A ginkgo biloba soft capsule and its preparation method

Abstract

This application relates to the technical field of soft capsules, and specifically discloses a ginkgo biloba soft capsule and a preparation method thereof. The ginkgo biloba soft capsule is composed of a content composition and a soft capsule shell; the content composition is mainly made of the following raw materials in parts by weight: 25-35 parts of ginkgo biloba extract, 40-50 parts of soybean oil, 3-7 parts of phosphatidylcholine, and 18-22 parts of mannitol; the soft capsule shell is mainly made of the following raw materials in parts by weight: 35-48 parts of water, 20-25 parts of gelatin, 9-11 parts of modified starch, 7-9 parts of sodium alginate, 2-4 parts of potassium citrate, and 10-20 parts of plasticizer; the modified starch is obtained by treating starch with sodium trimetaphosphate and phosphonodipeptide sodium. This ginkgo biloba soft capsule exhibits the advantages of short disintegration time, high strength of the soft capsule shell, uniform wall thickness of the soft capsule shell, few surface defects, and high qualification rate through the synergistic effect among the raw materials, meets the market demand, and has economic value.

Description

Technical Field

[0001] The present application relates to the technical field of soft capsules, and more specifically, to a ginkgo biloba soft capsule and a preparation method thereof. Background Art

[0002] Ginkgo biloba leaves, also known as ginkgo fruit leaves, have high medicinal value. They not only contain a variety of medicinal components, such as flavonol glycosides, terpene lactones, etc., but also contain a variety of trace elements and amino acids. They can dissolve cholesterol in the body, dilate blood vessels, activate blood circulation and remove stasis to dredge collaterals. They have obvious effects on the auxiliary prevention and treatment of patients with cardiovascular and cerebrovascular system diseases such as hyperlipidemia regulation, hypertension and coronary heart disease. They also have significant curative effects on stroke, angina pectoris, chest obstruction, hemiplegia, and aphasia caused by blood stasis blocking collaterals. At the same time, they also have good effects on weight loss for obese people.

[0003] The ginkgo biloba soft capsules on the market are made of a content composition and a soft capsule shell. The content composition mainly includes ginkgo biloba leaf extract and a diluent. The soft capsule shell is made of a soft capsule shell composition. The soft capsule shell composition mainly includes gelatin and water. The content composition and the soft capsule shell composition are prepared in advance, and then the content composition and the soft capsule shell composition are put into a pill press to be directly pressed into shape to obtain the ginkgo biloba soft capsule. The applicant found in actual processing that the ginkgo biloba soft capsules prepared by the above method have a soft capsule shell rupture force of about 0.89 N, with poor strength, and are prone to defects such as sand holes, air bubbles, and rough edges on the surface, reducing the qualified rate of the product. Summary of the Invention

[0004] In order to increase the soft capsule shell rupture force and the qualified rate, the present application provides a ginkgo biloba soft capsule and a preparation method thereof.

[0005] In a first aspect, the present application provides a ginkgo biloba soft capsule, adopting the following technical solution:

[0006] A ginkgo biloba soft capsule is made of a content composition and a soft capsule shell;

[0007] The content composition is mainly made of the following raw materials in parts by weight: 25 - 35 parts of ginkgo biloba leaf extract, 40 - 50 parts of soybean oil, 3 - 7 parts of phosphatidylcholine, and 18 - 22 parts of mannitol;

[0008] The soft capsule shell is mainly made of the following raw materials in parts by weight: 35 - 48 parts of water, 20 - 25 parts of gelatin, 9 - 11 parts of modified starch, 7 - 9 parts of sodium alginate, 2 - 4 parts of potassium citrate, and 10 - 20 parts of plasticizer;

[0009] The modified starch is obtained by treating starch with sodium trimetaphosphate and phosphonodipeptide sodium.

[0010] The ginkgo biloba soft capsules of the present application not only have good curative effects on the body, but also through the synergistic effect among the raw materials, the disintegration time is < 600 s, the bursting force of the soft capsule shell is > 1.6 N, the thickness dispersion is < 0.2, and the qualification rate is > 99%. It shows the advantages of short disintegration time, high strength of the soft capsule shell, uniform wall thickness of the soft capsule shell, few surface defects, and high qualification rate, meeting the market demand and having economic value.

