阅读说明：本技术 淀粉成膜组合物及其制备胶囊壳的方法 (Starch film-forming composition and method for preparing capsule shell by using same ) 是由 李绪发 陈琼 杨旭腾 陈洁伟 于 2020-12-31 设计创作，主要内容包括：本发明提供了淀粉成膜组合物及其制备胶囊壳的方法。该淀粉成膜组合物包含结冷胶和至少一种淀粉,其中结冷胶的总酰基含量为14-34％。本发明的淀粉成膜组合物的优点具有较好的成膜强度和韧性,应用于软胶囊可得到成型粘合包封性好的软胶囊,不含动物来源成分,适合于世界各族人群食用,可以在全球推广应用。(The invention provides a starch film-forming composition and a method for preparing a capsule shell by using the same. The starch film-forming composition comprises gellan gum and at least one starch, wherein the total acyl content of the gellan gum is 14 to 34%. The starch film-forming composition has the advantages of good film-forming strength and toughness, can be used for obtaining soft capsules with good forming, bonding and encapsulating properties when being applied to the soft capsules, does not contain animal-derived components, is suitable for all groups of people in the world to eat, and can be popularized and applied globally.)

1. A starch film-forming composition comprising:

A. a first gelling agent;

B. starch;

the first gelling agent is single-gelling-temperature gellan gum, the total acyl content of the single-gelling-temperature gellan gum is 14% -34%, and the weight ratio of the single-gelling-temperature gellan gum to the starch is 0.02-0.5.

2. A starch film-forming composition according to claim 1 wherein the gellan gum has a glyceroyl content of 12% to 26% total acyl groups and/or an acetyl content of 2% to 8%.

3. The starch film-forming composition of claim 1 wherein the starch is present in an amount of from 15% to 50% by weight.

4. The starch film-forming composition of claim 1 wherein the gellan gum is present in an amount of 1 wt% to 8 wt%, preferably the gellan gum is present in an amount of 2 wt% to 7 wt%.

5. The starch film-forming composition of any one of claims 1-4, wherein the starch is a native starch selected from one or more of wheat starch, waxy corn starch, pea starch, corn starch, potato starch, and tapioca starch.

6. The starch film-forming composition of any of claims 1-4 wherein the starch is a starch derivative that is one or more of acid-treated starch, hydroxypropyl starch, oxidized starch, acetate starch, oxidized hydroxypropyl starch, hydroxypropyl distarch phosphate, starch phosphate, sodium starch octenyl succinate, acetylated distarch phosphate, and dextrin.

7. The starch film-forming composition of claim 1, further comprising a plasticizer in an amount of 10 wt% to 35 wt%, preferably the plasticizer is selected from one or more of glycerol, sorbitol, maltitol, erythritol, xylitol, fructose and trehalose.

8. The starch film-forming composition of claim 1, further comprising a secondary gelling agent, preferably the secondary gelling agent is selected from one or more of carrageenan, agar, sodium alginate, pectin, high acyl gellan gum, low acyl gellan gum, konjac gum, xanthan gum, locust bean gum, guar gum, and pullulan; preferably the second gelling agent is present in an amount of 0.2 wt% to 3.5 wt%, preferably the pectin is one or more of low methoxyl pectin, high methoxyl pectin and amide pectin; preferably wherein the low methoxyl pectin has a DE < 50% degree of esterification and the amide pectin has a DA 5% to 25% degree of amide.

9. The starch film-forming composition of claim 1 further comprising 35 wt% to 60 wt% water.

10. A process for preparing a capsule shell using the starch film-forming composition of claim 7, which comprises 1) A) premixing and dispersing the first gelling agent and the plasticizer uniformly, adding into water under stirring, heating and stirring at 60-98 ℃ until the first gelling agent is dissolved; B) adding starch, and continuously heating and stirring at 60-98 ℃ until the starch is dissolved; C) removing air bubbles to obtain glue solution;

2) pelleting; and

3) and (5) drying.

11. The process for preparing a capsule shell of claim 10, said a) further comprising adding a second gelling agent; and A) premixing and uniformly dispersing a first gelling agent, a second gelling agent and a plasticizer, adding the mixture into water under stirring, and heating and stirring the mixture at the temperature of 60-98 ℃ until the first gelling agent and the second gelling agent are dissolved.

