A compound licorice tablet that can be processed by dry powder direct compression
Through the dry powder direct pressing process and the use of specific auxiliary materials, the problems of poor fluidity and low compressibility of compound licorice tablets in traditional preparation processes are solved, the quality and efficacy of the product are improved, and the process flow is simplified.
Patent Information
- Application Number
- CN202310049703.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-12-24
- Publication Date
- 2025-02-28
- Estimated Expiration
- 2041-12-24
AI Technical Summary
In the traditional preparation process, compound licorice tablets have problems such as poor fluidity, low compressibility, unqualified frigidity, high hardness but unqualified frigidity, white spots and pockmarks on the surface of the tablet, low volatile oil content and large differences in the main components of the finished product, which affects the efficacy and appearance.
The dry powder direct pressing process is adopted to improve the pressurization and adsorption and stability of volatile oils by controlling the average particle size of the primary mixture, and the use of new auxiliary materials polyvinylpyrrolidone (VA64) and silica, thereby simplifying the process and improving efficiency.
It improves the fluidity, compressibility and volatile oil content of compound licorice tablets, improves the appearance and efficacy of the tablets, improves the overall product quality, and simplifies the process to make it more economical and feasible.
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Abstract
Description
[0001] This application is a divisional application. Parent application number: 202111600573.4, application date: December 24, 2021, invention title: A compound licorice tablet that can be made by dry powder direct compression process and its preparation method. Technical Field
[0002] The invention relates to the technical field of pharmaceutical manufacturing, and in particular to a compound licorice tablet which can be processed by a dry powder direct compression process. Background Art
[0003] Compound licorice tablets are a natural compound preparation unique to my country. They contain licorice extract, poppy fruit extract powder, camphor, star anise oil and other Chinese medicinal ingredients. They are the first-line medicine used clinically for antitussive and expectorant purposes. They are included in the National Essential Medicines List. They are effective, inexpensive and have been used in my country for more than 60 years. They are very popular among both doctors and patients.
[0004] The traditional preparation process of compound licorice tablets is to wet granulate licorice extract and other raw materials, use fine powder or necessary external auxiliary materials to absorb volatile oil, and then mix with other particles to form tablets. The fine powder or external auxiliary materials cannot completely absorb volatile oil or the effect is poor, and the prepared particles have poor fluidity, which often leads to the following defects in tableting:
[0005] (1) Poor fluidity and difficulty in tableting;
[0006] (2) The tablets can be pressed smoothly but the compressibility is low, and the brittleness is not up to standard, and even the edges and corners are broken during transportation;
[0007] (3) The tablet hardness is high but the friability is still unqualified;
[0008] (4) The tablet surface is prone to appearance problems such as white spots and pitting, which affects consumer use;
[0009] (5) The volatile oil content of the finished product is low, which affects the therapeutic effect;
[0010] (6) The content of the main ingredients varies greatly within batches of tablets, which may affect the efficacy.
[0011] In addition, patent CN104382993A discloses a compound licorice tablet and its preparation process, which adopts a powder direct tableting process, and the volatile oil is adsorbed by one or a combination of calcium hydrogen phosphate, calcium carbonate, aluminum oxide and magnesium oxide, and the adsorption effect is poor, resulting in a low volatile oil content and low compressibility of the tablet (see comparative example 11 of the present invention). Summary of the invention
[0012] The technical problem to be solved by the present invention is to overcome the technical defects of the background technology and provide a compound licorice tablet that can be used in a dry powder direct compression process and a preparation method thereof. The present invention fundamentally guarantees the appearance of the preparation by controlling the average particle size of the primary mixture (a mixture of licorice extract, poppy fruit extract powder and sodium benzoate); the present invention solves the compressibility and solubility problems by screening and selecting a new auxiliary material polyvinyl pyrrolidone (VA64); the present invention solves the adsorption and stability problems of volatile oils by using silicon dioxide, and improves the fluidity and compressibility of particles; the present invention simplifies the process, improves efficiency, increases the content of volatile oils in the finished product, improves the efficacy, and improves the quality of the compound licorice tablets as a whole by using a direct tableting method; the process route of the present invention is simpler, more efficient and economically feasible than the prior art.