[0011] Adding gelatin to the raw materials of the soft capsule shell facilitates the curing and molding of the soft capsule shell. Adding starch to the gelatin, after the starch is treated with sodium trimetaphosphate and phosphonodipeptide sodium, it can undergo cross-linking and grafting reactions with the hydroxyl groups on the starch surface, not only increasing the cross-linking degree and grafting degree of the starch, but also introducing active groups such as phosphoxy groups, carboxyl groups, amino groups, and acyl groups on the starch surface. Cooperating with sodium alginate and gelatin, using intermolecular forces, a three-dimensional network structure is formed, greatly enhancing the bonding strength, improving the strength of the soft capsule shell of the ginkgo biloba soft capsules and the wall thickness uniformity, reducing surface defects at the same time, increasing the qualification rate, and facilitating the processing and application of the ginkgo biloba soft capsules.

[0012] Optionally, the modified starch is prepared by the following method: adding starch and sodium sulfate to water, heating to 45 - 55 °C, adjusting the pH value to 13 - 14, then adding sodium trimetaphosphate and phosphonodipeptide sodium, stirring for 3 - 5 h, adjusting the pH value to 4 - 5, cooling to room temperature, filtering, washing, and drying to obtain the modified starch.

[0013] Optionally, the weight ratio of the starch, sodium trimetaphosphate, and phosphonodipeptide sodium is 100:(1 - 3):(2 - 4).

[0014] Optionally, the weight ratio of the starch, water, and sodium sulfate is 10:(12 - 15):(1 - 2).

[0015] By adopting the above technical solution, first, the starch is dispersed in water, then the pH value is adjusted to be alkaline, and then sodium trimetaphosphate and phosphonodipeptide sodium are added. Sodium trimetaphosphate and phosphonodipeptide sodium can cross-link and graft with the hydroxyl groups in the starch, not only increasing the cross-linking and grafting of the starch, but also introducing a large number of active groups on the starch surface, enhancing the use effect of the modified starch, and improving the bursting force of the soft capsule shell and the qualification rate.

[0016] Optionally, the ginkgo biloba extract is prepared by the following method:

[0017] T1. Crushing the ginkgo biloba medicinal materials, then adding hemicellulase and mixing, then adding water, heating to 45 - 55 °C, holding for 30 - 50 min, filtering to obtain the first - stage filter residue and the first - stage filtrate;

[0018] T2. Add ethanol to the primary filter residue, heat up to 60 - 70 °C, hold for 30 - 50 min, filter to obtain the secondary filter residue and the secondary filtrate;

[0019] T3. Wash the secondary filter residue to obtain the washing solution;

[0020] T4. Mix the primary filtrate, the secondary filtrate, and the washing solution, then perform evaporation and concentration, and drying to obtain the ginkgo biloba extract.

[0021] Optionally, the weight ratio of the ginkgo biloba medicinal material, hemicellulase, water, and ethanol is 10:(3 - 5):(10 - 30):(10 - 30).

[0022] By adopting the above technical solution, first crush the ginkgo biloba medicinal material, then carry out enzymatic hydrolysis using hemicellulase, then extract with ethanol, then wash, and mix the primary filtrate, the secondary filtrate, and the washing solution to further obtain the ginkgo biloba extract. Through the mutual cooperation of enzymatic hydrolysis and ethanol extraction, the extraction rate and the yield of the ginkgo biloba extract are improved.

[0023] Further, in step T3, wash the secondary filter residue with an ethanol solution 2 - 5 times. The usage amount of the ethanol solution for each wash is 0.3 - 0.8 times the total weight of the ginkgo biloba medicinal material, and the mass concentration of the ethanol solution is 30 - 70%.

[0024] In multiple embodiments, in step T3, wash the secondary filter residue with an ethanol solution 3 times, and the number of washes can also be set to 2 times, 4 times, 5 times, etc. according to needs. In multiple embodiments, in step T3, the usage amount of the ethanol solution for each wash is 0.5 times the total weight of the ginkgo biloba medicinal material, and the multiple can also be set to 0.3 times, 0.4 times, 0.6 times, 0.7 times, 0.8 times, etc. according to needs. In multiple embodiments, in step T3, the mass concentration of the ethanol solution is 50%, and the mass concentration can also be set to 30%, 40%, 60%, 70%, etc. according to needs.