12. A capsule shell comprising the starch film-forming composition of any one of claims 1-9.

13. The capsule shell of claim 12, having a water content of 8 to 25%.

14. Use of a starch film-forming composition according to any one of claims 1 to 9 in medicine, food or cosmetics.

Technical Field

The invention relates to the field of edible compositions, in particular to a starch film-forming composition, a method for preparing a capsule shell by using the starch film-forming composition and the prepared capsule shell.

Background

The soft capsule is widely applied in the fields of medicine, food, cosmetics and the like, and the gelatin has excellent film forming property and mechanical strength and is widely used as a traditional soft capsule material. But because of the characteristics of the gelatin, a plurality of quality defects are shown in the application process, for example, gelatin molecules can generate a tough and elastic water-insoluble surface film on the surface of the gelatin soft capsule through self-oxidation or cross-linking reaction with functional groups such as aldehyde groups, so that the release of the medicine is prevented, and the soft capsule is not qualified in disintegration; in addition to religions, vegetarians and the continuous occurrence of mad cow disease, foot and mouth disease and other events around the world, people are trying to develop substitutes for gelatin and research on preparing soft capsules.

For example, chinese patent No. CN100528950C proposes a mixture of different acyl gellan gums and starch, comprising: a. high acyl gellan gum; b. low acyl gellan gum; c. starch; plasticizers, the films made using such mixtures have high modulus and good strength and extensibility, and the soft capsules made have good sealability. The high-acyl gellan gum and the low-acyl gellan gum as compound gels can improve the strength and toughness of the rubber to a certain degree, but the prepared soft capsule has poor transparency, and the crack is not firm in sealing and is easy to leak oil. Japanese patent No. JP2007153851A proposes a film composition of soft capsules of non-animal origin obtained by mixing water, starch and natural type gellan gum. European patent No. EP2815745a1 proposes a soft capsule comprising a high acyl gellan gum, at least one starch and at least one plasticizer, and a method of preparation. The gel formed by the high acyl gellan gum has the characteristics of soft texture and rich elasticity, the rubber formed by combining the high acyl gellan gum with starch has poor toughness, and the high acyl gellan gum has thin crack and low breaking force and is easy to leak oil during pelleting. Chinese patent No. CN 108659137A proposes a novel gellan gum product with double gel temperatures, which has lower double gel temperatures, and the formed gel has excellent gel characteristics and texture and can be widely applied to the field of food.

In conclusion, the soft capsule reported in the prior art, which uses gellan gum as the main capsule wall material, has the defects of high viscosity of the gum solution, easy gelation during high-temperature storage, low strength and poor toughness of the formed rubber, thin crack of the formed pill, easy oil leakage and the like, and cannot realize the industrial production of the soft capsule.

Disclosure of Invention

It is an object of the present invention to provide starch film-forming compositions comprising gellan gum and starch of a specific acyl content. In the research process of the starch film-forming composition, the inventor finds that the gellan gum with the specific acyl content between the high acyl gellan gum (natural gellan gum) and the low acyl gellan gum has a single gel temperature range of 20-75 ℃, so that the gel formed by the starch film-forming composition containing the gellan gum with the specific acyl content has excellent gel characteristics and texture, is obviously superior to the prior art in the aspects of rubber strength, toughness and forming adhesion when used for preparing soft capsules, completely meets the industrial production requirements of the soft capsules, and can be used as an alternative substitute for the soft capsule technology. The inventors have also found that a starch composition comprising a specific range of gellan gum to starch ratio is superior to a starch composition outside this range in the combined effect of gum strength, toughness and form adhesion.

In one aspect, the present invention provides a starch film-forming composition comprising:

A. a first gelling agent;

B. starch;

the first gelling agent is single-gelling-temperature gellan gum, the total acyl content of the single-gelling-temperature gellan gum is 14-34%, and the weight ratio of the single-gelling-temperature gellan gum to the starch is 0.02-0.5.

In one embodiment, the gellan gum has a glyceroyl content of 12 to 26% of total acyl groups and/or an acetyl content of 2 to 8%.

In one embodiment, the starch is present in an amount of 15 wt% to 50 wt%.

