A convenient tablet excipient, a convenient tablet and a preparation method thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a Dian Tong tablet auxiliary material, a Dian Tong tablet and a preparation method thereof. The auxiliary material of the Dian Tong tablet comprises a filler, a lubricant, a disintegrant and a coating material; the disintegrant is microcrystalline cellulose and sodium carboxymethyl starch with a mass ratio of 1:2.5-5. The quality of the Dian Tong tablet is controllable, and the stability is good. Through selection of specific tabletting auxiliary materials and a ratio, tabletting parameters, the friability of the prepared Dian Tong tablet is low, and the integrity and qualified rate are significantly improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to an adjuvant for Biantong tablets, Biantong tablets and a preparation method thereof. Background Art

[0002] Biantong tablets can invigorate the spleen and strengthen the kidney, moisten the intestine and relieve constipation, and are used for constipation caused by deficiency of the spleen and kidney and qi stagnation in the intestinal tract; symptoms include: constipation or weak defecation, fatigue, shortness of breath, dizziness, soreness and weakness of the waist and knees, etc.; its active ingredients are Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, Mori fructus, Fructus aurantii immaturus and Aloe vera.

[0003] Atractylodes macrocephala: taste: bitter, sweet, warm; meridian tropism: spleen, stomach meridians; has the effects of invigorating the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and preventing miscarriage; can be used for poor appetite due to spleen deficiency, abdominal distension and diarrhea, phlegm retention and dizziness, edema, spontaneous sweating, fetal restlessness. Cistanche deserticola: taste: sweet, salty, warm; meridian tropism: kidney, large intestine meridians; has the effects of tonifying the kidney yang, nourishing essence and blood, and moistening the intestine and relieving constipation; used for insufficiency of kidney yang, deficiency of essence and blood, impotence and infertility, soreness and weakness of the waist and knees, weakness of bones and muscles, intestinal dryness and constipation. Angelica sinensis: taste: sweet, spicy, warm; meridian tropism: liver, heart, spleen meridians; can enrich blood and promote blood circulation, regulate menstruation and relieve pain, moisten the intestine and relieve constipation; used for sallow complexion due to blood deficiency, dizziness and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency-cold abdominal pain, rheumatic arthralgia, traumatic injury, carbuncle and ulcer, intestinal dryness and constipation. Mori fructus: taste: sweet, sour, cold; meridian tropism: heart, liver, kidney meridians; can nourish yin and enrich blood, promote the production of body fluid and moisten dryness; used for deficiency of liver and kidney yin, dizziness and tinnitus, palpitation and insomnia, premature whitening of hair, thirst due to fluid impairment, internal heat and polydipsia, intestinal dryness and constipation. Fructus aurantii immaturus: taste: bitter, pungent, sour, slightly cold; meridian tropism: spleen, stomach meridians; has the effects of breaking qi and reducing accumulation, resolving phlegm and dispersing stagnation; used for internal retention of accumulation, fullness and distending pain, tenesmus after diarrhea, constipation, phlegm stagnation and qi obstruction, chest stuffiness, knotted chest, visceral ptosis. Aloe vera: taste: bitter, cold; meridian tropism: liver, stomach, large intestine meridians; can induce defecation, clear the liver and purge fire, kill parasites and treat infantile malnutrition; used for constipation due to heat accumulation, epilepsy and convulsion, infantile malnutrition; externally treat tinea; at the same time, it can reduce blood lipid, blood sugar and blood pressure, improve the circulatory system and sleep quality, prevent and treat digestive system diseases and improve appetite and other multiple therapeutic effects.

[0004] Tablets are one of the solid dosage forms of solid preparations in the field of drugs or foods, and are solid preparations obtained by compressing powders into a predetermined shape, and have advantages such as easy handling. Especially in the field of drugs, tablets account for about 50% of all products and are the most widely used.

[0005] Chinese invention patent application CN104288490A discloses a laxative tablet and its preparation method. This medicine achieves its laxative effect by nourishing yin and promoting body fluid production, clearing heat and detoxifying, and tonifying the kidneys and blood. It can be taken long-term without adverse reactions. By weight, the medicine contains 1-2 parts of Ophiopogon japonicus, 2-3 parts of mulberry leaf, 1-2 parts of Cistanche deserticola, 1-2 parts of pregelatinized starch, 0.5-1 part of micronized silica gel, and 0.5-1 part of magnesium stearate. The preparation method includes extraction and powdering, mixing, and tableting steps. However, the disintegration and flowability of the tablets prepared by this invention need further improvement.