[0025] Optionally, the gelatin is one or both of cortical gelatin and bone gelatin; the starch is one or several of corn starch, wheat starch, and sweet potato starch. Preferably, the gelatin is cortical gelatin; the starch is corn starch.

[0026] By adopting the above technical solution, further defining the gelatin and starch facilitates the selection of gelatin and starch, and the raw material sources are rich and stable, which is convenient for the processing of ginkgo biloba soft capsules.

[0027] Optionally, the plasticizer is one or several of glycerol, xylitol, trehalose, sorbitol, and maltitol.

[0028] By adopting the above technical solution, the plasticizer is further defined, which facilitates the selection of the plasticizer. Moreover, when the plasticizer is selected from glycerol, xylitol, trehalose, sorbitol, and maltitol, the expected effects can be achieved.

[0029] Optionally, the weight ratio of the content composition to the soft rubber shell is 1:(1.5 - 2.5).

[0030] By adopting the above technical solution, the ratio of the content composition to the soft rubber shell is defined, which ensures the efficacy of the ginkgo biloba soft capsule and also facilitates the processing of the ginkgo biloba soft capsule.

[0031] In multiple embodiments, the weight ratio of the content composition to the soft rubber shell is 1:1.7, and it can also be set to 1:1.5, 1:2, 1:2.2, 1:2.5, etc. according to needs.

[0032] In a second aspect, the present application provides a preparation method of the above-mentioned ginkgo biloba soft capsule, adopting the following technical solution:

[0033] A preparation method of the above-mentioned ginkgo biloba soft capsule includes the following steps:

[0034] S1. At a temperature of 70 - 80 °C, mix ginkgo biloba extract, soybean oil, phosphatidylcholine, and mannitol to obtain a content composition;

[0035] S2. At a temperature of 70 - 80 °C, add gelatin to water and mix, then add modified starch, sodium alginate, potassium citrate, and plasticizer and mix to obtain a soft rubber composition;

[0036] S3. Mix the content composition and the soft rubber composition, press and form, and the soft rubber composition cures to form a soft rubber shell to obtain the ginkgo biloba soft capsule.

[0037] By adopting the above technical solution, the content composition and the soft rubber composition are prepared in advance, then the two are mixed, and a pill press is used for pressing and forming, which facilitates the preparation of the ginkgo biloba soft capsule.

[0038] In summary, the present application has at least the following beneficial effects:

[0039] 1. The ginkgo biloba soft capsule of the present application not only has a good curative effect on the body, but also modified starch and sodium alginate are added to gelatin, and the synergistic effect between them is utilized to make the disintegration time of the ginkgo biloba soft capsule < 600 s, the rupture force of the soft rubber shell > 1.6 N, the thickness dispersion < 0.2, and the qualification rate > 99%. It shows the advantages of short disintegration time, high strength of the soft rubber shell, uniform wall thickness of the soft rubber shell, few surface defects, and high qualification rate, meets the market demand, and has economic value.

[0040] 2. In the preparation method of modified starch, first, the starch is dispersed in water, the pH value is adjusted to be alkaline, and then sodium trimetaphosphate and sodium phosphonodipeptide are added for crosslinking and grafting reactions, introducing a large number of active groups on the starch surface, which not only increases the use effect of the modified starch but also has a simple preparation process and is easy to control. Detailed implementation mode

[0041] To make the present application easier to understand, the following will further elaborate on the present application in combination with embodiments. These embodiments are only illustrative and are not limited to the application scope of the present application. The raw materials or components used in the present application can be obtained through commercial channels or conventional methods without special instructions.

[0042] Preparation example

[0043] Preparation example I-1

[0044] A modified starch is prepared by the following method:

[0045] 100 g of corn starch and 15 g of sodium sulfate are added to 130 g of water, and stirred for 10 min. The temperature is raised to 50 °C, and the pH value is adjusted to 13.5 with a 20% sodium hydroxide solution by mass concentration. Then 2 g of sodium trimetaphosphate and 3 g of sodium phosphonodipeptide are added, and stirred for 4 h. The pH value is adjusted to 4.5 with a 20% sulfuric acid solution by mass concentration. The temperature is lowered to 25 °C, and filtered. Washed three times with water, and the amount of washing water used each time is 30 g. Dried to constant weight at a temperature of 50 °C to obtain the modified starch.

