Danqi soft capsule as well as preparation method and application thereof
By using a specific ratio of soybean oil, monolinoleic acid glycerides, beeswax, and Span-80 as a matrix, the problems of large volume and easy hardening and brittleness of Danqi soft capsules during storage have been solved, thus improving the stability of the capsules and patient compliance.
Patent Information
- Application Number
- CN202511650774.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-11-11
- Publication Date
- 2025-12-19
AI Technical Summary
The existing Danqi soft capsules have a large volume due to the large amount of matrix added, resulting in poor patient compliance and making them prone to hardening and brittleness during storage.
Using soybean oil, monolinoleic acid glycerides, beeswax and Span-80 in a specific ratio as the matrix, and with the weight ratio of Danqi dry extract powder to the matrix being 1:0.7~0.8, Danqi soft capsules with good flowability were prepared by grinding, shaping and drying through a colloid mill.
The reduced capsule volume improves stability and patient compliance, maintains long-term capsule stability, and avoids hardening and brittleness during storage.
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Abstract
Description
TECHNICAL FIELD
[0001] The application belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a Danqi soft capsule and a preparation method and application thereof. BACKGROUND
[0002] The base material (auxiliary material) in the capsule has no drug effect, but has key roles such as molding, dissolution aid, and stabilization, and reducing the amount of the auxiliary material may cause problems such as hardening and brittleness of the capsule. The Danqi soft capsule has the effects of promoting blood circulation to remove blood stasis and dredging vessels to relieve pain, and is widely used in clinical application. In the existing Danqi soft capsule, a large amount of base material is required to carry an effective dose of Danqi, resulting in a large amount of added base material, so that the prepared capsule has a specification of 0.6 g / pill. In clinical application, it is found that the patients have poor compliance due to the large volume of the capsule, and the capsule becomes hard and brittle during storage. The existing base materials of the soft capsule include peanut oil, soybean oil, camellia oil, corn oil, sunflower seed oil, wheat germ oil, palm oil, liquid paraffin, and flaxseed oil, which cannot solve the problems of a large amount of base material added in the Danqi soft capsule, a large volume of the soft capsule, and hardening and brittleness of the soft capsule during storage. Therefore, it is urgent to provide a Danqi soft capsule which can effectively exert the drug activity and solve the problems of a large volume of the Danqi soft capsule and hardening and brittleness of the soft capsule during storage. SUMMARY
[0003] In view of the above technical problems, a first object of the present application is to provide a Danqi soft capsule. The present application improves the flowability of the capsule content and reduces the volume / weight ratio of the capsule, improves the hardening and brittleness of the capsule due to water absorption, improves the stability of the capsule and the compliance of the patients, and better exerts the effect of promoting blood circulation to remove blood stasis.
[0004] A second object of the present application is to provide a preparation method of the Danqi soft capsule.
[0005] A third object of the present application is to provide application of the preparation method in reducing the volume / weight ratio of the Danqi soft capsule.
[0006] A fourth object of the present application is to provide application of the preparation method in improving the stability of the Danqi soft capsule.
[0007] To achieve the above objects, the technical solutions of the present application are as follows. The present application provides a Danqi soft capsule, which is composed of Danqi dry extract powder and a base material, and the weight ratio of the Danqi dry extract powder to the base material is 1:0.7-0.8, and the base material is composed of soybean oil, monolinolein, beeswax, and Span-80 at a weight ratio of (11-13):(5-7):1:1.
[0008] The application further provides a preparation method of the Danqi soft capsule, which comprises the following steps: uniformly mixing Danqi dry extract powder and a matrix according to a weight ratio of 1:0.7-0.8, grinding and crushing the mixture by using a colloidal mill, compressing the mixture into a gelatin capsule, shaping, drying, and washing the capsule; and the matrix is prepared by mixing soybean oil, monolinolein, beeswax and Span-80 according to a weight ratio of (11-13):(5-7):1:1, and melting and preparing.
[0009] As an implementation form, the particle size of the ground and crushed product is 80-120 mesh.
[0010] As an implementation form, the drying temperature is 23-28 DEG C, and the drying time is 20-30 h.
[0011] As an implementation form, the Danqi dry extract powder is added into the matrix and uniformly mixed.
