Compound Yiganling capsule with detoxification and enzyme reduction effects and preparation method thereof

Abstract

The present invention discloses a compound Yiganling capsule with detoxification and enzyme reduction effects and a preparation method thereof, comprising the following steps: S1, extracting silymarin extract powder; S2, extracting silymarin; S3, weighing fillers, stabilizers, flow aids and other auxiliary materials according to the formula; S4, mixing and granulating; S5, drying; S6, total mixing to ensure that each component is uniform; S7, filling the mixed granules into capsules and performing packaging operations. The present invention ensures the activity and uniform distribution of the main effective ingredients by optimizing the extraction process and the preparation method. The preparation of the capsule preparation solves the problems of low bioavailability and poor patient compliance in traditional tablets, and significantly improves the absorption efficiency and therapeutic effect of the drug. The compound Yiganling capsule of the present invention adopts silymarin and silymarin extract powder as the main active ingredients, supplemented with fillers, stabilizers and flow aids, has the significant effect of detoxification and enzyme reduction, and is suitable for the auxiliary treatment of various liver injuries.

Description

Technical Field

[0001] The invention relates to the field of preparation of a compound Yiganling capsule, and more specifically to a compound Yiganling capsule with detoxification and enzyme reduction effects and a preparation method thereof. Background Art

[0002] Compound Yiganling preparation is a widely used drug in clinical practice. It is mainly used to reduce liver cell damage, lower serum transaminase and alanine aminotransferase levels, and is safe and non-toxic. The current mainstream compound Yiganling preparations usually consist of silymarin, Schisandra chinensis extract powder or Herba Crepisae extract powder and excipients. Among them, the compound Yiganling preparation with Herba Crepisae extract powder as the main ingredient has shown good clinical effects in the treatment of liver damage.

[0003] However, the main dosage form of compound Yiganling preparations on the market is tablets. As a common oral solid preparation, tablets have certain limitations:

[0004] ① Low bioavailability: The absorption rate of tablets is slow, and the utilization rate of the drug in the body is relatively low. It takes a long time for the therapeutic effect to appear, which affects the timeliness of treatment.

[0005] ② Insufficient patient compliance: For patients who need to take medication for a long time, the slow onset of efficacy of tablets may reduce their medication compliance, thereby affecting the treatment effect.

[0006] ③ Limited medication method: Tablets are not suitable for all patients, especially for the elderly, children or patients with swallowing difficulties, as tablets will increase the difficulty for patients to take the medicine.

[0007] Based on the above problems, the existing compound Yiganling preparations are in urgent need of improvement in dosage form and preparation method. Therefore, the development of a new compound Yiganling preparation with detoxification and enzyme-lowering effects and its preparation method, especially a preparation with capsules as the main dosage form, will help overcome the defects of traditional tablets and has important research significance and clinical application value. Summary of the invention

[0008] In order to solve the deficiencies of the prior art, a method for preparing a compound Yiganling capsule having the effects of detoxification and enzyme reduction is provided, which specifically comprises the following steps:

[0009] A method for preparing a compound Yiganling capsule having the effects of detoxification and enzyme reduction, the method comprising the following steps:

[0010] S1. Extracting the extract powder of Creeping Jasmine: putting fresh Creeping Jasmine into an extraction tank and soaking and extracting it twice, filtering and precipitating it, concentrating and drying the filtrate to obtain the extract powder of Creeping Jasmine;

[0011] By soaking and extracting twice, the effective ingredients of the creeping vine can be fully released and the extraction rate can be improved. At the same time, the precipitation process is used to remove impurities, further improving the purity of the extract powder, which helps to improve the efficacy and stability of the drug.

[0012] S2, extracting silymarin: extracting, concentrating, roughing, adsorbing, dissolving, concentrating and drying the raw material of silymarin to obtain silymarin dry powder;

[0013] The oil removal process can reduce impurities and improve the extraction purity of silymarin; the adsorption and dissolution combined with concentration and drying method can effectively improve the stability of silymarin and ensure the quality uniformity and efficacy of the preparation;

[0014] S3. Add auxiliary materials and weigh ingredients: weigh auxiliary materials including fillers, stabilizers, and flow aids for later use;

[0015] Fillers can improve the fluidity and compression properties of particles, ensuring uniform distribution of materials in capsules; stabilizers can improve the mechanical stability of particles to prevent them from failing due to moisture or external forces during storage; flow aids can reduce friction between particles, improve material processing efficiency and capsule filling consistency.