[0046] Among them, the corn starch is selected from Hebei Pengyu Biotechnology Co., Ltd.

[0047] Preparation example I-2

[0048] A modified starch, the difference from Preparation example I-1 is that the preparation method is different and is prepared by the following method: 100 g of corn starch and 10 g of sodium sulfate are added to 120 g of water, and stirred for 20 min. The temperature is raised to 55 °C, and the pH value is adjusted to 14 with a 20% sodium hydroxide solution by mass concentration. Then 1 g of sodium trimetaphosphate and 4 g of sodium phosphonodipeptide are added, and stirred for 3 h. The pH value is adjusted to 5 with a 20% sulfuric acid solution by mass concentration. The temperature is lowered to 25 °C, and filtered. Washed three times with water, and the amount of washing water used each time is 30 g. Dried to constant weight at a temperature of 55 °C to obtain the modified starch.

[0049] Preparation example I-3

[0050] A modified starch, which is different from Preparation Example I-1 in that the preparation method is different and it is prepared by the following method: Add 100 g of corn starch and 20 g of sodium sulfate to 150 g of water, and stir for 10 min. Heat up to 45 °C, and adjust the pH value to 13 with a sodium hydroxide solution with a mass concentration of 20%. Then add 4 g of sodium trimetaphosphate and 2 g of sodium phosphonodipeptide, and stir for 5 h. Adjust the pH value to 4 with a sulfuric acid solution with a mass concentration of 20%. Cool down to 25 °C and filter. Wash three times with water, and the amount of washing water used each time is 30 g. Dry at 45 °C to constant weight to obtain the modified starch.

[0051] Preparation Example II-1

[0052] A ginkgo leaf extract, which is prepared by the following method:

[0053] T1. Crush 100 g of ginkgo leaf medicinal materials, then add 40 g of hemicellulase, and stir for 10 min. Then add 200 g of water, heat up to 50 °C, keep warm for 40 min, and filter to obtain the first-stage filter residue and the first-stage filtrate.

[0054] Among them, the ginkgo leaf medicinal materials are selected from Bozhou Huozhengtang Pharmaceutical Co., Ltd.; the enzyme activity of the hemicellulase is 6000, and it is selected from Hebei Jiuyu Biotechnology Co., Ltd.

[0055] T2. Add 200 g of ethanol to the first-stage filter residue, heat up to 65 °C, keep warm for 40 min, and filter to obtain the second-stage filter residue and the second-stage filtrate.

[0056] T3. Wash the second-stage filter residue three times with an ethanol solution with a mass concentration of 50%, and the amount of washing ethanol solution used each time is 50 g to obtain the washing solution.

[0057] T4. Add the second-stage filtrate and the washing solution to the first-stage filtrate, stir for 5 min, and then perform evaporation and concentration until the relative density is 1.15 g / cm 3 , and then dry at 50 °C to constant weight to obtain the ginkgo leaf extract.

[0058] Preparation Example II-2

[0059] A ginkgo leaf extract, which is different from Preparation Example II-1 in that in the preparation method, Step T1 and Step T2 are different.

[0060] Step T1 is specifically: Crush 100 g of ginkgo leaf medicinal materials, then add 30 g of hemicellulase, and stir for 10 min. Then add 300 g of water, heat up to 45 °C, keep warm for 50 min, and filter to obtain the first-stage filter residue and the first-stage filtrate.

[0061] Step T2 specifically is: Add 100 g of ethanol to the primary filter residue, heat up to 70 °C, hold for 30 min, filter to obtain the secondary filter residue and the secondary filtrate.

[0062] Preparation Example II-3

[0063] A ginkgo biloba extract, which is different from Preparation Example II-1 in that in the preparation method, Step T1 and Step T2 are different.

[0064] Step T1 specifically is: Crush 100 g of ginkgo biloba medicinal materials, then add 50 g of hemicellulase, stir for 10 min. Then add 100 g of water, heat up to 55 °C, hold for 30 min, filter to obtain the primary filter residue and the primary filtrate.

[0065] Step T2 specifically is: Add 300 g of ethanol to the primary filter residue, heat up to 60 °C, hold for 50 min, filter to obtain the secondary filter residue and the secondary filtrate.