[0006] Chinese invention patent application CN1814131A discloses a traditional Chinese medicine for treating constipation, composed of six herbs: Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, Citrus aurantium, Morus alba, and Aloe vera. This invention has the functions of strengthening the spleen and kidneys, moistening the intestines and promoting bowel movements. It is used for constipation due to deficiency, characterized by symptoms such as hard stools or difficulty in defecation, pale or sallow complexion, fatigue, shortness of breath, dizziness, weakness in the lower back and knees, pale tongue with a white coating, and a thin or weak pulse. Preclinical animal experiments have shown that this medicine can promote defecation in mouse models of dry constipation and heat-related constipation; increase the percentage of small intestinal propulsion; increase the frequency and tension of isolated guinea pig ileum contractions; inhibit water absorption in the mouse large intestine; and improve some of the body's immune capabilities. However, this invention does not disclose how to prepare the medicine into tablets.

[0007] Therefore, the purpose of this invention is to develop a laxative tablet excipient and a laxative tablet and its preparation method, so as to prepare a tablet for treating constipation with stable quality, low brittleness, high integrity and high pass rate. Summary of the Invention

[0008] To address the aforementioned shortcomings, this invention provides a laxative tablet excipient, a laxative tablet, and a method for preparing the same. This invention provides specific laxative tablet excipients and optimizes the amount of excipients added. The resulting laxative tablet can meet the quality requirements of the final product. The production process is simple, stable, and feasible, and is suitable for mass production.

[0009] To achieve the objectives of this invention, the following technical solution is adopted:

[0010] A laxative tablet excipient, comprising a filler, a lubricant, a disintegrant, and a coating material; wherein the disintegrant is microcrystalline cellulose and sodium carboxymethyl starch in a mass ratio of 1:2.5-5.

[0011] Preferably, the mass ratio of the microcrystalline cellulose to sodium carboxymethyl starch is 1:4.

[0012] Preferably, the filler is starch, the lubricant is magnesium stearate, and the coating material is GS-N coating material.

[0013] A laxative tablet, the raw materials of which include: stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry, Citrus aurantium, aloe vera and the above-mentioned excipients.

[0014] Preferably, the ingredients of the laxative tablets, by weight, include: 28-32 parts of stir-fried Atractylodes macrocephala, 18-24 parts of Cistanche deserticola, 15-18 parts of Angelica sinensis, 10-15 parts of mulberry, 10-15 parts of Citrus aurantium, and 5-8 parts of aloe vera.

[0015] Preferably, the ingredients of the laxative tablets, by weight, include: 29.6 parts of stir-fried Atractylodes macrocephala, 21 parts of Cistanche deserticola, 17 parts of Angelica sinensis, 12.7 parts of mulberry, 12.7 parts of Citrus aurantium, and 6.5 parts of aloe vera.

[0016] This invention also relates to a method for preparing the above-mentioned laxative tablets, comprising the following steps:

[0017] (1) Mix stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry and immature bitter orange, add water and decoct, filter, concentrate to obtain a thick paste for relieving constipation;

[0018] (2) Dry the aloe vera and pulverize it to obtain aloe vera fine powder;

[0019] (3) Mix the filler, laxative paste and aloe vera powder, granulate to obtain index component granules;

[0020] (4) Granulate the index component particles, add lubricant and disintegrant, mix, compress into tablets, and obtain plain tablets;

[0021] (5) Dissolve the coating material in water to prepare a coating solution, and coat the uncoated tablets to obtain a laxative tablet.

[0022] Preferably, the decoction in step (1) is performed 2-3 times, with 5-7 times the amount of water added each time, and the decoction is performed for 2-3 hours. After decoction, the filtrates are combined and allowed to stand for 10-14 hours, then filtered and concentrated to a relative density of 1.26-1.28. The drying temperature in step (2) is 60-70℃, the drying time is 4-6 hours, and the powder is passed through an 80-120 mesh sieve.

