Lamiophlomis rotata granules for preparing lamiophlomis rotata capsules and preparation method of lamiophlomis rotata granules

Abstract

The invention discloses lamiophlomis rotata granules for preparing lamiophlomis rotata capsules and a preparation method of the lamiophlomis rotata granules, the granule weight of ten thousand lamiophlomis rotata capsules is taken as a prescription dosage, and the lamiophlomis rotata granules comprise the following raw materials: lamiophlomis rotata thick paste which is equivalent to the thick paste of ten thousand lamiophlomis rotata capsules; 1%-6% of corn starch, 0.5% of silicon dioxide and 0.5% of magnesium stearate according to the prescription dosage. The lamiophlomis rotata capsule is prepared from lamiophlomis rotata particles used for preparing the lamiophlomis rotata capsule, and 0.3 g of lamiophlomis rotata particles are filled into each capsule through a capsule filling machine. The lamiophlomis rotata tablet is prepared by directly mixing thick paste of lamiophlomis rotata with a small amount of filler, drying, crushing, mixing with a small amount of flow aid and lubricant, and carrying out dry granulation, can be formed only through one-time drying, avoids twice drying of medicines, reduces the production time cost and the energy consumption cost, and further reduces the quality risk.

Description

Technical Field

[0001] The invention relates to a preparation method of a radix ophiopogonis capsule, in particular to a radix ophiopogonis granule used for preparing the radix ophiopogonis capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background Art

[0002] Functions and indications of Duyiwei Capsule: promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding. It is used for various surgical wound pain and bleeding, traumatic fractures, sprains of tendons and bones, rheumatic pain, metrorrhagia, dysmenorrhea, gingival swelling and pain, and bleeding. For its preparation method, please refer to Figure 2 Process flow chart of .

[0003] The specific process is as follows: crush the Radix Angelicae Pubescentis, add water and boil three times, each time for 1 hour, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, dry below 80°C, crush, add an appropriate amount of starch, make granules, dry, put into capsules, and make 1000 capsules.

[0004] However, the dry extract powder formed after water extraction, concentration and drying is sensitive to moisture and heat, and has strong hygroscopicity and stickiness. After being mixed with an appropriate amount of corn starch, it will increase production costs and production time during the granulation and capsule filling process. This is specifically reflected in the following aspects:

[0005] (1) During the wet granulation (including drying) process, the extract powder is sensitive to water and temperature, and is prone to agglomeration during wet granulation.

[0006] (2) During the capsule filling process, the particles have low fluidity and cannot be discharged smoothly from the hopper, requiring manual assistance. At the same time, the particles are highly hygroscopic and sticky, which causes repeated adhesion to the mold and punch during capsule filling, resulting in multiple cleaning of the equipment, which ultimately leads to extended production time and increased production costs.

[0007] (3) The small bulk density of the particles causes the particles to overflow and the capsules have quality risks.

[0008] In view of this, it is necessary to propose a kind of Du Yiwei granules for preparing Du Yiwei capsules and a preparation method thereof to solve the above technical problems. Summary of the invention

[0009] In order to solve the shortcomings of the above-mentioned technology, the present invention provides a granule of Radix Angelicae Pubescentis for preparing Radix Angelicae Pubescentis capsules and a preparation method thereof. The Radix Angelicae Pubescentis granule provided by the present invention uses less auxiliary materials, and its hygroscopicity, bulk density and fluidity are improved, thereby reducing production costs and quality risks.

[0010] In order to solve the above technical problems, the technical solution adopted by the present invention is: a kind of Du Yiwei granules for preparing Du Yiwei capsules, with the weight of granules of 10,000 Du Yiwei capsules as one prescription amount, and its raw materials include: Du Yiwei thick paste, which is equivalent to the thick paste of 10,000 Du Yiwei capsules; 1%-6% prescription amount of corn starch, 0.5% prescription amount of silicon dioxide, and 0.5% prescription amount of magnesium stearate.

