Aloe, folium sennae and fructus cannabis oil soft capsule and preparation method thereof

By using gelatin and chitosan hydrochloride as shell materials in aloe vera, senna leaf, and hemp seed oil soft capsules, combined with fucoidan and sodium alginate as intermediate membranes, the problems of slow disintegration and leakage caused by hemp seed oil oxidation were solved, achieving stable release and antioxidant effects of the soft capsules.

CN121129789AInactive Publication Date: 2025-12-16ANHUI JISHENGYUAN PHARM CO LTD
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Patent Information

Application Number
CN202511407953.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-29
Publication Date
2025-12-16
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

Hemp seed oil is prone to oxidation and rancidity, which causes an insoluble film to form on the inner wall of aloe vera, senna leaf, and hemp seed oil soft capsules. This film prevents the release of the contents, resulting in slow disintegration and potential leakage.

Method used

Using a suitable formula, gelatin and chitosan hydrochloride are used as the soft capsule shell, combined with fucoidan and sodium alginate as the intermediate membrane. The shell and membrane are tightly bound by electrostatic interaction and self-viscosity. The antioxidant properties are improved by titanium dioxide and magnesium stearate, which block oxygen and aldehyde compounds and prevent gelatin cross-linking.

Benefits of technology

It significantly improved the slow disintegration and leakage problems of soft capsules, maintained the stability and bioavailability of the contents, and improved antioxidant and mechanical properties.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a soft capsule containing aloe, folium sennae and fructus cannabis oil. The soft capsule comprises a content, a middle film and a soft capsule shell, the content comprises the following raw materials in parts by weight: 3-4 parts of aloe whole leaf powder, 7-9 parts of a folium sennae extract, 13-16 parts of hemp seed oil, 2-3 parts of an emulsifier, 2-4 parts of an antioxidant A, 3-4 parts of beewax and 60-70 parts of soybean oil; the soft capsule shell comprises the following raw materials in parts by weight: 30-32 parts of gelatin, 8-10 parts of chitosan hydrochloride, 10-12 parts of sorbitol, 4-6 parts of a hydrophobic material, 1-2 parts of an antioxidant B and 40-45 parts of water; the raw material of the middle film is a mixture of fucoidin, sodium alginate and vitamin C. The invention further discloses a preparation method of the aloe, folium sennae and fructus cannabis oil soft capsule. The problems that the aloe, folium sennae and fructus cannabis oil soft capsules are easy to disintegrate slowly and leak liquid can be solved.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of health care product preparation, and particularly relates to aloe, senna leaf and hemp seed oil soft capsule and a preparation method thereof. BACKGROUND

[0002] The aloe, senna leaf and hemp seed oil soft capsule is a soft capsule health care product containing aloe whole leaf powder, senna leaf extract and hemp seed oil, and has the effect of lubricating the intestines and defecating. The hemp seed oil contains various fatty acids, and the content of unsaturated fatty acids is the highest. The unsaturated fatty acids mainly include palmitoleic acid, oleic acid, linoleic acid, alpha-linolenic acid and gamma-linolenic acid.

[0003] Due to the high unsaturation degree of the hemp seed oil, the hemp seed oil is prone to oxidation and rancidity. The aldehyde compounds generated by the oxidation of the hemp seed oil, and the inevitable aldehyde compounds in the aloe whole leaf powder and the senna leaf extract, will crosslink with the gelatin of the soft capsule shell to generate crosslinking compounds, so that a layer of water-insoluble film is generated on the inner wall of the capsule shell, which prevents the release of the content of the soft capsule, causes delayed disintegration, and reduces the bioavailability of the soft capsule. SUMMARY

[0004] Based on the technical problems in the background art, the present application provides an aloe, senna leaf and hemp seed oil soft capsule and a preparation method thereof. The present application selects a suitable formula, which can improve the antioxidant properties of the content and the soft capsule shell itself, and sets a suitable intermediate film to block oxygen from entering the content and to block the reaction between the aldehyde compounds in the content and the gelatin, so as to greatly improve the problem of easy delayed disintegration of the aloe, senna leaf and hemp seed oil soft capsule, and to improve the problem of liquid leakage of the soft capsule.

[0005] The present application provides an aloe, senna leaf and hemp seed oil soft capsule, which comprises: content, an intermediate film and a soft capsule shell.