[0013] The technical solution adopted by the present invention to solve the above technical problems is as follows:
[0014] A preparation method of a compound licorice tablet that can be prepared by a dry powder direct compression process comprises the following steps: weighing → initial mixing → sieving → dissolving and adsorbing → premixing → total mixing → tableting → packaging:
[0015] (1) Weighing: According to the prescription amount, weigh the raw materials and excipients, namely, 112.5 mg of licorice extract, 4 mg of poppy fruit extract powder, 2 mg of sodium benzoate, 2 mg of camphor, 2 mg of star anise oil, 4-20 mg of silicon dioxide, 0-100 mg of microcrystalline cellulose, 0-100 mg of lactose, 1-20 mg of polyvinyl pyrrolidone, 5-50 mg of talc, and 1-10 mg of magnesium stearate, and set aside;
[0016] (2) Primary mixing: placing the licorice extract, poppy fruit extract powder and sodium benzoate in step (1) in the same plastic bag, referred to as the primary mixture, mixing the primary mixture evenly and then pulverizing the primary mixture to obtain a material a with an average particle size of about 50 to 70 μm;
[0017] (3) Sieving: The microcrystalline cellulose, lactose and polyvinyl pyrrolidone in step (1) are respectively passed through a 60-120 mesh sieve to obtain material b, which is set aside; the silicon dioxide, talc and magnesium stearate in step (1) are respectively passed through a 60-120 mesh sieve to set aside;
[0018] (4) Dissolution and adsorption: dissolving the camphor described in step (1) in the star anise oil described in step (1), adding the silicon dioxide described in step (3) under stirring for adsorption, and sealing and standing for 6 to 24 hours; rubbing the obtained material to disperse, passing through a 60 to 120 mesh sieve, and obtaining material C for standby use;
[0019] (5) Premixing: adding the material a described in step (2), the material b described in step (3), and the material c described in step (4) to a wet granulator in sequence, and mixing them uniformly to obtain material d;
[0020] (6) total mixing: uniformly mixing the material d described in step (5) with the talc powder and magnesium stearate described in step (3) to obtain material e;
[0021] (7) tableting: tableting the material e described in step (6) to obtain plain tablets;
[0022] (8) Packaging: Packing the tablets described in step (7) to obtain.
[0023] Preferably, in step (1), the polyvinyl pyrrolidone is polyvinyl pyrrolidone (VA64).
[0024] Preferably, in the step (2), the pulverizing process adopts any one or more of a universal pulverizer, a jet pulverizer, a needle pulverizer and a hammer pulverizer.
[0025] Preferably, in the step (2), the mesh size of the primary mixture after pulverization is 100 mesh.
[0026] Preferably, in the step (3), the microcrystalline cellulose, lactose and polyvinyl pyrrolidone are respectively passed through a 60-mesh sieve to obtain material b.
[0027] Preferably, in step (3), the silicon dioxide, talc and magnesium stearate are respectively sieved through a 60-mesh sieve.
[0028] Preferably, in step (4), the sealed standing time is 6 hours.
[0029] Preferably, in step (5), the parameters during mixing are: stirring speed of 100 to 300 rpm, shear speed of 1000 to 2000 rpm, and mixing time of 2 to 4 min.
[0030] More preferably, in step (5), the parameters during mixing are: stirring speed is 200 rpm, shear speed is 1000 rpm, and mixing time is 2 min.
[0031] Preferably, in step (6), the mixing time is 3 to 20 minutes.
[0032] More preferably, in step (6), the mixing time is 5 minutes.
[0033] Preferably, in the step (7), the tableting is performed using a tablet press.
