KR101440100B1 - Use of ascorbyl palmitate and ascorbyl stearate as glidant for tablets - Google Patents

Abstract

The present invention relates to a novel use as a lubricant for the purification of ascorbyl palmitate and ascorbyl stearate, which is a liposoluble form of vitamin C. More specifically, the present invention relates to a lubricant composition And tablets comprising it as a glidant.
According to the present invention, ascorbyl palmitate and ascorbyl stearate have been conventionally used as antioxidants for oils in vitamin C derivatives. However, it has been found that ascorbyl palmitate and ascorbyl stearate are used as antioxidants in oils, It can be usefully used as a lubricant since the effect of reducing friction is excellent.

Description

[0001] USE OF ASCORBYL PALMITATE AND ASCORBYL STEARATE AS GLIDANT FOR TABLETS [0002]

The present invention relates to functional excipients that can be used in tablets, one of the common dosage forms. More specifically, in order to produce a tablet, a powder is mixed and compressed using a tablet machine after mixing, and at this time, a glidant functioning to reduce the friction between the metal material such as die and punch and the tablet, .

The tablets are easy to take the tablet in a certain shape, can be dosed accurately, can technically control the action, and it is possible to calibrate omies, odor, irritation and the like by making the tablet. It is also the first formulated and studied formulation that has the advantage of being able to prevent deterioration and contamination with proper packaging and to maintain quality for a long time. In general, tablets are composed of several kinds of substances besides liquor. These additives are harmless and do not affect the efficacy of the laxatives and should not interfere with the various tests prescribed. Additives are classified into excipients, binders, disintegrants and lubricants depending on their function. The excipient is diluted or added for the purpose of increasing the size of the tablet when it is small. The binder is a substance that imparts the binding force of the powder and facilitates the tableting. Disintegrants are substances that promote disintegration. The lubricant improves the fluidity of the powder to enhance the filling of the die, reduce the friction between the dies and the punches, reduce the friction between the die and the punches, compress the tablets, and facilitate discharge from the die. It also prevents sticking of the powder to the die and punch when performing compression molding.

The lubricant of the tablet improves the fluidity of the powder (meaning powder mixed before tableting) to increase the filling property of the die, and reduces the friction between the powder and the granules or the friction between the die and the punch, Quot; refers to a functional raw material that facilitates the production of the " Therefore, when the lubricant is not used, the tablets are not discharged from the die, resulting in breakage or sticking to the punch. The selection of such a lubricant is selected according to the type of raw material and the amount thereof. Functional excipients such as lubricants have been developed for decades and can be selected by reference to Handbook of pharmaceutical excipient (author Raymond C. Rowe, Paul J. Sheskey, 2003). Considering the advantages and disadvantages of lubricants, careful consideration should be given to the choice of lubricant depending on the formulation of the tablet contents.

Talc, magnesium stearate, Carnauba wax, silicon dioxide and the like are mainly used as lubricants, and the problem of stability of the talc is emerging. According to the Material Safety Data Sheet (MSDS), talc toxicity is reported to be carcinogenic when inhaled by the respiratory tract, but not by absorption through the digestive tract during oral ingestion. There are no specific reports on the carcinogenicity and toxicity of talc, but there is much controversy on the use of medicines and food products since the stability has not been proven. Also, most talc are known to contain trace amounts of iron, so that certain formulations may optionally be used when iron-catalyzed drugs are included.

Magnesium stearate is the most commonly used lubricant for tablets. The lubricant is finally mixed in the tablet after all the granules, mixing process. Other than talc, the other lubricant is strong in hydrophobicity, and when added for a long time, the lubricant surrounds the granular material to deteriorate the bonding property and delay the disintegration time. In most of the lubricants, the mixing time is proportional to the addition amount, and the longer the mixing time is, the lower the particle discharge speed, the hardness becomes weak, and the disintegration time is delayed. This phenomenon is a typical feature of magnesium stearate.

 Carnauba wax is a refined wax obtained from palm leaves and buds of palm and Brazilian wax palm leaves. According to MSDS, it is recommended to use bitumen, varnish, water repellent and cosmetics. In particular, carnauba wax is known to cause severe eye irritation to skin and may cause respiratory irritation.

Silicon dioxide, which is widely used as anti-caking agent and lubricant, is a colloid type and is widely used for refining.

