CN114073681B

CN114073681B - A capsule content containing policosanol, and its preparation method and soft capsule

Info

Publication number: CN114073681B
Application number: CN202010793407.XA
Authority: CN
Inventors: 袁建成; 陶安进; 蔡磊; 邹菁
Original assignee: Hubei Zhonggu Biopharmaceutical Co ltd
Current assignee: Hubei Zhonggu Biopharmaceutical Co ltd
Priority date: 2020-08-10
Filing date: 2020-08-10
Publication date: 2023-04-25
Anticipated expiration: 2040-08-10
Also published as: CN114073681A

Abstract

The invention relates to the technical field of policosanol preparations, and provides a policosanol-containing capsule content, a preparation method thereof and a soft capsule, wherein the capsule content comprises policosanol, a solubilizer, a surfactant and a matrix; the solubilizer is selected from alcohols; the surfactant is a nonionic surfactant for assisting dissolution; the matrix is vegetable oil; the policosanol content is above 5 mg. The invention can improve the dispersion state of the policosanol by designing the prescription and the process, greatly reduce the particle size of the policosanol in the prescription composition, improve the dispersity and the solubility of the policosanol, and further improve the bioavailability of the policosanol in a human body. Namely, the soft capsule containing policosanol provided by the invention can effectively improve the oral absorption rate. In addition, the preparation process of the invention is simple and feasible.

Description

A capsule content containing policosanol, and its preparation method and soft capsule

Technical Field

The invention relates to the technical field of policosanol preparations, in particular to a policosanol-containing capsule content, a preparation method thereof and a soft capsule.

Background

The policosanol is a mixture of eight higher fatty alcohols such as octacosanol extracted from cane wax. Animal experiments show that policosanol can reduce serum cholesterol and low density lipoprotein (LDL-C) levels of normal and endogenous high cholesterol animals. Various animal model researches show that policosanol can reduce cholesterol in liver, adipose tissue and heart. The active ingredient drug is orally taken with little acute toxicity, and has no genetic toxicity, reproductive toxicity and carcinogenicity.

The policosanol tablet was first developed by the company of the laboratory limited of copa damer and was approved by the copa drug administration in 1991 for sale in copa. In China, approval by the Chinese drug administration was obtained in 2006 first and imported into China. The traditional policosanol tablet is a common tablet, and the prescription contains the policosanol as an effective component, and also contains auxiliary materials such as diluents (also called fillers) and the like used by the conventional oral tablet. However, the particle size of the policosanol in the prior oral policosanol tablet is larger, and the oral bioavailability of the policosanol is lower.

The policosanol product also has soft capsule for sale as health product, and mainly contains soybean oil or fish oil, glycerol, etc. as adjuvants. However, the policosanol soft capsule belongs to a health care product, and cannot improve the current situation that the existing tablet has low oral absorptivity, and also cannot obtain the examination and approval of the medicine supervision institutions of various countries.

Based on the research on the medicines and health products sold in the market of the policosanol, the existing policosanol preparation is found to have low oral absorption rate.

Disclosure of Invention

In view of the above, the application provides a capsule content containing policosanol, a preparation method thereof and a soft capsule, and the policosanol in the capsule content provided by the invention has a good dispersion state and can effectively improve the oral absorption rate of the policosanol.

The invention provides a capsule content containing policosanol, which comprises policosanol, a solubilizer, a surfactant and a matrix; the solubilizer is selected from alcohols; the surfactant is a nonionic surfactant for assisting dissolution; the matrix is vegetable oil; the policosanol content is above 5mg, preferably 5-80 mg.

Preferably, the solubilizer is selected from one or more of polyethylene glycol and small molecule alcohol; the molecular weight of the polyethylene glycol is preferably 200 to 40000, more preferably 200 to 20000; the small molecule alcohol is preferably one or more of ethanol, isopropanol, propylene glycol and glycerol.

