CN111228224B

CN111228224B - Aloe-containing constipation-relieving pellet preparation and preparation method thereof

Info

Publication number: CN111228224B
Application number: CN201811440114.2A
Authority: CN
Inventors: 关永霞; 李蔚群
Original assignee: Lunan Pharmaceutical Group Corp
Current assignee: Lunan Pharmaceutical Group Corp
Priority date: 2018-11-28
Filing date: 2018-11-28
Publication date: 2022-05-20
Anticipated expiration: 2038-11-28
Also published as: CN111228224A

Abstract

The invention belongs to the field of traditional Chinese medicine preparations, and discloses a aloe laxative pellet preparation, wherein the prescription of the pellet preparation comprises 25-34% of aloe laxative extract fine powder, 56-66% of pelleting accelerator and 6-14% of viscosity regulator. The invention also discloses a preparation method of the aloe laxative pellet preparation, which comprises the preparation of the aloe laxative extract fine powder and the preparation of the pellet preparation. Compared with the traditional Haihei cathartic capsule, the Haihei cathartic pellet has the advantages of regular shape, good fluidity, small dosage, high drug release speed, high bioavailability, good clinical effect, no influence by gastrointestinal rhythm, reduced unpleasant odor of the preparation, improved compliance of patients, and wide market development prospect as an upgraded and updated product of the traditional Haihei cathartic capsule.

Description

Aloe-containing constipation-relieving pellet preparation and preparation method thereof

Technical Field

The invention relates to a traditional Chinese medicine pellet preparation and a preparation method thereof, in particular to a aloe bowel-relaxing pellet preparation and a preparation method thereof, belonging to the field of traditional Chinese medicine preparations.

Background

Chinese patent CN100453105C discloses a Chinese medicinal composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat and a preparation method thereof, and the product is a Chinese medicinal compound preparation 'Shoihui laxative capsule' for treating functional constipation. The Hui Tongbian capsule is a new Chinese medicine 6 class developed by Lunan Kangpu pharmacy Co., Ltd, is a unique product, has independent intellectual property rights of core technologies such as prescription, process, quality standard and application, obtains a production lot (national medicine standard Z20150041) and a new medicine certificate (national medicine certificate Z20150005) 5 and 6 days 2015, and is successfully marketed.

The prescription of the Hui Tong Jiao (Aloe and laxative Capsule) is derived from clinical proved prescription and comprises eight traditional Chinese medicines of fleece-flower root, aloe, cassia seed, medlar, donkey-hide gelatin, ginseng, largehead atractylodes rhizome and immature bitter orange. The prescription takes the theory of traditional Chinese medicine as guidance, integrates clinical experience, supplements blood-enriching and dryness-moistening products in products for relaxing bowel, purging turbidity and expelling toxin, and supplements qi-tonifying and spleen-invigorating products, so that the medicine has the efficacies of descending turbidity and relieving distension and fullness. The formula has good effect of relaxing bowel and treating constipation caused by internal accumulation of toxin and deficiency of yin liquid, can comprehensively improve gastrointestinal function, has definite curative effect, quick response and no toxic or side effect, and has the effects of expelling toxin, beautifying, losing weight and reducing fat. Clinical application shows that the traditional Chinese medicine composition has definite curative effect, is suitable for the old and weak patients to take, and is well received by doctors and patients. At present, the Hui Tongbiang capsule has the defects of large paste quantity, high paste viscosity, large using amount of auxiliary materials, easy moisture absorption of finished capsule preparations and the like in the preparation process.

The pellet (Micropills) is various spherical or spheroidal solid medicinal preparations with diameter of 0.5-2.5mm, and is prepared by adding appropriate pill forming agent and/or viscosity regulator into Chinese medicinal extract to obtain pill with uniform particle diameter and good fluidity. The pellet is used as semi-finished product, and can be further filled into pellet capsule or pressed into pellet tablet. The pellet preparation can mask the bad smell of partial Chinese medicinal materials, reduce irritation, increase stability, improve dissolution rate and bioavailability, and reduce burst effect, and has the advantages of large drug loading amount, good appearance, etc.

Chinese patent No. CN100546596C discloses a Chinese medicinal pellet preparation for treating cervical spondylosis and lumbar spondylosis and a preparation method thereof, and particularly discloses a preparation formula and a preparation process. The effect of the extrusion spheronization method for preparing the traditional Chinese medicine pellets is researched (J. journal of mathematical and medical science, 2004, (27) 6: 723-. However, the prescription and the preparation method of the pellet preparation are designed aiming at a specific traditional Chinese medicine prescription, and because the decoction pieces and the weight parts of each compound traditional Chinese medicine prescription are different, the extraction and purification processes are different, the types and the dosage of the auxiliary materials are also different, and whether the aloe constipation-relieving pellets prepared by the two compound traditional Chinese medicine pellet preparation processes are feasible or not needs to be further proved.

The extruding, rounding and pelletizing technology is widely applied pellet preparation process, and includes the steps of extracting, purifying, drying, crushing, mixing with dry powder, making soft material, extruding soft material, rounding, extruding, drying pellet, etc. However, the aloe laxative extract is influenced by inherent factors such as large paste output amount, high paste viscosity, large auxiliary material usage amount, low drug-loading amount and the like, the pellet preparation difficulty is large, and in the aloe laxative pellet preparation process, the usage amount of the auxiliary materials such as a pelleting accelerator, a viscosity regulator or a wetting agent is changed, the soft material property is greatly changed, and the problems of poor pellet roundness, low yield, unstable preparation and the like are caused. In the preparation process of the aloe constipation relieving pellet, the inventor tries to prepare the aloe constipation relieving pellet by referring to the prior preparation process of the traditional Chinese medicine pellet, but the forming effect of the aloe constipation relieving pellet preparation is not ideal due to the difference of the components of the prescription decoction pieces and the difference of the preparation process of the traditional Chinese medicine extract.