[0066] Example

[0067] Table 1 Raw material content of the content composition (unit: g)

[0068]

[0069] Table 2 Raw material content of the soft gelatin shell (unit: g)

[0070]

[0071] Example 1

[0072] A ginkgo biloba soft capsule, which is made of a content composition and a soft gelatin shell. The weight ratio of the content composition to the soft gelatin shell is 1:1.7, and the raw materials and raw material ratios of the content composition are shown in Table 1, and the raw materials and raw material ratios of the soft gelatin shell are shown in Table 2.

[0073] Among them, the soybean oil is selected from Shijiazhuang Xuyi Grain and Oil Co., Ltd.; the gelatin is pigskin gelatin and is selected from Hebei Runbu Biotechnology Co., Ltd.; the sodium alginate is selected from Hebei Pengyu Biotechnology Co., Ltd.; the plasticizer is xylitol; the ginkgo biloba extract is prepared by the method of Preparation Example II-1; the modified starch is prepared by the method of Preparation Example I-1.

[0074] A preparation method of a ginkgo biloba soft capsule, comprising the following steps:

[0075] S1. At a temperature of 75 °C, add the ginkgo biloba extract, phosphatidylcholine, and mannitol to the soybean oil, stir for 30 min to obtain the content composition.

[0076] S2. At a temperature of 75 °C, gelatin is added to water and stirred for 30 min. Then, modified starch, sodium alginate, potassium citrate, and a plasticizer are added and stirred for 30 min to obtain a soft gel composition.

[0077] S3. Take 50 g of the content composition and 85 g of the soft gel composition. Put the content composition and the soft gel composition into a pill press and press them into shape. The soft gel composition solidifies to form a soft gel shell, obtaining Ginkgo biloba soft capsules with a specification of 0.5 g per capsule.

[0078] Example 2

[0079] A Ginkgo biloba soft capsule, which is different from Example 1 in that the raw material ratio of the content composition is different, the raw material ratio of the soft gel shell is different, and the raw materials and their ratios of the content composition are shown in Table 1, and the raw materials and their ratios of the soft gel shell are shown in Table 2.

[0080] Example 3

[0081] A Ginkgo biloba soft capsule, which is different from Example 1 in that the raw material ratio of the content composition is different, the raw material ratio of the soft gel shell is different, and the raw materials and their ratios of the content composition are shown in Table 1, and the raw materials and their ratios of the soft gel shell are shown in Table 2.

[0082] Example 4

[0083] A Ginkgo biloba soft capsule, which is different from Example 1 in that among the raw materials of the content composition, the source of the Ginkgo biloba extract is different, and the Ginkgo biloba extract is obtained by the method of Preparation Example II-2.

[0084] Example 5

[0085] A Ginkgo biloba soft capsule, which is different from Example 1 in that among the raw materials of the content composition, the source of the Ginkgo biloba extract is different, and the Ginkgo biloba extract is obtained by the method of Preparation Example II-3.

[0086] Example 6

[0087] A Ginkgo biloba soft capsule, which is different from Example 1 in that among the raw materials of the soft gel shell, the source of the modified starch is different, and the modified starch is obtained by the method of Preparation Example I-2.

[0088] Example 7

[0089] A Ginkgo biloba soft capsule, which is different from Example 1 in that among the raw materials of the soft gel shell, the source of the modified starch is different, and the modified starch is obtained by the method of Preparation Example I-3.

[0090] Comparative Example

[0091] Comparative Example 1

[0092] A ginkgo biloba soft capsule, the difference from Example 1 is that in the raw materials of the soft capsule shell, an equal amount of starch is used to replace the modified starch.

[0093] Comparative Example 2

[0094] A ginkgo biloba soft capsule, the difference from Example 1 is that in the raw materials of the soft capsule shell, in the preparation method of the modified starch, an equal amount of sodium trimetaphosphate is used to replace sodium phosphonodipeptide.

[0095] Comparative Example 3

[0096] A ginkgo biloba soft capsule, the difference from Example 1 is that in the raw materials of the soft capsule shell, in the preparation method of the modified starch, an equal amount of sodium phosphonodipeptide is used to replace sodium trimetaphosphate.

[0097] Comparative Example 4

[0098] A ginkgo biloba soft capsule, the difference from Example 1 is that in the raw materials of the soft capsule shell, an equal amount of modified starch is used to replace sodium alginate.

