Preparation method of ginseng-radix notoginseng heart-dredging capsule
By using corn starch instead of traditional starch and adjusting the mixing time, the problem of insufficient dissolution of Shenqi Xinshu Capsules was solved, higher dissolution and absorption effects were achieved, and the efficacy of the drug was enhanced.
Patent Information
- Application Number
- CN202510909650.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-02
- Publication Date
- 2025-09-12
AI Technical Summary
The solubility of existing Shenqixinshu capsules is insufficient, resulting in insufficient absorption of active ingredients and affecting therapeutic efficacy.
Corn starch is used as an auxiliary material instead of traditional starch, and the mixing time and mixing mechanism of salvia miltiorrhiza, kudzu vine and Panax notoginseng powder are adjusted to improve dissolution rate.
The solubility of Shenqixinshu Capsules is significantly improved, ensuring that more active ingredients are dissolved and absorbed, thereby enhancing the efficacy of the drug.
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Abstract
Description
Technical Field
[0001] The present application relates to the technical field of traditional Chinese medicine, and in particular to a preparation method of Shenqixinshu capsules. Background Art
[0002] Shenqi Xinshu Capsules are composed of Panax notoginseng, Salvia miltiorrhiza, Ganoderma lucidum, Pueraria lobata, Carthamus tinctorius, Ligusticum chuanxiong, Dalbergia odorifera, Eucommia ulmoides, Rhizoma Cynanchum, Opuntia cochinchinensis, and Licorice root. Their primary effects are regulating qi and promoting blood circulation, unblocking meridians, and alleviating pain. They are used for chest pain caused by qi stagnation and blood stasis, characterized by chest tightness, pain, and palpitations, as well as angina pectoris associated with coronary heart disease.
[0003] The efficacy of a drug is affected by a variety of factors, including individual differences, medication specifications, and drug properties. Among them, drug solubility is closely related to the rate of drug absorption in the body. Before being absorbed, drugs in solid dosage forms must undergo a process of disintegration, dissolution, and conversion into solution. Good solubility helps increase drug absorption. High solubility means that more active ingredients can be dissolved from the dosage form and absorbed into the bloodstream, thereby achieving higher drug concentrations in the body and enhancing the drug's therapeutic effect. If the solubility is low, the active ingredients cannot be fully dissolved. Even if the drug dosage is the same, the amount of drug that enters the body to exert its effect will be reduced, potentially resulting in poor therapeutic efficacy. Summary of the Invention
[0004] In order to solve the above technical problems, the purpose of the present invention is to provide a preparation method of Shenqi Xinshu Capsules; the preparation method of Shenqi Xinshu Capsules provided in this application can improve the dissolution rate of Shenqi Xinshu Capsules.
[0005] The technical solutions provided by the present invention are as follows: A preparation method of Shenqixinshu capsules comprises the following steps: S1. Grind Danshen, Puerariae lobatae, and Panax notoginseng separately into fine powder; S2. Soak safflower, dalbergia odorifera, cactus, ligusticum chuanxiong, ganoderma lucidum, eucommia bark, scutellaria baicalensis, and licorice in water for 6 hours, then decoct three times with water, adding water 6-7 times, 5-6 times, and 4-5 times the weight of the total weight of the medicinal materials each time, decoct for 1-1.5 hours each time, and at a temperature of 90-97°C. After decoction, filter the mixture several times with a 120-140 mesh filter, combine the filtrates, and concentrate to obtain a thick paste. S3, mixing the fine powder obtained in step S1 for 5-10 minutes to obtain a powdery mixture; adding the powdery mixture to the thick paste obtained in step S2, and mixing for another 10-15 minutes to obtain a wet material; S4. Dry, crush, and sieve the wet material, add corn starch and mix it. The mixing frequency is 25-30 Hz and the mixing time is 30-40 min. Put it into capsules to obtain the product. There is no order requirement between step S1 and step S2.
[0006] Preferably, in step S1, after the salvia miltiorrhiza, kudzu vine root and Panax notoginseng are crushed, they are passed through an 80-100 mesh sieve to obtain fine powder.