[0012] As an implementation form, the preparation method of the Danqi dry extract powder comprises the following steps: Danqi is decocted with water for 2-3 times, each time for 1-2 h, the extract is combined, filtered, and concentrated to obtain a Danqi thick extract; the same weight of Panax notoginseng as the Danqi is crushed into Danqi fine powder; the Panax notoginseng fine powder and the Danqi thick extract are uniformly mixed, dried, crushed, and sieved.
[0013] As an implementation form, the relative density of the Danqi thick extract is 1.35-1.40, and the detection temperature of the relative density is 45-55 DEG C.
[0014] As an implementation form, the added amount of water is 6-10 times the weight of the Danqi.
[0015] The application further provides application of the preparation method in reducing the volume / weight ratio of the Danqi soft capsule.
[0016] The application further provides application of the preparation method in improving the stability of the Danqi soft capsule. Compared with the prior art, the application has the following beneficial effects: The application adds monolinolein into the Danqi soft capsule, and uses a mixture of components in a specific ratio as the matrix, so that the property of the matrix is improved, the flowability of the capsule content is improved when the Danqi with the same effective dose is loaded, the added amount of the matrix (auxiliary material) is reduced, the volume / weight ratio of the capsule is reduced, the patient compliance is improved, and the water absorption of the capsule shell is improved. DETAILED DESCRIPTION
[0017] The application provides a Danqi soft capsule, which is composed of Danqi dry extract powder and a matrix. The weight ratio of the Danqi dry extract powder to the matrix is 1:0.7-0.8, preferably 1:0.75; the matrix is composed of soybean oil, monolinolein, beeswax and Span-80 in a weight ratio of (11-13):(5-7):1:1, preferably (11.5-12.5):(5.5-6.5):1:1, more preferably 12:6:1:1. The application adds monolinolein to the Danqi soft capsule and uses a specific proportion of mixed components as the matrix, which improves the matrix property, increases the flowability of the capsule content when the Danqi with the same effective dose is loaded, reduces the addition amount of the matrix (excipients), reduces the capsule volume / weight ratio, increases the patient compliance, and also improves the water absorption, brittleness and hardness of the capsule shell.
[0018] The application also provides a preparation method of the above Danqi soft capsule, which comprises the following steps: uniformly mixing the Danqi dry extract powder and the matrix in a weight ratio of 1:0.7-0.8, preferably 1:0.75 in the application; as an optional embodiment, the Danqi dry extract powder is added to the matrix and uniformly mixed. After mixing, the mixture is ground and crushed by a colloid mill, and the liquid medicine after the colloid mill is sieved through a 80-120 mesh sieve, preferably a 90 mesh, 100 mesh or 110 mesh sieve; after sieving, the mixture is pressed into a gel pill by a rotary die pressing method, and is shaped for 15-30 min under the conditions of a temperature of 18-25 DEG C and a humidity of 40%-60%; then the mixture is dried to a water content of 30-45% at a temperature of 23-28 DEG C, and the drying time is 20-30 h, preferably 25 h; after drying, the mixture is sprayed and washed under the conditions of a washing pressure of 0.1-0.2 MPa and a temperature of 20-25 DEG C, and then is centrifuged and dehydrated at 500-800 r / min and is air-dried at 30-35 DEG C for 5-10 min to complete the pill washing.
[0019] In the application, the matrix is mixed by soybean oil, monolinolein, beeswax and Span-80 in a weight ratio of (11-13):(5-7):1:1, and is prepared by heating and melting at 60-80 DEG C. As an optional embodiment, the soybean oil, monolinolein, beeswax and Span-80 are mixed in a weight ratio of (11.5-12.5):(5.5-6.5):1:1, preferably 12:6:1:1. In the application, the heating and melting temperature is 70 DEG C, and the time is 40 min; as an optional embodiment, the heating and melting is carried out by a beaker.
[0020] In the present application, the preparation method of the Danshentong dry extract powder comprises the following steps: Danshen is decocted with water for 2-3 times, each time for 1-2 hours, the extraction liquid is combined, sieved, and the filtrate is concentrated to obtain Danshen thick extract; as an optional embodiment, the amount of water added is 6-10 times the weight of Danshen, preferably 7, 8 or 9 times; the mesh size of the sieving is 60-100 meshes; the relative density of the Danshen thick extract is 1.35-1.40, and the relative density is preferably 1.36, 1.37, 1.38 or 1.39; the detection temperature of the relative density is 45-55℃, and the detection temperature is preferably 50℃. In the present application, the same weight of Sanqi as Danshen is pulverized into fine powder (fine powder: can pass through No. 5 sieve, and contains not less than 95% of powder passing through No. 6 sieve); the Sanqi fine powder and the Danshen thick extract are mixed uniformly, dried at 80℃ for 20 hours, pulverized, and sieved through 100 mesh.
