Bowel-relaxing oral liquid and preparation method thereof

[0029] Embodiment 1, the preparation of laxative oral liquid

[0030] The preparation of the laxative oral liquid of Experimental Example 1-10 and Comparative Example 1-3 includes the following steps:

[0031] (1) Dissolution: According to the ratio shown in Table 1, weigh purified water and each component, and stir and dissolve at room temperature.

[0032] (2) Filling.

[0033] Table 1 Experimental example and prescription of comparative example

[0034]

[0035]

[0036] Example 2. Stability test

[0037] The ascorbic acid component is easily oxidized. In order to verify and test the stability of the oral liquid of the present invention and the ascorbic acid component, the following experiments were carried out.

[0038] 1. Detection method

[0039] Test samples: Experimental Examples 1-10, Comparative Examples 1 and 3.

[0040] Test conditions: high temperature (60℃), light (4500±500Lux).

[0041] Sampling time: 0 days, 7 days, 14 days, 28 days

[0042] Detection indicators/standards:

[0043] Solution color: Compared with the same volume of yellow No. 4 standard colorimetric solution, it should not be darker.

[0044] Determination method of ascorbic acid component content (in L-ascorbic acid): refer to the content detection method of vitamin C (L-ascorbic acid) contained in the 2020 edition of the "Chinese Pharmacopoeia", and use the iodine titration method to determine.

[0045]Ascorbic acid content standard: 90.0-110.0%.

[0046] 2. Experimental results

[0047] The solution color statistic result is shown in Table 2, and the ascorbic acid component content (calculated by L-ascorbic acid) statistic result is shown in Table 3.

[0048] Table 2 Statistical results of the color of the stability test solution

[0049]

[0050]

[0051] Table 3 Stability test ascorbic acid component content (calculated as ascorbic acid) results statistics

[0052] sample name 0 days High temperature 7D High temperature 14D High temperature 28D Illumination 7D Lighting 14D Lighting 28D Experimental example 1 99.2％ 98.9％ 97.3％ 94.2％ 98.1％ 97.7％ 97.0％ Experimental example 2 98.5％ 99.4％ 98.4％ 98.3％ 98.9％ 98.6％ 97.8％ Experimental example 3 100.2％ 98.6％ 97.2％ 94.6％ 97.9％ 97.5％ 96.8％ Experimental example 4 101.4％ 99.8％ 96.8％ 96.7％ 98.3％ 97.5％ 97.0％ Experimental example 5 99.6％ 100.3％ 97.4％ 93.3％ 98.9％ 98.1％ 97.6％ Experimental example 6 98.4％ 99.4％ 97.2％ 93.7％ 98.3％ 97.7％ 97.1％ Experimental example 7 99.5％ 100.2％ 97.6％ 94.4％ 98.9％ 98.2％ 97.6％ Experimental example 8 100.9％ 99.4％ 97.7％ 92.0％ 98.6％ 98.1％ 97.4％ Experimental example 9 100.1％ 99.3％ 98.3％ 99.2％ 98.8％ 98.5％ 97.7％ Experimental Example 10 98.7％ 100.7％ 96.6％ 94.9％ 98.1％ 97.7％ 97.0％ Comparative Example 1 99.6％ 95.4％ 90.1％ 81.5％ 97.4％ 94.6％ 86.7％ Comparative Example 3 100.6％ 98.7％ 94.6％ 85.7％ 97.9％ 96.0％ 89.3％

[0053] The results in Table 2 and Table 3 show that, under high temperature and light conditions, the color of the solution of Experimental Examples 1-10 of the present invention remains stable, indicating that the solution as a whole has good stability, and the content of ascorbic acid is always maintained at 92%~101% %, even at high temperature for 28 days, the content of ascorbic acid remains at about 97%. The above results show that the oral liquid of the present invention has excellent stability. In contrast, Comparative Examples 1 and 3 had poor stability, and the content of ascorbic acid gradually decreased with time, especially at high temperature and 28 days of light, which was significantly lower than that of Experimental Examples 1-10 of the present invention.