PLB 2021 45 24 BH 2H) China Pharmacist 2021, Vol.24 No.2 HERBRES RRS FR Re EM AA END it ae RE Bh SR (OU EH AHN BE AK 610097) fi EAM, HERR MALAAMREDAAAA MM, Hik SAE RRA RA Ao ik AAP SE RA aR A BDFESDE EIN BEML GA RAW AAA RAH RES, BR, 58 MARR. PHA 100% ORE FARHAD RGAE 100%, FAL AR HARI RA, AH RRMKEH RNS By, th HAAR WRHER AA EMER AMAL, ME, RR Hah RuRRAM, th AAR A ARIE HE 12 AT A F* de sh ik hak ik yh SB AG aK PRPS: RIT. 1 #15 Se YAAG-E5B. (NMP A) BBCI op He LS A, TY S8 at AT Se TR AR a Ra Hh PARRA Rib ATA SERIA A SCHR B 1008-049X 2021 02.0301-04 Quality Research of Mannatide Injection Li Yan, Ma Jing, Zou Jian, Lin Tao, Wang Juexiao, Qin Li, Chen Jie, Yuan Jun (Sichuan Institute for Food and Drug Control, Chengdu 610097, China) ABSTRACT Objective: To research the quality status and existing problems in mannatide injection. Methods; After performing. questionnaire survey and visiting the manufacturers of mannatide raw material and injection searched through the website database of National Medical Products Administration(NMPA) , 58 batches of mannatide injection were tested according to the approved specifica tion, New methods for molecular weight, molecular weight distribution and content determination were studied. ‘The results of approved specification test and exploratory research were statistically analyzed to comprehensively evaluate the quality status of mannatide injee- tion, Results; Totally 58 batches of mannatide injection were tested according to the approved specification, and the qualified rate was 100%, und combined with the results of exploratory research, the qualified rate was 100%. At the same time, the results of explorato- vy research showed that the molecular weight of mannatide injection measured by the approved specification couldn’ t control the quality of mannatide injection strictly. The strain management and production management of mannatide were relatively supefcial. Conelue sion; The results of approved specification test and exploratory research show that there is still space to improve the quality of mannati- de injection. Manufacturers should strengthen the basic research, strain management and production management of the product. KEY WORDS. HBR SRNR (94% BH BE ) EA PA OY ARIE EE SRA ERP AT BRED We PEA: He BE LRG BD WAIT VA We AHF RSH FA BE BOAR BREA! SEE BEAR BR es ELAINE , WOR , CHPUEIAD GF WA stoi SEBEL AS 1 ARE eH) one RPM BEHELD) NMP) DS Se PE BR EAs ae EK GY ( dE HOS TRAUIEOS) epi 5 BADESOS 5 4 1 SRORIRTE SBE 7 dh 11 FE, EHEC LS SEALE FATAL 2 EAA THE ATK DAE, NE 1 RE. 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