Recently, due to recognition of harmful foods, stability of products has been emphasized, and consumers' interest in organic foods has been increasing as interest in safe food has increased. To increase the reliability of organic labeling, the government also licenses organic processed foods to the Ministry of Food, Agriculture, Forestry and Fisheries and legally controls food or health functional food labeling standards. More than 95% of the raw materials used in the processing of the processed food are enriched forest products that have been certified according to the certification standards for organic agriculture and forestry products and organic livestock products under the "Environmentally Friendly Agriculture Promotion Act".

Food, etc. According to the Notification No. 2011-67 of Organic processed food according to Article 3 (1) (Food and Drug Administration Notice No. 2011-67), organic food and non-organic agricultural products should not be mixed with raw materials And raw materials other than raw materials which are legally notified shall not be used when manufacturing and processing food.

Among the processing aids that can be used in the processing of organic processed foods, the additives that can act as lubricants are talc, carnauba wax, silicon dioxide (gel and colloidal solution), and the most commonly used magnesium stearate Can not be used in organic processed foods. Talc is free to be used in medicine, but it can not be used for food or health functional food other than chewing gum, filtration aid (filtration, decolorization, deodorization, refining) and refining agent surface treatment agent in manufacturing or processing talc. Carnauba wax and silicon dioxide can be used in organic processed foods, but the lubricating effect is significantly lower than that of magnesium stearate, which causes many problems in manufacturing. Therefore, in the case of organic processed food in the form of tablets, the use of a lubricant such as magnesium stearate is limited, and a substitute material is needed to overcome this.

The present inventors have studied to find substances capable of substituting for the function of a lubricant such as magnesium stearate, which can be used in tablets of organic processed food, and ascorbyl palmitate and ascorbyl stearate are added to magnesium stearate Confirming that there is a lubricating effect and completed the present invention.

Korean Patent Publication No. 10-2009-0104862 Tablet-in-tablet compositions The prior art is directed to a tablet composition comprising at least one estrogen in the first layer and a therapeutic agent in the second layer, wherein the antioxidant comprises ascorbic acid, sodium ascorbate, ascorbyl palmitate and the like have.

Accordingly, it is a main object of the present invention to provide a novel lubricant composition which can be used for refining organic processed foods and the like in place of conventional lubricants.

It is another object of the present invention to provide a tablet comprising the lubricant composition.

The present invention relates to a component that can replace the excipient used as a lubricant for tablet, which is a typical oral dosage form. In particular, the present invention relates to an alternative component that exhibits a lubricating effect that can be applied to organic processed foods in tablet form. Ascorbyl palmitate and ascorbyl stearate, which are fatty acid derivatives of vitamin C, have not been used in conventional processed organic food products, and have excellent lubricating effect and can not be used in organic tablets And can be tableted without the use of magnesium stearate as a lubricant.

Ascorbyl stearate and ascorbyl palmitate are the derivatives of stearic acid or palmitic acid ester-bonded to the carbon-6-position hydroxyl group of ascorbic acid. It is mainly used as vitamin C enhancer and antioxidant. Crystalline powder that emits white to yellowish white. It is a lipophilic substance with a physiological effect as vitamin C. It is not soluble in water, so it is not easy to oxidize and is relatively stable to heat or heavy metals compared to vitamin C.

Vitamin C, which is widely used in medicine, food, and cosmetics, is used as nutrients, antioxidants, and antioxidants. In the case of tablets, it is a solid preparation, so no additional antioxidants are added. Therefore, ascorbyl palmitate and ascorbyl stearate, which have so far been in the form of tablets, serve as functions of nutrients and antioxidants and have not been used as a lubricant. In addition, there is no example used at all in organic processed foods in the form of tablets.

According to one aspect of the present invention, there is provided a tableting glidant composition comprising ascorbyl palmitate or ascorbyl stearate as an active ingredient.

In the present invention, the tablet may be any kind of tablets requiring a lubricant upon tableting, but is preferably an organic processed food or a health functional food. Particularly, in the case of organic food processed in the form of tablets, since the use of a lubricant such as magnesium stearate is limited, the lubricant of the present invention is useful as a substitute for overcoming this problem.

In the present invention, the tablet may be used in any form of tablets requiring a lubricant when compressed, and specifically, it is a lubricant, a film-coated tablet, a foamed tablet, or a multilayer tablet.

In the present invention, the ascorbyl palmitate or ascorbyl stearate provides lubricity to the powder and reduces the friction between the punch and the die during tableting. In the examples of the present invention, in order to confirm the effect of ascorbyl palmitate and ascorbyl stearate, the angle of view, which is an index for judging the fluidity of the powder, and the basic quality control items of tablet, such as hardness, We compared several problems that may arise during the process.

