Salted fructus gardeniae sustained-release capsule
By optimizing the prescription and preparation process of salt Gardenia sustained-release capsules, the problem of unstable release of existing salt Gardenia preparations has been solved, and the slow and continuous release of salt Gardenia drugs has been achieved, stabilizing blood drug concentration, reducing the number of medications, and improving patient compliance and treatment effect.
Patent Information
- Application Number
- CN202510391234.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-31
- Publication Date
- 2025-05-27
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The existing salt gardenia preparations are unstable in the human body, resulting in large fluctuations in blood drug concentrations, increasing the risk of adverse reactions, and making it difficult to maintain effective treatment effects, affecting patient compliance and treatment effects.
By optimizing the prescription and preparation process, salt Gardenia sustained-release capsules were developed, using hydroxypropyl methylcellulose as the skeleton material, lactose as the filler, povidone as the binder, croscarmellose sodium as the disintegrant, combined with ethanol reflux extraction, salt Gardenia extract was extracted, and sustained-release particles and immediate-release particles were prepared by extrusion granulation method, mixed and loaded into the capsule to achieve stable drug release.
It has achieved slow and continuous release of salt gardenia drugs, stabilized blood drug concentration, reduced the number of medications, improved patient compliance and treatment effect, and significantly reduced the risk of adverse reactions.
Smart Images
Figure CN120037211A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of medicines, and in particular to a salt gardenia sustained-release capsule and a preparation method thereof. Background Art
[0002] Gardenia is a common Chinese herbal medicine with the effects of purging fire and relieving restlessness, clearing heat and removing dampness, cooling blood and detoxifying. As a processed product of Gardenia, Salt Gardenia has a unique therapeutic effect in the clinical application of traditional Chinese medicine. Its active ingredients can be better absorbed by the human body, enhancing the effects of clearing heat and cooling blood. However, most of the preparations for Salt Gardenia on the market are ordinary dosage forms, which have some obvious shortcomings.
[0003] After entering the human body, the common salt gardenia preparation releases the drug rapidly, resulting in large fluctuations in blood drug concentration. In the early stage of drug release, the blood drug concentration may rise rapidly and exceed the effective therapeutic concentration range, increasing the risk of adverse reactions; in the later stage, the blood drug concentration will drop rapidly, making it difficult to maintain an effective therapeutic effect, so that patients need to take the drug frequently to maintain the stability of the blood drug concentration, which not only brings great inconvenience to patients, but also easily leads to patients interrupting treatment due to forgetting to take the drug, affecting the treatment effect.
[0004] From the perspective of drug efficacy, unstable blood drug concentrations cannot continuously act on the lesion site, making it difficult to fully exert the therapeutic effect of salt gardenia. Taking the treatment of chronic inflammation as an example, ordinary preparations cannot continuously and effectively inhibit inflammatory responses, making inflammation prone to recurrence and prolonging the treatment cycle.
[0005] In terms of patient compliance, frequent medication brings many troubles to patients' daily lives, especially for patients who need to take medication for a long time. It is difficult for them to take medication on time and in the right amount, which affects the overall effect of treatment. According to relevant research statistics, among some patients who need to take ordinary preparations for a long time, the proportion of treatment failure due to irregular medication is as high as 30%-40%.
[0006] Therefore, the development of a sustained-release capsule of Gardenia salsa that can achieve slow and sustained release of Gardenia salsa drugs, stabilize blood drug concentrations, reduce the number of medications, and improve patient compliance has important clinical significance and market demand. Summary of the invention
[0007] The invention aims to provide a salt gardenia sustained-release capsule, which can achieve slow and stable release of effective ingredients of the salt gardenia by optimizing the prescription and preparation process, prolong the drug action time, reduce the fluctuation of blood drug concentration, and improve the drug efficacy and the medication compliance of patients.
[0008] The technical solution adopted by the present invention to solve the technical problem is: the salt gardenia sustained-release capsule is composed of salt gardenia extract, skeleton material, filler, binder, disintegrant, etc. Among them, the skeleton material is hydroxypropyl methylcellulose, the filler is lactose, the binder is povidone, and the disintegrant is cross-linked sodium carboxymethylcellulose.
[0009] Preparation of salt gardenia extract: Take an appropriate amount of salt gardenia, crush it, and extract it by ethanol reflux extraction. Concentrate and dry the extract to obtain the salt gardenia extract.
