Process for producing amylase resistant granular starch
制药工程专业英语课后练习题含答案 (2)
制药工程专业英语课后练习题含答案题目一：Drug Substance Manufacturing1.What is Drug Substance Manufacturing?–A. It is the process of producing a finished drug product.–B. It is the process of producing the activeingredient or drug substance used in a drug product.–C. It is the process of packaging and labeling a finished drug product.–D. It is the process of performing clinical trials ona drug product.Answer: B. It is the process of producing the active ingredient or drug substance used in a drug product.2.What are the steps involved in Drug Substance Manufacturing?–A. Synthesis, isolation, and purification.–B. Packaging, labeling, and testing.–C. Clinical trials, manufacturing, and distribution.–D. None of the above.Answer: A. Synthesis, isolation, and purification.3.What is the mn purpose of Drug Substance Manufacturing?–A. To produce a finished drug product for human use.–B. To provide the active ingredient or drug substance used in a drug product.–C. To test and validate the safety and efficacy of a drug product.–D. To distribute a drug product to consumers.Answer: B. To provide the active ingredient or drug substance used in a drug product.题目二：Pharmaceutical Formulation1.What is Pharmaceutical Formulation?–A. It is the process of producing a finished drug product.–B. It is the process of selecting and combining ingredients to produce a drug product.–C. It is the process of packaging and labeling a finished drug product.–D. It is the process of performing clinical trials ona drug product.Answer: B. It is the process of selecting and combining ingredients to produce a drug product.2.What are the key considerations in PharmaceuticalFormulation?–A. Safety, efficacy, and stability.–B. Cost, avlability, and taste.–C. Appearance, texture, and smell.–D. None of the above.Answer: A. Safety, efficacy, and stability.3.What is the role of excipients in Pharmaceutical Formulation?–A. They are the active ingredients in a drug product.–B. They are the inactive ingredients in a drug product that help to improve its properties.–C. They are the ingredients in a drug product that are responsible for the color and flavor.–D. None of the above.Answer: B. They are the inactive ingredients in a drug product that help to improve its properties.题目三：Good Manufacturing Practice (GMP)1.What is Good Manufacturing Practice (GMP)?–A. It is a set of regulations and guidelines that ensure the quality and safety of pharmaceutical products.–B. It is a set of regulations and guidelines that ensure the efficacy of pharmaceutical products.–C. It is a set of regulations and guidelines that ensure the affordability of pharmaceutical products.–D. None of the above.Answer: A. It is a set of regulations and guidelines that ensure the quality and safety of pharmaceutical products.2.What are the key components of Good Manufacturing Practice(GMP)?–A. Quality control, documentation, and facility design.–B. Clinical trials, manufacturing, and distribution.–C. Cost control, inventory management, and customer service.–D. None of the above.Answer: A. Quality control, documentation, and facility design.3.Why is Good Manufacturing Practice (GMP) important?–A. It helps to ensure the quality and safety ofpharmaceutical products.–B. It helps to reduce the cost of producingpharmaceutical products.–C. It helps to increase the avlability ofpharmaceutical products.–D. None of the above.Answer: A. It helps to ensure the quality and safety of pharmaceutical products.总结本文介绍了制药工程专业英语中的几个重要概念和术语，包括Drug Substance Manufacturing（药品物质制造）、Pharmaceutical Formulation（制剂开发）以及Good Manufacturing Practice（良好生产规范）。
PROCESS FOR THE PRODUCTION OF AN AMYLASE INHIBITOR
专利名称：PROCESS FOR THE PRODUCTION OF AN AMYLASE INHIBITOR发明人：FROMMER W,DT,PULS W,DT,SCHMIDT D,DT 申请号：US33668773申请日：19730228公开号：US3855066A公开日：19741217专利内容由知识产权出版社提供摘要：The invention relates to an amylase inhibitor for glycoside-hydrolases derived from a new strain of micro-organism, mutants and variants thereof, of the order Actinomycetales, means for their production comprising cultivation of the new strain of the order Actinomycetales, mutants and variants thereof, in appropriate nutrient solutions under conditions most favorable to growth and production of said amylase inhibitor and recovering an amylase inhibitor from culture broths of said nutrient solutions and said new strain of microorganism, mutants and variants thereof, of the order Actinomycetales as well as the use of said enzyme inhibitor in pharmaceutically acceptable therapeutic compositions suitable for use in the treatment and relief of conditions indicative of obesity, diabetes, pre-diabetes, gastritis, gastric and duodenal ulcers, hyperlipidemia (atheriosclerosis) and the like. The invention also contemplates the provision of methods of inhibiting the reaction of carbohydrates and glycoside-hydrolase enzymes, and particularly carbohydrate-splitting glycoside-hydrolase enzymes of the digestive tract by means of conducting said reaction of said carbohydrates and glycoside-hydrolase enzyme in the presence of a glycoside-hydrolase enzyme inhibitor derived from a new strain, mutants and variants thereof, of the order Actinomycetales. Theinvention further contemplates the provision of method for the treatment of indications of the group consisting of obesity, hyperlipidemia (atheriosclerosis), diabetes, pre-diabetes, gastritis, gastric ulcer, duodenal ulcer and dental caries induced by the action of glycoside-hydrolase enzymes and carbohydrates which comprises employing an enzyme inhibitor for glycoside-hydrolase enzymes produced by a new strain of microorganism of the order Actinomycetales of the family Actinoplanaceae.申请人：BAYER AG,DT更多信息请下载全文后查看。