Preferably, the surfactant is selected from one or more of sucrose esters, phospholipids, polysorbate, polyoxyethylene fatty acid esters and medium chain fatty acid glycerides, and the content is 1-10 times, preferably 1-5 times, more preferably 1-3 times the mass of policosanol.

Preferably, the matrix is selected from one or more of soybean oil, linseed oil and palm oil.

Preferably, the policosanol in the capsule content is in a dissolved state or a suspension state; wherein the particle size of policosanol is not more than 5 μm, and the preferred range is not more than 1 μm.

The invention provides a preparation method of a capsule content containing policosanol, which comprises the following steps:

mixing and dispersing the policosanol, the solubilizer, the surfactant and the vegetable oil according to the prescription amount to obtain the capsule content containing the policosanol;

the solubilizer is selected from alcohols; the surfactant is a nonionic surfactant for assisting dissolution, preferably one or more of sucrose esters, phospholipids, polysorbate, polyoxyethylene fatty acid esters and medium-chain fatty acid glycerides; the policosanol content is above 5mg, preferably 5-80 mg.

Preferably, the preparation method of the policosanol-containing capsule content specifically comprises the following steps:

stirring and dispersing the prescribed amount of solubilizer and surfactant, and then heating to 60-80 ℃ to obtain a first solution; the solubilizer comprises polyethylene glycol and small molecule alcohol, wherein the small molecule alcohol is preferably one or more of ethanol, isopropanol, propylene glycol and glycerin;

adding the policosanol with the prescription amount into the first solution under the stirring state, and dissolving to obtain a second solution;

adding vegetable oil with a prescription amount into the second solution, heating to 50-100deg.C under stirring, preferably 60-90deg.C, volatilizing small molecular alcohol to obtain capsule content containing policosanol.

stirring and dispersing the prescribed amount of solubilizer and surfactant, and then heating to 60-80 ℃ to obtain a first solution; the solubilizer is selected from one or more of polyethylene glycol and small molecular alcohol;

adding the policosanol with the prescription amount into the first solution under the stirring state, and grinding by a colloid mill to obtain a mixture;

adding vegetable oil with a prescription amount into the colloid mill, and grinding to obtain capsule content containing policosanol.

Preferably, the amount of the surfactant is 1-10 times of the weight of the policosanol, preferably 1-5 times, more preferably 1-3 times; the dosage of the solubilizer is 1-100 times, preferably 1-50 times of the weight of the policosanol.

The invention provides a policosanol-containing soft capsule which consists of a soft capsule shell and contents thereof, wherein the contents are the policosanol-containing capsule contents; the content of policosanol in each soft capsule is 5mg-80mg, preferably 5mg-40mg.

Preferably, the soft capsule shell consists essentially of pharmaceutically acceptable dry gelatin, sorbitol and glycerin.

Compared with the prior art, the invention provides a soft capsule pharmaceutical preparation containing policosanol, wherein the capsule content consists of a certain amount of policosanol, a surfactant, a solubilizer and a matrix, and the policosanol content is more than 5 mg; the solubilizer is selected from alcohols, the surfactant is nonionic surfactant for assisting dissolution, and the matrix is one or more of vegetable oil. The invention can improve the dispersion state of the policosanol by designing the prescription and the process, greatly reduce the particle size of the policosanol in the prescription composition, improve the dispersity and the solubility of the policosanol, and further improve the bioavailability of the policosanol in a human body. Namely, the soft capsule containing policosanol provided by the invention can effectively improve the oral absorption rate.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely, and it is apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

The invention provides a capsule content containing policosanol, which comprises policosanol, a solubilizer, a surfactant and a matrix; the solubilizer is selected from alcohols; the surfactant is a nonionic surfactant for assisting dissolution; the matrix is vegetable oil; the policosanol content is above 5 mg.