[0010] Preparation of sustained-release granules: Accurately weigh 1 g of salt gardenia extract, add 4 g of hydroxypropyl methylcellulose as the skeleton material and 7 g of lactose as the filler, mix well, add 5 g of starch slurry as the binder, granulate using a 20-mesh sieve by extrusion granulation, dry at 60°C, granulate and set aside.
[0011] Preparation of rapid-release granules: adopt the wet granulation method, weigh the salt gardenia extract and polyethylene glycol 6000, mix and melt, quickly dry and then crush through an 80-mesh sieve, mix thoroughly, then add appropriate diluents and adhesives to make a soft material, granulate through a 24-mesh sieve by extrusion granulation, dry at 60°C, and granulate to obtain the quick-release granules.
[0012] The quick-release granules and the sustained-release granules are mixed in a certain proportion, loaded into capsule shells, and made into salt gardenia sustained-release capsules.
[0013] Preferably, the weight ratio of the salt gardenia extract to polyethylene glycol 6000 is 1:4. This ratio has been verified by a large number of experiments, and at this ratio, the release performance of the quick-release granules is optimal. When it is lower than this ratio, such as 1:3, the drug release is slow, and it is impossible to reach an effective blood drug concentration within the prescribed time, affecting the initial therapeutic effect of the drug; when it is higher than this ratio, such as 1:5, although the early release rate is fast, it may cause a large amount of drug release in a short time, and the blood drug concentration fluctuates greatly, increasing the risk of adverse reactions. Through comparative studies of different ratios, it was found that the ratio of 1:4 can enable quick-release granules to achieve a good release effect within 5-30 minutes, which not only meets the needs of rapid initial release of drugs, but also ensures the stability of release, laying the foundation for the subsequent sustained-release granules to play a role.
[0014] Preferably, the weight ratio of the salt gardenia extract to lactose is 1:5. This ratio has an important influence on the overall performance of the salt gardenia sustained-release capsule. If the ratio is 1:3, the early release rate is too slow and the drug efficacy cannot be exerted in time; if it is 1:4, although the early drug release rate is faster, the release rate does not meet the rapid release requirements within half an hour. After many experimental tests, at a ratio of 1:5, lactose can effectively promote the release of salt gardenia extract, so that the rapid-release particles reach the maximum release amount in about 20 minutes, which meets the requirements of rapid release. At the same time, when it is subsequently combined with sustained-release particles, it can ensure the overall stability of drug release and ensure that the blood drug concentration is maintained within the effective treatment range for a long time.
[0015] Preferably, the weight ratio of the cross-linked sodium carboxymethyl cellulose to the salt gardenia extract is 1:4. This ratio is a key factor affecting the dissolution rate of the salt gardenia rapid-release granules. When the weight ratio of cross-linked sodium carboxymethyl cellulose to rapid-release granules is 1:3, the release is the slowest and cannot meet the rapid-release requirements; when the ratio is 1:5, the drug is released faster in the early stage, but the maximum release amount cannot be reached in about 15 minutes. After repeated experimental studies on different ratios, it was determined that the ratio of 1:4 was the optimal dosage. At this ratio, cross-linked sodium carboxymethyl cellulose can give full play to the disintegration effect, so that the rapid-release granules reach the maximum release amount in about 15 minutes, ensuring the rapid release of the drug and improving the bioavailability of the drug.
[0016] Preferably, the mixing ratio of the quick-release granules and the sustained-release granules is 1:5. This mixing ratio is obtained through a large number of experimental optimizations and has a significant effect on the release behavior of the salt gardenia sustained-release capsules. When the ratio is 1:3 or 1:4, the slope of the drug release curve is small, the early release rate is slow, and the effective therapeutic concentration cannot be quickly reached; when the ratio is 1:6, although the early release rate is improved, the later sustained-release effect is not good. At a ratio of 1:5, the slope of the release curve of the salt gardenia quick-release-sustained-release granules is larger in the early stage, the release rate is faster, and the drug effect can be quickly exerted. As time increases, the slope decreases, meeting the requirements of sustained release, so that the drug can be continuously and stably released in the body, and the blood drug concentration can be effectively maintained.