In one embodiment, the gellan gum content is from 1 wt% to 8 wt%, preferably, the gellan gum content is from 2 wt% to 7 wt%.

In one embodiment, the starch is a native starch selected from one or more of wheat starch, waxy corn starch, pea starch, corn starch, potato starch and tapioca starch.

In one embodiment, the starch is a starch derivative that is one or more of acid-treated starch, hydroxypropyl starch, oxidized starch, acetate starch, oxidized hydroxypropyl starch, hydroxypropyl distarch phosphate, starch phosphate, sodium starch octenyl succinate, acetylated distarch phosphate, and dextrin.

In one embodiment, the starch film-forming composition further comprises a plasticizer in an amount of 10 wt% to 35 wt%, preferably the plasticizer is selected from one or more of glycerol, sorbitol, maltitol, erythritol, xylitol, fructose and trehalose.

In one embodiment, the starch film-forming composition further comprises a second gelling agent. Preferably, the second gelling agent is selected from one or more of carrageenan, agar, sodium alginate, pectin, high acyl gellan gum, low acyl gellan gum, konjac gum, xanthan gum, locust bean gum, guar gum and pullulan; preferably the second gelling agent is present in an amount of 0.2 wt% to 3.5 wt%, preferably the pectin is one or more of low methoxyl pectin, high methoxyl pectin and amide pectin; preferably wherein the low methoxyl pectin has a DE < 50% degree of esterification and the amide pectin has a DA 5% to 25% degree of amide.

In one embodiment, the starch film-forming composition comprises from 35 wt% to 60 wt% water.

In another aspect, the present invention provides a method for preparing a capsule shell using the starch film-forming composition of the present invention, which comprises 1) a) premixing and uniformly dispersing a first gelling agent and a plasticizer, adding to water under stirring, heating and stirring at 60 to 98 ℃ until the first gelling agent is dissolved; B) adding starch, and continuously heating and stirring at 60-98 ℃ until the starch is dissolved; C) removing air bubbles to obtain glue solution; 2) pelleting; and 3) drying. Pelleting can be carried out as follows: and conveying the glue solution to a glue box of a soft capsule filling machine by adopting a soft capsule production line, cooling the glue solution on the surface of a rotary drum to form a rubber sheet, pressing and bonding the rubber sheet by packaging fillers, and further shaping the rubber sheet by a rotary cage. Drying may be carried out as follows: drying the formed or cage-shaped capsule until the water content of the capsule skin is 8-25%.

In one embodiment, said a) further comprises adding a second gelling agent; the A) is formed by premixing and uniformly dispersing a first gelling agent, a second gelling agent and a plasticizer, adding the mixture into water under stirring, and heating and stirring the mixture at 60-98 ℃ until the first gelling agent and the second gelling agent are dissolved.

In another aspect, the invention provides a capsule shell comprising the starch film-forming composition of the invention.

In one embodiment, the water content of the capsule shell is 8-25%.

In another aspect, the present invention provides the use of the starch film-forming composition of the invention in medicine, food or cosmetics.

The invention also comprises the following scheme:

embodiment 1. a starch film-forming composition comprising the following ingredients:

1 wt% to 8 wt% of a first gelling agent;

0.2 wt% to 3.5 wt% of a second gelling agent;

15-50 wt% starch;

10 wt% -35 wt% of plasticizer; and

water, make up to 100 wt%;

wherein the first gel is selected from one or more of carrageenan, agar, sodium alginate, gellan gum, konjac gum, xanthan gum, locust bean gum, guar gum and pullulan;

the second gelling gum is pectin.

Embodiment 2. the starch film-forming composition of embodiment 1, wherein the pectin is one or more of low methoxyl pectin, high methoxyl pectin, and amide pectin.

Embodiment 3. the starch film-forming composition of the above embodiment, wherein the low methoxyl pectin has a DE < 50% esterification degree, or the amide pectin has a 5-25% amide degree DA.

Embodiment 4. the starch film-forming composition of the above embodiment, wherein the gellan gum is a high acyl gellan gum, a low acyl gellan gum, or a gellan gum having a total acyl content of 14 to 34%, preferably the gellan gum is a gellan gum having a total acyl content of 14 to 34%, preferably the gellan gum has a glyceroacyl content of 12 to 26% in total acyl groups, and/or an acetyl content of 2 to 8%.

