http://rdf.ncbi.nlm.nih.gov/pubchem/patent/CN-102727429-B

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classificationIPCInventive http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K9-08
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filingDate 2012-07-02-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2014-07-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_d9d8308a3d435be5ae51df9720621d3a
http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_2215c94e3dc4713e9a61a197269d0712
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publicationDate 2014-07-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-102727429-B
titleOfInvention Pidotimod injection with modified stability, and preparation method thereof
abstract The invention relates to a pidotimod injection with modified stability. The injection is characterized in that: the injection comprises an effective component pidotimod with a concentration of 1-10%, and preferably 5-8%; the injection comprises a stabilizing agent of hydroxypropyl-beta-cyclodextrin, wherein the weight ratio of hydroxypropyl-beta-cyclodextrin to pidotimod is 1:1-1:8, and preferably 1:2-1:5; the injection comprises an alkali which is preferably a mixture of sodium hydroxide and trometamal, wherein the amount of sodium hydroxide accounts for 0.1-5% of that of the solution, and preferably 0.5-2%, and the amount of trometamal preferably accounts for 0.3-1.5% of that of the solution; and the pH value of the injection is preferably in a range of 6.5-7.0. A preparation method of the injection is characterized in that: the stabilizing agent is added into partial injection water according to a weight ratio of the stabilizing agent to the effective component pidotimod; the stabilizing agent is dissolved in the injection water; pidotimod is added into the solution, and the solution is stirred until the solution is clarified; an alkaline solution is added for adjusting the pH to 6.5-7.0; the solution is diluted until a total amount of the injection is reached; the concentration of the effective component pidotimod contained in the injection water is described above; pyrogen is removed by using active carbon; carbon-removing is carried out; the mixture is filtered by using a 0.22mum micro-porous filter membrane; the obtained material is subjected to filling, nitrogen filling, and sealing; and the obtained material is sterilized for 15min under a temperature of 121 DEG C, such that a finished product is obtained. Both after the injection is sterilized for 15min under the temperature of 121 DEG C, and within a investigation period of 6 months, the sums of related substances of the injection are lower and can be maintained at a value below 0.2%. The injection is more hardly affected by temperatures.
priorityDate 2012-07-02-04:00^^<http://www.w3.org/2001/XMLSchema#date>
type http://data.epo.org/linked-data/def/patent/Publication

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