[0017] Preferably, in the ethanol reflux extraction method, the concentration of ethanol is 70%-80%. The ethanol concentration has an important influence on the quality and active ingredient content of the salt gardenia extract. When the ethanol concentration is lower than 70%, the active ingredients in the salt gardenia are not completely extracted, resulting in a low content of active ingredients in the extract, affecting the efficacy of the drug; when the ethanol concentration is higher than 80%, too many impurities may be extracted, increasing the difficulty of subsequent separation and purification, and may also destroy the structure of some active ingredients. After multiple experimental comparisons, it was found that an ethanol concentration of 70%-80% can reduce the extraction of impurities while ensuring the extraction rate of the active ingredients, thereby improving the purity and quality of the extract.
[0018] Preferably, when preparing the sustained-release granules, the drying temperature is controlled at 55°C-65°C. The drying temperature has a direct impact on the quality and performance of the sustained-release granules. If the drying temperature is lower than 55°C, the granules are dried for too long, which may cause microbial growth and affect product quality; if the drying temperature is higher than 65°C, some components in the granules may decompose or denature, affecting the stability and efficacy of the drug. Experimental studies have found that a drying temperature of 55°C-65°C can enable the sustained-release granules to dry quickly while ensuring quality, and will not adversely affect the structure and composition of the granules, thereby ensuring the stability and sustained-release performance of the sustained-release granules.
[0019] Preferably, when preparing the quick-release granules, the amount of the adhesive 5% povidone K30 solution in the process of preparing the soft material is based on the standard of holding it in a ball by hand and squeezing it into loose particles. The amount of adhesive directly affects the molding quality and release performance of the quick-release granules. If the amount of adhesive is too little, the soft material cannot be formed, the particles are loose, and problems such as stratification and flakes are prone to occur during the preparation and storage process; if the amount of adhesive is too much, the particles will be too hard, affecting the release rate of the drug, and the quick-release granules will not be able to release enough drugs within the specified time. Controlling the amount of adhesive based on the standard of holding it in a ball by hand and squeezing it into loose particles can ensure that the quick-release granules have good formability and release performance, and ensure the effectiveness and stability of the drug.
[0020] Beneficial effects of the present invention: 1. Stabilize blood drug concentration: The salt gardenia sustained-release capsule of the present invention has a unique prescription design. The quick-release granules release part of the drug quickly in the initial stage, so that the blood drug concentration quickly reaches the effective treatment concentration. Then the sustained-release granules continue to slowly release the drug to maintain the stability of the blood drug concentration. When treating chronic diseases, it can continuously act on the lesion site, avoid the adverse effects caused by too high or too low blood drug concentration, and significantly improve the treatment effect. Animal experiments have shown that compared with ordinary salt gardenia preparations, the sustained-release capsule of the present invention reduces the fluctuation range of blood drug concentration by more than 50% within 12 hours, and can exert the drug effect more stably.
[0021] 2. Reduce the number of medications: Ordinary salt gardenia preparations may need to be taken 3-4 times a day, while the sustained-release capsules of the present invention can achieve a slow release of 12 hours or even longer, and patients only need to take 1-2 times a day, which greatly reduces the number of medications. This greatly facilitates patients, especially those with a fast pace of life and busy work, and elderly patients who need to take medication for a long time, reduces the possibility of forgetting to take medication, and improves patients' medication compliance. According to clinical observations, patients taking the sustained-release capsules of the present invention have a 30%-40% increase in medication compliance.
[0022] 3. Improve the bioavailability of the drug: The optimized prescription and preparation process enable the effective ingredients of the salt gardenia to be better absorbed by the human body. The structure of the sustained-release capsule can protect the effective ingredients from being rapidly decomposed and destroyed in the gastrointestinal tract, prolong the action time of the drug in the body, and thus improve the bioavailability of the drug. Animal experiments show that compared with ordinary preparations, the salt gardenia sustained-release capsule of the present invention increases the bioavailability of the effective ingredients of the salt gardenia by 20%-30%, and can more fully exert the medicinal value of the salt gardenia. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The present invention is further described below in conjunction with the accompanying drawings and embodiments.
[0024] Figure 1 This is a drug release curve diagram of the Gardenia Salt Sustained Release Capsules provided by the present invention. DETAILED DESCRIPTION
[0025] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further explained below in conjunction with specific implementation methods.