[0021] The Danshentong soft capsules prepared based on the present application have less amount of matrix (excipient) added when encapsulating the same effective dose of Danshentong, which can effectively reduce the capsule volume of the same amount of effective ingredients, and the present application also provides the application of the above preparation method in reducing the volume / weight ratio of Danshentong soft capsules. The specification of the Danshentong soft capsules of the present application can be made into 0.47 g / pill, which is 26% smaller in volume compared with the commercially available Danshentong soft capsules.
[0022] The Danshentong soft capsules prepared based on the present application can improve the condition of capsule becoming brittle and hard after absorbing water, and the present application also provides the application of the above preparation method in improving the stability of Danshentong soft capsules. The Danshentong soft capsules of the present application can maintain the disintegration time within 17 minutes during the 24-month long-term storage process, maintaining long-term stability, and the stability is much higher than that of the commercially available Danshentong soft capsules.
[0023] In order to make the purpose, technical scheme and advantages of the present application more clear and explicit, the present application will be described in detail below combined with examples, but they should not be understood as limiting the scope of protection of the present application.
[0024] In the following examples, the materials, reagents, etc. are commercially available unless otherwise specified, and the reagents and consumables involved in the present application can be obtained from commercial channels, and if no specific use conditions are specified, they are usually used according to conventional conditions or according to the conditions recommended by the company.
[0025] Example 1 A preparation method of Danshentong soft capsules: The preparation method of the Danqi dry extract powder is as follows: 8 times the amount of water is added to Danshen and decocted for 3 times, each time for 2 hours, the extract is combined, filtered through a 80-mesh sieve, and the filtrate is concentrated to a thick Danshen extract with a relative density of 1.35 (50°C) for standby use; the same weight of Sanqi as Danshen is crushed into fine powder for standby use; the fine Sanqi powder is mixed with the Danshen thick extract, dried at 80°C for 20 hours, and then crushed through a 100-mesh sieve to prepare the Danqi dry extract powder.
[0026] The soybean oil, monolinoleic glyceride, beeswax, and Span-80 are mixed in a weight ratio of 12:6:1:1, melted in a beaker at 70°C, and then the Danqi dry extract powder is added into the matrix in a weight ratio of 1:0.75, stirred uniformly, ground for 3 times with a colloid mill, filtered through a 80-mesh sieve, and then the content is good in flowability, pressed into a gelatin pill by a rotary die pressing method, shaped for 20 minutes at a temperature of 25°C and a humidity of 40%, dried at a temperature of 30°C until the water content is 40%, sprayed and washed at 0.1 MPa and 25°C after drying, centrifuged at 600 r / min after washing, and then dehydrated by air drying at 35°C for 10 minutes to complete the washing of the pill, so that the Danqi soft capsule is prepared.
[0027] Example 2 A preparation method of a Danqi soft capsule is provided. The preparation method of the Danqi dry extract powder is as follows: 8 times the amount of water is added to Danshen and decocted for 3 times, each time for 2 hours, the extract is combined, filtered through a 80-mesh sieve, and the filtrate is concentrated to a thick Danshen extract with a relative density of 1.35 (50°C) for standby use; the same weight of Sanqi as Danshen is crushed into fine powder for standby use; the fine Sanqi powder is mixed with the Danshen thick extract, dried at 80°C for 20 hours, and then crushed through a 100-mesh sieve to prepare the Danqi dry extract powder.
[0028] The soybean oil, monolinoleic glyceride, beeswax, and Span-80 are mixed in a weight ratio of 12:6:1:1, melted in a beaker at 70°C, and then the Danqi dry extract powder is added into the matrix in a weight ratio of 1:0.75, stirred uniformly, ground for 3 times with a colloid mill, filtered through a 80-mesh sieve, and then the content is good in flowability, pressed into a gelatin pill by a rotary die pressing method, shaped for 20 minutes at a temperature of 25°C and a humidity of 40%, dried at a temperature of 30°C until the water content is 40%, sprayed and washed at 0.1 MPa and 25°C after drying, centrifuged at 600 r / min after washing, and then dehydrated by air drying at 35°C for 10 minutes to complete the washing of the pill, so that the Danqi soft capsule is prepared.