[0099] Comparative Example 5

[0100] A ginkgo biloba soft capsule, the difference from Example 1 is that in the raw materials of the soft capsule shell, an equal amount of sodium alginate is used to replace the modified starch.

[0101] Performance Detection

[0102] (1) Respectively take the ginkgo biloba soft capsules obtained in Examples 1 - 7 as samples, and according to GB5009 and GB / T4789, conduct physical and chemical index detection on the samples. Moreover, the total arsenic content of the ginkgo biloba soft capsules in Examples 1 - 7 is ≤0.5mg / kg, the total lead content is ≤0.5mg / kg, the total mercury content is ≤0.1mg / kg, coliforms are not detected, Staphylococcus aureus is not detected, and Salmonella is not detected, showing good safety.

[0103] (2) Respectively take the ginkgo biloba soft capsules obtained in Examples 1 - 7 and Comparative Examples 1 - 5 as samples, and conduct the following performance detections on the samples. The detection results are shown in Table 3.

[0104] Among them, the disintegration time adopts the following method: Add the ginkgo biloba soft capsule into water at a temperature of 37°C, and record the disintegration time of the ginkgo biloba soft capsule.

[0105] The rupture force of the soft capsule shell adopts the following method: Use a physical property tester to puncture the ginkgo biloba soft capsule, record the rupture force of the soft capsule shell, and the greater the rupture force of the soft capsule shell, the higher the strength of the soft capsule shell.

[0106] The method for the wall thickness uniformity of the soft gelatin shell is as follows: Cut the ginkgo leaf soft capsule along the middle into a circular ring part, then drain the content composition, and then evenly select 10 positions along the circumferential direction of the circular ring part, measure the thickness at the 10 positions, and calculate the thickness dispersion. The smaller the thickness dispersion, the more uniform the wall thickness of the soft gelatin shell.

[0107] Thickness dispersion = (maximum thickness - minimum thickness) / average thickness, and average thickness = sum of 10 thicknesses / 10.

[0108] The method for the qualified rate is as follows: Take 500 samples, observe the surface of the samples, record the number of samples with sand holes, air bubbles, and rough edges, and mark them as unqualified, and then calculate the qualified rate.

[0109] Table 3 Test Results

[0110]

[0111]

[0112] It can be seen from Table 3 that the ginkgo leaf soft capsules obtained in this application have a lower disintegration time and a higher soft gelatin shell rupture force. The disintegration time is 516 - 594 s, and the soft gelatin shell rupture force is 1.63 - 1.82 N, showing the advantages of fast disintegration and high strength of the soft gelatin shell. Moreover, it has a lower thickness dispersion, with the thickness dispersion being 0.11 - 0.19, indicating that the wall thickness of the soft gelatin shell is uniform. At the same time, it also has a high qualified rate, with the qualified rate being 99.4 - 99.8%, reducing the defects of sand holes, air bubbles, and rough edges in the ginkgo leaf soft capsules, showing the advantage of a high qualified rate and meeting the market demand.

[0113] Compare Comparative Examples 1 - 3. Unmodified starch is added to the raw material of the soft gelatin shell in Comparative Example 1; starch modified with sodium trimetaphosphate is added to the raw material of the soft gelatin shell in Comparative Example 2; starch modified with sodium phosphonodipeptide is added to the raw material of the soft gelatin shell in Comparative Example 3. It can be seen from this that by modifying the starch, the usage effect of the starch can be effectively increased. Combining with Example 1, starch modified with sodium trimetaphosphate and sodium phosphonodipeptide is added to the raw material of the soft gelatin shell in Example 1. It can be seen from this that synchronously modifying the starch with sodium trimetaphosphate and sodium phosphonodipeptide greatly increases the surface active groups of the modified starch, improves the interaction between the modified starch and gelatin and sodium alginate, not only reduces the disintegration time and the thickness dispersion of the soft gelatin shell, but also increases the soft gelatin shell rupture force, reduces the defects of sand holes, air bubbles, and rough edges in the ginkgo leaf soft capsules, and improves the qualified rate.