[0006] The raw materials of the content include, by weight, 3-4 parts of aloe whole leaf powder, 7-9 parts of senna leaf extract, 13-16 parts of hemp seed oil, 2-3 parts of emulsifier, 2-4 parts of antioxidant A, 3-4 parts of beeswax and 60-70 parts of soybean oil.

[0007] The raw materials of the soft capsule shell include, by weight, 30-32 parts of gelatin, 8-10 parts of chitosan hydrochloride, 10-12 parts of sorbitol, 4-6 parts of hydrophobic material, 1-2 parts of antioxidant B and 40-45 parts of water.

[0008] The raw material of the intermediate film is a mixture of fucoidan, sodium alginate and vitamin C.

[0009] The gelatin is acid gelatin.

[0010] Preferably, the weight ratio of fucoidan, sodium alginate and vitamin C is 1:0.6-1.5:0.02-0.04.

[0011] Preferably, the emulsifier is soybean phospholipid.

[0012] Preferably, the antioxidant A is vitamin E.

[0013] Preferably, the antioxidant B is vitamin C.

[0014] Preferably, the hydrophobic material is a mixture of titanium dioxide and magnesium stearate.

[0015] Preferably, the weight ratio of titanium dioxide and magnesium stearate is 1-2:1.

[0016] The present application also provides a preparation method of the aloe senna cannabis oil soft capsule, comprising the following steps:

[0017] The raw materials of the content are heated, mixed, ground and filtered to obtain the content; sorbitol, the hydrophobic material, antioxidant B and water are mixed, then gelatin and chitosan hydrochloride are added and heated to dissolve to obtain a glue solution; fucoidan, sodium alginate and vitamin C are dissolved in water to obtain an intermediate film solution;

[0018] The glue solution is prepared into a glue skin, then the intermediate film solution is coated on the surface of the glue skin to form a film, and the content is injected and pressed to obtain the aloe senna cannabis oil soft capsule.

[0019] The glue solution is prepared into a glue skin, then the intermediate film solution is coated on the surface of the glue skin to form a film, and the content is injected and pressed to obtain the aloe senna cannabis oil soft capsule.

[0020] Preferably, the mass fraction of fucoidan in the intermediate film solution is 1-3wt%.

[0021] Preferably, the temperature of the glue solution is 55-65℃.

[0022] Preferably, the temperature of the intermediate film solution is 55-65℃.

[0023] Preferably, the pore size of the filter screen for grinding and filtering is 150-180μm.

[0024] Preferably, the weight ratio of the content and the glue solution is 1:0.3-0.4.

[0025] Preferably, the coating thickness of the intermediate film solution is 1-5μm.

[0026] The application selects soybean phospholipid as an emulsifier, which can cooperate with beeswax to make aloe vera whole leaf powder and senna leaf extract uniformly dispersed in oil and maintain the uniform stability of the contents, and avoid the aloe vera whole leaf powder and senna leaf extract from settling; and the soybean phospholipid, vitamin E and beeswax can also improve the antioxidant and rancidity resistance of hemp seed oil and soybean oil, reduce the generation of aldehyde compounds, and thus reduce the reaction with gelatin.

[0027] The application selects gelatin and chitosan hydrochloride as the soft capsule shell raw material, and the aqueous solution thereof is acidic, and the gelatin and chitosan hydrochloride both have positive charges; a mixture of fucoidan, sodium alginate and vitamin C is used as the intermediate film, and the aqueous solution thereof is acidic, and the fucoidan and sodium alginate have negative charges; when the glue solution is used to prepare the glue skin, the intermediate film solution is coated on the surface of the glue skin to form a film, and the soft capsule shell and the intermediate film are tightly adhered by electrostatic action and their own viscosity; the intermediate film can block oxygen and the like, further improve the antioxidant performance of the contents, and reduce the generation of aldehyde compounds; on the other hand, the intermediate film can block the contact between aldehyde compounds and gelatin, avoid the cross-linking of gelatin and the formation of a water-insoluble film, and thus solve the problem of slow disintegration of gelatin soft capsules.

[0028] In addition, the application accidentally finds that when fucoidan or sodium alginate is used alone, the soft capsule is prone to leakage, but when fucoidan and sodium alginate are used in a suitable ratio, the problem of easy leakage of the soft capsule can be avoided; in addition, fucoidan itself has antioxidant properties, which can further improve the antioxidant properties of hemp seed oil and soybean oil, and further reduce the generation of aldehyde compounds, thereby reducing the cross-linking reaction with gelatin.