[0011] Preferably, the weight of 10,000 Du Yiwei capsules is used as one prescription quantity, the corn starch is 0.03kg-0.18kg, the silicon dioxide is 0.015kg, and the magnesium stearate is 0.015kg.

[0012] A method for preparing radix ophiopogonis granules for preparing radix ophiopogonis capsules comprises the following steps:

[0013] Step S1, preparing a thick paste of Radix Angelicae Pubescentis;

[0014] Step S2, preparing raw materials of Lamiophlomis lappa paste, 1%-6% corn starch, 0.5% silicon dioxide, and 0.5% magnesium stearate, wherein the amount of corn starch = the total amount of the prescription - the amount of silicon dioxide - the amount of magnesium stearate - the amount of solids in the thick paste;

[0015] Step S3, mixing the raw material Lamiophlomis lappa paste and the auxiliary material corn starch evenly by a trough mixer, and then drying by vacuum decompression, turning the material halfway, and obtaining a dry paste for standby use;

[0016] Step S4, grinding the dry paste by a grinder to make powdery particles, that is, obtaining the dry paste powder for preparing the Lamiaceae capsules, and setting aside;

[0017] Step S5, transferring the dry paste powder, silicon dioxide and magnesium stearate into a three-dimensional mixer for mixing, and obtaining the Duyiwei granules by a dry method.

[0018] The pulverized dry paste powder is mixed with a flow aid, silicon dioxide, and a lubricant, magnesium stearate, and then dry granulated. The main drug is dried and formed once.

[0019] Preferably, step S1 comprises the following steps:

[0020] Step S11, take the Chinese medicinal material Lamiophlomis lappa, screen it through a cleaning table to remove the sediment, and then select the impurities and non-medicinal parts to obtain the clean Chinese medicinal material Lamiophlomis lappa for use;

[0021] Step S12, taking clean Chinese medicinal materials of Lamiophlomis lappa, crushing them with a medicine cutter, setting the cutting depth to 0.7 cm, and obtaining Lamiophlomis lappa decoction pieces;

[0022] Step S13, taking the Radix Angelicae Pubescentis slices and crushing them by a grinder to prepare Radix Angelicae Pubescentis coarse powder;

[0023] Step S14, take the coarse powder of Radix Angelicae Pubescentis, wrap it in a nylon bag, each bag contains 2-3 kg, put it into a sandwich decoction pot, add water and decoct it 3 times, first quickly heat it to a slight boil, then control the temperature of the medicinal liquid within the range of 95-100° C., decoct it in a sealed container for 1 hour each time, filter the decoction liquid through 200 meshes each time, and set it aside;

[0024] Step S15, combining the decoction filtrates, concentrating under reduced pressure to a thick paste, and storing in a cold storage for later use;

[0025] Step S16, taking samples, detecting the water content of the thick paste, calculating the weight of the solid matter contained in the thick paste, and obtaining the Lamiaceae thick paste.

[0026] Preferably, in step S3, the vacuum drying temperature is below 80°C, and the material is discharged when the moisture content of the dry paste reaches 2±0.5%.

[0027] Preferably, in step S4, the dried paste is crushed into 80-100 meshes.

[0028] Preferably, in step S13, the mesh size of the sieve used when crushing the Radix Angelicae Pubescentis slices is 24 meshes.

[0029] The pieces of Lamiophlomis lappa are crushed into coarse powder and used for decoction.

[0030] Preferably, in step S14, the coarse powder of Radix Angelicae Pubescentis is packed in a 200-mesh nylon bag, the size of the bag is 1.27m×1.27m, and the amount of water added for three decoctions is 8 times, 6 times, and 6 times the amount of the medicinal material, respectively.

[0031] Preferably, in step S15, the reduced pressure concentration temperature is ≤80°C, and the relative density of the thick paste detected at 60°C is 1.3±0.05.

[0032] A radix ophiopogonis capsule is prepared by using radix ophiopogonis granules for preparing radix ophiopogonis capsules, and the radix ophiopogonis granules are filled into capsules by a capsule filling machine at a rate of 0.3 g per granule.