[0023] Preferably, the amount of filler added in step (3) is 20%-25% of the mass of the index component particles; the amount of disintegrant added in step (4) is 3%-5% of the mass of the index component particles; and the amount of lubricant added is 0.3%-0.5% of the mass of the index component particles.

[0024] Preferably, the tablet weight in step (4) is 0.442g-0.478g, the tableting pressure is 30±5Kn, the hardness is >4kg, and the tablet weight difference is ±4%.

[0025] Preferably, the mass concentration of the coating solution in step (5) is 15%-17%, and the amount of coating material added is 1%-3% of the mass of the uncoated tablets.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) The present invention produces a convenient tablet that meets the quality requirements of the final product by using specific excipients and specific amounts of excipients. The production process is simple, stable and feasible, and suitable for mass production.

[0028] (2) The quality of the diaphoretic tablets of the present invention is controllable and the stability is good. By selecting microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate as tableting excipients and selecting specific ratios and tableting parameters, the diaphoretic tablets are less brittle and the integrity and pass rate are significantly improved. Detailed Implementation

[0029] The present invention will be further described in detail below with reference to specific embodiments. The following embodiments are not intended to limit the present invention, but only to illustrate the present invention. Unless otherwise specified, the experimental methods used in the following embodiments are generally performed under conventional conditions. Unless otherwise specified, the materials and reagents used in the following embodiments are commercially available.

[0030] Example 1

[0031] A laxative tablet, the raw materials are: 2.96kg of stir-fried Atractylodes macrocephala, 2.10kg of Cistanche deserticola, 1.27kg of mulberry, 1.27kg of Citrus aurantium, 1.70kg of Angelica sinensis, 0.65kg of aloe vera, 1.00kg of starch, 40g of microcrystalline cellulose, 160g of sodium carboxymethyl starch, 20g of magnesium stearate and 75g of GS-N coating material.

[0032] The preparation method of the above-mentioned laxative tablets is as follows:

[0033] (1) Weigh out the stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry and immature bitter orange, add 6 times the amount of water, steam pressure 0.18Mpa, decoct for 2 hours, extract twice, let the combined filtrate stand for 12 hours, filter, concentrate at 65℃ and vacuum degree -0.06Mpa to a relative density of 1.27 to obtain the laxative ointment;

[0034] (2) The aloe vera was dried at 65℃ for 5 hours, cooled, pulverized, and passed through a 100-mesh sieve to obtain aloe vera fine powder;

[0035] (3) Granulation: First, add starch to the bottom of the spray granulator, then add aloe vera powder. Close the spray granulator, turn on the heater and fan to keep the material boiling for 10 minutes, adjust the air inlet temperature to maintain the air inlet temperature inside the machine at 80℃, and keep the material temperature at 50℃. Take the viscous tablet paste as a binder, and adjust the atomization pressure of the inner layer of the spray gun to 25 kg / cm². 2Turn on the peristaltic pump and control the speed to 400n / min. Spray granulation is performed. After the thick paste is sprayed, dry for 30 minutes to obtain 4400g of index component particles.

[0036] (4) Install a 14-mesh sieve, add index component particles for granulation, add the granulated particles to a two-dimensional motion mixer, then add microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate, mix at 10 rpm for 30 min, discharge, compress at 30 Kn, control the tablet weight to 0.46 g, hardness > 4 kg, tablet weight difference ± 4%, to obtain plain tablets.

[0037] (5) Take GS-N coating material and add it to purified water. After it is completely dissolved, prepare a film coating solution with a mass concentration of 16%. Set the high-efficiency coating machine to an air inlet temperature of 75℃, a rotation speed of 5rpm, and a peristaltic pump speed of 30rpm to coat the uncoated tablets to obtain the finished product, Bian Tong tablets.

[0038] Example 2

[0039] A laxative tablet, the raw materials are: 2.96kg of stir-fried Atractylodes macrocephala, 2.10kg of Cistanche deserticola, 1.27kg of mulberry, 1.27kg of Citrus aurantium, 1.70kg of Angelica sinensis, 0.65kg of aloe vera, 0.90kg of starch, 50g of microcrystalline cellulose, 150g of sodium carboxymethyl starch, 20g of magnesium stearate and 75g of GS-N coating material.

