Double-layer controlled-release tablets for improving sleep and beautifying features and preparation method
A technology for improving sleep and controlled-release tablets, applied in the field of food, can solve problems such as too fast release, and achieve the effects of improving sleep, reducing the frequency of taking, and prolonging the action time.
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Embodiment 1
[0033] Example 1 Preparation of double-layer controlled-release tablets for improving sleep and beauty (1000 mg per tablet)
[0034] Table 1 The weight of the double-layer controlled-release tablets of each sample S1-3 and reference substance C2-5 (1 piece, 1000mg)
[0035]
[0036]
[0037] Table 2 The content and ratio of each active ingredient in the immediate-release layer and the sustained-release layer
[0038]
[0039] Note: Content refers to the mass percentage in the whole double-layer controlled-release tablet.
[0040] Take each raw material according to table 1 weight, carry out tablet preparation according to the following method:
[0041] (1) Take jujube seed extract, GABA, sodium hyaluronate, magnesium-containing compounds, disintegrants, fillers, and lubricants and pass through an 80-mesh sieve, and set aside;
[0042] (2) Preparation of immediate-release layer: Weigh GABA, sodium hyaluronate, disintegrant, filler, lubricant and mix evenly, add an ap...
Embodiment 2
[0047] Example 2 Determination of Release
[0048] With reference to the second appendix XD first method of the 2015 edition of the Pharmacopoeia, take each 6 double-layer controlled-release tablets obtained in the examples and comparative examples, add 1000ml of 0.1mol / L hydrochloric acid solution, centrifuge, and rotate at 100r / min for 2 hours. , 4 hours, 8 hours, 12 hours, and 18 hours respectively take out 10mL of the solution, filter, and add 10mL of 0.1mol / L hydrochloric acid solution in the operation container in time. Take the filtrate and measure the GABA content according to the method stipulated in the high-performance liquid chromatography determination method of gamma-aminobutyric acid in "Health Food Functional Components Detection Method" (Bai Hong. China Press of Traditional Chinese Medicine, 2011), calculate the cumulative release percentage of GABA, and the result as shown in Table 3.
[0049] Table 3 Cumulative release percentage of different tablets
[00...
Embodiment 3
[0052] Example 3 Product Safety Verification
[0053] 1. Materials and methods
[0054] 1.1 Subjects
[0055] 400 volunteers with frequent insomnia, easy to wake up, insomnia, dry skin (skin moisture ≤ 10), and sallow complexion were selected as test subjects, half male and half male, aged 35-60 years old.
[0056] Subject exclusion criteria:
[0057] (1) Pregnant or breastfeeding women, allergic constitution and those who are allergic to this health food;
[0058] (2) Combined with cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases and mental illness history;
[0059] (3) Taking items related to the test function in a short period of time, which will affect the judgment of the results;
[0060] (4) Failure to take the test sample according to the test requirements, unable to determine the efficacy or incomplete data affect the efficacy or safety judgment.
[0061] Table 4 Grouping of subjects (mean ± standard deviation)
[0062] ...
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