[0029] Example 3 A preparation method of a Danqi soft capsule is provided. The preparation method of the Danqi dry extract powder is as follows: 10 times the amount of water is added to Danshen and decocted for three times, each time for 2 hours, the extract is combined, and the filtrate is concentrated to a thick Danshen extract with a relative density of 1.38 (45°C) for standby use; Sanqi is ground into fine powder with the same weight as Danshen, and standby use; the fine Sanqi powder is mixed with the Danshen thick extract, dried at 80°C for 20 hours, and then ground and sieved through a 100-mesh sieve to obtain the Danqi dry extract powder.
[0030] The soybean oil, monolinolein, beeswax, and Span-80 are mixed in a weight ratio of 11.5:6.5:1:1, and then melted in a beaker at 70°C to obtain the matrix. The Danqi dry extract powder is added to the matrix in a weight ratio of 1:0.75, stirred uniformly, ground four times with a colloid mill, and then sieved through an 80-mesh sieve. The content has good fluidity, and is pressed into a gel pill by a rotary die pressing method. The gel pill is shaped at a temperature of 25°C and a humidity of 50% for 25 minutes, and then dried at a temperature of 35°C until the water content is 35%. After drying, the gel pill is washed by spraying and flushing at 0.2 MPa and 20°C, and then centrifuged at 800 r / min to remove water. The washing of the gel pill is completed by air-drying at 30°C for 10 minutes. The Danqi soft gelatin capsule is obtained.
[0031] Comparative Example 1 The difference from Example 1 is that the matrix in Example 1 is replaced by soybean oil, beeswax, and Span-80 mixed in a weight ratio of 18:1:1, and the other steps are the same as those in Example 1.
[0032] Comparative Example 2 The difference from Example 1 is that the matrix in Example 1 is replaced by monolinolein, beeswax, and Span-80 mixed in a weight ratio of 18:1:1, and the other steps are the same as those in Example 1.
[0033] Comparative Example 3 The difference from Example 1 is that the matrix in Example 1 is replaced by soybean oil, monolinolein, beeswax, and Span-80 mixed in a weight ratio of 14.4:3.6:1:1, and the other steps are the same as those in Example 1.
[0034] Comparative Example 4 The difference from Example 1 is that the matrix in Example 1 is replaced by soybean oil, monolinolein, beeswax, and Span-80 mixed in a weight ratio of 10.3:7.7:1:1, and the other steps are the same as those in Example 1.
[0035] Comparative Example 5 The difference from Example 1 is that the matrix in Example 1 is replaced by soybean oil, monolinolein, beeswax, and Span-80 mixed in a weight ratio of 9:9:1:1, and the other steps are the same as those in Example 1.
[0036] Comparative Example 6 Commercial product: Danqi soft capsules (purchased from Beijing Great Wall Pharmaceutical Co., Ltd.) with a 0.6 g / capsule specification.
[0037] Test Example 1 1. 2800 g of Danshen and 2000 g of Sanqi were respectively taken according to the different preparation methods of Example 1 and Comparative Examples 1-5 to prepare Danqi soft capsules, and the weight of each soft capsule was 0.47 g. The actual preparation and performance of the soft capsules in each group are shown in Table 1.
[0038] Table 1 Preparation of soft capsules with different proportions of contents
[0039] Note: The dispersion speed is divided into fast, faster, medium, slower, and slow from fast to slow.
[0040] The results show that in Comparative Example 1, when the matrix is soybean oil: beeswax: Span-80 at a ratio of 18:1:1, the soft capsule content has poor flowability after passing through the colloid mill, and it cannot be formed during the pill-making process; in Comparative Examples 2 and 5, when the matrix ratio is monolinoleate glyceride: beeswax: Span-80 at a ratio of 18:1:1, and soybean oil: monolinoleate glyceride: beeswax: Span-80 at a ratio of 9:9:1:1, the dispersion speed is slow, and the finished product separates after being placed for ten days, indicating that the Danqi soft capsule content is unstable; in Comparative Example 3, when the matrix ratio is soybean oil: monolinoleate glyceride: beeswax: Span-80 at a ratio of 14.4:3.6:1:1, the flowability is barely acceptable, and the yield of soft capsule finished product is low; in Example 1 and Comparative Example 4, when the matrix ratio is soybean oil: monolinoleate glyceride: beeswax: Span-80 at a ratio of 12:6:1:1 and 10.3:7.7:1:1, the flowability is good, and finished products can be prepared, and it is found through inspection that the appearance of the two specifications of capsules is symmetrical, and there is no liquid leakage and other phenomena.
