Stable liquid pharmaceutical composition containing broadleaf holly leaf saponin compound
A technology of liquid medicine, picridin, which is applied in the field of liquid pharmaceutical compositions containing picridinic compounds, which can solve the problems of insignificant effects on survival rate and quality of life, damage to heart and kidney function, and large side effects
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Embodiment 1
[0106] According to the preparation formula in Table 1, take the water for injection of the formula amount, add disodium hydrogen phosphate, potassium dihydrogen phosphate, and disodium edetate in the formula amount, stir evenly, adjust the pH to about 7, and make a buffer solution; at the same time Weigh the formula amount of ethanol and Tween 80, add a part of the prepared buffer solution into it, stir evenly, prepare a solution with an ethanol concentration of about 50%, add the formula amount of picroside A to it, and stir until completely dissolved ; Finally, add the rest of the buffer and stir well. Obtained 3 formulation preparations.
[0107] Table 1: Formulation of formulations
[0108]
[0109] (2) Filling
[0110] Blowing, filling and sealing (BFS) integrated production line is used for filling, and 3 formulations of 3 different thicknesses (0.6mm, 1.0mm, 1.2mm) of low density polyethylene (Low Density Polyethylene, LDPE) bottle, 2ml per bottle.
[0111] (3) ...
Embodiment 2
[0120] Low-density polyethylene bottles (LDPE bottles) produced by the blow-fill-seal method are now used for inhalation preparations as packaging materials for direct contact with drugs. The bottle is easy and other advantages. However, the semi-permeability of LDPE bottles will cause the content of certain solvents (such as ethanol) stored in them to decrease due to volatilization. Due to the decrease of ethanol content, the solubility of the active compound KA decreases, which eventually leads to the precipitation of KA. Therefore, the inventors need to prevent the volatilization of ethanol to enhance the stability of the preparation and prolong its storage time. To this end, the inventors explored the stability of ethanol content in different sample formulations in Table 2.
[0121] Take the 9 kinds of KA preparation samples obtained in Table 2 of Example 1 and carry out the stability test of ethanol content to explore the change of ethanol content in the preparation unde...
Embodiment 3
[0146] Select sample 6 shown in embodiment 1 for use, carry out stability test by the condition shown in table 7:
[0147] Table 7: Stability test conditions
[0148]
[0149]
[0150] The content of KA was determined according to the external standard method in the general rule 0512 high performance liquid chromatography of "Chinese Pharmacopoeia" (2020 edition, volume four). Wherein, the chromatographic condition parameters used in high performance liquid chromatography are as follows:
[0151] Chromatographic column: C18 (2.1*100mm, 1.8μm);
[0152] Mobile phase: acetonitrile: water (26:74);
[0153] Flow rate: 0.6mL / min;
[0154] Column temperature: 38°C;
[0155] Detection wavelength: 225nm;
[0156] Injection volume: 5 μL;
[0157] Elution time: 28min.
[0158] According to the "Chinese Pharmacopoeia" (2020 Edition, Volume 4) general rule 0512 high performance liquid chromatography, the principal component self-control method with a correction factor was add...
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Abstract
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