[0034] Preferably, in step (7), tabletting is performed using a 6.5-10.5 mm, round shallow concave or flat punch die, with a main pressing force of 6-20 KN.
[0035] Preferably, in step (7), the tabletting is performed using a 7mm, round shallow concave, and a main pressure of 8KN.
[0036] Preferably, in step (8), the packaging is bottle packaging.
[0037] A compound licorice tablet that can be prepared by a dry powder direct compression process. According to the prescription amount, the formula of each compound licorice tablet comprises 112.5 mg of licorice extract, 4 mg of poppy fruit extract powder, 2 mg of sodium benzoate, 2 mg of camphor, 2 mg of star anise oil, 4-20 mg of silicon dioxide, 0-100 mg of microcrystalline cellulose, 0-100 mg of lactose, 1-20 mg of polyvinyl pyrrolidone, 5-50 mg of talc, and 1-10 mg of magnesium stearate; according to the prescription amount, the core of each compound licorice tablet has a total of 133.5-422.5 mg.
[0038] Preferably, according to the prescription amount, the formula of each compound licorice tablet includes 2 to 6 mg of magnesium stearate.
[0039] In the above technical solution, the polyvinyl pyrrolidone (VA64) is an adhesive.
[0040] In the above technical solution, the silicon dioxide is a substance that absorbs volatile oil.
[0041] In the above technical scheme, the value range of the components involved in the formula of the compound licorice tablets is A~B, which means that the endpoint values A and B can be taken. For example, the content of silicon dioxide is 4~20 mg, which means that the lower limit of the silicon dioxide content can be 4 mg, and the upper limit of the content can be 20 mg; for example, the content of microcrystalline cellulose is 0~100 mg, and the content of lactose is 0~100 mg, which means that the lower limit of the content of microcrystalline cellulose and lactose can both be 0 mg, and the upper limit of the content can both be 100 mg.
[0042] Basic principles of the present invention:
[0043] The technical solution provided by the present invention fully utilizes the excellent formulation performance of silicon dioxide as a flow aid and adsorbent. It has a large specific surface area, and the surface hydroxyl groups and a large number of surface cavities can have a strong adsorption and accumulation effect with small molecules of volatile oils, and can also have a strong hydrogen bond adsorption with water, which greatly improves the fluidity and compressibility of the material without affecting the dissolution. On this basis, the present invention develops and provides an optimal dosage range of silicon dioxide through the use of different dosages and combined with the comparison of formulation performance, which can not only fully adsorb and maintain the stability of the volatile oil content, but also provide good flow aid performance and good powder compressibility, thereby ensuring that the key quality attributes of the tablets, such as appearance, hardness and dissolution, meet the predetermined quality requirements.
[0044] Compared with the prior art, the present invention has the following beneficial effects:
[0045] (1) The present invention fundamentally ensures the appearance of the preparation by controlling the particle size of the premix (a mixture of licorice extract, poppy fruit extract powder, and sodium benzoate, with an average particle size of 50 to 70 μm);
[0046] (2) The present invention uses a new excipient polyvinyl pyrrolidone (VA64) with good compressibility, which not only improves the compressibility of the preparation but also does not affect the dissolution rate;
[0047] (3) The present invention uses silicon dioxide to adsorb volatile oil. On the one hand, because silicon dioxide has a large specific surface area, its adsorption effect is stronger than other adsorbents, such as magnesium oxide, aluminum hydroxide, calcium hydrogen phosphate and cyclodextrin, at the same dosage. On the other hand, because silicon dioxide has a small particle size, it is easy to adsorb on the surface of other solid auxiliary materials, thereby improving the fluidity of the particles.