[0029] In addition, a suitable amount of chitosan hydrochloride is used to cooperate with gelatin, which can reduce the amount of gelatin, improve the problem of slow disintegration, improve the mechanical properties of the soft capsule shell, and improve the problem of leakage.

[0030] In addition, the application selects titanium dioxide and magnesium stearate as hydrophobic materials, and cooperates with vitamin C as antioxidant B, which can improve the anti-ultraviolet performance, high-temperature resistance and hydrophobicity of the soft capsule shell, thereby further avoiding the problems of accelerated cross-linking and slow disintegration of gelatin caused by high temperature, high humidity and ultraviolet radiation; the use of titanium dioxide and magnesium stearate can make the soft capsule maintain a suitable disintegration time.

[0031] The application selects a suitable formula to improve the antioxidant properties of the contents and the soft capsule shell itself, and sets a suitable intermediate film to block oxygen from entering the contents and block the reaction between aldehyde compounds in the contents and gelatin, thereby greatly improving the problem of slow disintegration of the gelatin soft capsule shell, and improving the problem of leakage of the soft capsule. DETAILED DESCRIPTION

[0032] The technical solutions of the present application are described in detail below through specific examples, but it should be made clear that these examples are only used for illustration and are not construed as limiting the scope of the present application.

[0033] Examples 1-3

[0034] The aloe senna cannabis oil soft capsule formula of examples 1-3 is shown in Table 1.

[0035] Table 1 Aloe senna cannabis oil soft capsule formula of examples 1-3

[0036]

[0037]

[0038] The preparation methods of the above aloe senna cannabis oil soft capsules are the same, comprising the following steps:

[0039] Mix beeswax, soybean oil, cannabis oil, and vitamin E, heat to 70℃ and stir to mix, then mix with soybean phospholipid, then mix with aloe whole leaf powder and senna extract, grind and filter (filter screen aperture is 150-180μm), cool to 40℃, obtain the content, and keep warm for standby;

[0040] Mix sorbitol, titanium dioxide, magnesium stearate, vitamin C, and water, then add gelatin and chitosan hydrochloride, heat to 70℃ and stir to dissolve, cool to 60℃, obtain the glue solution, and keep warm for standby;

[0041] Add fucoidan, sodium alginate, and vitamin C to water, heat to 60℃ and stir to dissolve, obtain the intermediate film solution, and keep warm for standby, wherein the mass fraction of fucoidan in the intermediate film solution is 3wt%;

[0042] After the glue skin is prepared from the glue solution, immediately coat the intermediate film solution with a thickness of 4μm on the surface of the glue skin, dry to form a film, then weigh the content according to the weight ratio of content to glue solution of 1:0.35, inject the content, press the pills, dry, and obtain the aloe senna cannabis oil soft capsules.

[0043] Place the aloe senna cannabis oil soft capsules of examples 1-3 under the condition of 40±2℃ and humidity of 75%±5% for 6 months, detect the appearance, whether leaking, and disintegration time of 0 days and 6 months of placement. The results are shown in Table 2.

[0044] The detection method of disintegration time is as follows: refer to the method of Chinese Pharmacopoeia, volume 4, detect the disintegration time in artificial gastric juice at a temperature of 37℃.

[0045] Table 2 Disintegration time results of examples 1-3

[0046]

[0047] From Table 2, it can be seen that the aloe fex leaf hemp seed oil soft capsules of the present application placed at 40±2℃ and 75%±5% humidity for 6 months have smooth surfaces, no deformation, no liquid leakage, and no significant change in disintegration time.

[0048] Comparative Example 1

[0049] No intermediate film was added, and the other conditions were the same as in Example 1.

[0050] Comparative Example 2

[0051] The fucoidan in the intermediate film was replaced with sodium alginate, and the other conditions were the same as in Example 1.

[0052] Comparative Example 3

[0053] The sodium alginate in the intermediate film was replaced with fucoidan, and the other conditions were the same as in Example 1.

[0054] Comparative Example 4

[0055] The sodium alginate in the intermediate film was replaced with pectin, and the other conditions were the same as in Example 1.