[0040] The preparation method of the above-mentioned laxative tablets is as follows:

[0041] (1) Weigh out the stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry and immature bitter orange, add 7 times the amount of water, steam pressure 0.15Mpa, decoct for 3h, extract twice, combine the filtrates and let stand for 10h, filter, concentrate (temperature 60℃, vacuum degree -0.06Mpa) to a relative density of 1.26, to obtain the laxative ointment;

[0042] (2) Dry aloe vera at 60℃ for 6 hours, cool, and pulverize through a 90-mesh sieve to obtain aloe vera fine powder;

[0043] (3) Granulation: First, add starch to the bottom of the spray granulator, then add aloe vera powder. Close the spray granulator, turn on the heater and fan to keep the material boiling for 10 minutes, adjust the air inlet temperature to maintain the air inlet temperature inside the machine at 70℃, and keep the material temperature at 40℃. Take the viscous tablet paste as a binder, and adjust the atomization pressure of the inner layer of the spray gun to 30 kg / cm². 2 The peristaltic pump was turned on and the speed was controlled at 200n / min. Granulation was carried out by spraying. After the thick paste was sprayed, it was dried for 30 minutes to obtain 4400g of index component particles.

[0044] (4) Install a 14-mesh sieve, add index component particles for granulation, add the granulated particles to a two-dimensional motion mixer, then add microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate, mix at 10 rpm for 30 min, discharge, compress at 25 Kn, control the tablet weight to 0.44 g, hardness > 4 kg, tablet weight difference ± 4%, to obtain plain tablets.

[0045] (5) Take GS-N coating material and add it to purified water. After it is completely dissolved, a 15% film coating solution is prepared. Set the high-efficiency coating machine to an air inlet temperature of 70℃, a rotation speed of 10rpm, and a peristaltic pump speed of 40rpm to coat the uncoated tablets to obtain the finished product.

[0046] Example 3

[0047] A laxative tablet contains the following ingredients: 2.96 kg of stir-fried Atractylodes macrocephala, 2.1 kg of Cistanche deserticola, 1.27 kg of mulberry, 1.27 kg of Citrus aurantium, 1.7 kg of Angelica sinensis, 0.65 kg of aloe vera, 1.1 kg of starch, 55 g of microcrystalline cellulose, 145 g of sodium carboxymethyl starch, 20 g of magnesium stearate, and 75 g of GS-N coating material.

[0048] The preparation method of the above-mentioned laxative tablets is as follows:

[0049] (1) Weigh out the stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry and Citrus aurantium, add 5 times the amount of water, steam pressure 0.20 MPa, decoct for 2 hours, extract 3 times, combine the filtrates and let stand for 14 hours, filter, concentrate (temperature 70℃, vacuum degree -0.07 MPa) to a relative density of 1.28, and obtain the laxative ointment;

[0050] (2) Dry aloe vera at 70℃ for 4 hours, cool, and pulverize through a 110-mesh sieve to obtain aloe vera fine powder;

[0051] (3) Granulation: Operate according to the standard operating procedure of the fluidized bed dryer granulator. First, add starch to the bottom of the spray granulator, then add aloe vera powder. Close the spray granulator, turn on the heater and fan to keep the material in a boiling state for 10 minutes, adjust the air inlet temperature to maintain the air inlet temperature inside the machine at 60℃, and keep the material temperature at 50℃. Take the viscous tablet paste as a binder, and adjust the atomization pressure of the inner layer of the spray gun to 20 kg / cm². 2 The peristaltic pump was turned on and the speed was controlled at 300n / min. Granulation was carried out by spraying. After the thick paste was sprayed, it was dried for 30 minutes to obtain 4400g of index component particles.

[0052] (4) Install a 14-mesh sieve, add index component particles for granulation, add the granulated particles to a two-dimensional motion mixer, then add microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate, mix at 10 rpm for 30 min, discharge, compress at 35 Kn, control the tablet weight to 0.48 g, hardness > 4 kg, tablet weight difference ± 4%, to obtain plain tablets.

[0053] (5) Take GS-N coating material and add it to purified water. After it is completely dissolved, prepare a 17% film coating solution. Set the high-efficiency coating machine to an air inlet temperature of 80℃, a rotation speed of 2rpm, and a peristaltic pump speed of 15rpm to coat the uncoated tablets to obtain the finished product, Bian Tong tablets.