Embodiment 5. the starch film-forming composition of the above embodiment, wherein the starch is a native starch selected from one or more of wheat starch, waxy corn starch, pea starch, corn starch, potato starch, and tapioca starch.

Embodiment 6 the starch film-forming composition of the above embodiment, wherein the starch is a starch derivative that is one or more of acid-treated starch, hydroxypropyl starch, oxidized starch, acetate starch, oxidized hydroxypropyl starch, hydroxypropyl distarch phosphate, starch phosphate, sodium starch octenyl succinate, acetylated distarch phosphate, and dextrin.

Embodiment 7 the starch film-forming composition of the above embodiment, wherein the plasticizer is selected from one or more of glycerol, sorbitol, maltitol, erythritol, xylitol, fructose and trehalose.

Embodiment 8. a method for preparing a capsule shell using the starch film-forming composition of any one of embodiments 1 to 7, comprising 1) a) premixing and dispersing the first gelling agent, the second gelling agent and the plasticizer uniformly, adding to water with stirring, heating and stirring at 60 to 98 ℃ until the first gelling agent and the second gelling agent are dissolved; B) adding starch, and continuously heating and stirring at 60-98 ℃ until the starch is dissolved; C) removing air bubbles to obtain glue solution;

2) pelleting; and

3) and (5) drying.

Embodiment 9. Capsule shells comprising the starch film-forming composition of any of embodiments 1-8.

Embodiment 10 the capsule shell of embodiment 9, having a water content of 8 to 25%.

Embodiment 11. use of the starch film-forming composition of any one of embodiments 1 to 8 in medicine, food or cosmetics.

Advantages of the starch film-forming composition of the present invention include: the soft capsule has good film forming strength and toughness, can be used for obtaining the soft capsule with good forming, bonding and encapsulating properties, does not contain animal-derived components, is suitable for all people in the world to eat, and can be popularized and applied in the world.

Detailed Description

The following is provided to further illustrate the invention.

As used herein, "%" or "wt%" refers to weight percent unless indicated to the contrary.

The present invention provides a starch film-forming composition comprising a first gelling agent which is gellan gum and starch. Gellan gums can be classified into low acyl gellan gums, high acyl gellan gums, and partially deacylated gellan gums based on total acyl content. In the present invention, the total acyl content of gellan gum may be 14-34%, for example 14%, 16%, 17%, 19%, 27%, 28%, 30%, 31%, 32%, or 34%. The total acyl content of gellan gum can be calculated as the sum of the content of glyceroyl and acetyl groups. The glyceryl group content may be 12-26%, e.g. 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24% or 25%. The acetyl content may be 2-8%, for example 3%, 4%, 5%, 6% or 7%.

The gellan gum content in the starch film-forming composition can be 1 wt% to 8 wt%, e.g., 2 wt%, 3 wt%, 4 wt%, 5 wt%, 6 wt%, 7 wt%, or 8 wt%. Preferably, the gellan gum content may be 2 wt% to 7 wt%.

The starch content in the starch film-forming composition may be 15 wt% to 50 wt%, such as 20 wt%, 25 wt% or 35 wt%, 45 wt%.

The starch may be native starch or a derivative or combination of starch produced by physical, chemical, enzymatic means of native starch. The natural starch can be selected from one or combination of wheat starch, waxy corn starch, pea starch, corn starch, potato starch and cassava starch. The starch derivative can be selected from one or combination of acid-treated starch, hydroxypropyl starch, oxidized starch, acetate starch, oxidized hydroxypropyl starch, hydroxypropyl distarch phosphate, starch phosphate, sodium starch octenyl succinate, acetylated distarch phosphate and dextrin. For example, the starch of each of the above types is independently present in an amount of 7 wt% to 50 wt%, such as 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, 13 wt%, 14 wt%, 15 wt%, 16 wt%, 17 wt%, 18 wt%, 19 wt%, 20 wt%, 21 wt%, 22 wt%, 23 wt%, 24 wt%, 25 wt%, or 30 wt%. The weight ratio of gellan gum to starch may be 0.02 to 0.5, for example 0.04, 0.06, 0.09, 0.11, 0.12, 0.16, 0.17, 0.20, 0.23, 0.24 or 0.50.