[0016] S4, mixing and granulating: the materials for preparing the compound Yiganling capsule are weighed according to their components, and put into the granulator, the equipment is turned on for premixing for 5 minutes, and then 75% ethanol is added and granulated for 2 to 3 minutes;

[0017] S5, drying: drying the material obtained in S4 until the moisture content is ≤5%;

[0018] S6. Total mixing: adding the dried granules to a granulator, setting the mesh size of the sieve, collecting the granules passing through the sieve, and adding the collected granules to a mixer for total mixing;

[0019] S7, filling: add the mixed granules into the capsule filling machine, set the single-granule weight, start the equipment to fill the capsules, collect the filled capsules, and package the capsules.

[0020] Furthermore, in S1, drinking water is used to soak the creeping grass for 1.5 to 3.5 hours, and after heating to boiling, it is maintained at a slight boil for 50 to 80 minutes, and then filtered; the sedimentation time of the filtrate in the sedimentation tank is greater than 5 hours, and the judgment standard for stopping the concentrated heating is to stop when the concentrated density reaches 1.05-1.1.

[0021] Furthermore, the filler described in S3 is lactose or dextrin, or a mixture of both.

[0022] Furthermore, the stabilizer described in S3 is sodium carboxymethyl starch or carboxymethyl cellulose, or a mixture of both.

[0023] Furthermore, the glidant described in S3 is one or a mixture of several of silicon dioxide, magnesium stearate and calcium stearate.

[0024] Furthermore, the speed during premixing in S4 is 45-55 r / min, and the time is 5 min.

[0025] Furthermore, S5 is dried in a hot air circulation oven, the temperature is controlled at 60-65° C., and the material is dried for 3.5 hours.

[0026] Furthermore, the mesh number of the S6 sieve is 14 to 18. The total mixing time is 10 minutes.

[0027] A compound Yiganling capsule with detoxification and enzyme-reducing effects prepared by the above preparation method comprises the following components in percentage by mass: silymarin 20-25%; filler 45-52%; stabilizer 5-10%; flow aid 5-10%; and creeping vine extract powder 8-15%.

[0028] Beneficial effects:

[0029] The present invention provides a compound Yiganling capsule with detoxification and enzyme reduction effects and a preparation method thereof. The present invention successfully prepares a compound Yiganling capsule that meets the requirements through a carefully designed formula and actual experiments. Compared with the tablets commonly used in the market, the present invention has the following beneficial effects:

[0030] (1) The use of silybum extract powder to replace Schisandra chinensis is more friendly to hepatitis patients with stomach problems. It avoids excessive intake of Schisandra chinensis in the old prescription that causes gastric acid. On the other hand, it will not cause recurrence and the indicators will not suddenly increase after stopping the drug. At the same time, it also makes up for the defect that silymarin cannot treat acute poisoning.

[0031] (2) Increasing the dosage form of Compound Yiganling Capsules: The present invention provides a new dosage form of Compound Yiganling Capsules, which provides patients with more choices and helps to meet the needs of patients with different needs.

[0032] (3) Improve the bioavailability of drugs: Capsules have a faster absorption rate than tablets, which helps to improve the bioavailability of drugs in the body, thereby improving the therapeutic effect.

[0033] (4) Increase the number of beneficiaries: The capsule dosage form is easy to swallow and is particularly suitable for special groups such as the elderly and children who have difficulty swallowing.

[0034] (5) Improving drug stability: The fillers and stabilizers used in the present invention can improve drug stability and reduce the rate of drug decomposition, thereby ensuring the effectiveness of the drug.

[0035] (6) Simple preparation process: The preparation method of the compound Yiganling capsule provided by the present invention has a simple process and is easy to operate, which is conducive to large-scale production.

[0036] In summary, the compound Yiganling capsule provided by the present invention has significant beneficial effects, which not only improves the efficacy of the drug, but also expands the beneficiary population, and at the same time has good production and application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 The present invention is a flow chart of a method for preparing a compound Yiganling capsule having the effects of detoxification and enzyme reduction. DETAILED DESCRIPTION

[0038] In order to deepen the understanding of the present invention, the present invention will be further described in detail below in conjunction with examples. The examples are only used to explain the present invention and do not constitute a limitation on the protection scope of the present invention.