[0054] Example 4

[0055] A laxative tablet contains the following ingredients: 2.96 kg of stir-fried Atractylodes macrocephala, 2.10 kg of Cistanche deserticola, 1.27 kg of mulberry, 1.27 kg of Citrus aurantium, 1.70 kg of Angelica sinensis, 0.65 kg of aloe vera, 1.0 kg of starch, 39.6 g of microcrystalline cellulose, 158.4 g of sodium carboxymethyl starch, 19.8 g of magnesium stearate, and 74.3 g of GS-N coating material.

[0056] The preparation method of the above-mentioned laxative tablets is as follows:

[0057] (1) Weigh out the stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry and Citrus aurantium, add 6 times the amount of water, steam pressure 0.18Mpa, decoct for 3 hours, extract 3 times, let the combined filtrate stand for 12 hours, filter, concentrate at 65℃ and vacuum degree -0.06Mpa to a relative density of 1.27 to obtain the laxative ointment;

[0058] (2) The aloe vera was dried at 65℃ for 5 hours, cooled, pulverized, and passed through a 100-mesh sieve to obtain aloe vera fine powder;

[0059] (3) Granulation: First, add starch to the bottom of the spray granulator, then add aloe vera powder. Close the spray granulator, turn on the heater and fan to keep the material boiling for 10 minutes, adjust the air inlet temperature to maintain the air inlet temperature inside the machine at 80℃, and keep the material temperature at 50℃. Take the viscous tablet paste as a binder, and adjust the atomization pressure of the inner layer of the spray gun to 25 kg / cm². 2 The peristaltic pump was turned on and the speed was controlled at 400 n / min. Spraying was used for granulation. After the thick paste was sprayed, it was dried for 30 minutes to obtain 4356g of index component particles.

[0060] (4) Install a 14-mesh sieve, add index component particles for granulation, add the granulated particles to a two-dimensional motion mixer, then add microcrystalline cellulose, sodium carboxymethyl starch and magnesium stearate, mix at 10 rpm for 30 min, discharge, compress at 30 Kn, control the tablet weight to 0.46 g, hardness > 4 kg, tablet weight difference ± 4%, to obtain plain tablets.

[0061] (5) Take GS-N coating material and add it to purified water. After it is completely dissolved, prepare a film coating solution with a mass concentration of 16%. Set the high-efficiency coating machine to an air inlet temperature of 75℃, a rotation speed of 5rpm, and a peristaltic pump speed of 30rpm to coat the uncoated tablets to obtain the finished product, Bian Tong tablets.

[0062] Effect test

[0063] According to the tablets section of Part IV of the 2020 edition of the Chinese Pharmacopoeia, the disintegration time, friability, and microbial limits of the above-mentioned Bian Tong tablets were tested; the angle of repose was determined according to the international standard ISO 4324-1977 "Surfactants - Powders and particles - Measurement of angle of repose"; the identification and content detection of the components were also carried out in accordance with the 2020 edition of the Chinese Pharmacopoeia.

[0064] The pilot-scale results of the preparation process of the laxative tablets in Examples 1-4 are shown in Table 1.

[0065] Table 1. Pilot-scale results of Examples 1-4

[0066] project Example 1 Example 2 Example 3 Example 4 Planned production (pieces) 10,000 10,000 10,000 10,000 Finished product quantity (pieces) 9985 9970 9990 9980 Disintegration timeout (min) 27 35 32 31 Core hardness 12kg 12kg 12kg 12kg Core brittleness 2‰ 2‰ 2‰ 2‰ Angle of repose 30.3° 31.8° 32.1° 32.6° Aloe-glycoside content (mg) 11.35 10.87 11.02 10.82 Identification of Atractylodes macrocephala Compliant Compliant Compliant Compliant Identification of Angelica sinensis Compliant Compliant Compliant Compliant Identification of Citrus aurantium and Aloe vera Compliant Compliant Compliant Compliant Bacterial count ≤10000 / g 100 200 210 210 Mold count 100 / g ＜10 ＜10 ＜10 ＜10

[0067] Comparative Examples 1-4

[0068] The only difference between Comparative Examples 1-4 and Example 1 is the type of disintegrant. The disintegrants used in Comparative Examples 1-4 were starch, microcrystalline cellulose (MCC), sodium carboxymethyl starch (CMS-Na), and low-substituted hydroxypropyl cellulose (L-HPC), respectively, and the addition amount and pressure were the same as in Example 1.

