JP5869764B2 - Capsule filling composition - Google Patents

Description

  The present invention relates to a capsule filling composition filled in a capsule film such as a soft capsule.

  In a general soft capsule, an oily and water-insoluble filling composition is filled in a water-soluble capsule film. Such a filling composition is oil-soluble when the target substance itself to be filled in the capsule is oily, such as DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), squalene, egg yolk oil, etc. The target substance is roughly divided into a case where the target substance is dissolved in fats and oils as a solvent, and a case where a hardly oil-soluble target substance is suspended in fats and oils as a dispersion medium. Here, when the filling composition is a suspension of a hardly oil-soluble target substance, it is important that the target substance is well dispersed with high stability. Therefore, an emulsifier (surfactant) such as glycerin fatty acid ester or sucrose fatty acid ester is added to the conventional filling composition in order to increase the affinity between the hardly oil-soluble substance and the oil. In addition, stabilizers such as waxes (beeswax, rice wax, candelilla wax, etc.) and hardened oils are used to suppress the separation caused by the difference in specific gravity between the target substance and fats and oils and stabilize the dispersion state. Is added.

  The present applicant has found that ascorbic acid fatty acid ester, which has been known as an antioxidant for fats and oils, exhibits an excellent dispersion stabilizing action, and is a poorly oil-soluble substance using animal fats and vegetable fats and oils as a dispersion medium. Has proposed a composition for capsule filling in which L-ascorbic acid fatty acid ester is added as a dispersant to the above suspension (see Patent Document 1). According to this, the dispersion state of the suspension can be made better with addition of a lower concentration than conventionally known dispersants.

  In general, when the content of the hardly oil-soluble substance is increased, the viscosity of the filling composition is increased, and the filling property into the capsule film is reduced. According to the technique of Patent Document 1, The increase in the viscosity accompanying the increase in the concentration of the hardly oil-soluble target substance is small, and the content of the target substance can be increased. For example, if the royal jelly powder having a relatively large bulk specific gravity (bulk specific gravity of 0.75 g / ml) or lactose powder (bulk specific gravity of 0.94 g / ml), the content can be increased to 60% by mass. Even with a vinegar extract powder having a small specific gravity (bulk specific gravity of 0.44 g / ml), the content can be increased to 30% by mass.

  However, the capsule filling composition is always required to further increase the content of the target substance. This is because if the content of the target substance in the capsule filling composition is high, a predetermined amount can be contained even if the soft capsule is miniaturized, so that the soft capsule becomes easy to drink. In addition, the number of soft capsules necessary for taking a predetermined amount of the target substance is small.

  In view of the above circumstances, an object of the present invention is to provide a capsule-filling composition capable of containing a poorly oil-soluble powdery substance with a higher content and good dispersibility.

  In order to solve the above problems, the composition for capsule filling according to the present invention is “a composition for filling capsules in which a powdery substance is suspended in oil and fat, and has 8 carbon atoms in the constituent fatty acids of the oil and fat. The ratio of the sum of the fatty acid and the C10 fatty acid is 70% by mass to 100% by mass.

  In conventional capsules, when oil-soluble powdery substances are suspended in fats and oils, oils such as safflower oil, olive oil, sesame oil, soybean oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, coconut oil And vegetable oils such as fish oil, shark liver oil, horse oil and egg yolk oil are used. These fats and oils, except for coconut oil, generally have long-chain fatty acids having 16 to 18 carbon atoms as constituent fatty acids, and the constituent fatty acids in coconut oil are 60 to 70% by mass and have 12 to 14 carbon atoms. It is a medium and long chain fatty acid.

  The present inventors use fats and oils in which the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acids is 70% by mass to 100% by mass as the fats and oils for suspending the powdery substance. As a result, a powdery substance can be contained at a higher content than before, and the dispersion stability is excellent, and the capsule capsule has a practical composition for filling capsule capsules. It has been found out that it can be obtained and has led to the present invention. Here, in general, a fatty acid having 6 to 12 carbon atoms is referred to as a medium chain fatty acid. In the present invention, among the medium chain fatty acids, a fatty acid having 8 to 10 carbon atoms in particular is the main constituent fatty acid. Use oils and fats.