A process for producing exogenous protein in the m
专利名称：A process for producing exogenous protein in the milk of trangenic mammals and aprocess for purifying proteins therefrom 发明人：LINO BARANAO,CARLOS ALBERTOMELO,CESAR CARBONNETTO申请号：AU2004278747申请日：20040929公开号：AU2004278747A1公开日：20050414专利内容由知识产权出版社提供摘要：The invention relates to a method of producing a protein of interest, comprising making a non-human transgenic mammal that produces said protein in its milk, obtaining said milk from the non-human transgenic mammal and purifying said protein of interest from the milk. Transgenic bovine animals were generated, which are able to produce human growth hormone in mammary glands. The method involves cloning of a genetic construct encoding hGH gene and beta casein promoter conveniently in an expression vector. It also includes transfection procedures into fetal bovine somatic cells, generally fibroblasts, and the nuclear transfer into enucleated bovine oocytes, generating thus transgenic embryos. The method also includes other procedures to generate transgenic embryos for the further expansion of the transgenic herd, such as the subcloning of transgenic female bovines, the superovulation of transgenic cows and their insemination with semen from a non-transgenic or a transgenic male bovine, and the superovulation of non-transgenic cows and their insemination with semen from a transgenic male bovine. Afterwards, transgenic embryos give rise to transgenic cattle that produce humangrowth hormone in huge amounts in their milk, from which the hormone is completely purified and analysed to fulfill all the requirements for the manufacture of a pure biopharmaceutical product.申请人：STERRENBELD BIOTECHNOLOGIE NORTH AMERICA, INC.更多信息请下载全文后查看。
Process for producing extract for cell-free protei
专利名称：Process for producing extract for cell-free protein synthesis and cell extract producedthereby发明人：Natsuko Matsuda,Takanori Kigawa,Namtip Chumpolkulwong,Chie Takemoto,MikakoShirouzu,Akiko Tanaka,Shigeyuki Yokoyama 申请号：US11282613申请日：20051121公开号：US20060134735A1公开日：20060622专利内容由知识产权出版社提供摘要：It is intended to provide a process for producing an extract for cell-free protein synthesis whereby the productivity of a protein and the production efficiency can be improved. Cells are cultured under suppressed growth conditions. In the stationary phase of the culture, the cells are collected and then disrupted. The above-described cells are preferably bacterial cells, in particular, cells. In the suppressed growth conditions as described above, the culture temperature is preferably from 20 to 32° C., more preferably 26° C. or higher and lower than 30° C.申请人：Natsuko Matsuda,Takanori Kigawa,Namtip Chumpolkulwong,Chie Takemoto,Mikako Shirouzu,Akiko Tanaka,Shigeyuki Yokoyama地址：Yokohama-shi JP,Yokohama-shi JP,Yokohama-shi JP,Yokohama-shiJP,Yokohama-shi JP,Yokohama-shi JP,Yokohama-shi JP国籍：JP,JP,JP,JP,JP,JP,JP更多信息请下载全文后查看。
Process for producing soybean protein material
专利名称：Process for producing soybean protein material发明人：Tatsumi Miyazaki,Toru Kudo,YasuoOtani,Motohiko Hirotsuka申请号：US08/693099申请日：19960809公开号：US05663058A公开日：19970902专利内容由知识产权出版社提供摘要：There is disclosed a process for producing a soybean protein material which comprises the steps of: hydrolyzing soybean protein with a protease in an aqueous system to an extent of hydrolysis of 5 to 20; if necessary, emulsifying an oil-and-fat ingredient with soybean protein in an amount of 5 to 50 parts by weight per 100 parts by weight of the soybean protein before or after the hydrolysis step; drying the resultant emulsified mixture; and, optionally, a step for dispersing an emulsifier being provided at any stage after emulsification with the oil-and-fat ingredient. The soybean protein material thus obtained has taste, color and water-dispersibility suitable for a pickling solution having a high concentration and thick drinking food such as soup with less foaming property.申请人：FUJI OIL COMPANY, LIMITED代理机构：Wenderoth, Lind & Ponack更多信息请下载全文后查看。
Process for producing cycloolefin resin compositio
专利名称：Process for producing cycloolefin resincomposition发明人：Kimiyoshi Miura,Sadao Yoshimoto,NoboruKoga,Takeshi Suzuki,Atsushi Shibuya申请号：US11794237申请日：20051227公开号：US07674413B2公开日：20100309专利内容由知识产权出版社提供专利附图：摘要：A process for producing a cycloolefin resin composition comprising a cycloolefin resin and an additive by using a twin-screw extruder is provided, in which loss of theadditive caused by volatilization through a vent during kneading is reduced and kneading of resin material with the additive can be sufficiently carried out. When the cycloolefin resin and the additive are kneaded by using a vented twin-screw extruder () to produce the cycloolefin resin composition containing the additive, an additive introduction opening () is disposed downstream of a vent () located nearest to a discharge opening () of the twin-screw extruder, and the additive is charged through the additive introduction opening located at a distance from the discharge opening of the twin-screw extruder in the range between longer than 10D and not longer than 30D.申请人：Kimiyoshi Miura,Sadao Yoshimoto,Noboru Koga,Takeshi Suzuki,Atsushi Shibuya地址：Hatsukaichi JP,Iwakuni JP,Iwakuni JP,Otake JP,Funabashi JP国籍：JP,JP,JP,JP,JP代理机构：Buchanan Ingersoll & Rooney PC更多信息请下载全文后查看。