[0026] like Figure 1 As shown, the present invention provides the following technical solutions: Example 1: Preparation of salt gardenia extract: 500 g of salt gardenia was crushed into coarse powder, placed in a round-bottom flask, and 10 times the amount of 70% ethanol was added, and refluxed for extraction 3 times, each time for 2 hours. The extracts were combined, concentrated under reduced pressure until there was no alcohol taste, and then freeze-dried to obtain 50 g of salt gardenia extract.
[0027] Preparation of sustained-release granules: Accurately weigh 1g of salt gardenia extract, 4g of hydroxypropyl methylcellulose, and 7g of lactose, and mix them thoroughly in a mortar. Slowly add 5g of 10% starch slurry as a binder and stir to make a soft material. Use a 20-mesh sieve to granulate, put the wet granules into a 60°C oven for drying, and sieve the whole granules after drying to obtain sustained-release granules.
[0028] Preparation of immediate-release granules: Weigh 1 g of salt gardenia extract and 4 g of polyethylene glycol 6000, mix, heat to a molten state, quickly cool and dry, then crush, and pass through an 80-mesh sieve. Add 5 g of lactose as a diluent and an appropriate amount of 5% povidone K30 solution as a binder to make a soft material. Use a 24-mesh sieve to extrude granules, dry at 60°C, and granulate to obtain immediate-release granules.
[0029] Capsule preparation: Mix the immediate-release granules and sustained-release granules in a ratio of 1:5 and fill them into No. 5 capsule shells to make salt gardenia sustained-release capsules.
[0030] Quality inspection: The prepared salt gardenia sustained-release capsules were subjected to quality inspection, including appearance, filling volume difference, release rate and other indicators. The appearance inspection found that the capsule surface was complete and smooth, without adhesion and deformation; the filling volume difference inspection results showed that the error between the filling volume of each capsule and the average filling volume of 10 capsules randomly selected was within the specified range; the release rate measurement results showed that the sustained-release capsules had good release of the immediate-release particles within 0-1 hour, and the sustained-release particles continued to release slowly after 1 hour, and the cumulative release in 12 hours reached more than 90%, which met the expected design requirements.
[0031] Example 2: Preparation of salt gardenia extract: 800 g of salt gardenia was taken, crushed and passed through a 40-mesh sieve, and ultrasonically extracted with 8 times the amount of 80% ethanol at 60°C for 3 times, each time for 1.5 hours. The extracts were filtered, combined, concentrated by rotary evaporation, and then spray-dried to obtain 70 g of salt gardenia extract.
[0032] Preparation of sustained-release granules: Weigh 1 g of salt gardenia extract, 5 g of hydroxypropyl methylcellulose, and 8 g of lactose, mix well, add 6 g of 12% starch slurry to make a soft material, granulate with a 20-mesh sieve, and dry the whole granules at 60°C to obtain sustained-release granules.
[0033] Preparation of immediate-release granules: 1 g of Gardenia jasminoides extract and 5 g of polyethylene glycol 6000 were mixed, melted, dried, crushed and sieved. 6 g of lactose was added, and a 5% polyvidone K30 solution was used as a binder to prepare a soft material, sieved with a 24-mesh sieve, and dried to obtain immediate-release granules.
[0034] Capsule preparation: Mix the immediate-release granules and sustained-release granules in a ratio of 1:6 and fill them into No. 5 capsule shells to make salt gardenia sustained-release capsules.
[0035] Quality inspection: The capsules were inspected for quality, and the appearance was good, and the difference in filling volume met the regulations. The release test results showed that the drug release was about 25% within 0-1 hour, and slowly released continuously from 1-12 hours, and the cumulative release in 12 hours was about 92%, which met the performance requirements of sustained-release capsules.
[0036] Example 3: Preparation of salt gardenia extract: Weigh 1000 g of salt gardenia, crush it into fine powder, and use 9 times the amount of 75% ethanol for percolation extraction. Collect the percolation liquid, concentrate and dry it to obtain 90 g of salt gardenia extract.
[0037] Preparation of sustained-release granules: Take 1g of salt gardenia extract, 3.5g of hydroxypropyl methylcellulose, and 6.5g of lactose, mix well, add 4.5g of 8% starch slurry to make a soft material, granulate through a 20-mesh sieve, and dry the whole granules at 60°C to obtain sustained-release granules.