[0039] Figure 1 The present invention is a flow chart of a preparation method of a compound Yiganling capsule having the effects of detoxification and enzyme reduction. As shown in the figure, the preparation method comprises the following steps:

[0040] S1. Extracting the extract powder of Creeping Jasmine: putting fresh Creeping Jasmine into an extraction tank and soaking and extracting it twice, filtering and precipitating it, concentrating and drying the filtrate to obtain the extract powder of Creeping Jasmine;

[0041] S2, extracting silymarin: extracting, concentrating, roughing, adsorbing, dissolving, concentrating and drying the raw material of silymarin to obtain silymarin dry powder;

[0042] S3. Add auxiliary materials and weigh ingredients: weigh auxiliary materials including fillers, stabilizers, and flow aids for later use;

[0043] S4, mixing and granulating: weighing the materials for preparing the compound Yiganling capsule according to their components, and putting them into a granulator;

[0044] S5, drying: drying the material obtained in S4;

[0045] S6. Total mixing: adding the dried granules to a granulator, setting the mesh size of the sieve, collecting the granules passing through the sieve, and adding the collected granules to a mixer for total mixing;

[0046] S7, filling: add the mixed granules into the capsule filling machine, set the single-granule weight, start the equipment to fill the capsules, collect the filled capsules, and package the capsules.

[0047] The specific embodiments are as follows:

[0048] Embodiment 1:

[0049] A compound Yiganling capsule, taking 1000 capsules as an example, comprises the following components by weight:

[0050] Silymarin: 100g

[0051] Lactose (filler): 210g

[0052] Sodium carboxymethyl starch (stabilizer): 32g

[0053] Silicon dioxide (glidant): 32g

[0054] Creeping weed extract powder: 42g

[0055] The preparation method comprises the following steps:

[0056] (1) Picking materials

[0057] (2) Weighing materials: Weigh the corresponding materials according to the percentage of each component and put them into the granulator.

[0058] (3) Premixing and granulation: Turn on the equipment, set the speed to 50 r / min during premixing, mix for 5 minutes, then add 100 g of 75% ethanol, and continue granulation for 2 to 3 minutes, with the granulation spindle speed at 50 r / min and the cutter speed at 1000 r / min.

[0059] (4) Drying: The granulated drug particles are placed in a dryer at a temperature of 65°C for 20 minutes to ensure that the moisture content is ≤5%.

[0060] (5) Granulation: Add the dried granules into a granulator, set the sieve mesh number to 16, and collect the granules that pass through the sieve.

[0061] (6) Total mixing: Add the collected particles into a mixer for total mixing.

[0062] (7) Capsule filling and aluminum-plastic packaging: The mixed granules are subjected to intermediate product inspection. After passing the inspection, they are added to the capsule filling machine, and the single granule weight is set to 400 mg. The equipment is turned on for capsule filling, and the filled capsules are collected and packaged.

[0063] (8) Finished product storage: Finished products are stored after passing inspection.

[0064] Embodiment 2:

[0065] A compound Yiganling capsule, taking 1000 capsules as an example, comprises the following components by weight:

[0066] Silymarin: 100g

[0067] Lactose and dextrin mixture: 210g

[0068] Sodium carboxymethyl starch (stabilizer): 32g

[0069] Silicon dioxide (glidant): 32g

[0070] Creeping weed extract powder: 42g

[0071] The preparation method comprises the following steps:

[0072] (1) Picking materials

[0073] (2) Weighing materials: Weigh the corresponding materials according to the percentage of each component and put them into the granulator.

[0074] (3) Premixing and granulation: Turn on the equipment and set the speed to 50 r / min during premixing. Add 100 g of 75% ethanol and continue granulation for 2 to 3 minutes, with the granulation spindle speed at 50 r / min and the cutter speed at 1000 r / min.

[0075] (4) Drying: The granulated drug particles are placed in a dryer at a temperature of 65°C for 20 minutes to ensure that the moisture content is ≤5%.

[0076] (5) Granulation: Add the dried granules into a granulator, set the sieve mesh number to 16, and collect the granules that pass through the sieve.

[0077] (6) Total mixing: Add the collected particles into a mixer for total mixing.