The composition containing the policosanol provided by the invention can be used as capsule contents, wherein the policosanol has a good dispersion state, and further the solubility, the oral bioavailability and the like of the policosanol are improved.

The capsule is a solid preparation prepared by filling the medicine into the materials of the saccular structure, can improve compliance, medicine stability and the like, realizes the solid dosage form of the liquid medicine, controls the medicine release and the like; can be divided into hard capsule, soft capsule, slow release capsule, etc., and is mainly used for oral administration.

The embodiment of the invention adopts the prescription containing the policosanol, the solubilizer, the surfactant and the matrix, can improve the dispersion state of the policosanol in the prescription composition, and further obtains the medicine soft capsule preparation with the prescription composition as the content and higher bioavailability. Wherein the policosanol is an effective component of a drug for regulating dyslipidemia, and is a mixture of eight higher fatty alcohols such as octacosanol extracted from cane wax. The policosanol content is above 5mg, preferably 5mg-80mg, more preferably 5mg-40mg. The content can be in a uniform liquid, suspension, semisolid, solid and other states; the policosanol in the content of the embodiment of the invention is in a dissolution state or a suspension state, the grain diameter of the policosanol is not more than 5 mu m, and the preferable range is not more than 1 mu m.

In the invention, the solubilizer is selected from alcohols, preferably one or more of polyethylene glycol and small molecular alcohols, and can dissolve policosanol to a certain extent; if the policosanol is not contained with a solubilizer, the policosanol is difficult to disperse uniformly. Among them, the relative molecular weight of the polyethylene glycol is preferably 200 to 40000, more preferably 200 to 20000, further preferably 200 to 10000, such as polyethylene glycol 400, polyethylene glycol 1000, polyethylene glycol 2000, and the like. The small molecule alcohol is preferably one or more of ethanol, isopropanol, propylene glycol and glycerol, more preferably ethanol. In some embodiments of the invention, the solubilizing agent is a combination of ethanol and polyethylene glycol; in other embodiments, the solubilizing agent is polyethylene glycol. The amount of the solubilizer used in the preparation of the content may be 1-100 times, preferably 1-50 times, the amount of the policosanol used.

In addition, the invention adopts a pharmaceutically acceptable nonionic (surfactant) to mainly assist the further dissolution of the policosanol. The nonionic surfactant is preferably one or more of sucrose esters, phospholipids, polysorbate, polyoxyethylene fatty acid esters and medium-chain fatty acid glycerides, more preferably sucrose esters, phospholipids or medium-chain fatty acid glycerides. Sucrose esters, collectively referred to as sucrose fatty acid esters (SE), have a broad distribution of HLB values; currently commercially available products are mainly mono-, di-, tri-esters of sucrose esterified with stearic acid, palmitic acid or oleic acid, and their mixed esters and the like. Phospholipids are a class of lipids containing phosphate groups, such as phosphoglycerides. Polyoxyethylene fatty acid esters, also known as fatty acid polyoxyethylene (ether) esters, have a hydrophilicity proportional to the degree of polymerization of the ethoxy groups; medium chain fatty acid glycerides typically employ medium chain triglycerides, such as caprylic acid triglycerides, lauric acid triglycerides, and the like. The content of the surfactant can be 1-10 times of the mass of the policosanol, preferably 1-5 times, and more preferably 1-3 times.

The solubility of policosanol in the solubilizer increases with the rise of temperature, the temperature ranges from 50 ℃ to 100 ℃, and the preferable range is from 60 ℃ to 90 ℃; with the temperature decrease, policosanol can be separated out. If the surfactant is added into the solubilizer in a preferable amount, the solubility of the policosanol can be increased, the precipitation of the policosanol can be reduced when the temperature is reduced, the particle size of the policosanol after precipitation can be reduced, the aggregation of the policosanol can be effectively prevented, and the stability of the particle size of the policosanol during long-term storage can be improved. Thus, the formulation of the present invention is excellent in particle size and stability.