In the present invention, the lubricant composition is characterized in that the amount of ascorbyl palmitate or ascorbyl stearate is 0.1 to 10 parts by weight, preferably 0.5 to 3 parts by weight, based on the total weight of the tablets.

According to another aspect of the present invention, the present invention provides a tablet comprising the lubricant composition according to the present invention.

In the present invention, it is preferable that the tablets contain organic processed product raw materials, sugars, sugar alcohols, acid anhydrides, and flavors.

Hereinafter, the present invention will be described more specifically.

The ascorbyl palmitate and ascorbyl stearate used in the present invention were raw materials of DSM Nutritional Products Ltd., Basel, Switzerland.

When ascorbyl palmitate or ascorbyl stearate is used in the organic processed food in tablets form, there is no problem in the case of 0.5% or more of tableting, and capping or lamination problems occurring when a large amount of the lubricant is used up to 10% I did. Therefore, the amount of ascorbyl palmitate or ascorbyl stearate which can exert a lubricating effect is 0.1 to 10 parts by weight, preferably 0.5 to 3 parts by weight, of the composition.

In order to specifically explain the effect of ascorbyl palmitate and ascorbyl stearate as a lubricant of tablets through the present invention, ascorbyl palmitate [Example 1 , Talc [Comparative Example 1], carnauba wax [Comparative Example 2], magnesium stearate [Comparative Example 3], silicon dioxide [Comparative Example 4] ] And a comparative test [Experimental Example 1]. In addition, to the powder component having an organic raw material in an amount of 95 parts by weight or more in the total weight of the tablets, ascorbyl palmitate [Example 3], ascorbyl stearate composition [Example 4] and talc as a generally used lubricant [Comparative Example 5 ], Carnauba wax [Comparative Example 6], magnesium stearate [Comparative Example 7], silicon dioxide [Comparative Example 8] and Comparative Test [Experimental Example 2].

The use of magnesium stearate as an organic processed food is not possible, but it is judged whether or not the contact effect of ascorbyl palmitate and ascorbyl stearate is compared with magnesium stearate which is most commonly used as a lubricant.

In order to ascertain the effect of ascorbyl palmitate and ascorbyl stearate of the present invention, it is necessary to determine the effect of ascorbyl palmitate and ascorbyl stearate on the hardness, marshness, disintegration and tableting, I have compared several problems that can occur.

The angle of repose is the angle formed by the free surface of the solid powdered sediments with the horizontal, to evaluate the fluidity of the powder. Particle size, particle shape, and surface state of the particles. The measurement is made by discharging the powder from the udo on the shale with a base of radius r. At this time, the height (h) of the deposit layer is measured.

The smaller the?, the greater the fluidity. In order to improve the fluidity, there is a method of increasing the particle diameter, drying the powder, and adding a small amount of a lubricant. In the present invention, the fluidity is evaluated by comparing the angle of repose according to the type of the lubricant. The angle-of-attack measuring instrument used in this test was the DigiX New MODEL DXN-360 model.

The hardness affects the disintegration and dissolution rate of the tablet, and when the granules in the die are filled, the hardness increases and the thickness decreases as the compressive force increases. Applying a compressive force greater than the point at which the hardness value becomes maximum and the thickness becomes minimum results in the lamination or capping of the tablets, destroying the original properties of the tablets. When using the same tablet machine, it is possible to physically control the properties of tablets by controlling the hardness of tablets by adjusting the amount of filling and the compressive force within the tablets. Depending on the choice and concentration of the lubricant, it affects the hardness. Hardness is the force required to fracture tablets by diameter compression test. This test is carried out by placing the tablets between two anvils and applying force to record the force of breaking tablets. The hardness tester used in this test was an Erweka tester TBH-100 model.

Compressing tablets with too large hardness tends to cause capping on the wear surface and tends to cause the top to fall off, so the hardness of the tablet can not be an absolute indicator of tablet strength. Therefore, there is a risk of grinding in other ways of measuring the strength of the tablet. The degree of wear measured by the measuring machine is generally considered to be appropriate if the value of the wasted value is 0.5 1% or less when measured by a total of 100 rotations for 4 minutes at 25 rpm. In addition to the hardness, the degree of grindability is an indicator of the strength of the tablet, and lamination or capping can be identified according to the appropriate choice and amount of lubricant. Capping is a phenomenon in which the upper or lower layer of the tablet is partly or wholly separated, and lamination is a phenomenon in which the tablets are separated into two or more tablets more certainly than capping. This may occur immediately after tableting, or may occur several days after tableting. The abrasion meter used in this test was a FRIABILATOR DAEJU SCIENCE model.