[0048] (4) The present invention adopts a wet granulator, which has a better mixing effect than a general mixer and ensures the uniformity of the content of each main component;
[0049] (5) The present invention adopts a direct tableting method, which not only improves efficiency and makes commercial production more economical and feasible, but also greatly reduces the loss of volatile oil in the intermediate preparation process, greatly increases the content of volatiles in the tablets, and improves the therapeutic effect. DETAILED DESCRIPTION
[0050] In order to better understand the content of the present invention, further description is given below in conjunction with specific embodiments. It should be understood that these embodiments are only used to further illustrate the present invention, and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content described in the present invention, those skilled in the art make some non-essential changes or adjustments to the present invention, which still belong to the protection scope of the present invention.
[0051] Example 1
[0052] A method for preparing a compound licorice tablet that can be prepared by a dry powder direct compression process comprises the following steps:
[0053] (1) Weighing: Weigh 10,000 tablets, and weigh the raw and auxiliary materials, namely, 1125.0 g of liquorice extract, 40 g of poppy fruit extract powder, 20 g of sodium benzoate, 20 g of camphor, 20 g of star anise oil, 40 g of silicon dioxide, 50 g of microcrystalline cellulose, 50 g of lactose, 20 g of polyvinyl pyrrolidone (VA64), 50 g of talc, and 30 g of magnesium stearate, and set aside;
[0054] (2) Primary mixing: the licorice extract, poppy fruit extract powder and sodium benzoate described in step (1) are placed in the same plastic bag, which is referred to as the primary mixture. The primary mixture is mixed evenly and then passed through a universal grinder with 100 meshes to obtain a mean particle size of about 70 gm, thereby obtaining material a.
[0055] (3) Sieving: The microcrystalline cellulose, lactose and polyvinyl pyrrolidone (VA64) described in step (1) are respectively passed through a 60-mesh sieve to obtain material b, which is set aside; the silicon dioxide, talc and magnesium stearate described in step (1) are respectively passed through a 60-mesh sieve to set aside;
[0056] (4) Dissolution and adsorption: dissolving the camphor described in step (1) in the star anise oil described in step (1), adding the silicon dioxide described in step (3) under stirring for adsorption, and allowing to stand in a sealed container for 6 hours; passing the obtained material through a 120-mesh vibrating sieve to obtain material C, which is set aside;
[0057] (5) Premixing: Add the material a described in step (2), the material b described in step (3), and the material c described in step (4) into the wet granulator in sequence, stir at 200 rpm, shear at 1000 rpm, and mix for 2 min to obtain material d;
[0058] (6) Total mixing: mixing the material d described in step (5) with the talc powder and magnesium stearate described in step (3) for 5 minutes to obtain material e;
[0059] (7) tabletting: the material e described in step (6) is tabletted, using a 7.0 mm, round shallow concave, main pressure of 8KN, to obtain a plain tablet;
[0060] (8) Packaging: Packing the tablets described in step (7) to obtain.
[0061] Example 2
[0062] This embodiment is substantially the same as embodiment 1, except that 50 g of microcrystalline cellulose and 50 g of lactose in step (1) of embodiment 1 are replaced with 0 g of microcrystalline cellulose and 0 g of lactose, respectively.
[0063] Example 3
[0064] This embodiment is substantially the same as embodiment 1, except that 50 g of microcrystalline cellulose and 50 g of lactose in step (1) of embodiment 1 are replaced with 100 g of microcrystalline cellulose and 0 g of lactose, respectively.
[0065] Example 4
[0066] This embodiment is substantially the same as Embodiment 1, except that the 50 g of microcrystalline cellulose and the 50 g of lactose in step (1) of Embodiment 1 are replaced with 0 g of microcrystalline cellulose and 100 g of lactose, respectively.
[0067] Example 5
[0068] This embodiment is basically the same as embodiment 1, except that the primary mixture in step (2) of embodiment 1 is treated as follows: the primary mixture is mixed evenly and then crushed with a needle mill to have an average particle size of about 60 μm.