[0007] Preferably, in step S1, the salvia miltiorrhiza, kudzu vine root and Panax notoginseng are cleaned, washed and dried at 70-80° C. to a moisture content of ≤5% before being crushed.
[0008] Preferably, in step S2, safflower, dalbergia odorifera, and cactus are cleaned and used; After being cleaned and washed, Chuanxiong, Ganoderma lucidum, Eucommia ulmoides, and Pleurotus ostreatus are cut into pieces ≤ 5 cm in size and then dried at 70-80°C until the moisture content is ≤ 9% before use. Licorice slices can be used directly.
[0009] Preferably, in step S2, the mixture is concentrated to obtain a thick paste having a relative density of 1.30-1.35 at 50°C.
[0010] Preferably, in step S4, the wet material is dried under reduced pressure at a vacuum degree of 0.05-0.1 MPa and a temperature of 70-80° C. to a moisture content of ≤5%, and then pulverized and passed through a 60-80 mesh sieve.
[0011] Preferably, in step S4, the amount of corn starch used is 6-7% by weight of the dry paste powder.
[0012] Preferably, the Shenqi Xinshu Capsule comprises the following raw materials in parts by weight: 60-120 parts by weight of Panax notoginseng, 60-120 parts by weight of Salvia miltiorrhiza, 100-200 parts by weight of Ganoderma lucidum, 60-120 parts by weight of Pueraria lobata, 50-100 parts by weight of Carthamus tinctorius, 60-120 parts by weight of Lignum chuanxiong, 90-180 parts by weight of Dalbergia odorifera, 100-200 parts by weight of Eucommia ulmoides, 100-200 parts by weight of Polygonum multiflorum, 300-600 parts by weight of Opuntia coccinella, and 30-60 parts by weight of Licorice.
[0013] Preferably, the Shenqi Xinshu Capsule comprises the following raw materials, in parts by weight: 60 parts by weight of Panax notoginseng, 60 parts by weight of Salvia miltiorrhiza, 100 parts by weight of Ganoderma lucidum, 60 parts by weight of Pueraria lobata, 50 parts by weight of Carthamus tinctorius, 60 parts by weight of Ligusticum chuanxiong, 90 parts by weight of Dalbergia odorifera, 100 parts by weight of Eucommia ulmoides, 100 parts by weight of Polygonum multiflorum, 300 parts by weight of Opuntia cochinchinensis, and 30 parts by weight of Licorice.
[0014] The preparation method of Shenqi Xinshu Capsules provided in this application replaces the original auxiliary material starch with corn starch, and creatively discovers that the mixing timing and mixing time of Salvia miltiorrhiza, Pueraria lobata, and Panax notoginseng fine powder have a synergistic effect with the change of auxiliary materials, which can greatly improve the dissolution rate of Shenqi Xinshu Capsules.
[0015] In this application, during the drying process, samples are taken to detect moisture according to the drying conditions, and drying is stopped when the moisture content of the medicinal material or material reaches the target range. DETAILED DESCRIPTION
[0016] In order to help those skilled in the art better understand the technical solutions in this application, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without making any creative efforts shall fall within the scope of protection of this application.
[0017] 1. Instruments and reagents: 1. Instruments High performance liquid chromatograph: Waters e2695-2998, PDA detector Chromatographic column: YMC-Pack ODS-AQ C18 (4.6×250mm, 5μm) Dissolution tester: Model RC1208D, Tianda Tianfa Technology Co., Ltd. Electronic balance: 1 / 100,000, model EP225SM-DR, Precisa, Switzerland, used for weighing reference and test samples Electronic balance: 1 / 1000, model LS620Mscs, Precisa, Switzerland, used for weighing the test solution and preparing the test solution Ultrasonic cleaner: Model KQ-500DV, Kunshan Ultrasonic Instrument Co., Ltd. Centrifuge: Model LXJ-IIB, Shanghai Anting Scientific Instrument Factory 2. Reference substances In the current quality standard of Shenqixinshu Capsules, the content of ginsenoside Rg1 is determined by thin-layer chromatography scanning, which has lower sensitivity than high-performance liquid chromatography. When determining the dissolution rate, only one Shenqixinshu Capsule is taken and 6 portions are measured in parallel. It is difficult to accurately detect ginsenoside Rg1 at the above-mentioned determination concentration, so the dissolution data of ginsenoside Rg1 is not provided. Tanshinone IIA is a fat-soluble component. Water is used as the solvent for the dissolution determination. Tanshinone IIA is not completely extracted, so the dissolution data of Tanshinone IIA is not provided. This application uses water-soluble tanshinone B as a reference substance to conduct dissolution test experiments.