[0038] Preparation of rapid-release granules: Mix 1 g of Gardenia jasminoides extract with 3.5 g of polyethylene glycol 6000, add 4.5 g of lactose and an appropriate amount of 5% povidone K30 solution to prepare a soft material, sieve through a 24-mesh sieve, and dry the whole granules to obtain rapid-release granules.
[0039] Capsule preparation: Mix the immediate-release granules and the sustained-release granules in a ratio of 1:4 and load them into No. 5 capsule shells to make salt gardenia sustained-release capsules.
[0040] Quality inspection: After inspection, the capsule appearance and filling volume difference were qualified. In terms of release, the 0-1 hour rapid release granules released rapidly, with a release amount of about 20%, and the 1-12 hour sustained release granules released steadily, with a cumulative release of 93% in 12 hours, indicating that the capsule has good sustained release performance.
[0041] The capsule release rate is calculated using the formula: Calculate, where The release degree at each time point, is the drug concentration measured at each time point, The main drug content, is the volume of the release medium, The single sampling volume.
[0042] The formula for calculating the cumulative drug release rate is as follows: The cumulative drug release rate is obtained by measuring the release rate at different time points and gradually accumulating the release rate to evaluate the release of the drug at different times.
[0043] Comparison table of various embodiments: ,
[0044] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention. The scope of the present invention is defined by the attached claims and their equivalents.
Claims
1. Salt Gardenia Sustained Release Capsules, characterized in that: It comprises a salt gardenia extract, a skeleton material, a filler, a binder, and a disintegrant, wherein the skeleton material is hydroxypropyl methylcellulose, the filler is lactose, the binder is povidone, and the disintegrant is cross-linked sodium carboxymethyl cellulose; The salt gardenia sustained-release capsule is prepared by preparing the salt gardenia extract into rapid-release granules and sustained-release granules, which are mixed in a certain proportion and loaded into a capsule shell; The preparation method of the salt gardenia extract is as follows: taking an appropriate amount of salt gardenia, crushing it, extracting it by ethanol reflux extraction, concentrating and drying the extract to obtain the salt gardenia extract; The preparation method of the sustained-release granules is as follows: accurately weigh 1 g of the salt gardenia extract, add 4 g of the skeleton material hydroxypropyl methylcellulose and 7 g of the filler lactose, mix well, add 5 g of the adhesive starch slurry, granulate with a 20-mesh sieve by extrusion granulation, dry at 60°C, and granulate; The preparation method of the rapid-release granules is as follows: the salt gardenia extract and polyethylene glycol 6000 are weighed and mixed and melted by the wet granulation method, and then the mixture is quickly dried and crushed through an 80-mesh sieve, mixed thoroughly, and then a suitable diluent and a binder are added to make a soft material, and granulated by an extrusion granulation method through a 24-mesh sieve, and dried at 60°C to form the whole granules.
2. The salt-gardenia sustained-release capsule according to claim 1, characterized in that: The weight ratio of the salt gardenia extract to polyethylene glycol 6000 is 1:
4. This ratio has been verified by a large number of experiments. Under this ratio, the release performance of the rapid-release granules is optimal. When the ratio is lower than this, such as 1:3, the drug is released slowly and cannot reach an effective blood concentration within the prescribed time, affecting the initial therapeutic effect of the drug; when the ratio is higher than this, such as 1:5, although the initial release rate is fast, it may lead to a large amount of drug release in a short period of time, resulting in large fluctuations in blood concentration and increasing the risk of adverse reactions; Through comparative studies of different ratios, it was found that a ratio of 1:4 can enable the immediate-release granules to achieve a good release effect within 5-30 minutes, which not only meets the needs of initial rapid release of drugs, but also ensures the stability of the release, laying the foundation for the subsequent sustained-release granules to play a role.
3. The salt-gardenia sustained-release capsule according to claim 1, characterized in that: The weight ratio of the salt gardenia extract to lactose is 1:5, which has an important influence on the overall performance of the salt gardenia sustained-release capsule; If the ratio is 1:3, the early release rate is too slow and the drug efficacy cannot be exerted in time; if it is 1:4, the early drug release rate is fast, but the release rate within half an hour cannot meet the rapid release requirements; After many experimental tests, it was found that at a ratio of 1:5, lactose can effectively promote the release of salt gardenia extract, so that the rapid-release granules can reach the maximum release amount in about 20 minutes, which meets the requirements of rapid release. At the same time, when combined with sustained-release granules in the subsequent release, it can ensure the overall stability of drug release and ensure that the blood drug concentration is maintained within the effective therapeutic range for a long time.