[0033] The dry paste powder of the granular raw material for forming the capsule is mixed with a glidant and a lubricant for dry granulation, and then filled into the capsule.

[0034] Compared with the granulation method of the Duyiwei capsule in the "Chinese Pharmacopoeia" 2020 (twice drying and molding), the granulation method of the Duyiwei capsule of the present invention saves production time cost, reduces energy consumption, and avoids double drying of the drug, thereby reducing production cost and quality risk. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The present invention is a process flow chart for preparing the Lamiaceae capsules.

[0036] Figure 2The present invention is a process flow chart for preparing Duyiwei capsules using the prior art. DETAILED DESCRIPTION

[0037] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0038] Example 1

[0039] The weight of 20,000 Du Yiwei capsules is taken as one prescription quantity, and the prescription quantity is 6 kg.

[0040] The radix ophiopogonis granules include solids of radix ophiopogonis thick paste and auxiliary materials of corn starch, silicon dioxide and magnesium stearate, and the weight ratio of the three is 5.65:0.29:0.03:0.03.

[0041] The granules of Duyiwei are prepared by the following method:

[0042] S1. Take a single Chinese herbal medicine, filter it through a cleaning table to remove the mud and sand, and then select the impurities and non-medicinal parts to obtain a clean single Chinese herbal medicine for use.

[0043] S2. Take clean Chinese herbal medicine Du Yiwei and cut it into pieces of about 0.7 cm using a medicine cutter to obtain Du Yiwei medicinal slices.

[0044] S3. Take the Radix Angelicae Pubescentis slices and grind them through a grinder (through a 24-mesh sieve) to make Radix Angelicae Pubescentis coarse powder.

[0045] S4. Take 20kg of coarse powder of Radix Angelicae Pubescentis (prepared according to the prescription of 20,000 grains), wrap it with 7-10 nylon bags (1.27m×1.27m) of 200 mesh, put 2-3kg in each bag, put it into the interlayer decoction pot, add 160kg, 120kg, and 120kg of water respectively, decoct it 3 times, each time for 1 hour. First quickly heat it to a slight boil, then control the temperature of the liquid medicine within the range of 97-100℃, decoct it in a sealed container for 1 hour, filter the decoction liquid through 200 mesh, and set aside.

[0046] S5. Combine the decoction filtrates, concentrate under reduced pressure (≤80°C) to a thick paste (ρ1.3±0.05, 60°C), and obtain 10.02 kg of thick paste for preparing the Duyiwei granules for Duyiwei capsules. Store in a cold storage for later use.

[0047] S6. Samples were taken from the thick paste of Radix Angelicae Pubescentis, and the moisture content of the paste was 43.61%, and the weight of the solid matter was 5.65 kg.

[0048] S7. According to the test results, calculate the amount of corn starch added: corn starch amount = total amount of the prescription - silicon dioxide amount - magnesium stearate amount - solid amount. Add 0.5% silicon dioxide, 0.5% magnesium stearate, and 1%-6% corn starch of the total amount of the prescription into the thick paste.

[0049] S8. Evenly mix 10.02 kg of Lamiophlomis thick paste and 0.29 kg (4.8% of the total amount of the prescription) of the auxiliary material corn starch in a trough mixer, and dry under vacuum (≤80°C), turning the material over halfway, and discharging the material when the moisture content of the dry paste is about 2±0.5%. To obtain 5.52 kg of dry paste for preparing Lamiophlomis granules, set aside.

[0050] S9. Grind 5.52 kg of dry paste through a 80-100 mesh grinder to make 4.88 kg of powdered dry paste for later use.

[0051] S10. Transfer 4.88 kg of dry paste powder, 0.03 kg of silicon dioxide (0.5% of the total amount of the prescription), and 0.03 kg of magnesium stearate (0.5% of the total amount of the prescription) into a three-dimensional mixer, and mix and dry granulate to obtain 4.89 kg of Du Yiwei granules for preparing Du Yiwei capsules, which are set aside.

[0052] S11. Use a capsule filling machine to fill each capsule with 0.3 g of the Lamiophlomis granules.