[0018] Salvianolic acid B (China National Institute for Food and Drug Control, batch number 111562-202318).
[0019] 2. Medicinal ingredients and dosage of Shenqixinshu Capsules
[0020] 3. Dissolution Study Example 1 The preparation method is as follows: S1. Select and wash Salvia miltiorrhiza, Pueraria lobata, and Panax notoginseng, dry them at 75°C until the moisture content is ≤5%, grind them separately, and pass them through an 80-mesh sieve to obtain fine powder; S2. Carthamus tinctorius, Dalbergia odorifera, and Opuntia cactus were cleaned and processed, and Chuanxiong rhizome, Ganoderma lucidum, Eucommia ulmoides, and Psoralea corylifolia were processed as follows: cleaned, washed, cut into pieces ≤ 5 cm, and then dried at 75°C until the moisture content was ≤ 9% before use; Licorice slices can be used directly; The processed safflower, dalbergia odorifera, cactus, ligusticum chuanxiong, ganoderma lucidum, eucommia bark, scutellaria baicalensis, and licorice were soaked in water for 6 hours, then decocted three times with water, with the weight of water added each time being 6 times, 5 times, and 4 times the total weight of the medicinal materials, each decoction lasting 1 hour at 95°C; after decoction, the mixture was filtered through a 120-mesh filter in batches, the filtrates were combined, and concentrated to obtain a thick paste having a relative density of 1.30 at 50°C; S3, mixing the fine powder obtained in step S1 for 5 minutes to obtain a powdery mixture; adding the powdery mixture to the thick paste obtained in step S2, and mixing for another 10 minutes to obtain a wet material; S4. The wet material is dried under reduced pressure at a vacuum degree of 0.05-0.1 MPa and a temperature of 75°C to a moisture content of ≤5%, then pulverized and passed through a 60-mesh sieve. Corn starch (6% by weight of the dry paste powder) is added and mixed. The mixing frequency is 25 Hz and the mixing time is 30 min. The material is then filled into capsules to obtain the product. There is no order requirement between step S1 and step S2.
[0021] Example 2 The same as Example 1, except that in step S3, the fine powder is mixed for 10 minutes to obtain a powdery mixture, which is then added to the thick paste.
[0022] Example 3 The same as Example 1, except that in step S3, the fine powder is mixed for 7 minutes to obtain a powdery mixture, which is then added to the thick paste.
[0023] Comparative Example 1 Preparation Process of Shenqixinshu Capsules Refer to the [Preparation Method] section of quality standard WS-10363 (ZD-0363)-2002-2011Z for preparation, as summarized below: Grind salvia miltiorrhiza, kudzu vine root and Panax notoginseng into fine powder; Soak Ganoderma lucidum, safflower, Chuanxiong, Dalbergia odorifera, Eucommia ulmoides, Phellodendron chinense, Opuntia cochinchinensis, and Licorice root in water for 6 hours, decoct three times for 1 hour each time, filter, combine the filtrates, and concentrate to a thick paste with a relative density of 1.30 (50°C); Mix well with fine powder of Salvia miltiorrhiza and other herbs, dry, crush, sieve, add appropriate amount of starch, mix well, and put into capsules.
[0024] Comparative Example 2 The same as Example 1, except that in step S4, the corn starch used is replaced by starch.