In the capsule contents of the present invention, the matrix is one or more of vegetable oils, preferably one or more of soybean oil, linseed oil and palm oil. Furthermore, the present invention has no special requirements on the properties of the substrate.

Correspondingly, the invention provides a preparation method of the content of the policosanol-containing capsule, which comprises the following steps:

mixing and dispersing the policosanol, the solubilizer, the surfactant and the vegetable oil according to the prescription amount to obtain the capsule content containing the policosanol; the solubilizer is selected from alcohols; the surfactant is a nonionic surfactant for assisting dissolution; the policosanol content is above 5 mg.

In the production method of the present invention, the kinds of the components and the like of the prescription of the content are as described above; the policosanol in the content is in a dissolved state or a suspension state, the grain diameter of the policosanol is not more than 5 μm, the preferable range is not more than 1 μm, and the nanometer level (for example, 0.1-1 μm,0.2-0.7 μm) can be further achieved.

In some embodiments, the preparation method of the policosanol-containing capsule content specifically comprises the following steps:

(1) Stirring and dispersing the prescribed amount of solubilizer and surfactant, and then heating to 60-80 ℃ to obtain a first solution; the solubilizer comprises polyethylene glycol and small molecule alcohol;

(2) Adding the policosanol with the prescription amount into the first solution under the stirring state, and dissolving to obtain a second solution;

(3) Adding vegetable oil with a prescription amount into the second solution, heating to 50-100deg.C under stirring, preferably 60-90deg.C, volatilizing small molecular alcohol to obtain capsule content containing policosanol. The method of the embodiment of the invention can obviously reduce the particle size of the policosanol and is beneficial to application.

In other embodiments, the preparation method of the policosanol-containing capsule content specifically comprises the following steps:

(1) Stirring and dispersing the prescribed amount of solubilizer and surfactant, and then heating to 60-80 ℃ to obtain a first solution; the solubilizer is selected from one or more of polyethylene glycol and small molecular alcohol;

(2) Adding the policosanol with the prescription amount into the first solution under the stirring state, and grinding by a colloid mill to obtain a mixture;

(3) Adding vegetable oil with a prescription amount into the colloid mill, and grinding to obtain capsule content containing policosanol.

In the two preparation processes, the policosanol which accords with the national standard is adopted as a raw material, is insoluble in water and can be dissolved in solvents such as hot ethanol, acetone and the like; the auxiliary materials are corresponding commercial products. The dosage of the policosanol is more than 5mg, preferably 5mg-80mg, more preferably 5mg-40mg; the dosage of the surfactant is 1-10 times of the weight of the policosanol, preferably 1-5 times, and more preferably 1-3 times; the dosage of the solubilizer is 1-100 times, preferably 1-50 times of the weight of the policosanol.

And the dosage of the vegetable oil is 5-50 times of the total dosage of the policosanol and the surfactant, and the vegetable oil has no special requirement. The stirring and heating are all operations well known to those skilled in the art; wherein the colloid mill grinds and makes the material be effectively emulsified, dispersed, homogenized and smashed, can reach the effect of superfine crushing and emulsification of material.

The embodiment of the invention also provides a soft capsule containing policosanol, which consists of a soft capsule shell and the content in the soft capsule shell, wherein the content is the capsule content containing policosanol.

The invention provides a policosanol soft capsule which has simple and feasible preparation process and higher bioavailability compared with the existing preparation, and the medicine is used for regulating dyslipidemia.

The capsule shell (or capsule wall) of the soft capsule has plasticity and elasticity, and is mainly composed of gelatin and plasticizer. In an embodiment of the present invention, the prescription of the soft capsule shell mainly comprises medicinal dry gelatin, sorbitol and glycerin. In addition, a dripping method and a pressing method are commonly used for preparing soft capsules. In embodiments of the present invention, the policosanol content of each soft capsule may be 5mg to 80mg, preferably 5mg to 40mg, for example 5mg,10mg,15mg,20mg,30mg,40mg. Illustratively, the amount of gelatin in the capsule shell may be 40mg to 80mg, the amount of sorbitol 4m to 8mg, and the amount of glycerin 8mg to 16mg per capsule shell.