The form of the drug, which can be easily used by the human body, is in solution. For most tablets, the first important step in solution is the process of destroying tablets, which are smaller particles or granules, which is called disintegration. Hydrophilic lubricants act favorably on disintegration of the formulation, but hydrophobic lubricants such as magnesium stearate can inhibit disintegration. In general, the lubricant is highly water-repellent, and when it is used in a large amount, the hardness is lowered and the disintegration is delayed. In this study, Health functional food test method, 2 General test method, 1 Disintegration test method, 4.2.1. The disintegration measuring instrument was DIT-200, LABFINE. INC. Model.

The content of the tablets used in the present invention may be selected from the group consisting of raw materials for organic processed products, saccharides (glucose, fructose, sugar, lactose, dextrin and the like), sugar alcohols (maltitol, sorbitol, mannitol, xylitol, erythritol, , Acetic acid, phosphoric acid, etc.), fragrance (food or food additive for flavoring).

1 is a photograph for measuring the angle of repose, which is an index for judging the fluidity of the powder.
Fig. 2 is a photograph showing the degree of warpage measurement of Experimental Example 1 and Example 1. Fig.
Fig. 3 is a photograph showing the degree of warpage measurement in Experimental Examples 1 and 2. Fig.
4 is a photograph showing the degree of warpage measurement of Experimental Example 1 and Comparative Example 1. Fig.
Fig. 5 is a photograph showing the degree of warpage measurement of Experimental Example 1 and Comparative Example 2. Fig.
Fig. 6 is a photograph of measurement of the degree of warpage of Experimental Example 1 and Comparative Example 3. Fig.
Fig. 7 is a photograph showing the degree of warpage measurement of Experimental Example 1 and Comparative Example 4. Fig.
FIG. 8 is a photograph of the tablets after tableting and the tablets after tableting in Experimental Examples 1 and 1.
FIG. 9 is a photograph of the tablets after tableting and tablets after tableting in Experimental Examples 1 and 2.
FIG. 10 is a photograph of the tablets after tableting and tablet after tableting of Experimental Example 1 and Comparative Example 1. FIG.
Fig. 11 is a photograph of the tablets of Examples 1 and 2 and the tablets after tableting. Fig.
FIG. 12 is a photograph of the tablets after the tabletting in Experimental Example 1 and Comparative Example 3, and the tablets after tableting. FIG.
Fig. 13 is a photograph of the tablets after the tabletting in Experimental Example 1 and Comparative Example 4, and the tablets after tableting. Fig.
Fig. 14 is a photograph showing the degree of fatigue measurement in Experimental Examples 2 and 3; Fig.
Fig. 15 is a photograph of the degree of wear measurement of Experimental Examples 2 and 4; Fig.
16 is a photograph showing the degree of warpage measurement of Experimental Example 2 and Comparative Example 5. Fig.
17 is a photograph showing the degree of warpage measurement of Experimental Example 2 and Comparative Example 6. Fig.
18 is a photograph showing the degree of warpage measurement of Experimental Example 2 and Comparative Example 7. Fig.
19 is a photograph showing the degree of warpage measurement of Experimental Example 2 and Comparative Example 8. Fig.
FIG. 20 is a photograph of the tablets after tableting and tablets after tableting in Experimental Examples 2 and 3; FIG.
Fig. 21 is a photograph of the tablets after the tabletting in Examples 2 and 4, and the tablets after tableting. Fig.
Fig. 22 is a photograph of the tablets after the tabletting in Experimental Example 2 and Comparative Example 5, and the tablets after tableting. Fig.
FIG. 23 is a photograph of the tablets of Examples 2 and 6 and the tablet after tableting. FIG.
Fig. 24 is a photograph of tablets after tableting and tablets after tableting in Experimental Example 2 and Comparative Example 7. Fig.
Fig. 25 is a photograph of the tablets after the tableting in Experiment 2 and the tablet of Comparative Example 8 after tableting. Fig.

Hereinafter, the present invention will be described in more detail with reference to Examples. These embodiments are only for illustrating the present invention, and thus the scope of the present invention is not construed as being limited by these embodiments. Comparative Examples for comparing the effects of the present invention with those of the present invention were prepared as follows. All of the lubricants were tested using the same amount. The tablet contents were prepared as follows.

