exact in curative effect, the weight and the survival rate of a chicken farm can be remarkably improved, and the economic benefit is remarkably improved.

The present invention provides a solid oral pharmaceutical composition comprising a pharmaceutically effective amount of live microorganisms and one or more pharmaceutically acceptable water-absorbing excipients, wherein the water content of the composition is between 0.5% and 30% by weight of the total composition, as determined according to the European Pharmacopoeia 9.4 section 2.5.12. The present invention also provides a process for its preparation and its use in therapy. The live cell-based composition of the present invention is stable under mild conditions.