The embodiment of the invention improves the dispersion state of the policosanol by mainly designing the prescription and the process of the capsule content, greatly reduces the particle size of the policosanol in the prescription composition, improves the dispersity and the solubility of the policosanol, and further improves the bioavailability of the policosanol in a human body. The preparation process is simple, and the medicine has high grain size stability during long-term storage and is favorable for application.

For further understanding of the present application, the contents of the capsule containing policosanol provided herein, and methods of preparing the same, and soft capsules are specifically described below in connection with examples. It is to be understood that these examples are provided for the purpose of illustrating the details of the invention and the particular process and are not intended to limit the scope of the invention, which is defined solely by the claims, but not by the way of limitation.

Example 1:

weighing 10g of ethanol, 2g of polyethylene glycol 400 and 2g of sucrose monooleate, uniformly stirring, and heating to 70 ℃ to obtain a solution (1); weighing 1g of policosanol, adding into the solution (1) while stirring, and continuously stirring to dissolve the policosanol to obtain a solution (2); 200g of palm oil is weighed and added into the solution (2), the temperature is raised to 80 ℃ after uniform stirring, and the temperature is lowered to below 35 ℃ after ethanol is volatilized, so as to obtain capsule contents;

the soft capsule shell is adopted, and the obtained capsule content is prepared into 1000 soft capsules. The content of policosanol in each soft capsule is 10mg.

Wherein, the soft capsule shell prescription comprises: 50g of medicinal dry gelatin, 5g of sorbitol and 10g of glycerin. Adding the prescribed amount of purified water, glycerol and sorbitol into a sol tank, heating in a water bath and heating to 60 ℃; adding medicinal dry gelatin under stirring to prevent gelatin agglomeration, continuously heating to dissolve gelatin completely, heating to above 70deg.C, and vacuum-removing air bubbles and water; filtering the glue solution into a heat-preserving barrel by using a stainless steel screen, preserving heat for more than 2 hours at 60+/-5 ℃ and removing bubbles to obtain the soft capsule material.

And filling the capsule content into the soft capsule material by a pressing method to obtain the policosanol soft capsule.

Example 2:

weighing 30g of ethanol, 8g of polyethylene glycol 400 and 8g of caprylic triglyceride, uniformly stirring, and heating to 70 ℃ to obtain a solution (1); weighing 4g of policosanol, adding into the solution (1) while stirring, and continuously stirring to dissolve the policosanol to obtain a solution (2); weighing 400g of soybean oil, adding into the solution (2), stirring uniformly, heating to 80 ℃, volatilizing ethanol, and cooling to below 35 ℃ to obtain capsule contents;

the soft capsule shell is adopted, and the obtained capsule content is prepared into 1000 soft capsules. The content of policosanol in each soft capsule is 40mg.

Wherein, the soft capsule shell prescription comprises: 80g of medicinal dry gelatin, 8g of sorbitol and 16g of glycerin. Adding the prescribed amount of purified water, glycerol and sorbitol into a sol tank, heating in a water bath and heating to 60 ℃; adding medicinal dry gelatin under stirring to prevent gelatin agglomeration, continuously heating to dissolve gelatin completely, heating to above 70deg.C, and vacuum-removing air bubbles and water; filtering the glue solution into a heat-preserving barrel by using a stainless steel screen, preserving heat for more than 2 hours at 60+/-5 ℃ and removing bubbles to obtain the soft capsule material.

