Film coating premix for fading of aluminum color lakes

Abstract

The invention relates to a film coating premix for fading of aluminum color lakes, which comprises the following components in percentage by weight: 10-15% of titanium dioxide; 16-20% of talcum powder; 25 to 30% of hydroxypropyl methylcellulose; 20-25% of polyvinyl alcohol; 8 to 10% of triethyl triacetate; 2-4% of dibutyl sebacate and 3-5% of lake. According to the premixing agent, triethyl triacetate and dibutyl sebacate are added, and research finds that glycerol triacetate and dibutyl sebacate can enhance the stability of pigments such as brilliant blue, indigo blue and carmine in many aluminum color lakes to light, temperature and humidity, so that a coated film is not easy to fade. And the problems of lake migration and color fading of lake raw materials can be prevented, so that the color is still the same after the coating is placed for a period of time, and the product quality is greatly improved.

Description

Technical Field

[0001] The invention relates to the technical field of film coating premixes, in particular to a film coating premix aimed at preventing aluminum color lakes from fading. Background Art

[0002] Film coating premixes are mainly made of film-forming agents, plasticizers, anti-adhesive agents and other materials through physical mixing. Their main functions are: 1. Moisture-proof, light-proof, and air-isolated to increase drug stability; 2. Mask bad odors and reduce irritation; 3. Improve appearance for easy identification; 4. Control the site of drug release, such as releasing those that are easily destroyed in gastric juice in the intestine; 5. Control drug diffusion and release rate; 6. Overcome incompatibility taboos, etc.

[0003] Adding different pigments to the film coating premix can give the coating powder different appearances, thereby achieving the purpose of easy identification, improving the stability of the preparation and improving patient compliance. However, the instability of some pigments has brought great challenges to the appearance of the preparation. In particular, pigments such as brilliant blue, indigo, and carmine in aluminum color lakes are unstable to light, temperature and humidity, and are prone to fading, which in turn affects the quality of the preparation. Summary of the invention

[0004] In order to solve the above problems, the present invention provides a film coating premix for aluminum color lake fading, so as to reduce the influence of temperature, humidity and light on the fading of the coating.

[0005] The technical solution adopted by the present invention is:

[0006] A film coating premix for aluminum color lake fading, comprising the following components and the weight percentage of each component:

[0007] Titanium dioxide 10-15%; talc 16-20%; hypromellose 25-30%; polyvinyl alcohol 20-25%; triethyl triacetate 8-10%; dibutyl sebacate 2-4% and lake 3-5%.

[0008] The beneficial effects of the present invention are as follows: the premix is ​​added with triethyl triacetate and dibutyl sebacic acid. Through research, it is found that triacetin and dibutyl sebacic acid can enhance the stability of many aluminum-colored lakes such as brilliant blue, indigo, carmine and the like to light, temperature and humidity, and promote the coating film after coating to be not easy to fade. The present invention is used in a film coating premix, which can prevent the problem of lake migration and fading of the lake raw material itself, thereby ensuring that the color of the coating remains the same after being placed for a period of time, and greatly improving the product quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 The color difference curves of the pink coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under accelerated conditions.

[0010] Figure 2 The color difference curves of the pink coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under lighting conditions.

[0011] Figure 3 The graph shows the color changes of the pink coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under accelerated conditions.

[0012] Figure 4 The graph shows the color changes of the pink coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under light conditions.

[0013] Figure 5 The color difference curves of green coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under accelerated conditions.

[0014] Figure 6 The color difference curves of the green coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under lighting conditions.

[0015] Figure 7 The graphs are color change diagrams of green coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under accelerated conditions.

[0016] Figure 8 The graph shows the color changes of green coated tablets of Formula 1, Formula 2 and Formula 3 of the present invention under light conditions. DETAILED DESCRIPTION

[0017] A film coating premix for aluminum color lake fading, comprising the following components and the weight percentage of each component:

[0018] Titanium dioxide 10-15%; talc 16-20%; hypromellose 25-30%; polyvinyl alcohol 20-25%; triethyl triacetate 8-10%; dibutyl sebacate 2-4% and lake 3-5%.

[0019] The above formula does not contain dibutyl sebacate and triethyl triacetate components as blank group formula 1, the above formula does not contain dibutyl sebacate components as comparison group formula 2, and the above formula is experimental group formula 3. The three groups of formulas are compared in terms of coating effect, film forming property and stability. The weight percentage content of each component is as follows;

[0020] Formula 1: titanium dioxide 10-15%; talc 16-20%; hypromellose 25-30%; polyvinyl alcohol 20-25% and lake 3-5%.