[0069] Example 6
[0070] This embodiment is basically the same as embodiment 1, except that the primary mixture in step (2) of embodiment 1 is treated as follows: the primary mixture is mixed evenly and then crushed with a jet mill to have an average particle size of about 50 μm.
[0071] Example 7
[0072] This embodiment is basically the same as embodiment 1, except that the amount of silicon dioxide in step (1) of embodiment 1 is replaced with 80 g; and the material in step (4) of embodiment 1 is passed through a 100-mesh vibrating sieve.
[0073] Example 8
[0074] This embodiment is basically the same as Embodiment 1, except that the amount of silicon dioxide in step (1) of Embodiment 1 is replaced with 120 g; and the material in step (4) of Embodiment 1 is passed through an 80-mesh vibrating sieve.
[0075] Example 9
[0076] This embodiment is basically the same as Embodiment 1, except that the amount of silicon dioxide in step (1) of Embodiment 1 is replaced with 200 g; and the material in step (4) of Embodiment 1 is passed through a 60-mesh vibrating sieve.
[0077] Comparative Example 1
[0078] This comparative example is basically the same as Example 2, except that the amount of silicon dioxide in step (1) of Example 2 is replaced with 20 g.
[0079] Comparative Example 2
[0080] This comparative example is basically the same as Example 6, except that the amount of silicon dioxide in step (1) of Example 6 is replaced with 250 g.
[0081] Comparative Example 3
[0082] This comparative example is basically the same as Example 2, except that the wet granulator in step (5) of Example 2 is replaced by a hopper mixer.
[0083] Comparative Example 4
[0084] This comparative example is basically the same as Example 1, except that the primary mixture in step (2) of Example 1 is treated as follows: the primary mixture is mixed evenly without being crushed, and the particle size is measured, and the average particle size is about 110 μm.
[0085] Comparative Example 5
[0086] This comparative example is basically the same as Example 2, except that the auxiliary material polyvinyl pyrrolidone (VA64) in step (1) of Example 2 is replaced with povidone K30.
[0087] Comparative Example 6
[0088] This comparative example is basically the same as Example 2, except that the auxiliary material polyvinyl pyrrolidone (VA64) in step (1) of Example 2 is replaced by hydroxypropyl cellulose.
[0089] Comparative Example 7
[0090] This comparative example is basically the same as Example 2, except that the silicon dioxide as the auxiliary material in step (1) of Example 2 is replaced by magnesium oxide.
[0091] Comparative Examples 8 to 10
[0092] Mainstream products produced by China National Pharmaceutical Group Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd. and Qinghai Pharmaceutical Co., Ltd. were taken as comparative examples 8 to 10, respectively.
[0093] Comparative Example 11
[0094] A method for preparing a compound licorice tablet comprises the following steps:
[0095] (1) Weighing: Weigh 10,000 tablets, and weigh the raw and auxiliary materials, namely, 1125.0 g of liquorice extract, 40 g of poppy fruit extract powder, 20 g of sodium benzoate, 20 g of camphor, 20 g of star anise oil, 20 g of silicon dioxide, 200 g of calcium hydrogen phosphate, 70 g of powdered sugar, 3 g of acesulfame potassium, and 20 g of talc, and set aside;
[0096] (2) Dissolution and adsorption: dissolving the camphor in step (1) in the star anise oil in step (1), adding the camphor to the calcium hydrogen phosphate in step (1), stirring and mixing, and then standing for 48 hours to obtain an adsorbent powder;
[0097] (3) Grinding: Grind the licorice extract, poppy fruit extract powder, sodium benzoate, powdered sugar, and acesulfame potassium described in step (1) into fine powder, pass through a 120-mesh sieve, and set aside;
[0098] (4) mixing: adding the poppy fruit extract powder, sodium benzoate, powdered sugar and acesulfame potassium described in step (3) to the licorice extract described in step (3) in equal amounts and mixing them uniformly to obtain a mixture, adding the adsorbent powder prepared in step (2), and then adding the talcum powder and silicon dioxide described in step (1), and mixing them uniformly;
[0099] (5) Tableting: The material in (4) is tableted using a 7.0 mm round shallow concave punch die.