[0069] The tablet compression test results of Comparative Examples 1-4 are shown in Table 2.

[0070] Table 2 Tablet Compression Test Results

[0071] Group Types and dosages of excipients Core hardness Disintegration Time friability Comparative Example 1 200g of starch 6kg 21min 7‰ Comparative Example 2 MCC200g 17kg 53min 1‰ Comparative Example 3 CMS-Na 200g 4kg 15min 5‰ Comparative Example 4 L-HPC 200g 14kg 63min 4‰

[0072] Table 3 shows that when starch is used for tableting, the compressibility is poor, the tablet core hardness is low, and the brittleness is high; when MCC is used for tableting, the tablet core hardness is high and the brittleness is low, but the disintegration time is significantly prolonged; when CMS-Na is used for tableting, the compressibility is also poor, the tablet core hardness is low, and the tablets are prone to loosening; when L-HPC is used for tableting, the disintegration time is significantly prolonged and the flowability is poor.

[0073] Comparative Examples 5-7

[0074] The only difference between Comparative Examples 5-7 and Example 1 is the ratio of microcrystalline cellulose (MCC) to sodium hydroxymethyl starch (CMS-Na). The ratios of microcrystalline cellulose to sodium hydroxymethyl starch in Comparative Examples 5-7 are 1:2, 3:1, and 4:1, respectively.

[0075] The test results of the pressed core are shown in Table 3.

[0076] Table 3. Core Testing Results

[0077] MCC and CMS-Na dosage Core hardness Disintegration Time Core brittleness Comparative Example 5 MCC:CMS-Na = 1:2 9kg 19min 6‰ Comparative Example 6 MCC:CMS-Na = 3:1 13kg 40min 1‰ Comparative Example 7 MCC:CMS-Na = 4:1 13kg 35min 1‰

[0078] Comparative Examples 8-9

[0079] The only difference between Comparative Examples 8-9 and Example 1 is the type of lubricant. In Comparative Examples 8-9, the lubricants are talc and micronized silica gel, respectively.

[0080] The results of the liquidity test are shown in Table 4.

[0081] Table 4 Results of Angle of Repose Test

[0082] Types of lubricants Angle of repose Comparative Example 8 talcum powder 36.1° Comparative Example 9 Micronized silica 35.2°

[0083] Comparative Examples 10-13

[0084] The only difference between Comparative Examples 10-13 and Example 1 is the amount of magnesium stearate added as a lubricant. In Comparative Examples 10-13, the amounts of magnesium stearate added were 0.2%, 0.6%, 0.8%, and 1.0% of the mass of the indicative component particles, respectively.

[0085] The results of the angle of repose test are shown in Table 5.

[0086] Table 5 Results of Angle of Repose Test

[0087] magnesium stearate dosage Angle of repose Comparative Example 10 0.2％ 35.1° Comparative Example 11 0.6％ 38.7° Comparative Example 12 0.8％ 34.6° Comparative Example 13 1.0％ 32.1°

[0088] Comparative Examples 14-15

[0089] The only difference between Comparative Example 14 and Example 1 is the type of coating material. In Comparative Example 14, the coating material GS-N (purchased from Shandong Taian Ruitai Cellulose Co., Ltd.) was replaced with WXL010510-3 (purchased from Wenzhou Xiaolun Coating Technology Co., Ltd.), and the amount used was 75g in both cases.

[0090] The difference between Comparative Example 15 and Example 1 lies in the amount of coating material added. In Comparative Example 15, the amount of coating material GS-N (purchased from Shandong Taian Ruitai Cellulose Co., Ltd.) was 50g.

[0091] The moisture-proof performance of the products prepared in Example 1 and Comparative Examples 14-15 was tested according to the method of loss on drying in the 2020 edition of the Chinese Pharmacopoeia. The results are shown in Table 6.

