Description
Introduction
Dolutegravir (Dolutegravir, Tivicay) is a new anti-AIDS drug developed by the British pharmaceutical giant GlaxoSmithKline (GSK) and Japan's Shionogi Pharmaceutical Company (Shionogi). In July 2012, GlaxoSmithKline Pharmaceuticals and Shionoyoshi Pharmaceuticals announced the results of the Phase III clinical trial of the new AIDS drug Dolutegravir. After receiving dolutegravir and two other old-version AIDS drugs for 48 weeks, 88% of the patients' bodies The virus was successfully suppressed, and Gilead Sciences' three-in-one oral drug Atripla (Efavirenz/Emtricitabine/TenofovirDisoproxilFumarate) After that, 81% of the virus in the patient's body was suppressed. It can be seen that the dolutegravir drug of GlaxoSmithKline is slightly better. According to the researchers, in the comparison trial, due to the side effects of the drug, 10% of the patients eventually stopped taking Gilead's Atripla drug, but only 2% of the patients stopped taking GlaxoSmithKline's dolutegravir. Drugs, it can be seen that the safety of GlaxoSmithKline dolutegravir is slightly higher.
USE:
Dolutegravir (Dolutegravir, Tivicay) is a new anti-AIDS drug developed by the British pharmaceutical giant GlaxoSmithKline (GSK) and Japan's Shionogi Pharmaceutical Company (Shionogi). In July 2012, GlaxoSmithKline Pharmaceuticals and Shionoyoshi Pharmaceuticals announced the results of the Phase III clinical trial of the new AIDS drug Dolutegravir. After receiving dolutegravir and two other old-version AIDS drugs for 48 weeks, 88% of the patients' bodies The virus was successfully suppressed, and Gilead Sciences' three-in-one oral drug Atripla (Efavirenz/Emtricitabine/TenofovirDisoproxilFumarate) After that, 81% of the virus in the patient's body was suppressed. It can be seen that the dolutegravir drug of GlaxoSmithKline is slightly better. According to the researchers, in the comparison trial, due to the side effects of the drug, 10% of the patients eventually stopped taking Gilead's Atripla drug, but only 2% of the patients stopped taking GlaxoSmithKline's dolutegravir. Drugs, it can be seen that the safety of GlaxoSmithKline dolutegravir is slightly higher.
USE:
Dulutvir sodium salt is a second-generation HIV-1 integrase chain transfer inhibitor. Dulutvir sodium is currently in phase III clinical trials for the treatment of HIV infection. It has been shown that Dulutvir Chemicalbook sodium salt can effectively inhibit HIV replication in cells infected with inactivated PHIV lentiviral vectors (such as peripheral blood mononuclear cells (PBMC), MT-4 cells and CIP4 cells).
| Items | Standard | Results |
| Appearance | White to faint yellow powder | White powder |
| Solubility | Slightly solube in water,very slightly solube in methanol. | Complies |
| Identification | The IR spectrum of test sample is concordant with that of the dolutegravir Sodium Reference Standard obtained in the similar manner. | Complies |
| The retention time of the major peak in the chromatogram of the test solution corresponds to that in the chromatogram of the reference standard solution,as obtained in the test of assay. | Complies | |
| The water solution of this product presents identification reaction of sodium salt. | Complies | |
| Water | Not more than 1.0% | 0.10% |
| Enantiomer | RR enantiomer is not more than 0.15% | 0.01% |
| SR enantiomer is not more than 0.15% | 0.03% | |
| RS enantiomer is not more than 0.15% | Not detected | |
| Organic impurities | Impurity C is not more than 0.15% | 0.00% |
| Impurity D is not more than 0.15% | 0.03% | |
| Impurity E is not more than 0.15% | 0.03% | |
| Impurity F is not more than 0.15% | 0.02% | |
| Any individual unspecified impurity is not more than 0.10% | 0.02% | |
| Total impurities is not more than 1.0% | 0.15% | |
| Residual Solvents | Tetrahydrofuran(THF)is not more than 0.072% | Not Detected |
| Ethanol is not more than 0.5% | Not Detected | |
| Total residual solvents is not more than 0.5% | Not Detected | |
| Assay | 98.0%-102.0%(on anhydous basis) | 100.70% |