[0078] (7) Capsule filling and aluminum-plastic packaging: The mixed granules are subjected to intermediate product inspection. After passing the inspection, they are added to the capsule filling machine, and the single granule weight is set to 400 mg. The equipment is turned on for capsule filling, and the filled capsules are collected and packaged.

[0079] (8) Finished product storage: Finished products are stored after passing inspection.

[0080] Embodiment 3:

[0081] A compound Yiganling capsule, taking 1000 capsules as an example, comprises the following components by weight:

[0082] Silymarin: 100g

[0083] Lactose (filler): 210g

[0084] Carboxymethyl cellulose and mixture of carboxymethyl cellulose (stabilizer): 32g

[0085] Silicon dioxide (glidant): 32g

[0086] Creeping weed extract powder: 42g

[0087] The preparation method comprises the following steps:

[0088] (1) Picking materials

[0089] (2) Weighing materials: Weigh the corresponding materials according to the percentage of each component and put them into the granulator.

[0090] (3) Premixing and granulation: Turn on the equipment and set the speed to 50 r / min during premixing. Add 100 g of 75% ethanol and continue granulation for 2 to 3 minutes, with the granulation spindle speed at 50 r / min and the cutter speed at 1000 r / min.

[0091] (4) Drying: The granulated drug particles are placed in a dryer at a temperature of 65°C for 20 minutes to ensure that the moisture content is ≤5%.

[0092] (5) Granulation: Add the dried granules into a granulator, set the sieve mesh number to 16, and collect the granules that pass through the sieve.

[0093] (6) Total mixing: Add the collected particles into a mixer for total mixing.

[0094] (7) Capsule filling and aluminum-plastic packaging: The mixed granules are subjected to intermediate product inspection. After passing the inspection, they are added to the capsule filling machine, and the single granule weight is set to 400 mg. The equipment is turned on for capsule filling, and the filled capsules are collected and packaged.

[0095] (8) Finished product storage: Finished products are stored after passing inspection.

[0096] Embodiment 4:

[0097] A compound Yiganling capsule, taking 1000 capsules as an example, comprises the following components by weight:

[0098] Silymarin: 100g

[0099] Lactose (filler): 210g

[0100] Sodium carboxymethyl starch (stabilizer): 32g

[0101] Mixture of magnesium stearate and calcium stearate (glidant): 32g

[0102] Creeping weed extract powder: 42g

[0103] The preparation method comprises the following steps:

[0104] (1) Picking materials

[0105] (2) Weighing materials: Weigh the corresponding materials according to the percentage of each component and put them into the granulator.

[0106] (3) Premixing and granulation: Turn on the equipment and set the speed to 50 r / min during premixing. Add 100 g of 75% ethanol and continue granulation for 2 to 3 minutes, with the granulation spindle speed at 50 r / min and the cutter speed at 1000 r / min.

[0107] (4) Drying: The granulated drug particles are placed in a dryer at a temperature of 65°C for 20 minutes to ensure that the moisture content is ≤5%.

[0108] (5) Granulation: Add the dried granules into a granulator, set the sieve mesh number to 16, and collect the granules that pass through the sieve.

[0109] (6) Total mixing: Add the collected particles into a mixer for total mixing.

[0110] (7) Capsule filling and aluminum-plastic packaging: The mixed granules are subjected to intermediate product inspection. After passing the inspection, they are added to the capsule filling machine, and the single granule weight is set to 400 mg. The equipment is turned on for capsule filling, and the filled capsules are collected and packaged.

[0111] (8) Finished product storage: Finished products are stored after passing inspection.

[0112] Embodiment 5:

[0113] A compound Yiganling capsule, taking 1000 capsules as an example, comprises the following components by weight:

[0114] Silymarin: 104g

[0115] Lactose (filler): 187.2g

[0116] Sodium carboxymethyl starch (stabilizer): 20.8g

[0117] Silicon dioxide (glidant): 20.8g

[0118] Creeping sedge extract powder: 62.4g

[0119] The preparation method comprises the following steps:

[0120] (1) Picking materials

[0121] (2) Weighing materials: Weigh the corresponding materials according to the percentage of each component and put them into the granulator.

[0122] (3) Premixing and granulation: Turn on the equipment and set the speed to 45 r / min during premixing. Add 100 g of 75% ethanol and continue granulation for 2 to 3 minutes, with the granulation spindle speed at 50 r / min and the cutter speed at 1000 r / min.