[0056] Comparative Example 5

[0057] The sodium alginate in the intermediate film was replaced with carrageenan, and the other conditions were the same as in Example 1.

[0058] Comparative Example 6

[0059] The chitosan hydrochloride was replaced with acid gelatin, and the other conditions were the same as in Example 1.

[0060] The soft capsules of Comparative Examples 1-6 were placed at 40±2℃ and 75%±5% humidity for 6 months, and the appearance, liquid leakage, and disintegration time were detected at 0 days and after 6 months of storage. The results are shown in Table 3.

[0061] Table 3 Disintegration time results for Comparative Examples 1-6

[0062]

[0063]

[0064] Note: If liquid leakage is found in the sample, then the disintegration time is no longer detected.

[0065] From Table 3, it can be seen that the use of suitable raw materials and ratios to prepare the intermediate film, and the placement of the intermediate film between the contents and the soft capsule shell, can greatly improve the disintegration delay and liquid leakage problems of aloe fex leaf hemp seed oil soft capsules.

[0066] The above merely describes preferred specific embodiments of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art, according to the technical solution and inventive concept of the present application, makes equivalent replacement or change within the technical range disclosed by the present application, which should be covered within the protection scope of the present application.

Claims

1. A soft capsule containing aloe vera, senna leaf, and hemp seed oil, characterized in that... It includes: Contents, intermediate membrane, and soft capsule shell; The ingredients of the contents include, by weight: 3-4 parts aloe vera whole leaf powder, 7-9 parts senna leaf extract, 13-16 parts hemp seed oil, 2-3 parts emulsifier, 2-4 parts antioxidant A, 3-4 parts beeswax, and 60-70 parts soybean oil; The raw materials for the soft capsule shell, by weight, include: 30-32 parts gelatin, 8-10 parts chitosan hydrochloride, 10-12 parts sorbitol, 4-6 parts hydrophobic material, 2 parts antioxidant B1, and 40-45 parts water. The intermediate membrane is made from a mixture of fucoidan, sodium alginate, and vitamin C.

2. The aloe vera, senna leaf, and hemp seed oil soft capsule according to claim 1, characterized in that, The weight ratio of fucoidan, sodium alginate and vitamin C is 1:0.6-1.5:0.02-0.

04.

3. The aloe vera, senna leaf, and hemp seed oil soft capsule according to claim 1 or 2, characterized in that, The emulsifier is soybean lecithin.

4. The aloe vera, senna leaf, and hemp seed oil soft capsules according to any one of claims 1-3, characterized in that, Antioxidant A is vitamin E.

5. The aloe vera, senna leaf, and hemp seed oil soft capsules according to any one of claims 1-4, characterized in that, Antioxidant B is vitamin C.

6. The aloe vera, senna leaf, and hemp seed oil soft capsules according to any one of claims 1-5, characterized in that, The hydrophobic material is a mixture of titanium dioxide and magnesium stearate.

7. The aloe vera, senna leaf, and hemp seed oil soft capsule according to claim 6, characterized in that, The weight ratio of titanium dioxide to magnesium stearate is 1-2:

1.

8. A method for preparing aloe vera, senna leaf, and hemp seed oil soft capsules as described in any one of claims 1-7, characterized in that, Includes the following steps: Take the raw materials of the contents, heat and mix them, grind and filter to obtain the contents; mix sorbitol, hydrophobic material, antioxidant B and water, then add gelatin and chitosan hydrochloride, heat and dissolve to obtain a gel solution; dissolve fucoidan, sodium alginate and vitamin C in water to obtain an intermediate membrane solution; The adhesive solution was used to prepare a rubber sheet, and then an intermediate film solution was coated on the surface of the rubber sheet to form a film. The contents were then injected and the film was pressed into pellets to obtain aloe vera, senna leaf and hemp seed oil soft capsules.

9. The preparation method of the aloe vera, senna leaf, and hemp seed oil soft capsules according to claim 8, characterized in that, The temperature of the adhesive solution is 55-65℃; preferably, the temperature of the intermediate film solution is 55-65℃.

10. The method for preparing aloe vera, senna leaf, and hemp seed oil soft capsules according to claim 8 or 9, characterized in that, The mesh size of the grinding and filtration filter is 150-180μm; preferably, the weight ratio of contents to adhesive is 1:0.3-0.4; preferably, the coating thickness of the intermediate membrane solution is 1-5μm.