The starch film-forming composition may further comprise one or more of a plasticizer and a secondary gelling agent. The plasticizer may be one or more of glycerol, sorbitol, maltitol, erythritol, xylitol, fructose and trehalose. The second gelling agent may be one or more of carrageenan, agar, sodium alginate, low methoxyl pectin, high methoxyl pectin, amide pectin, high acyl gellan gum, low acyl gellan gum, konjac gum, xanthan gum, locust bean gum, guar gum, and pullulan. The plasticizer may be present in an amount of 10 wt% to 35 wt%, for example 15 wt%, 17 wt%, 18 wt%, 20 wt%, 25 wt% or 30 wt%.

The starch film-forming composition of the invention also comprises water, for example 35 wt% to 60 wt% water, for example 36 wt%, 39 wt%, 42 wt%, 43 wt%, 46 wt%, 47 wt%, 48 wt%, 49 wt% or 56 wt%. Water may be used to make up the total amount of the composition to 100 wt%.

Soft capsules can be prepared using the starch film-forming compositions of the present invention. The preparation of the soft capsule can comprise 1) A) premixing and dispersing the first gelling agent and the plasticizer uniformly, adding the mixture into water under stirring, and heating and stirring the mixture at 60-98 ℃ until the first gelling agent is dissolved; B) adding starch, and continuously heating and stirring at 60-98 ℃ until the starch is dissolved; C) removing air bubbles to obtain glue solution; 2) pelleting; and 3) drying.

The preparation of the soft capsule may include 1) a) premixing and uniformly dispersing a first gelling agent, a second gelling agent and a plasticizer, adding to water under stirring, heating and stirring at 60-98 ℃ until the first gelling agent and the second gelling agent are dissolved; B) adding starch, and continuously heating and stirring at 60-98 ℃ until the starch is dissolved; C) removing air bubbles to obtain glue solution; 2) pelleting; and 3) drying. The starch film-forming composition can be prepared into soft capsules with good forming, bonding and encapsulating properties, and can be applied to medicines, foods or cosmetics.

The present invention provides a starch film-forming composition comprising pectin. Preferably, the pectin is one or more of a low methoxyl pectin, a high methoxyl pectin and an amide pectin. The pectin may be present in an amount of 0.2 wt% to 3.5 wt%, e.g. 0.50 wt%, 1.25 wt%, 1.5 wt%, 2.50 wt% or 3.5 wt%. In this case, the starch film-forming composition may further comprise one or more of carrageenan, agar, sodium alginate, gellan gum, konjac gum, xanthan gum, locust bean gum, guar gum, and pullulan. In one embodiment of this aspect, the starch film-forming composition further comprises gellan gum. For example, the gellan gum is a high acyl gellan gum, a low acyl gellan gum, or a gellan gum having a total acyl content of 14 to 34%, preferably the gellan gum has a total acyl content of 12 to 26% of glycerol acyl groups and/or an acetyl content of 2 to 8%. The gellan gum content and acyl content may be as defined above.

The pectin-containing starch film-forming composition may also comprise starch, and its type and content are as defined above. In one embodiment, the starch may be hydroxypropyl starch and hydroxypropyl distarch phosphate, for example each independently 7 wt% to 25 wt%, such as 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, 13 wt%, 14 wt%, 15 wt%, 16 wt%, 17 wt%, 18 wt%, 19 wt%, 20 wt%, 21 wt%, 22 wt%, 23 wt%, or 24 wt%.

The pectin-containing starch film-forming composition may further comprise a plasticizer. The type and amount of plasticizer may be as defined above. The pectin-containing starch film-forming composition may also be water. The water content may be as defined above. The present invention demonstrates that a starch film-forming composition that does not contain pectin disintegrates in the stomach and cannot be delivered to the intestine. In contrast, the pectin containing starch film forming composition of the present invention complies with the relevant regulations for enteric capsules in the disintegration time limit detection method in the chinese pharmacopoeia. This is unexpected.

To facilitate an understanding of the invention, exemplary embodiments are provided below. It is to be understood that these embodiments are illustrative only and not restrictive. The scope of the invention is to be determined solely by the scope of the appended claims.