[0123] (4) Drying: The granulated drug particles are placed in a dryer at a temperature of 60°C for 10 minutes, ensuring that the moisture content is ≤5%.

[0124] (5) Granulation: Add the dried granules into a granulator, set the sieve mesh number to 18, and collect the granules that pass through the sieve.

[0125] (6) Total mixing: Add the collected particles into a mixer for total mixing.

[0126] (7) Capsule filling and aluminum-plastic packaging: The mixed granules are subjected to intermediate product inspection. After passing the inspection, they are added to the capsule filling machine, and the single granule weight is set to 400 mg. The equipment is turned on for capsule filling, and the filled capsules are collected and packaged.

[0127] (8) Finished product storage: Finished products are stored after passing inspection.

[0128] The items and results of the finished product inspection described in the above embodiment are shown in the following table:

[0129]

[0130] As a further improvement, the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A method for preparing a compound Yiganling capsule having the effects of detoxification and enzyme reduction, characterized in that: The preparation method comprises the following steps: S1. Extracting the extract powder of Creeping Jasmine: putting fresh Creeping Jasmine into an extraction tank and soaking and extracting it twice, filtering and precipitating it, concentrating and drying the filtrate to obtain the extract powder of Creeping Jasmine; S2, extracting silymarin: extracting, concentrating, roughing, adsorbing, dissolving, concentrating and drying the raw material of silymarin to obtain silymarin dry powder; S3. Add auxiliary materials and weigh ingredients: weigh auxiliary materials including fillers, stabilizers, and flow aids for later use; S4, mixing and granulating: the materials for preparing the compound Yiganling capsule are weighed according to their components, and put into the granulator, the equipment is turned on for premixing for 5 minutes, and then 75% ethanol is added and granulated for 2 to 3 minutes; S5, drying: drying the material obtained in S4 until the moisture content is ≤5%; S6. Total mixing: adding the dried granules to a granulator, setting the mesh size of the sieve, collecting the granules passing through the sieve, and adding the collected granules to a mixer for total mixing; S7, filling: add the mixed granules into the capsule filling machine, set the single-granule weight, start the equipment to fill the capsules, collect the filled capsules, and package the capsules.

2. The method for preparing the compound Yiganling capsule with detoxification and enzyme-lowering effects according to claim 1, characterized in that: In S1, drinking water is used to soak the creeping grass for 1.5 to 3.5 hours, heated to boiling, and then kept at a slight boil for 50 to 80 minutes, and then filtered; the sedimentation time of the filtrate in the sedimentation tank is greater than 5 hours, and the judgment standard for stopping the concentrated heating is to stop when the concentrated density reaches 1.05-1.

1.

3. The method for preparing the compound Yiganling capsule with detoxification and enzyme-lowering effects according to claim 1, characterized in that: The filler described in S3 is lactose or dextrin or a mixture of the two.

4. The method for preparing the compound Yiganling capsule with detoxification and enzyme-lowering effects according to claim 1, characterized in that: The stabilizer described in S3 is sodium carboxymethyl starch or carboxymethyl cellulose, or a mixture of both.

5. The method for preparing the compound Yiganling capsule with detoxification and enzyme-lowering effects according to claim 1, characterized in that: The glidant described in S3 is one or a mixture of silicon dioxide, magnesium stearate and calcium stearate.

6. The method for preparing the compound Yiganling capsule with detoxification and enzyme-lowering effects according to claim 1, characterized in that: The speed during premixing in S4 is 45-55 r / min and the time is 5 min.

7. The method for preparing the compound Yiganling capsule with detoxification and enzyme-lowering effects according to claim 1, characterized in that: S5 is dried in a hot air circulation oven, the temperature is controlled at 60-65°C, and the material is dried for 3.5 hours.

8. The method for preparing the compound Yiganling capsule with detoxification and enzyme-lowering effects according to claim 1, characterized in that: The mesh number of S6 sieve is 14-18; the total mixing time is 10 minutes.

9. A compound Yiganling capsule with detoxification and enzyme reduction effects prepared by the preparation method according to any one of claims 1 to 8, characterized in that: The compound Yiganling capsule comprises the following components in percentage by mass: 20-25% of silymarin; 45-52% of filler; 5-10% of stabilizer; 5-10% of flow aid; and 8-15% of silybum extract powder.

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