[Example 1]

The composition ratio is 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance, 5 parts by weight of dextrin and 1 part by weight of ascorbyl palmitate.

First, 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance and 5 parts by weight of dextrin were filtered through a 20 mesh sieve, Mix for 15 minutes.

1 part by weight of ascorbyl palmitate was added to the uniformly mixed contents by filtration through a 20-mesh sieve, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Example 2]

The composition ratio is 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance, 5 parts by weight of dextrin and 1 part by weight of ascorbyl stearate.

First, 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance and 5 parts by weight of dextrin were filtered through a 20 mesh sieve, Mix for 15 minutes.

1 part by weight of ascorbyl stearate is added to the uniformly mixed contents by filtration through a 20 mesh sieve, and the mixture is mixed for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 1]

The composition ratio is 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance, 5 parts by weight of dextrin and 1 part by weight of talc.

First, 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance and 5 parts by weight of dextrin were filtered through a 20 mesh sieve, Mix for 15 minutes.

1 part by weight of talc is filtered through a 20-mesh sieve to the uniformly mixed contents, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 2]

The composition ratio ratio is 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance, 5 parts by weight of dextrin and 1 part by weight of carnauba wax.

First, 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance and 5 parts by weight of dextrin were filtered through a 20 mesh sieve, Mix for 15 minutes.

1 part by weight of carnauba wax is added to 20 parts by weight of a homogeneously mixed content, and the mixture is mixed for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 3]

The composition ratio ratio is 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance, 5 parts by weight of dextrin and 1 part by weight of magnesium stearate.

First, 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance and 5 parts by weight of dextrin were filtered through a 20 mesh sieve, Mix for 15 minutes.

1 part by weight of magnesium stearate was filtered through a 20-mesh sieve into the uniformly mixed contents, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 4]

The composition ratio ratio is 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance, 5 parts by weight of dextrin and 1 part by weight of silicon dioxide.

First, 40 parts by weight of lactose, 35 parts by weight of sorbitol, 15 parts by weight of xylitol, 2 parts by weight of citric acid, 2 parts by weight of fragrance and 5 parts by weight of dextrin were filtered through a 20 mesh sieve, Mix for 15 minutes.

1 part by weight of silicon dioxide is added to the uniformly mixed contents by filtration through a 20-mesh sieve, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Experimental Example 1]

The mixed compositions were each pressed for about 1 hour or more, and the tablet compositions completed tableting had an angle of repose, a degree of grinding, scratches on the sides of tablets, no capping, hardness, disintegration, fixable time, , the quality of the tablets was assessed and compared with those of the die table.

 [Table 1] Experimental Example 1 Comparison of results

As a result, in the case of ascorbyl palmitate and ascorbyl acetate used in Example 1 and Example 2, it was possible to perform tableting with an effect similar to that of magnesium stearate used in Comparative Example 3. However, in the case of talc and silicon dioxide, the phenomenon of sticking to the punch and the die is so severe that it can not be used as a lubricant because it is not punctured and has a fatigue of 7% or more. In the case of carnauba wax, Masono was also good compared with talc and silicon dioxide, but it was impossible to fix it due to the phenomenon attached to the die and punch 5 minutes after the start of the tablet.

[Example 3]

The composition ratio was 14.75 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B group, 26.25 parts by weight of organic glucose, 0.5 parts by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, And 1 part by weight of ascorbyl palmitate.

First, 14.5 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B, 26.25 parts by weight of organic glucose, 0.5 part by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, , And 40 parts by weight of organic maltodextrin were filtered through a 20-mesh sieve, put into a double cone mixer, and mixed for 10-15 minutes.

1 part by weight of ascorbyl palmitate was added to the uniformly mixed contents by filtration through a 20-mesh sieve, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Example 4]

The composition ratio was 14.75 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B group, 26.25 parts by weight of organic glucose, 0.5 parts by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, And 1 part by weight of ascorbyl stearate.

First, 14.5 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B, 26.25 parts by weight of organic glucose, 0.5 part by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, , And 40 parts by weight of organic maltodextrin were filtered through a 20-mesh sieve, put into a double cone mixer, and mixed for 10-15 minutes.

1 part by weight of ascorbyl stearate is added to the uniformly mixed contents by filtration through a 20 mesh sieve, and the mixture is mixed for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 5]

The composition ratio was 14.75 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B group, 26.25 parts by weight of organic glucose, 0.5 parts by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, And 1 part by weight of talc.