[0100] Effect evaluation experiment
[0101] The dissolution determination method of compound licorice tablets was optimized with reference to the test method of the document "Research and Evaluation of Dissolution Behavior of Compound Licorice Tablets" published by Xiamen Drug Inspection Institute. The self-control method was adopted, the dissolution medium was pH 6.8 phosphate buffer, the dissolution volume was 900 ml, the rotation speed was 75 rpm, the absorbance was 260 nm, and the sampling time was 60 min.
[0102] The contents of volatile camphor and star anise oil in the compound licorice tablets were detected by gas chromatography according to the Chinese Pharmacopoeia 2020 edition. The effects of the compound licorice tablets prepared in Examples 1 to 9 and Comparative Examples 1 to 11 are compared in Table 1.
[0103] Table 1 Comparative Table of Effects of Compound Licorice Tablets Prepared by Examples 1 to 9 and Comparative Examples 1 to 11
[0104]
[0105]
[0106]
[0107] As can be seen from Table 1, Examples 1 to 9 used a primary mixture (a mixture of liquorice extract, poppy fruit extract powder and sodium benzoate) and controlled the particle size to 50 to 70 μm, ensuring that the appearance of the preparation had no pitting or white spots.
[0108] Examples 7 to 9 used different amounts of silicon dioxide adsorption; according to the prescription amount, each compound licorice tablet contained silicon dioxide adsorption in the range of 4 to 20 mg, and the appearance of the preparation tended to become lighter as the adsorption amount increased, but the overall color was uniform, and the appearance of the preparation was acceptable.
[0109] The silicon dioxide adsorption amount used in Comparative Examples 1 and 2 was too low or too high, and the tablet weight difference was unqualified, resulting in tableting failure.
[0110] After mixing in a hopper mixer, the particles of Comparative Example 3 had lumps and tableting failed.
[0111] The particle size of the initial mixture used in Comparative Example 4 is 110 μm, and the tablets have serious pitting on the surface, which affects the use of the tablets by consumers.
[0112] Comparative Example 5 uses Povidone K30 with poor compressibility, and has low compressibility (manifested by low hardness).
[0113] Comparative Example 6 uses hydroxypropyl cellulose with better compressibility, but its solubility is lower than that of mainstream products on the market.
[0114] In Comparative Example 7, conventional magnesium oxide was used to absorb volatile oil, and the overall mixed particles had poor fluidity, resulting in tableting failure.
[0115] The volatile oil content of the mainstream products in the market in Comparative Examples 8 to 10 is significantly lower than that in Examples 1 to 9 of the present invention, and the appearance and hardness of the preparations are also uneven.
[0116] The appearance of Comparative Example 11 is uniform, but it does not have the brightness of Examples 1-9, and the tableting hardness and volatile oil content are lower than Examples 1-9.
[0117] In summary, the present invention uses a specific prescription of polyvinyl pyrrolidone (VA64) and a dry powder direct compression process, which has unexpected effects compared with other similar products. All indicators are better than mainstream products on the market, and the overall quality is improved.
[0118] The above description is not intended to limit the present invention, and the present invention is not limited to the above examples. Any changes, modifications, additions or substitutions made by a person skilled in the art within the spirit and scope of the present invention shall also fall within the protection scope of the present invention.