  In addition, as a “powder substance” suspended in fats and oils, powders of pharmaceutical ingredients, herbal medicine ingredients, health food ingredients, and nutritional supplement ingredients can be used without particular limitation. Examples thereof include powders such as royal jelly, blueberry, vinegar, propolis, agaricus, turmeric, oligosaccharide, dietary fiber, water-soluble vitamins, calcium and the like.

  In addition to the above-described composition, the composition for filling capsules according to the present invention is “the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acids of the oil and fat is 98% by mass or more, The ratio of 8 fatty acids is 66% by mass or more.

  Thus, most of the constituent fatty acids are fatty acids having 8 and 10 carbon atoms, and 66 mass% or more of them are fatty acids having 8 carbon atoms, and the details will be described later. In addition, it is possible to provide a capsule filling composition having a very good filling property to the capsule film.

  In addition to the above-mentioned composition, the composition for capsule filling according to the present invention can be "the ratio of the fatty acid having 8 carbon atoms in the constituent fatty acid of the oil and fat is 90 mass% or less".

  For example, it may be recommended that the capsules be stored refrigerated, such as when royal jelly is used as the contents. When the oils and fats, in which most of the constituent fatty acids are fatty acids having 8 carbon atoms, are used as the dispersion medium, the filling properties of the capsule filling composition are very good. It was found to become cloudy. Although the quality of the oil does not deteriorate when the oil or fat is crystallized, such crystallization may not be desirable, for example, in the case of a soft capsule that places importance on a transparent and glossy appearance.

  By setting it as the said structure, namely, in the fats and oils in which most of the constituent fatty acids are fatty acids having 8 and 10 carbon atoms, the proportion of the fatty acids having 8 carbon atoms in the constituent fatty acids is suppressed to 90% by mass or less, and the corresponding 10 carbon atoms. As will be described in detail later, by securing the ratio of the fatty acid of the product to a predetermined value or more, it contains a powdery substance at a high content rate, and is excellent in stability of the dispersion state and filling property to the capsule film, and is stored in the refrigerator. However, the composition for capsule filling in which fats and oils do not crystallize can be provided.

  As described above, as an effect of the present invention, it is possible to provide a capsule-filling composition capable of containing a hardly oil-soluble powdery substance with a higher content and good dispersibility.

  Hereinafter, a capsule filling composition (hereinafter, simply referred to as “filling composition”) according to an embodiment of the present invention will be described. The filling composition of the present embodiment is obtained by suspending a powdery substance in fats and oils, and the ratio of the sum of fatty acids having 8 and 10 carbon atoms in the fatty acids constituting the fats and oils is 70 masses. % To 100% by mass.

  You may add additives, such as an emulsifier (surfactant) and the stabilizer which suppresses the separation resulting from the difference in specific gravity of a powdery substance and fats and oils, to the filling composition. Here, as the emulsifier, lecithin, glycerin fatty acid ester, sucrose fatty acid ester and the like can be used. Moreover, as stabilizers, waxes such as beeswax and hardened oils can be used.

  The filling composition having the above structure is prepared as follows. First, fats and oils and additives are heated and completely dissolved, and then allowed to cool to room temperature. A powdery substance is put into this solution and mixed well to obtain a suspension. Finally, the suspension is degassed under reduced pressure.

  Using royal jelly powder as a powdery substance and using fats and oils having different constituent fatty acid compositions, compositions R1, S1-1 to S1-6 having the compositions (mass%) shown in Table 1 were prepared. As the royal jelly powder, a powder obtained by freeze-drying raw royal jelly (bulk specific gravity 0.75 g / ml) is used, and the content of the royal jelly powder in the composition is higher than the content of the royal jelly in the conventional soft capsule filling composition. The amount was 62.5% by mass. Further, soybean lecithin was added as an emulsifier (surfactant), and beeswax was added as a stabilizer. In any composition, the mass% of royal jelly powder, fats and oils, emulsifiers and stabilizers is the same, and only the kind of fats and oils is different.