[0025] Comparative Example 3 The same as Example 1, except that in step S3, the fine powder is not mixed but directly added to the thick paste.
[0026] Comparative Example 4 The process is the same as in Example 1, except that in step S3, the fine powder is mixed for 2 minutes to obtain a powdery mixture, which is then added to the thick paste; and in step S4, the total mixing time is 15 minutes.
[0027] Comparison of dissolution rates between Examples 1-3 and Comparative Examples 1-4 The dissolution and release rate were determined according to the dissolution and release rate test method (Chinese Pharmacopoeia 2020 Edition Part IV General Chapter 0931 Method 3) and the high performance liquid chromatography method (Chinese Pharmacopoeia 2020 Edition Part IV General Chapter 0512).
[0028] The chromatographic conditions and system suitability test used octadecylsilane bonded silica gel as the filler; acetonitrile-0.1% phosphoric acid (22:78) as the mobile phase; the flow rate was 1.0 ml per minute; the detection wavelength was 287 nm; and the theoretical plate number calculated based on the salvianolic acid B peak should be no less than 2000.
[0029] Preparation of reference solution: Take an appropriate amount of salvianolic acid B reference substance, accurately weigh it, and add 70% methanol to make a solution containing 50 μg per 1 ml.
[0030] Preparation of the test solution: Take 6 capsules of each of the Shenqixinshu capsules prepared in Example 1-3 and Comparative Example 1-4, use 200 ml of water as the solvent, and rotate at 75 revolutions per minute. Operate according to the method. After 30 minutes, take a sample of 20 ml, filter, accurately measure 10 ml of the filtrate, evaporate to dryness, add 30 ml of 1.5% sodium chloride solution to the residue to dissolve it, transfer it to a separatory funnel, wash it with dichloromethane 3 times, 30 ml each time, discard the dichloromethane liquid, evaporate the water to dryness, add 70% methanol to dissolve the residue, and transfer it to a 10 ml volumetric flask, add 70% methanol to the scale, shake well, filter, discard 3 ml of the initial filtrate, and take the filtrate.
[0031] Preparation of control solution: Take the contents of 10 capsules of each of the Shenqixinshu capsules prepared in Examples 1-3 and Comparative Examples 1-4, accurately weigh them, mix them, take about 1 capsule, accurately weigh it, put it in a 200ml volumetric flask, add appropriate amount of water, ultrasonically treat it (300W, frequency 40kHz) for 30 minutes, take it out, let it cool, dilute it to the scale with water, shake it well, filter it, accurately measure 10ml of the filtrate, evaporate it to dryness, add 30ml of 1.5% sodium chloride solution to dissolve the residue, transfer it to a separatory funnel, wash it with dichloromethane 3 times, 30ml each time, discard the dichloromethane liquid, evaporate the water liquid to dryness, add 70% methanol to dissolve the residue, and transfer it to a 10ml volumetric flask, add 70% methanol to the scale, shake it well, filter it, discard 3ml of the initial filtrate, and take the filtrate.
[0032] The control solution was used as a self-control for the corresponding test sample. The samples were the same, except that the control solution was completely dissolved by ultrasonic extraction, while the test sample solution was dissolved for 30 minutes.
[0033] Determination: Accurately aspirate 10 μl of the test solution, control solution and reference solution, inject them into the liquid chromatograph, and determine. Use the external standard method to calculate the content of salvianolic acid B in the test solution and the control solution, respectively. The percentage of the test solution content to the control solution content is used as the dissolution result.
[0034] The results are shown in Table 1: Table 1: Dissolution test results of salvianolic acid B within 30 min
[0035] From the results in Table 1, it can be seen that the solubility of salvianolic acid B in comparative examples 1-4 is between 76.5% and 79.5%, while in examples 1-3, the solubility of salvianolic acid B reaches 86.4-87.4%, indicating that the improved scheme of the present application has a higher solubility of the prepared Shenqi Xinshu Capsules in the same time period compared with the quality standard, thereby improving the solubility of the effective ingredients of the Shenqi Xinshu Capsules.