First, 14.5 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B, 26.25 parts by weight of organic glucose, 0.5 part by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, , And 40 parts by weight of organic maltodextrin were filtered through a 20-mesh sieve, put into a double cone mixer, and mixed for 10-15 minutes.

1 part by weight of talc is filtered through a 20-mesh sieve to the uniformly mixed contents, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 6]

The composition ratio was 14.75 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B group, 26.25 parts by weight of organic glucose, 0.5 parts by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, And 1 part by weight of carnauba wax.

First, 14.5 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B, 26.25 parts by weight of organic glucose, 0.5 part by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, , And 40 parts by weight of organic maltodextrin were filtered through a 20-mesh sieve, put into a double cone mixer, and mixed for 10-15 minutes.

1 part by weight of carnauba wax is added to 20 parts by weight of a homogeneously mixed content, and the mixture is mixed for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 7]

The composition ratio was 14.75 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B group, 26.25 parts by weight of organic glucose, 0.5 parts by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, And 1 part by weight of magnesium stearate.

First, 14.5 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B, 26.25 parts by weight of organic glucose, 0.5 part by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, , And 39 parts by weight of organic maltodextrin were filtered through a 20-mesh sieve, put into a double cone mixer, and mixed for 10-15 minutes.

2 parts by weight of magnesium stearate was filtered through a 20-mesh sieve into the uniformly mixed contents, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

[Comparative Example 8]

The composition ratio was 14.75 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B group, 26.25 parts by weight of organic glucose, 0.5 parts by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, And 2 parts by weight of silicon dioxide.

First, 14.5 parts by weight of organic vitamin C, 13.5 parts by weight of organic vitamin B, 26.25 parts by weight of organic glucose, 0.5 part by weight of organic berries mixed powder, 2 parts by weight of organic fruit powder, 2 parts by weight of organic vegetable powder, , And 39 parts by weight of organic maltodextrin were filtered through a 20-mesh sieve, put into a double cone mixer, and mixed for 10-15 minutes.

2 parts by weight of silicon dioxide is added to the uniformly mixed contents by filtration through a 20-mesh sieve, followed by mixing for about 5 minutes.

The thus-mixed composition was tableted to a weight of 500 mg on a KT-1000 tablet machine using a 7 mm x 13 mm tablet punch.

 [Table 2] Experimental Example 2 Comparison of results

As a result, in the case of ascorbyl palmitate and ascorbyl acetate used in Example 3 and Example 4, the tablet was able to be tableted with an effect similar to that of magnesium stearate used in Comparative Example 7. However, in the case of talc and silicon dioxide, the punch and the die attaching phenomenon are so severe that the tablet is not ejected because the tablet is caught inside the die without being pressed, and the fatigue is also 36% or more. In the case of carnauba wax, Masono is better than talc or silicon dioxide, but after 5 minutes from the start of the punching, it was impossible to pinch with the die and punch, and the disintegration was also delayed.

As a result of Experimental Example 1 and Experimental Example 2, ascorbyl palmitate and ascorbyl stearate showed the same effect as magnesium stearate as a lubricant. Particularly, in case of using talc, carnauba wax and silicon dioxide as a lubricant, the composition was adhered to the abrasion, lamination, capping, punch and die in the case of tableting. However, when ascorbyl palmitate and ascorbyl stearate When the rate was used, the above problem did not occur.

As described above, the present invention provides ascorbyl palmitate and ascorbyl stearate as a nutritional ingredient of vitamin C, exhibiting an antioxidative function, and a synergistic effect equivalent to that of magnesium stearate, which is a commonly used lubricant used in conventional tablet compositions Which is superior to talc, carnauba wax and silicon dioxide, which can be used instead of magnesium stearate, which can not be used as a lubricant in organic processed foods, and can be used in a wider and more useful manner in the food industry.

Claims (7)

A tableting glidant composition comprising ascorbyl stearate as an active ingredient.
The lubricant composition according to claim 1, wherein the tablet is an organic processed food or a health functional food.
The lubricant composition of claim 1, wherein the tablet is an uncoated, film coated tablet, foamed tablet, or multilayer tablet.
The lubricant composition of claim 1, wherein the ascorbyl stearate improves flowability of the powder and reduces friction between the punch and die during tableting.
The lubricant composition according to claim 1, wherein the amount of the ascorbyl stearate is 0.1 to 10 parts by weight.
A tablet comprising the lubricant composition according to any one of claims 1 to 5.
7. The tablet according to claim 6, wherein the tablet comprises organic processed material, saccharides, sugar alcohols, acid anhydrides, and flavors.

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