  Here, the oil and fat of the composition R1 is safflower oil that is frequently used as a dispersion medium for powdered substances in conventional soft capsules, and almost all of the constituent fatty acids are long-chain fatty acids having 16 to 18 carbon atoms. On the other hand, the compositions S1-1 to S1-6 are filling compositions of the present embodiment, and all of them are the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acids of the fats and oils. Is 70% by mass to 100% by mass. Here, almost all the constituent fatty acids (98% by mass to 100% by mass) of the fats and oils of the compositions S1-1 to S1-5 are medium chain fatty acids having 8 and 10 carbon atoms. On the other hand, the constituent fatty acids of the oils and fats of composition S1-6 are about 2% by mass of medium chain fatty acids of carbon number 8 and about 20% of medium chain fatty acids of carbon number 12 in addition to medium chain fatty acids of carbon number 8 and 10. %, And the rest are long chain fatty acids having 14 or more carbon atoms.

  The prepared compositions R1, S1-1 to S1-6 were evaluated for filling properties and dispersion stability as follows. The results are shown in Table 1.

<Evaluation of fillability>
When the viscosity of the filling composition is measured and considering the fluidity that the capsule composition can be easily filled into the capsule film in rotary die type soft capsule molding, the case where the viscosity is 10000 mPa · s or less is “」 ”(very good) “◯” (good) when 10,000 mPa · s is exceeded but 15000 mPa · s or less, and “△” when 15000 mPa · s is exceeded but 20000 mPa · s or less (practical but somewhat good in filling properties) The case of exceeding 20000 mPa · s was evaluated as “x” (defect). Here, the viscosity was measured at a temperature of 25 ° C. using a B-type viscometer (No. 4 rotor, rotational speed 6 rpm).

<Evaluation of dispersion stability>
10 g of the filling composition was placed in a 20 ml sample bottle and allowed to stand for 100 hours in a thermostatic bath maintained at 40 ° C., and the presence or absence of phase separation in which the royal jelly powder and the oil phase were separated was visually observed. “○” indicates that no phase separation was observed, “Δ” indicates separation of a fat phase with a height of less than 1 mm, and “x” indicates separation of a fat phase with a height of 1 mm or more. ".

  As shown in Table 1, in the composition R1 using safflower oil, which is often used in conventional soft capsules, as a dispersion medium, the viscosity becomes remarkably high when the content of the royal jelly powder is 62.5% by mass. The filling property was poor. On the other hand, all of the compositions S1-1 to S1-6 of the present embodiment had practical filling properties and good dispersion stability. Among them, the composition S1- in which the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the fatty acid constituting the fat is 98 mass% or more and the ratio of the fatty acid having 8 carbon atoms is 66 mass% or more. 1 to S1-5 had very good filling properties.

  Next, to what extent the content of royal jelly can be increased was examined using compositions S2-1 to S2-4 having the compositions shown in Table 2. Here, as the dispersion medium, the same fat and oil as the composition S1-3, that is, the fat and oil in which the proportion of the fatty acid having 8 carbon atoms in the constituent fatty acid is 99% by mass and the proportion of the fatty acid having 10 carbon atoms is 9% by mass. It was used. Moreover, the same emulsifier and stabilizer as described above were added at the same ratio (mass%). In addition, the content rate of the royal jelly powder is increasing from composition S2-1 to S2-4, and the content rate of fats and oils is reduced in connection with this. The composition S2-1 is the same as the composition S1-3.

  The prepared compositions S2-1 to S2-4 were evaluated for fillability and dispersion stability in the same manner as described above. The results are also shown in Table 2.

  As shown in Table 2, the composition S2-4 in which the content of the royal jelly powder exceeds 67% by mass is too high in viscosity and is not suitable as a composition for capsule filling, but the compositions S2-1 to S2-3 Both had good filling properties and dispersion stability, and it was possible to increase the content of royal jelly powder to 65.6% by mass. As described above with respect to Patent Document 1, in the conventional soft capsule containing royal jelly as the contents, even if the content of the royal jelly powder is 60% by mass, it can be said that the content is sufficiently high compared to the previous conventional products. . In the technical field of soft capsules, it is very difficult to increase the content even if the content is 1% by mass, although it is always requested to increase the content of the target substance. Therefore, the content of the royal jelly powder in the filling composition can be increased to 65.6% by mass by using the above-described configuration using fats and oils in which the composition of the constituent fatty acid is within a specific range as a dispersion medium. Very significant.