[0021] Formula 2: titanium dioxide 10-15%; talc 16-20%; hypromellose 25-30%; polyvinyl alcohol 20-25%; triethyl triacetate 8-10% and lake 3-5%.

[0022] Formula 3: titanium dioxide 10-15%; talc 16-20%; hypromellose 25-30%; polyvinyl alcohol 20-25%; triethyl triacetate 8-10%; dibutyl sebacate 2-4% and lake 3-5%.

[0023] Example 1: The specific experimental ratio is

[0024] Formula 1: The weight percentages of the components are: titanium dioxide 10%; talc 20%; hypromellose 30%; polyvinyl alcohol 25%; polyethylene glycol 3350 10% and color lake 5%.

[0025] Formula 2: The weight percentages of the components are: titanium dioxide 10%; talc 20%; hypromellose 30%; polyvinyl alcohol 25%; triethyl triacetate 10% and color lake 5%.

[0026] Formula 3: The weight percentages of the components are: titanium dioxide 10%, talc 20%, hypromellose 30%, polyvinyl alcohol 22%, triethyl triacetate 10%, dibutyl sebacate 3% and color lake 5%.

[0027] According to the established coating process parameters, three groups of experimental sample powders were prepared with the formula, and the three groups of experimental sample powders were coated under the same conditions to form complete coated tablets. After the complete coated tablets were formed, the coating effects were compared. The specific coating process parameters are shown in Table 1:

[0028] Table 1

[0029]

[0030] 1) The apparent experimental items and conclusions are as follows:

[0031]

[0032]

[0033] 2) Film-forming property experiment: A film scraping experiment was conducted to examine the effects of Formula 1, Formula 2 and Formula 3 on the film-forming property of the film coating.

[0034]

[0035] 3) Stability test

[0036] The stability test of pink (the lake is carmine aluminum lake and lemon yellow aluminum lake) and green (the lake is bright blue aluminum lake and lemon yellow aluminum lake) new anti-fading film-coated tablets was investigated using blank tablets. The test items and test results are as follows:

[0037] Accelerated testing

[0038] Formula 1, Formula 2 and Formula 3 were subjected to accelerated test at a temperature of 40°C ± 2°C and a humidity of 75 ± 5%. The test items and test results are as follows:

[0039] (1) Pink coated tablets:

[0040]

[0041]

[0042] Figure 1 , Figure 2 The color difference curves of pink coated tablets under light and accelerated conditions are respectively for Formula 1, Formula 2 and Formula 3. It can be seen that Formula 3 has a better anti-fading effect under light and accelerated conditions.

[0043] (3) Green coated tablets:

[0044]

[0045] Figure 3 , Figure 4 The color difference curves of green coated tablets under light and accelerated conditions are respectively shown for Formula 1, Formula 2 and Formula 3. It can be seen that Formula 3 has a better anti-fading effect under light and accelerated conditions.

[0046] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0047] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0048] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0049] The embodiments of the present invention are described in detail above, but the contents described are only preferred embodiments of the present invention and cannot be considered to limit the scope of implementation of the present invention. All equivalent changes and improvements made within the scope of the present invention should still fall within the scope of the patent coverage of the present invention.

Claims

1. A film coating premix for fading of aluminum color lakes, characterized in that: It is composed of the following components and the weight percentage of each component: Titanium dioxide 10-15%; talc 16-20%; hypromellose 25-30%; polyvinyl alcohol 20-25%; triethyl triacetate 8-10%; dibutyl sebacate 2-4% and lake 3-5%.

2. The film coating premix for aluminum color lake fading according to claim 1, characterized in that: It is composed of the following components and the weight percentage of each component: Titanium dioxide 10-15%; talc 16-20%; hypromellose 25-30%; polyvinyl alcohol 20-25%; triethyl triacetate 8-10% and lake 3-5%.

3. The film coating premix for preventing aluminum color lake from fading according to claim 1, characterized in that: It is composed of the following components and the weight percentage of each component: Titanium dioxide 10%; talc 20%; hypromellose 30%; polyvinyl alcohol 22%; triethyl triacetate 10%; dibutyl sebacate 3% and lake 5%.

4. The film coating premix for preventing aluminum color lake from fading according to claim 2, characterized in that: It is composed of the following components and the weight percentage of each component: Titanium dioxide 10%; talc 20%; hypromellose 30%; polyvinyl alcohol 25%; triethyl triacetate 10% and lake 5%.

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