[0053] Example 2

[0054] The prescription quantity is 4.5 kg, with the weight of 15,000 capsules of Du Yiwei as one prescription quantity.

[0055] The granules of Radix Angelicae Pubescentis include the solids of the Radix Angelicae Pubescentis thick paste and auxiliary materials of corn starch, silicon dioxide and magnesium stearate, and the weight ratio of the three is 4.32:0.135:0.0225:0.0225.

[0056] The granules of Duyiwei are prepared by the following method:

[0057] S1. Take a single Chinese herbal medicine, filter it through a cleaning table to remove the mud and sand, and then select the impurities and non-medicinal parts to obtain a clean single Chinese herbal medicine for use.

[0058] S2. Take clean Chinese herbal medicine Du Yiwei and cut it into pieces of about 0.7 cm using a medicine cutter to obtain Du Yiwei medicinal slices.

[0059] S3. Take the Radix Angelicae Pubescentis slices and grind them through a grinder (through a 24-mesh sieve) to make Radix Angelicae Pubescentis coarse powder.

[0060] S4. Take 15kg of coarse powder of Radix Angelicae Pubescentis (according to the prescription of 15,000 grains), wrap it with 5-8 200-mesh nylon bags (1.27m×1.27m), put 2-3kg in each bag, put it into the interlayer decoction pot, add 120kg, 90kg, and 90kg of water respectively, decoct it 3 times, each time for 1 hour. First quickly heat it to a slight boil, then control the temperature of the liquid medicine within the range of 95-100℃, decoct it in a sealed container for 1 hour, filter the decoction liquid through 200 mesh, and set aside.

[0061] S5. Combine the decoction filtrates, concentrate under reduced pressure (≤80°C) to a thick paste (ρ1.3±0.05, 60°C), and obtain 7.83 kg of thick paste for preparing the Duyiwei granules for Duyiwei capsules. Store in a cold storage for later use.

[0062] S6. Samples were taken from the thick paste of Radix Angelicae Pubescentis, and the moisture content of the paste was 44.83%, and the weight of the solid matter was 4.32 kg.

[0063] S7. Calculate the amount of corn starch added based on the test results: corn starch amount = total amount of the recipe - silicon dioxide amount - magnesium stearate amount - solid amount. Add 1%-5% corn starch to the thick paste.

[0064] S8. Evenly mix 7.83 kg of Lamiophlomis thick paste and 0.135 kg (3% of the total amount of the prescription) of the auxiliary material corn starch in a trough mixer, and dry under vacuum (≤80°C), turning the material over halfway, and discharging the material when the moisture content of the dry paste is about 2±0.5%. 4.14 kg of dry paste for preparing Lamiophlomis granules is obtained and set aside.

[0065] S9. Crush 4.14 kg of dry paste with a 80-100 mesh grinder to make 3.75 kg of powdered particles for later use.

[0066] S10. Transfer 3.75 kg of dry paste powder, 0.0225 kg of silicon dioxide (0.5% of the total amount of the prescription), and 0.0225 kg of magnesium stearate (0.5% of the total amount of the prescription) into a three-dimensional mixer for mixing and dry granulation to obtain 3.78 kg of Duyiwei granules for preparing Duyiwei capsules.

[0067] S11. Use a capsule filling machine to fill each capsule with 0.3 g of the Lamiophlomis granules.

[0068] In Example 3 to Example 9: the weight of 15,000 particles of Du Yiwei capsules is taken as one prescription quantity, and the prescription quantity is 4.5 kg.

[0069] The Lamiaceae granules of Example 3 to Example 9 include the solids of the Lamiaceae thick paste, and the auxiliary materials corn starch, silicon dioxide, and magnesium stearate in proportions of 4.26:0.195:0.0225:0.225, 4.32:0.135:0.0225:0.225, 4.36:0.095:0.0225:0.225, 4.33:0.125:0.0225:0.225, 4.38:0.075:0.0225:0.225, 4.21:0.245:0.0225:0.225, and 4.25:0.205:0.0225:0.225, respectively. The amount of corn starch is 1.67%-5.44% of the prescribed amount, and the amounts of silicon dioxide and magnesium stearate are both 0.5% of the prescribed amount.

