http://rdf.ncbi.nlm.nih.gov/pubchem/patent/CN-102727429-B
Outgoing Links
Predicate | Object |
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assignee | http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_ef0c06d538a4a90a27d36888e71a1670 |
classificationIPCInventive | http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K9-08 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61P37-04 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K38-05 http://rdf.ncbi.nlm.nih.gov/pubchem/patentipc/A61K47-40 |
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 http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_c5fd60438fa8b22f89117055bc0cfde8 http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_ad3ce65132019dafb2b35a30e3f7dd38 http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_83bf0f1f7639a0aa74a14d260c280681 http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_4f912df57909eaa383d4adcfd59a26ab |
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 |
Incoming Links
Total number of triples: 80.