Examples

Judging method

In order to better illustrate the effect of the invention, the following soft capsule performance indexes are adopted for evaluation and illustration:

1) rubber strength and toughness indexes: selecting a spherical probe and a puncture mode by adopting a physical property tester, testing the speed at 1.0mm/s, and recording the force value (g) of the rubber sheet when the rubber sheet is broken and the corresponding breaking distance (mm). The breaking force of the rubber represents the rubber strength, and the larger the breaking force is, the better the rubber strength is; the fracture distance indicates the toughness of the rubber, and the larger the fracture distance, the better the toughness of the rubber is.

2) Forming crack bonding index: taking a sample of the example of the invention, cutting the capsule at a non-slit, squeezing to empty the contents, then keeping the slit perpendicular to the circle, cutting a circle containing two slits from the middle, placing the circle on a glass slide, making the two slits perpendicular to the glass slide, measuring the thickness of the two slits and the thickness of the capsule shell under a microscope, and calculating the ratio P (%) of the thinnest slit thickness to the capsule shell thickness.

TABLE 1 evaluation criteria for the soft capsule skin strength, toughness and molding adhesion

The rubber strength index, the toughness index and the forming adhesion index are used for comprehensive evaluation, the full score is 5, and each score (X) represents:

0 minute: can not be made into soft capsule;

x is more than 0 and less than or equal to 1 point: the soft capsule has poor forming performance and is easy to leak oil;

1< X is less than or equal to 2 min: the soft capsule has poor molding and is easy to leak oil;

2< X is less than or equal to 3 min: the soft capsule has good forming;

3< X is less than or equal to 4 min: the soft capsule is excellent in forming;

4< X is less than or equal to 5 min: the soft capsule molding is excellent.

Material

The present invention is illustrated by the following materials, but the present invention is not limited to the following materials, specifically, as follows.

Gellan gum (total acyl content 14.4%, glyceroyl 12.1%, acetyl 2.3%) (commercially available)

Gellan gum (total acyl content 16.5%, glyceroyl 12.8%, acetyl 3.7%) (commercially available)

Gellan gum (total acyl content 19.0%, glyceroyl 15.1%, acetyl 3.9%) (commercially available)

Gellan gum (total acyl content 27.5%, glyceroyl 19.8%, acetyl 7.7%) (commercially available)

Gellan gum (total acyl content 28.0%, glyceroyl 23.4%, acetyl 4.6%) (commercially available)

Gellan gum (total acyl content 30.6%, glyceroyl 25.1%, acetyl 5.5%) (commercially available)

Gellan gum (total acyl content 33.2%, glyceroyl 25.5%, acetyl 7.7%) (commercially available)

High acyl gellan gum (total acyl content 37.3%, glyceroyl group 20.4%, acetyl group 16.9%) (commercially available)

Low acyl gellan gum (total acyl content 11.2%, glyceroyl 8.1%, acetyl 3.1%) (commercially available)

Oxidized starch (commercially available)

Hydroxypropyl starch (commercially available)

Oxidized hydroxypropyl starch (commercially available)

Hydroxypropyl distarch phosphate (commercially available)

Oxidized starch (commercially available)

Acetate starch (commercially available)

Acetylated oxidized starch (commercially available)

Acetylated distarch phosphate (commercially available)

Glycerol (for sale)

Agar (commercially available)

Locust bean gum (commercially available)

Guar gum (commercially available)

Amide pectin (amide degree (DA: 5-25%), commercially available)

Low methoxyl pectin (degree of esterification (DE: < 50%), commercially available)

Konjak glue (market selling)

Method for preparing soft capsule

The method comprises the following steps:

1) sol: A) firstly, premixing and uniformly dispersing a first gelling agent and a plasticizer, adding the mixture into a proper amount of water under stirring, and heating and stirring the mixture at a temperature of between 60 and 98 ℃ until the first gelling agent is dissolved; if the second gelling agent is contained, the first gelling agent, the second gelling agent and the plasticizer are premixed and uniformly dispersed, added into water under stirring, and heated and stirred at 60-98 ℃ until the first gelling agent and the second gelling agent are dissolved; B) adding starch, and continuously heating and stirring at 60-98 ℃ until the starch is dissolved; C) removing air bubbles to obtain glue solution;

2) pelleting: and conveying the glue solution to a glue box of a soft capsule filling machine by adopting a soft capsule production line, cooling the glue solution on the surface of a rotary drum to form a rubber sheet, pressing and bonding the rubber sheet by packaging fillers, and further shaping the rubber sheet by a rotary cage.