[0041] Test Example 2 1. Ten Danqi soft capsules prepared by the two preparation methods of Example 1 and Comparative Example 4 were respectively taken from Test Example 1 for property detection. The main inspection was whether the appearance of the soft capsules was symmetrical, and whether there was liquid leakage and the like. Through inspection, the two specifications of Danqi soft capsules prepared by Example 1 and Comparative Example 4 had symmetrical appearance, and there was no liquid leakage phenomenon, and the property inspection was qualified.
[0042] 2. Ten Danqi soft capsules prepared by the two preparation methods of Example 1 and Comparative Example 4 were respectively taken from Test Example 1 for weight variation detection. The weight variation was detected according to the method in General Test 0103 of the Fourth Part of the 2015 Edition of the Chinese Pharmacopoeia, and the weight limit of the 0.47 g / capsule specification was ±7.5%, i.e. between 0.435-0.505 g. The weight variation detection results of the Danqi soft capsules prepared by Example 1 are shown in Table 2.
[0043] Table 2. Inspection table of weight variation of Danqi soft capsules of Example 1
[0044] The results of the weight variation inspection of Danqi soft capsules prepared in Comparative Example 4 are shown in Table 3.
[0045] Table 3. Inspection table of weight variation of Danqi soft capsules of Comparative Example 4
[0046] 3. Ten Danqi soft capsules prepared by the two preparation methods of Example 1 and Comparative Example 4 were taken from Test Example 1, respectively, for disintegration time detection. The disintegration time detection was performed according to the method of disintegration time inspection in General Test 0921 of the 2015 edition of Chinese Pharmacopoeia, and the solvent was artificial gastric juice. The results of the disintegration time detection of the two specifications of Danqi soft capsules prepared in Example 1 and Comparative Example 4 are shown in Table 4.
[0047] Table 4. Inspection table of disintegration time of Danqi soft capsules with different matrices
[0048] 4. Ten Danqi soft capsules prepared by the two preparation methods of Example 1 and Comparative Example 4, and three batches of commercially available 0.6 g / capsule specification of Danqi soft capsules of Comparative Example 6 were taken from Test Example 1 for volume detection. A measuring cylinder was taken, a certain amount of ethanol with a volume of V1 was added, 10 soft capsules were put into the measuring cylinder, the total volume V2 was recorded, and the volume of Danqi soft capsules was (V2-V1) / 10. The results of the volume inspection of Danqi soft capsules in each group are shown in Table 5.
[0049] Table 5. Inspection table of volume of Danqi soft capsules with different matrices
[0050] As can be seen from the above, the Danqi soft capsules prepared in Example 1 with the matrix of soybean oil: monolinolein glyceride: beeswax: Span-80 being 12:6:1:1 and Comparative Example 4 with the matrix of soybean oil: monolinolein glyceride: beeswax: Span-80 being 10.3:7.7:1:1 are all qualified in terms of appearance, weight variation, disintegration time, and volume inspection.
[0051] Test Example 3 Stability test: According to the 2020 edition of Chinese Pharmacopoeia Appendix 9001, Technical Guidelines for Stability Study of Traditional Chinese Medicines and Natural Medicines (Guoshifangzhizhun
[2006] 678), three batches of Danqi Soft Capsules produced by the preparation method of Example 1 (batch number: 20060901, 20060902, 20060903), three batches of Danqi Soft Capsules produced by the preparation method of Comparative Example 4 (batch number: 20060904, 20060905, 20060906) and three batches of Danqi Soft Capsules of 0.6 g / pill specification commercially available (batch number: 200606, 200607, 200608) were taken from Test Example 1 to investigate the accelerated stability (temperature: 40℃, humidity 75%) and long-term stability (temperature: 25℃, humidity 60%). The investigation items included appearance, identification, disintegration time limit, weight difference, content determination and microbial examination. The disintegration times of the accelerated stability test of each group are shown in Tables 6-12, and the disintegration times of the long-term stability test are shown in Tables 13-19. Among them, the three batches of Danqi Soft Capsules produced by the preparation method of Comparative Example 4 became hard and brittle, and showed liquid leakage phenomenon at one month of acceleration, and the stability test was not performed.
