Gentle preservative compositions for self-preserving solutions
A composition and preservative technology, applied in detergent compositions, lens cleaning compositions, detergent compounding agents, etc., can solve problems beyond clinical level, eye tissue irritation, etc.
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Embodiment 1
[0028] The preparation of embodiment 1 test solution
[0029] Sample solutions for testing were prepared according to the recipes listed in Table 1 below.
[0030] Table 1
[0031] Element
weight%
the solution
1
2
3
4
sodium borate
boric acid
EDTA
Polymer JR 30M
pH
Osmolarity (mOsm / Kg)
0.135
1.000
0.05
0.02
7.0-7.4
180-220
0.160
1.400
0.05
0.02
7.11
235
0.160
1.400
0.05
0.01
7.11
230
0.160
1.400
0.05
0.005
7.11
232
[0032] Table 1 - continued
[0033] Element
weight%
the solution
5
6
7
8
sodium borate
boric acid
EDTA
Polymer JR 30M
Polymer JR 400
pH
Osmolarity (mOsm / Kg)
0.160
1.400
0.10
0.02
0
7.03
...
Embodiment 2
[0036] Example 2 ISO / FDA Microbial Preservative Efficacy Testing of Test Solutions with 5 FDA / ISO Challenge Microorganisms
[0037] Using 5 kinds of FDA / ISO challenge microorganisms, namely 3 kinds of bacteria and 2 kinds of fungi, the test solutions prepared according to the above-mentioned Example 1 were subjected to ISO / FDA microbial preservative efficacy tests respectively. Acceptance criteria established for bacteria required at least a 3.0 log reduction in the number of viable bacteria per milliliter recovered at 14 days. After 14 days of re-challenge, the concentration of bacteria should have decreased by at least 3.0 logs by 28 days. Acceptance criteria established for yeast and fungi require that the number of viable yeast and fungi recovered per milliliter remain at or below the initial concentration within ±0.5 logs of experimental error within 14 days. After 28 days, the concentrations of fungi and yeast should remain at or below post-rechallenge within experiment...
Embodiment 3
[0042] The preparation of embodiment 3 preservative system
[0043] Sample solutions for testing were prepared according to the preservative system formulations listed in Table 3 below.
[0044] table 3
[0045] Element
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