  By the way, it may be recommended that soft capsules containing royal jelly are refrigerated. Therefore, the low temperature stability of the above compositions S1-1 to S1-6 and S2-1 to S2-3 was evaluated by the following method.

<Evaluation of low temperature stability>
The soft capsule filled with the soft capsule film with the filling composition was allowed to stand at a temperature of 10 ° C. for 100 hours. Thereafter, the appearance of the soft capsule was observed with the naked eye, and the case where even a slight turbidity of the oil and fat due to crystallization was observed was evaluated as “x”, and the case where no such turbidity was observed was evaluated as “◯”. The results are shown in Tables 3 and 4.

  As is apparent from Tables 3 and 4, compositions S1-1 (99 mass% of fatty acids having 8 carbon atoms) and S1-2 (dispersing oils and fats, most of which are fatty acids having 8 carbon atoms), and S1-2 ( In the case of 97 mass% of fatty acids having 8 carbon atoms, it was confirmed that fats and oils were crystallized by low-temperature storage. And since such crystallization was not observed in other compositions, if the ratio of the fatty acid having 8 carbon atoms to at least 90% by mass of the constituent fatty acid is 90% by mass or less, the fat and oil are not crystallized by low-temperature storage. It was confirmed that it could be a composition. Therefore, when providing capsules that are recommended for refrigerated storage, such as when royal jelly is used as the content, or when using soft capsules with an emphasis on appearance, carbon as a dispersion medium for the filling composition is carbon. It is desirable to use fats and oils in which the ratio of the number 8 fatty acid is 90% by mass or less.

  Next, compositions R3 and S3-1 to S3-5 having compositions (mass%) shown in Table 5 were prepared using blueberry powder as a powdery substance and using fats and oils having different constituent fatty acid compositions. As the blueberry powder, a powder obtained by vacuum drying a blueberry extract (bulk specific gravity 0.40 g / ml) was used, and the blueberry content in the composition was 50.0% by mass. In the same manner as above, soybean lecithin was added as an emulsifier (surfactant), and beeswax was added as a stabilizer. In any composition, the mass% of blueberry powder, fats and oils, emulsifiers and stabilizers is the same, and only the kind of fats and oils is different.

  The oil and fat of the composition R3 is safflower oil (almost all of the constituent fatty acids are long-chain fatty acids having 16 to 18 carbon atoms) that are frequently used as a dispersion medium for powdered substances in conventional soft capsules. On the other hand, the compositions S3-1 to S3-5 are filling compositions of the present embodiment, and all of them are the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acids of the fats and oils. Is 70% by mass to 100% by mass. Here, almost all the constituent fatty acids of the fats and oils of the compositions S3-1 to S3-4 (98% by mass to 100% by mass) are medium chain fatty acids having 8 and 10 carbon atoms. On the other hand, the fats and oils of the composition S3-5 are the same as the fats and oils of the composition S1-6, and the constituent fatty acid is about 2 medium-chain fatty acids in addition to the medium-chain fatty acids having 8 and 10 carbon atoms. It contains about 20% by mass of a medium chain fatty acid of 12% by mass and 12 carbon atoms, and the remainder is a long chain fatty acid having 14 or more carbon atoms.

  About the prepared compositions R3 and S3-1 to S3-5, the filling property and the dispersion stability were evaluated in the same manner as described above. The results are shown in Table 5.

  As shown in Table 5, in the composition R3 using safflower oil, which is often used in conventional soft capsules, as the dispersion medium, when the content of blueberry powder is 50.0% by mass, the viscosity becomes extremely high, and the capsule film The filling property was poor. On the other hand, each of the compositions S3-1 to S3-5 of this embodiment had practical filling properties and good dispersion stability. Among them, the composition S3- wherein the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acid is 98% by mass or more and the ratio of the fatty acid having 8 carbon atoms is 66% by mass or more. 1 to S3-4 had very good filling properties.