[0052] Table 6 Disintegration time of Danqi Soft Capsules in accelerated stability test
[0053] Table 7 Report of accelerated stability test of Danqi Soft Capsules of Example 1 (batch number: 20060901)
[0054] Table 8 Report of accelerated stability test of Danqi Soft Capsules of Example 1 (batch number: 20060902)
[0055] Table 9 Report of accelerated stability test of Danqi Soft Capsules of Example 1 (batch number: 20060903)
[0056] Table 10 Report of accelerated stability test of Danqi Soft Capsules of Comparative Example 6 (batch number: 200606)
[0057] Table 11 Report of accelerated stability test of Danqi Soft Capsules of Comparative Example 6 (batch number: 200607)
[0058] Table 12 Report of accelerated stability test of Danqi Soft Capsules of Comparative Example 6 (batch number: 200608)
[0059] Table 13 Disintegration time of Danqi soft capsules in long-term stability test
[0060] Table 14 Long-term stability test report of Danqi soft capsules of Example 1 (batch number: 20060901)
[0061] Table 15 Long-term stability test report of Danqi soft capsules of Example 1 (batch number: 20060902)
[0062] Table 16 Long-term stability test report of Danqi soft capsules of Example 1 (batch number: 20060903)
[0063] Table 17 Long-term stability test report of Danqi soft capsules of Comparative Example 6 (batch number: 200606)
[0064] Table 18 Long-term stability test report of Danqi soft capsules of Comparative Example 6 (batch number: 200607)
[0065] Table 19 Long-term stability test report of Danqi soft capsules of Comparative Example 6 (batch number: 200608)
[0066] In summary, the volume of the three batches of Danqi soft capsules produced by the preparation method of Example 1 of the present application is reduced by about 21.6% compared with the commercially available Danqi soft capsules of Comparative Example 6, which significantly reduces the volume of Danqi soft capsules. The disintegration time of the commercially available Danqi soft capsules of Comparative Example 6 significantly increases with the increase of the storage time, while the disintegration time of the three batches of Danqi soft capsules produced by the preparation method of Example 1 of the present application is relatively stable, which indicates that the matrix of the present application significantly improves the problem of hardening and brittleness of Danqi soft capsules during storage.
[0067] The above description is only an embodiment of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process conversion, or direct or indirect application in other related technical fields, is also included in the patent protection scope of the present application.
Claims
1. A Danqi soft capsule, characterized in that, The Danqi soft capsules are composed of Danqi dry extract powder and a matrix, wherein the weight ratio of Danqi dry extract powder to matrix is 1:0.7~0.8, and the matrix is composed of soybean oil, monolinoleic acid glyceride, beeswax and Span-80 in a weight ratio of (11~13):(5~7):1:
1.
2. The method for preparing Danqi soft capsules according to claim 1, characterized in that, Includes the following steps: The powdered danqi and the matrix are mixed at a weight ratio of 1:0.7~0.8, ground and pulverized with a colloid mill, pressed into capsules, shaped, dried and washed; the matrix is prepared by mixing soybean oil, monolinoleic acid glyceride, beeswax and Span-80 at a weight ratio of (11~13):(5~7):1:1 and heating to melt.
3. The preparation method according to claim 2, characterized in that, The particle size of the grinding and pulverizing process is 80~120 mesh.
4. The preparation method according to claim 2, characterized in that, The drying temperature is 23~28℃, and the time is 20~30 h.
5. The preparation method according to claim 2, characterized in that, Add the Danqi dry powder to the matrix and mix well.
6. The preparation method according to claim 2, characterized in that, The preparation method of the Danqi dry extract powder includes the following steps: Danshen was decocted in water 2-3 times, each time for 1-2 hours. The extracts were combined, sieved, and the filtrate was concentrated to obtain Danshen thick paste. Grind Panax notoginseng into fine powder of equal weight to Salvia miltiorrhiza. The fine powder of Panax notoginseng and the thick paste of Salvia miltiorrhiza are mixed evenly, dried, pulverized, and sieved.
7. The preparation method according to claim 6, characterized in that, The relative density of the tanshinone extract is 1.35~1.40, and the relative density is detected at a temperature of 45~55℃.
8. The preparation method according to claim 6, characterized in that, The amount of water added is 6 to 10 times the weight of the danshen.
9. The application of the preparation method according to any one of claims 2 to 8 in reducing the volume / weight ratio of Danqi soft capsules.
10. The application of the preparation method according to any one of claims 2 to 8 in improving the stability of Danqi soft capsules.