[0092] Table 6 Moisture-proof performance test

[0093] 0 days 1 day 3 days 5 days 10 days Example 1 0 3.29％ 5.72％ 8.93％ 13.83％ Comparative Example 14 0 5.97％ 7.87％ 11.23％ soften Comparative Example 15 0 7.93％ 12.36％ soften soften

[0094] The above detailed description is a specific description of one of the feasible embodiments of the present invention. This embodiment is not intended to limit the patent scope of the present invention. All equivalent implementations or modifications that do not depart from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A laxative tablet, characterized in that, The ingredients of the laxative tablets are: stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry, Citrus aurantium, aloe vera, and excipients; The excipients include fillers, lubricants, disintegrants, and coating materials; the disintegrant is microcrystalline cellulose and sodium carboxymethyl starch in a mass ratio of 1:2.5-5. The filler is starch, and the lubricant is magnesium stearate; The coating material is GS-N coating material; The ingredients of the laxative tablets, by weight, are: 28-32 parts of stir-fried Atractylodes macrocephala, 18-24 parts of Cistanche deserticola, 15-18 parts of Angelica sinensis, 10-15 parts of mulberry, 10-15 parts of immature bitter orange, and 5-8 parts of aloe vera. The method for preparing the laxative tablets includes the following steps: (1) Mix stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry and immature bitter orange, add water and decoct, filter, concentrate to obtain a thick paste for relieving constipation; (2) Dry the aloe vera and pulverize it to obtain fine aloe vera powder; (3) Mix the filler, laxative paste and aloe vera powder, granulate to obtain index component granules; (4) Granulate the index component particles, add lubricant and disintegrant, mix, compress into tablets, and obtain plain tablets; (5) Dissolve the coating material in water to prepare a coating solution, and coat the uncoated tablets to obtain a laxative tablet; The amount of disintegrant added in step (4) is 3%-5% of the mass of the index component particles, and the amount of lubricant added is 0.3%-0.5% of the mass of the index component particles; In step (5), the amount of coating material added is 1.2%-2.5% of the weight of the uncoated sheet.

2. The laxative tablet according to claim 1, characterized in that, The mass ratio of microcrystalline cellulose to sodium carboxymethyl starch is 1:

4.

3. The laxative tablet according to claim 1, characterized in that, The ingredients of the Bian Tong tablets, by weight, are: 29.6 parts of stir-fried Atractylodes macrocephala, 21 parts of Cistanche deserticola, 17 parts of Angelica sinensis, 12.7 parts of mulberry, 12.7 parts of Citrus aurantium, and 6.5 parts of aloe vera.

4. A method for preparing the laxative tablet according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Mix stir-fried Atractylodes macrocephala, Cistanche deserticola, Angelica sinensis, mulberry and immature bitter orange, add water and decoct, filter, concentrate to obtain a thick paste for relieving constipation; (2) Dry the aloe vera and pulverize it to obtain fine aloe vera powder; (3) Mix the filler, laxative paste and aloe vera powder, granulate to obtain index component granules; (4) Granulate the index component particles, add lubricant and disintegrant, mix, compress into tablets, and obtain plain tablets; (5) Dissolve the coating material in water to prepare a coating solution, and coat the uncoated tablets to obtain a laxative tablet; The amount of disintegrant added in step (4) is 3%-5% of the mass of the index component particles, and the amount of lubricant added is 0.3%-0.5% of the mass of the index component particles; the amount of coating material added in step (5) is 1.2%-2.5% of the mass of the uncoated sheet.

5. The preparation method according to claim 4, characterized in that, The decoction in step (1) is performed 2-3 times, with 5-7 times the amount of water added each time, and the decoction is performed for 2-3 hours. After decoction, the filtrates are combined and allowed to stand for 10-14 hours, then filtered and concentrated to a relative density of 1.26-1.

28. The drying temperature in step (2) is 60-70℃, and the drying time is 4-6 hours. After pulverizing, the filtrate is passed through an 80-120 mesh sieve.

6. The preparation method according to claim 4, characterized in that, The amount of filler added in step (3) accounts for 20%-25% of the mass of the index component particles.

7. The preparation method according to claim 4, characterized in that, The tablet weight in step (4) is 0.442g-0.478g, and the tableting pressure is 30±5Kn; the mass concentration of the coating solution in step (5) is 15%-17%.