  This result shows the same tendency as the above-described examination results by the compositions R1 and S1-1 to S1-6 in which the royal jelly powder is a powdery substance. Therefore, even if the ratio to be contained is different depending on the difference in the powdered substance, the ratio of the sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acid as the dispersion medium is 70% by mass to 100% by mass. By using fats and oils, it is practical even if more oil-soluble powdery substances are contained than conventional filling compositions using fats and oils with long-chain fatty acids as constituent fatty acids such as safflower oil. A filling composition having filling properties and good dispersion stability can be obtained, and the ratio of the sum of fatty acids having 8 and 10 carbon atoms in the constituent fatty acids is 98% by mass or more. In addition, the use of fats and oils having a proportion of fatty acids having 8 carbon atoms of 66% by mass or more can provide a filling composition with extremely good filling properties due to the difference in powdery substances. It was considered to be a common trend.

  Next, to what extent the content of blueberry powder can be increased was examined using compositions S4-1 to S4-4 having the compositions shown in Table 6. As a dispersion medium, the same fats and oils as the compositions S1-3 and S2-1 to S2-4 were used. Further, the same emulsifier and stabilizer as described above were added in the same ratio (mass%). In addition, the content rate of the blueberry powder is increasing from composition S4-1 to S4-4, and the content rate of fats and oils is reduced in connection with this.

  The prepared compositions S4-1 to S4-4 were evaluated for filling property and dispersion stability by the same method as described above. The results are shown in Table 6.

  As shown in Table 6, composition S4-4 having a blueberry powder content exceeding 64.5% by mass has a viscosity that is too high to be suitable as a capsule filling composition, but compositions S4-1 to S4. No. -3 had good filling properties and dispersion stability, and it was possible to increase the content of blueberry powder to 62.5% by mass. This content rate is that the bulk specific gravity of the blueberry powder is quite small, and it was impossible to suspend 50.0% by mass of the blueberry powder in the conventional filling composition using safflower oil as the dispersion medium. Considering the fact, the content is extremely high.

  As described above, according to the capsule filling composition of the present embodiment, a hardly oil-soluble powdery substance is suspended at a very high content rate compared to the prior art with good dispersion stability, and a soft capsule film It is possible to provide a capsule filling composition that can be filled with good filling properties.

  The present invention has been described with reference to the preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various improvements can be made without departing from the scope of the present invention as described below. And design changes are possible.

  For example, in the above embodiment, the case where the filling composition is filled in the soft capsule film is illustrated, but the present invention is not limited to this, and the hard capsule film may be filled. The base of the capsule film is not particularly limited. In addition to those based on gelatin, the capsule film using a non-gelatin base that has been proposed in various ways including the applicant of the present invention is used for filling of the present invention. The composition can be filled.

Japanese Patent No. 3559277

Claims (2)

A capsule filling composition in which a powdery substance is suspended in oil and fat,
As the powdery substance, containing 50.0 mass% to 62.5 mass% blueberry powder having a bulk specific gravity of 0.40 g / ml,
The sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acids of the fat is 98 mass% to 100 mass%, and the ratio of the fatty acid having 8 carbon atoms is 81 mass% to 90 mass%. And
A capsule filling composition, wherein the oil or fat is not crystallized by standing for 100 hours at a temperature of 10 ° C. A capsule filling composition in which a powdery substance is suspended in oil and fat,
As the powdery substance, containing 64.1% by mass to 65.6% by mass of royal jelly powder having a bulk specific gravity of 0.75 g / ml ,
The sum of the fatty acid having 8 carbon atoms and the fatty acid having 10 carbon atoms in the constituent fatty acids of the fat is 98 mass% to 100 mass%, and the ratio of the fatty acid having 8 carbon atoms is 81 mass% to 90 mass%. And
10 ° C. does not cause crystallization in the fat or oil by 100 hours standing <br/> be characterized and to Luke capsule fill composition of at a temperature of.