Comparative example 1:

weighing 1g of policosanol, adding into a solution consisting of 2g of polyethylene glycol 400 and 10g of ethanol, slowly heating to 70 ℃ while stirring, and continuously stirring for dissolving the policosanol to obtain a solution (1); 200g of soybean oil is weighed and added into the solution (1), the temperature is raised to 80 ℃ after stirring uniformly, the temperature is lowered to below 35 ℃ after ethanol is volatilized, and 1000 soft capsules are prepared by adopting soft capsule materials with the same prescription process according to the method of the embodiment 1 as the content of the capsules.

The capsules of examples 1-2 and comparative example 1 were placed in a constant temperature and humidity cabinet for long-term stability investigation (temperature 25 ℃ + -2 ℃ C., relative humidity 60% + -5%). Sampling at 3 months, 6 months, 9 months, 12 months, 18 months and 24 months, and measuring the particle size of policosanol.

The particle size measurement method comprises the following steps: the capsule is placed in a 50mL conical flask with a plug, 10mL of hydrochloric acid solution with pH of 1.2 is added, the conical flask with the plug is placed in a constant temperature shaking table with the temperature of 37 ℃ and the rotating speed of 50r/min for shaking for 10min, and a proper amount of solution is taken and the particle size of the solution is measured by a Markov laser particle sizer. The measurement results were as follows:

TABLE 1 determination of particle size of Polypolicosanol in Polypolicosanol Soft Capsule

0 month

3 months of

6 months of

9 months of

12 months of

18 months of

24 months of

Example 1

283nm

382nm

323nm

335nm

287nm

350nm

355nm

Example 2

223nm

235nm

276nm

268nm

255nm

324nm

331nm

Example 3

678nm

595nm

623nm

645nm

685nm

654nm

662nm

Comparative example 1

10.82μm

12.45μm

18.33μm

25.09μm

27.43μm

51.54μm

58.86μm

As can be seen from the above table, the particle size of the policosanol in the prepared soft capsule is larger than that of the policosanol in the prescription containing the surfactant according to the invention by adopting the prescription without the surfactant, and the particle size of the policosanol tends to increase along with the extension of the storage time. The invention greatly reduces the particle size of the policosanol in the prescription composition, is beneficial to improving the oral absorptivity of the policosanol, and has high stability of the particle size when the medicine is stored for a long time.

Example 3:

weighing 1g of polyethylene glycol 2000 and 5g of lauric acid triglyceride, mixing, and heating to 70 ℃ to obtain a solution (1); weighing 1g of policosanol, adding the policosanol into the solution (1) while stirring, and then adding the policosanol into a colloid mill to be ground uniformly to obtain a solution (2); 200g of soybean oil is weighed and added into the solution (2), grinding is continued until uniform, cooling is slowly carried out to below 35 ℃ to obtain capsule contents, and 1000 soft capsules are prepared according to the method of the example 1. Each soft capsule contains 10mg of policosanol, and the grain size data of the policosanol is shown in table 1.

30 SD rats weighing 180+ -10 g were randomly divided into 3 groups (group A, group B, group C) of 10. Taking the soft capsule content in the embodiment 3, and respectively filling the stomach of a group of rats according to the weight of 5 mg/kg; taking commercially available policosanol tablets (specification: 10 mg), grinding into powder, dispersing into suspension with purified water, and respectively lavaging group B rats according to 5mg/kg body weight; taking commercially available policosanol soft capsules (specification: 20 mg), and respectively lavaging the rats in group C according to the weight of 5 mg/kg; venous blood is taken at 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h and 8h after stomach irrigation, a gas chromatograph mass spectrometer is adopted after extraction, the concentration of octacosanol in the blood sample is measured, and pharmacokinetic parameters are calculated as follows:

TABLE 2 pharmacokinetic parameter results

	Nail group (n=10)	Group B (n=10)	Group C (n=10)
				Tmax(min)	43±22	89±31	63±26
Cmax(ng/mL)	2932±452	733±143	1585±326
				AUC _0-∞ (h*ng/mL)	19360±2865	4840±785	9886±1143

As can be seen from the data in the table, after the contents of the soft capsule in example 3 of the present invention were administered to rats by stomach, the Tmax was shortened, cmax and AUC were reduced as compared with the commercially available policosanol tablets and policosanol soft capsules _0-∞ (h is ng/mL) is greatly increased, which indicates that the invention can greatly improve the oral bioavailability of policosanol.