[0070] The preparation method and steps of the Radix Angelicae Pubescentis granules of Examples 3 to 9 are the same as those of Example 2, and the feeding amount of the Radix Angelicae Pubescentis coarse powder is 15 kg.

[0071] In Example 10-Example 12: the weight of 170,000 particles of Du Yiwei capsules is taken as one prescription quantity, and the prescription quantity is 51 kg.

[0072] The radix ophiopogonis granules of Example 10 to Example 12 include the solid matter of the radix ophiopogonis thick paste, and the auxiliary materials corn starch, silicon dioxide, and magnesium stearate in proportions of 48.91:1.58:0.255:0.255,

[0073] The composition of the invention is 49.32:1.17:0.255:0.255 and 46.36:1.96:0.255:0.255, the amount of corn starch is 2.29%-3.84% of the prescribed amount, and the amount of silicon dioxide and magnesium stearate are both 0.5% of the prescribed amount.

[0074] The preparation method and steps of the Lamiophlomis granules of Examples 10 to 12 are consistent with those of Examples 1 to 9, and the feeding amount of the Lamiophlomis coarse powder is 170 kg.

[0075] In the above Examples 1 to 12, the amount of corn starch as an auxiliary material in the Lamiophlomis granules is 1%-6% of the prescribed amount, and the amount of silicon dioxide and magnesium stearate are both 0.5% of the prescribed amount.

[0076] Table 1 is a summary of materials for Examples 1-12

[0077]

[0078] The present invention crushes the Radix Angelicae Pubescentis slices into coarse powder, adopts a wrapping and decocting method, so that the decoction is easy to filter, and the active ingredients of the Radix Angelicae Pubescentis can be fully transferred out. The prepared Radix Angelicae Pubescentis thick paste has high content and high solid content, so that a small amount of auxiliary material corn starch can be used as a filler to prepare the Radix Angelicae Pubescentis granules for Radix Angelicae Pubescentis capsules. It can be seen from Table 1 that the Radix Angelicae Pubescentis thick pastes prepared in Examples 1-12 have high content and high solid content.

[0079] Table 2 is a summary of the main drug component contents of the thick paste, dry paste and granules of Examples 1-12

[0080]

[0081] As can be seen from Table 2, the present invention directly mixes the thick paste of Radix Angelicae Pubescentis with a small amount of filler, dries, and crushes, and then mixes with a small amount of glidant and lubricant, and dry granulates the mixture, and can be formed by drying once, which can reduce production time cost and energy consumption cost, and improve its fluidity, hygroscopicity and stickiness, further reducing quality risks. As can be seen from Tables 1 and 2, the yield of Examples 1-12 is above 79%, and the capsule filling rate is above 85%. Therefore, the Radix Angelicae Pubescentis capsules prepared by the present invention have a high content and a high yield of finished products.

[0082] The above embodiments are preferred implementation schemes of the present invention. In addition, the present invention may also be implemented in other ways. Any obvious replacement without departing from the concept of the present invention is within the protection scope of the present invention.

[0083] The above implementation modes are not limitations of the present invention, and the present invention is not limited to the above examples. Changes, modifications, additions or substitutions made by technicians in this technical field within the scope of the technical solution of the present invention also belong to the protection scope of the present invention.

Claims

1. A granule of Radix Angelicae Pubescentis for preparing Radix Angelicae Pubescentis capsules, characterized in that: The weight of particles of 10,000 Duyiwei capsules is taken as one prescription quantity, and its raw materials include: Duyiwei thick paste, which is equivalent to the thick paste of 10,000 Duyiwei capsules; 1%-6% prescription quantity of corn starch, 0.5% prescription quantity of silicon dioxide, and 0.5% prescription quantity of magnesium stearate.

