Saponin adjuvant and evaluation method thereof
AssigneeObi Pharma, Inc.
InventorsCheng-Der Tony Yu, Yih-Huang Hsieh, Wei Han Lee, Yu Chen Lin, Nan Hsuan Wang
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Abstract
The present disclosure is related to the six isomer structures (OBI-821-1990-V1A, OBI-821-1990-V1B, OBI-821-1990-V2A, OBI-821-1990-V2B, OBI-821-1858-A, and OBI-821-1858-B) of isolated OBI-821 adjuvant and the method for evaluating the quality thereof. The method of the present disclosure adopts hydrophilic interaction liquid chromatography (HILIC) and reverse phase high performance liquid chromatography (RP-HPLC) either alone or in tandem and is able to separate the isomers of OBI-821 adjuvant in the consequent chromatography. Accordingly, the quality of OBI-821 adjuvant can be further evaluated.
Claims15
A saponin composition, comprising, by the total weight of the saponin composition:
- 45 to 65 wt % of the Compound 1990-V1A;
- 19.31 to 27.99 wt % of the Compound 1990-V2A;
- 0.29 to 7.71 wt % of the Compound 1990-V1B;
- 0.11 to 3.11 wt % of the Compound 1990-V2B;
- 11.94 to 21.25 wt % of the Compound 1858-A;
- 0.06 to 2.44 wt % of the Compound 1858-B;
- and
- a pharmaceutically acceptable carrier,
- wherein the mixture of Compound 1990 comprises Compound 1990-V1A, Compound 1990-V1B, Compound 1990-V2A, Compound 1990-V2B, or a mixture thereof;
- and the mixture of Compound 1858 comprises Compound 1858-A, Compound 1858-B, or a mixture thereof;
- wherein the Compound 1990-V1A, Compound 1990-V1B, Compound 1990-V2A, Compound 1990-V2B, Compound 1858-A, Compound 1858-B, are of the following formula respectively:
- Compound 1990-V1A:
- R1 is β-D-Apiose, R2 is
- and R3 is H;
- Compound 1990-V1B:
- R1 is β-D-Apiose, R2 is H, and R3 is
- Compound 1990-V2A:
- R1 is β-D-Xylose, R2 is
- and R3 is H;
- Compound 1990-V2B:
- R1 is β-D-Xylose, R2 is H, and R3 is
- Compound 1858-A:
- R1 is H, R2 is
- and R3 is H;
- and
- Compound 1858-B:
- R1 is H, R2 is Hand R3 is
Dependencies are inferred from the claim text.