Claims
1. A compound licorice tablet that can be processed by dry powder direct compression, characterized in that: According to the prescription amount, the formula of each compound licorice tablet includes 112.5 mg of licorice extract, 4 mg of poppy fruit extract powder, 2 mg of sodium benzoate, 2 mg of camphor, 2 mg of star anise oil, 4-20 mg of silicon dioxide, 0-100 mg of microcrystalline cellulose, 0-100 mg of lactose, 1-20 mg of polyvinyl pyrrolidone, 5-50 mg of talc, and 1-10 mg of magnesium stearate; according to the prescription amount, the core of each compound licorice tablet has a total of 133.5-422.5 mg; The preparation method of the compound licorice tablets that can be prepared by dry powder direct compression process comprises the following steps: (1) Weighing: According to the prescription amount, weigh the raw materials and excipients, namely, 112.5 mg of licorice extract, 4 mg of poppy fruit extract powder, 2 mg of sodium benzoate, 2 mg of camphor, 2 mg of star anise oil, 4-20 mg of silicon dioxide, 0-100 mg of microcrystalline cellulose, 0-100 mg of lactose, 1-20 mg of polyvinyl pyrrolidone, 5-50 mg of talc, and 1-10 mg of magnesium stearate, and set aside; (2) Primary mixing: placing the licorice extract, poppy fruit extract powder and sodium benzoate in step (1) in the same place, referred to as the primary mixture, mixing the primary mixture evenly and then pulverizing it to obtain an average particle size of 50 to 70 μm, thereby obtaining material a; (3) Sieving: The microcrystalline cellulose, lactose and polyvinyl pyrrolidone in step (1) are respectively passed through a 60-120 mesh sieve to obtain material b, which is set aside; the silicon dioxide, talc and magnesium stearate in step (1) are respectively passed through a 60-120 mesh sieve to set aside; (4) Dissolution and adsorption: dissolving the camphor described in step (1) in the star anise oil described in step (1), adding the silicon dioxide material described in step (3) under stirring for adsorption, and sealing and standing for 6 to 24 hours; rubbing the obtained material to disperse, passing through a 60 to 120 mesh sieve, and obtaining material C, which is set aside; (5) Premixing: adding the material a described in step (2), the material b described in step (3), and the material c described in step (4) to a wet granulator in sequence, and mixing them uniformly to obtain material d; (6) total mixing: uniformly mixing the material d described in step (5) with the talc powder and magnesium stearate described in step (3) to obtain material e; (7) tableting: tableting the material e described in step (6) to obtain plain tablets; (8) Packaging: Packaging the tablets prepared in step (7) to obtain; In the step (1), the polyvinyl pyrrolidone is polyvinyl pyrrolidone VA64.
2. A compound licorice tablet that can be processed by dry powder direct compression as claimed in claim 1, characterized in that: According to the prescription amount, the formula of each compound licorice tablet includes 2 to 6 mg of magnesium stearate.
3. The compound licorice tablet that can be processed by dry powder direct compression as claimed in claim 1, characterized in that: In the step (2), the pulverization process adopts any one or more of a universal pulverizer, a jet pulverizer, a needle pulverizer and a hammer pulverizer.
4. The compound licorice tablet that can be processed by dry powder direct compression as claimed in claim 1, characterized in that: In the step (5), the parameters during mixing are: stirring speed of 100 to 300 rpm, shearing speed of 1000 to 2000 rpm, and mixing time of 2 to 4 minutes.
5. The compound licorice tablet that can be processed by dry powder direct compression as claimed in claim 1, characterized in that: In the step (6), the mixing time is 3 to 20 minutes.
6. The compound licorice tablet that can be processed by dry powder direct compression as claimed in claim 1, characterized in that: In the step (7), the tableting is performed using a tablet press.
7. The compound licorice tablet that can be processed by dry powder direct compression as claimed in claim 1, characterized in that: In the step (7), the tabletting is performed using a 6.5-10.5 mm, round shallow concave or flat punch die, and the main pressing pressure is 6-20 KN.
8. The compound licorice tablet that can be processed by dry powder direct compression as claimed in claim 1, characterized in that: In the step (8), the packaging is bottle packaging.
Citation Information
Patent Citations
Compound liquorice tablet and preparation process thereof
CN104382993A
Compound liquorice tablet and preparation method thereof
CN104800290A