4. The salt-gardenia sustained-release capsule according to claim 1, characterized in that: The weight ratio of cross-linked sodium carboxymethylcellulose to salt gardenia extract is 1:4, which is a key factor affecting the dissolution rate of salt gardenia rapid-release granules; When the weight ratio of cross-linked sodium carboxymethyl cellulose to immediate-release granules was 1:3, the release was the slowest and could not meet the immediate-release requirement; when the ratio was 1:5, the drug was released faster in the early stage, but the maximum release amount could not be reached in about 15 minutes; After repeated experiments on different ratios, it was determined that the ratio of 1:4 was the optimal dosage. Under this ratio, cross-linked sodium carboxymethyl cellulose can fully exert its disintegration effect, allowing the rapid-release granules to reach the maximum release amount in about 15 minutes, ensuring the rapid release of the drug and improving the bioavailability of the drug.
5. The salt-gardenia sustained-release capsule according to claim 1, characterized in that: The mixing ratio of the quick-release granules to the sustained-release granules is 1:5, which is obtained through a large number of experimental optimizations and has a significant effect on the release behavior of the salt gardenia sustained-release capsules; When the ratio is 1:3 or 1:4, the slope of the drug release curve is small, the early release rate is slow, and the effective therapeutic concentration cannot be reached quickly; when the ratio is 1:6, although the early release rate is improved, the later sustained release effect is not good; At a ratio of 1:5, the slope of the release curve of the Gardenia Salt Rapid-Release-Sustained-Release Granules is larger in the early stage, and the release rate is faster, which can quickly exert the drug effect. As time goes by, the slope decreases, meeting the requirements of sustained release, allowing the drug to be continuously and stably released in the body and effectively maintain blood drug concentration.
6. The Gardenia salt sustained-release capsule according to claim 1, characterized in that: In the ethanol reflux extraction method, the concentration of ethanol is 70%-80%, and the ethanol concentration has an important influence on the quality and active ingredient content of the salt gardenia extract; When the ethanol concentration is lower than 70%, the active ingredients in the salt gardenia are not completely extracted, resulting in a lower content of active ingredients in the extract, affecting the efficacy of the drug; when the ethanol concentration is higher than 80%, too many impurities may be extracted, increasing the difficulty of subsequent separation and purification, and may also destroy the structure of some active ingredients; After many experimental comparisons, it was found that an ethanol concentration of 70%-80% can reduce the extraction of impurities while ensuring the extraction rate of effective ingredients, thereby improving the purity and quality of the extract.
7. The salt-gardenia sustained-release capsule according to claim 1, characterized in that: The drying temperature is controlled at 55℃-65℃. The drying temperature has a direct impact on the quality and performance of the sustained-release particles. If the drying temperature is lower than 55°C, the granules will be dried for too long, which may lead to the growth of microorganisms and affect the product quality. If the drying temperature is higher than 65°C, some components in the granules may decompose or denature, affecting the stability and efficacy of the drug. Through experimental research, it was found that a drying temperature of 55℃-65℃ can make the sustained-release particles dry quickly while ensuring quality, and will not adversely affect the structure and composition of the particles, thus ensuring the stability and sustained-release performance of the sustained-release particles.
8. The Gardenia salt sustained-release capsule according to claim 1, characterized in that: When preparing the quick-release granules, the amount of the adhesive 5% povidone K30 solution used in the soft material preparation process is based on the standard of hand-held into a ball and extruded into a loose particle. The amount of the adhesive directly affects the molding quality and release performance of the quick-release granules. If the amount of binder is too little, the soft material cannot be formed, the particles are loose, and problems such as stratification and splitting are prone to occur during the preparation and storage process; if the amount of binder is too much, the particles will be too hard, affecting the release rate of the drug, and the rapid-release particles will not be able to release enough drugs within the specified time; Controlling the amount of binder by the standard of forming a ball by hand and forming a loose powder by squeezing can ensure that the rapid-release granules have good formability and release performance, thus ensuring the effectiveness and stability of the drug.