2. The granules of Radix Angelicae Pubescentis for preparing Radix Angelicae Pubescentis capsules according to claim 1, characterized in that: The prescription quantity is based on the weight of 10,000 Du Yiwei capsules, which includes 0.03kg-0.18kg of corn starch, 0.015kg of silicon dioxide and 0.015kg of magnesium stearate.

3. A method for preparing the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules according to any one of claims 1 to 2, characterized in that: The steps include: Step S1, preparing a thick paste of Radix Angelicae Pubescentis; Step S2, preparing raw materials of Lamiophlomis lappa paste, 1%-6% corn starch, 0.5% silicon dioxide, and 0.5% magnesium stearate, wherein the amount of corn starch = the total amount of the prescription - the amount of silicon dioxide - the amount of magnesium stearate - the amount of solids in the thick paste; Step S3, mixing the raw material Lamiophlomis lappa paste and the auxiliary material corn starch evenly by a trough mixer, and then drying by vacuum decompression, turning the material halfway, and obtaining a dry paste for standby use; Step S4, grinding the dry paste by a grinder to make powdery particles, that is, obtaining the dry paste powder for preparing the Lamiaceae capsules, and setting aside; Step S5, transferring the dry paste powder, silicon dioxide and magnesium stearate into a three-dimensional mixer for mixing, and obtaining the Duyiwei granules by a dry method.

4. The method for preparing the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules according to claim 3, characterized in that: The step S1 comprises the following steps: Step S11, take the Chinese medicinal material Lamiophlomis lappa, screen it through a cleaning table to remove the sediment, and then select the impurities and non-medicinal parts to obtain the clean Chinese medicinal material Lamiophlomis lappa for use; Step S12, taking clean Chinese medicinal materials of Lamiophlomis lappa, crushing them with a medicine cutter, setting the cutting depth to 0.7 cm, and obtaining Lamiophlomis lappa decoction pieces; Step S13, taking the Radix Angelicae Pubescentis slices and crushing them by a grinder to prepare Radix Angelicae Pubescentis coarse powder; Step S14, take the coarse powder of Radix Angelicae Pubescentis, wrap it in a nylon bag, each bag contains 2-3 kg, put it into a sandwich decoction pot, add water and decoct it 3 times, first quickly heat it to a slight boil, then control the temperature of the medicinal liquid within the range of 95-100° C., decoct it in a sealed container for 1 hour each time, filter the decoction liquid through 200 meshes each time, and set it aside; Step S15, combining the decoction filtrates, concentrating under reduced pressure to a thick paste, and storing in a cold storage for later use; Step S16, taking samples, detecting the water content of the thick paste, calculating the weight of the solid matter contained in the thick paste, and obtaining the Lamiaceae thick paste.

5. The method for preparing the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules according to claim 3, characterized in that: In step S3, the vacuum drying temperature is below 80°C, and the material is discharged when the moisture content of the dry paste reaches 2±0.5%.

6. The method for preparing the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules according to claim 3, characterized in that: In step S4, the dried paste is crushed into 80-100 meshes.

7. The method for preparing the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules according to claim 4, characterized in that: In step S13, the mesh size of the sieve used when crushing the Radix Angelicae Pubescentis slices is 24 meshes.

8. The method for preparing the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules according to claim 4, characterized in that: In step S14, the coarse powder of Radix Angelicae Pubescentis is packed in a 200-mesh nylon bag with a size of 1.27 m×1.27 m. The amount of water added for three decoctions is 8 times, 6 times, and 6 times the amount of the medicinal material, respectively.

9. The method for preparing the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules according to claim 4, characterized in that: In step S15, the reduced pressure concentration temperature is ≤80°C, and the relative density of the thick paste detected at 60°C is 1.3±0.

05.

10. A capsule of Lamiophlomis lappa, characterized in that: The invention is prepared by using the Radix Angelicae Pubescentis granules for preparing Radix Angelicae Pubescentis capsules as claimed in claim 1, and is filled into capsules by a capsule filling machine at a rate of 0.3 g of Radix Angelicae Pubescentis granules per capsule.

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