3) And (3) drying: drying the formed or cage-shaped capsule until the water content of the capsule skin is 8-25%.

Examples 1 to 7 and comparative examples 1 to 3

Soft capsules were prepared with ingredients and contents as described in table 2, and tested and scored. The measurement results are shown in table 2.

Table 2: examples 1 to 7 and comparative examples 1 to 3

As can be seen from Table 2, the gellan gum having a specific acyl group content used in examples 1 to 7 was superior in the strength, toughness and molding adhesion, while the film-forming composition of the present invention used in comparative examples 1 to 2 had the same content as the components of the film-forming composition of the present invention, and the gellan gum having a high acyl group content was inferior in the strength and toughness but was superior in the molding adhesion, while the gellan gum having a low acyl group content was inferior in the toughness and could not be molded. Comparative example 3 two gellan gum compound gels with different acyl contents were used, and the compound gels had glyceroyl and acetyl contents close to the specified acyl content range of the present invention, but had poor mold adhesion. It is shown that soft capsules made using the specific acyl group content gellan gum and starch combination of the present invention are superior to the prior art.

Examples 8 to 18

Soft capsules were prepared with ingredients and contents as described in table 3, and tested and scored. The measurement results are shown in table 3.

Table 3 examples 8 to 18

Examples 8-18 with increasing gellan gum usage, the resulting skins had increased strength and near toughness, but the formed bond was reduced. It is unexpected that a starch composition comprising a specific range of gellan gum to starch ratio is superior in overall effect to a starch composition not within that range.

Examples 19 to 25

Soft capsules were prepared with ingredients and contents as described in table 4, and tested and scored. The measurement results are shown in table 4.

TABLE 4 examples 19 to 25

Examples 19-25 illustrate that the technical effect of gellan gum of a specific acyl content in combination with various starches for soft capsules is significantly superior to the prior art.

Examples 26 to 31

Soft capsules were prepared with ingredients and contents as described in table 5, and tested and scored. The measurement results are shown in table 5.

TABLE 5 examples 26 to 31

Examples 26-31 the technical effect of soft capsules prepared by combining gellan gum and starch with specific acyl contents with low acyl gellan gum, agar, locust bean gum, guar gum, and konjac gum, respectively, is superior to the prior art.

Examples 32 to 37

Soft capsules were prepared with the ingredients and contents as described in table 6 and were subjected to disintegration time testing as specified in relation to enteric capsules in the disintegration time detection method in chinese pharmacopoeia. The measurement results are shown in table 6.

The disintegration time of the samples of example 22, example 26 and examples 32 to 37 was measured according to the regulations related to enteric capsules in the disintegration time examination method of < chinese pharmacopoeia > and found as follows: the samples of example 22 and example 26 were examined in hydrochloric acid solution (9 → 1000) without a baffle and completely disintegrated within 60 minutes; the samples of the examples 32-37 are detected in the hydrochloric acid solution (9 → 1000) without adding a baffle, are not disintegrated within 120 minutes, are detected in the phosphate buffer solution (PH6.8), one baffle is added in each tube, and are disintegrated completely within 60 minutes, thereby meeting the requirement of the enteric-coated capsule on the disintegration time limit in the disintegration time limit detection method of < Chinese pharmacopoeia >. Therefore, the invention adopts the specific acyl group content gellan gum and starch to prepare the soft capsule by combining pectin (such as low methoxyl pectin or amide pectin), which can meet the requirement of the enteric soft capsule on disintegration time limit.

The soft capsule prepared by the composition of the gellan gum and the starch with specific acyl content has good film forming strength and toughness, the gellan gum proportion increases in a certain range, and the forming adhesiveness decreases with the increase of the gellan gum proportion. The soft capsule prepared from the composition of gellan gum and starch with specific acyl content is obviously superior to the prior art in rubber strength, toughness and molding adhesion, completely meets the requirement of industrial production of the soft capsule, and can be used as an alternative substitute for the soft capsule technology.

The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.