[0114] Example 1 was compared with Comparative Examples 4-5. Modified starch was added to the raw materials of the soft rubber shell in Comparative Example 4; sodium alginate was added to the raw materials of the soft rubber shell in Comparative Example 5; modified starch and sodium alginate were added to the raw materials of Example 1. It can be seen that by adding modified starch and sodium alginate simultaneously to the raw materials and through the synergistic effect between the two, in combination with gelatin, the disintegration time is greatly reduced, and the strength of the soft rubber shell, the wall thickness uniformity of the soft rubber shell, and the qualified rate are significantly increased, making the ginkgo biloba soft capsules exhibit better comprehensive performance.

[0115] It should be noted that the above-described embodiments are only used to explain the present application and do not constitute any limitation to the present application. The present application has been described by referring to typical embodiments, but it should be understood that the words used therein are descriptive and explanatory words rather than limiting words. Modifications can be made to the present application within the scope of the claims of the present application as provided, and the present invention can be revised without departing from the scope and spirit of the present application. Although the present application described therein relates to specific methods, materials, and embodiments, it does not mean that the present application is limited to the specific examples disclosed therein. On the contrary, the present application can be extended to all other methods and applications with the same function.

Claims

1. A ginkgo biloba soft capsule, characterized in that: It is made of a content composition and a soft gelatin shell; the weight ratio of the content composition to the soft gelatin shell is 1:(1.5 - 2.5); The content composition is made of the following raw materials in parts by weight: 25 - 35 parts of ginkgo leaf extract, 40 - 50 parts of soybean oil, 3 - 7 parts of phosphatidylcholine, and 18 - 22 parts of mannitol; The soft gelatin shell is made of the following raw materials in parts by weight: 35 - 48 parts of water, 20 - 25 parts of gelatin, 9 - 11 parts of modified starch, 7 - 9 parts of sodium alginate, 2 - 4 parts of potassium citrate, and 10 - 20 parts of plasticizer; the modified starch is obtained by treating starch with sodium trimetaphosphate and phosphonodipeptide sodium; The modified starch is prepared by the following method: Add starch and sodium sulfate to water, heat up to 45 - 55°C, adjust the pH value to 13 - 14, then add sodium trimetaphosphate and phosphonodipeptide sodium, stir for 3 - 5 h, adjust the pH value to 4 - 5, cool down to room temperature, filter, wash, and dry to obtain the modified starch; The weight ratio of the starch, sodium trimetaphosphate, and phosphonodipeptide sodium is 100:(1 - 3):(2 - 4); the weight ratio of the starch, water, and sodium sulfate is 10:(12 - 15):(1 - 2).

2. The ginkgo biloba soft capsule according to claim 1, wherein: The ginkgo leaf extract is prepared by the following method: T1. Crush the ginkgo leaf medicinal material, then add hemicellulase and mix, then add water, heat up to 45 - 55°C, keep warm for 30 - 50 min, filter to obtain the first - stage filter residue and the first - stage filtrate; T2. Add ethanol to the first - stage filter residue, heat up to 60 - 70°C, keep warm for 30 - 50 min, filter to obtain the second - stage filter residue and the second - stage filtrate; T3. Wash the second - stage filter residue to obtain the washing liquid; T4. Mix the first - stage filtrate, the second - stage filtrate, and the washing liquid, then perform evaporation and concentration, and dry to obtain the ginkgo leaf extract.

3. The ginkgo biloba soft capsule according to claim 2, wherein: The weight ratio of the ginkgo leaf medicinal material, hemicellulase, water, and ethanol is 10:(3 - 5):(10 - 30):(10 - 30).

4. A ginkgo biloba soft capsule according to claim 1, characterized in that: The gelatin is one or both of cortical gelatin and bone gelatin; the starch is one or several of corn starch, wheat starch, and sweet potato starch.

5. A ginkgo biloba soft capsule according to claim 1, characterized in that: The plasticizer is one or several of glycerol, xylitol, trehalose, sorbitol, and maltitol.

6. A preparation method of the ginkgo biloba soft capsule according to any one of claims 1-5, characterized in that: It includes the following steps: S1. At a temperature of 70 - 80°C, mix the ginkgo leaf extract, soybean oil, phosphatidylcholine, and mannitol to obtain the content composition; S2. At a temperature of 70 - 80°C, add gelatin to water and mix, then add modified starch, sodium alginate, potassium citrate, and plasticizer and mix to obtain the soft gelatin composition; S3. Mix the content composition and the soft gelatin composition, press into shape, and the soft gelatin composition solidifies to form a soft gelatin shell to obtain the ginkgo leaf soft capsule.

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