From the above examples, the content of the capsule of the present invention comprises a certain amount of policosanol, a surfactant, a solubilizer and a matrix, wherein the policosanol content is above 5 mg; the solubilizer is selected from alcohols, the surfactant is nonionic surfactant for assisting dissolution, and the matrix is one or more of vegetable oil. The invention can improve the dispersion state of the policosanol by designing the prescription and the process, greatly reduce the particle size of the policosanol in the prescription composition, improve the dispersity and the solubility of the policosanol, and further improve the bioavailability of the policosanol in a human body. Namely, the soft capsule containing policosanol provided by the invention can effectively improve the oral absorption rate.

The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications to these embodiments can be made by those skilled in the art without departing from the technical principles of the present invention, and these modifications should also be considered as the scope of the present invention.

Claims

1. The capsule content containing policosanol is characterized by comprising policosanol, a solubilizer, a surfactant and a matrix; the solubilizer is selected from one or more of polyethylene glycol and small molecular alcohol; the molecular weight of the polyethylene glycol is 400 to 2000, and the small molecular alcohol is ethanol; the dosage of the solubilizer is 1-100 times of the weight of the policosanol;

the surfactant is a nonionic surfactant for assisting dissolution, is one or two selected from sucrose esters and medium-chain fatty glyceride, and has a content of 1-10 times of the mass of the policosanol; the matrix is vegetable oil; the policosanol content is above 5 mg;

the policosanol in the capsule content is in a dissolution state or a suspension state, wherein the grain size of the policosanol is not more than 1 mu m.

2. The capsule content according to claim 1, wherein the surfactant content is 1-5 times the mass of policosanol.

3. The capsule content according to claim 2, wherein the surfactant content is 1-3 times the mass of policosanol.

4. A capsule content according to any one of claims 1 to 3, wherein the matrix is selected from one or more of soybean oil, linseed oil and palm oil.

5. A method for preparing the policosanol-containing capsule contents of any one of claims 1-4, comprising the steps of:

and mixing and dispersing the policosanol, the solubilizer, the surfactant and the vegetable oil according to the prescription amount to obtain the capsule content containing the policosanol.

6. The preparation method according to claim 5, characterized in that the preparation method specifically comprises:

stirring and dispersing the prescribed amount of solubilizer and surfactant, and then heating to 60-80 ℃ to obtain a first solution; the solubilizer comprises polyethylene glycol and small molecule alcohol;

adding vegetable oil with a prescription amount into the second solution, heating to 50-100 ℃ under stirring, volatilizing small molecular alcohol, and obtaining the capsule content containing policosanol.

7. The method according to claim 6, wherein a prescribed amount of vegetable oil is added to the second solution, and the temperature is raised to 60 to 90 ℃ with stirring to volatilize the small molecular alcohol.

8. The preparation method according to claim 5, characterized in that the preparation method specifically comprises:

stirring and dispersing the prescribed amount of solubilizer and surfactant, and then heating to 60-80 ℃ to obtain a first solution;

9. The preparation method according to any one of claims 5 to 8, wherein the amount of the solubilizing agent is 1 to 50 times the mass of policosanol.

10. A soft capsule containing policosanol, which consists of a soft capsule shell and contents thereof, and is characterized in that the contents are the capsule contents as claimed in any one of claims 1 to 4;

the content of policosanol in each soft capsule is 5mg-80mg.

11. The soft capsule of claim 10, wherein the policosanol content of each soft capsule is 5mg to 40mg.