[0036] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.
Claims
1. A preparation method of Shenqixinshu capsule, characterized in that: The following steps are involved: S1. Grind Danshen, Puerariae lobatae, and Panax notoginseng separately into fine powder; S2. Soak safflower, dalbergia odorifera, cactus, ligusticum chuanxiong, ganoderma lucidum, eucommia bark, scutellaria baicalensis, and licorice in water for 6 hours, then decoct three times with water, adding water 6-7 times, 5-6 times, and 4-5 times the weight of the total weight of the medicinal materials each time, decoct for 1-1.5 hours each time, and at a temperature of 90-97°C. After decoction, filter the mixture several times with a 120-140 mesh filter, combine the filtrates, and concentrate to obtain a thick paste. S3, mixing the fine powder obtained in step S1 for 5-10 minutes to obtain a powdery mixture; adding the powdery mixture to the thick paste obtained in step S2, and mixing for another 10-15 minutes to obtain a wet material; S4. Dry, crush, and sieve the wet material, add corn starch and mix it. The mixing frequency is 25-30 Hz and the mixing time is 30-40 min. Put it into capsules to obtain the product. There is no order requirement between step S1 and step S2.
2. The preparation method according to claim 1, characterized in that In step S1, salvia miltiorrhiza, kudzu vine root and Panax notoginseng are crushed and passed through an 80-100 mesh sieve to obtain fine powder.
3. The preparation method according to claim 2, characterized in that In step S1, Danshen, Puerariae lobata, and Panax notoginseng are cleaned, washed, dried at 70-80° C. to a moisture content of ≤5%, and then pulverized.
4. The preparation method according to claim 1, characterized in that In step S2, safflower, dalbergia odorifera, and cactus are cleaned and used; After being cleaned and washed, Chuanxiong, Ganoderma lucidum, Eucommia ulmoides, and Pleurotus ostreatus are cut into pieces ≤ 5 cm in size and then dried at 70-80°C until the moisture content is ≤ 9% before use. Licorice slices can be used directly.
5. The preparation method according to claim 1, characterized in that In step S2, the mixture is concentrated to obtain a thick paste having a relative density of 1.30-1.35 at 50°C.
6. The preparation method according to claim 1, characterized in that In step S4, the wet material is dried under reduced pressure at a vacuum degree of 0.05-0.1 MPa and a temperature of 70-80° C. to a moisture content of ≤5%, and then pulverized and passed through a 60-80 mesh sieve.
7. The preparation method according to any one of claims 1 to 6, characterized in that In step S4, the amount of corn starch used is 6-7% by weight of the dry paste powder.
8. The preparation method according to any one of claims 1 to 6, characterized in that The Shenqi Xinshu Capsule comprises the following raw materials, in parts by weight: 60-120 parts by weight of Panax notoginseng, 60-120 parts by weight of Salvia miltiorrhiza, 100-200 parts by weight of Ganoderma lucidum, 60-120 parts by weight of Pueraria lobata, 50-100 parts by weight of Carthamus tinctorius, 60-120 parts by weight of Lignum chuanxiong, 90-180 parts by weight of Dalbergia odorifera, 100-200 parts by weight of Eucommia ulmoides, 100-200 parts by weight of Polygonum multiflorum, 300-600 parts by weight of Opuntia coccinellae, and 30-60 parts by weight of Licorice.
9. The preparation method according to claim 8, characterized in that The Shenqi Xinshu Capsule comprises the following raw materials, calculated by weight: 60 parts by weight of Panax notoginseng, 60 parts by weight of Salvia miltiorrhiza, 100 parts by weight of Ganoderma lucidum, 60 parts by weight of Pueraria lobata, 50 parts by weight of Carthamus tinctorius, 60 parts by weight of Ligusticum chuanxiong, 90 parts by weight of Dalbergia odorifera, 100 parts by weight of Eucommia ulmoides, 100 parts by weight of Polygonum multiflorum, 300 parts by weight of Opuntia cochinchinensis, and 30 parts by weight of Licorice.