Disclosure of Invention

In order to overcome the defects of the existing aloe laxative capsule preparation and the need of upgrading and updating the aloe laxative preparation, the invention needs to invent a new dosage form which is different from the characteristics and the release mechanism of the common capsule and is suitable for the aloe laxative prescription.

The aloe laxative pellet preparation comprises the following components in percentage by weight:

A. aloe vera laxative extract fine powder 25% -34% (by weight)

B. 56% -66% (by weight) of pill accelerator

C. 6-14% by weight of a viscosity modifier;

the fine powder of the aloe laxative extract is prepared from the raw materials of polygonum multiflorum, aloe, cassia seed, medlar, donkey-hide gelatin, ginseng, largehead atractylodes rhizome and immature bitter orange; the pelleting accelerant is one or more of hydroxypropyl methyl cellulose (HPMC), Cellulose Acetate (CA), Ethyl Cellulose (EC), microcrystalline cellulose (MCC), chitosan and starch, and the viscosity regulator is one or more of sodium carboxymethyl starch (CMS), dextrin and micropowder silica gel.

Wherein the aloe vera laxative extract fine powder is prepared from the following raw materials:

60-150 parts of polygonum multiflorum, 100 parts of aloe, 80-180 parts of cassia seed and 200 parts of cassia seed

Ginseng 20-80 weight portions, wolfberry fruit 30-100 weight portions, donkey-hide gelatin 30-100 weight portions

80-150 parts of immature bitter orange and 20-80 parts of bighead atractylodes rhizome

Preferably, the aloe vera laxative extract fine powder is prepared from the following traditional Chinese medicine components:

80-120 parts of polygonum multiflorum, 120 parts of aloe, 160 parts of cassia seed, 100 parts of cassia seed, 150 parts of cassia seed

20-50 parts of ginseng, 50-80 parts of medlar, 40-80 parts of donkey-hide gelatin

80-120 parts of immature bitter orange and 30-50 parts of bighead atractylodes rhizome

120 parts of polygonum multiflorum, 160 parts of aloe and 140 parts of cassia seed

50 parts by weight of ginseng, 75 parts by weight of wolfberry fruit and 75 parts by weight of donkey-hide gelatin

120 parts of immature bitter orange and 50 parts of largehead atractylodes rhizome

Preferably, the pellet formulation comprises the following components in percentage by weight:

A. aloe vera laxative extract fine powder 28% (by weight)

B. Pill accelerator 65% (by weight)

C. Viscosity modifier 7% by weight.

Preferably, the pelleting accelerant is a mixture of microcrystalline cellulose (MCC) and chitosan, and the viscosity regulator is a mixture of dextrin and aerosil; preferably, the weight ratio of the microcrystalline cellulose to the chitosan is 1: 0.2-0.5, and the weight ratio of the superfine silica powder to the dextrin is 1: 0.6-1.2; preferably, the weight ratio of the microcrystalline cellulose to the chitosan is 1: 0.3, and the weight ratio of the micropowder silica gel to the dextrin is 1: 1.

The invention also aims to provide a preparation method of the aloe laxative pellet preparation. Wherein the extraction and purification process of the aloe cathartic extract fine powder comprises the following steps:

A. weighing colla Corii Asini, pulverizing into superfine powder, and sieving;

B. weighing ginseng, fleece-flower root, cassia seed and aloe, adding 50-70% ethanol, performing reflux extraction twice, 10 times of the ethanol for the first time, 8 times of the ethanol for the second time, filtering the mixture for 2 hours each time, and combining the filtrates;

C. weighing fructus Lycii, fructus Aurantii Immaturus, and Atractylodis rhizoma, decocting in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.10-1.20(80 deg.C), cooling to room temperature, stirring, adding ethanol to ethanol concentration of 50% -70% (20 deg.C), refrigerating and standing for 24-48 hr, and filtering;

D. mixing the ethanol extractive solution of step B and the water extractive solution of step C, concentrating to obtain soft extract with relative density of 1.30-1.35 (at 70 deg.C), drying, pulverizing into fine powder, and sieving;

E. and D, uniformly mixing the donkey-hide gelatin superfine powder obtained in the step A and the fine powder obtained in the step D to obtain the aloe cathartic extract fine powder for later use.

Preferably, the extraction and purification process comprises the following steps:

A. weighing colla Corii Asini, pulverizing into micropowder, and sieving with 150-mesh sieve and 200-mesh sieve to obtain colla Corii Asini micropowder;

B. weighing ginseng, fleece-flower root, cassia seed and aloe, adding 60% ethanol, performing reflux extraction twice, 10 times of the ethanol is added for the first time, 8 times of the ethanol is added for the second time, filtering the mixture every 2 hours, and combining the filtrates;

C. weighing fructus Lycii, fructus Aurantii Immaturus, and Atractylodis rhizoma, decocting in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.10-1.20 (at 80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol degree of 60% (at 20 deg.C), refrigerating and standing for 36 hr, and filtering;

D. mixing the ethanol extractive solution of step B and the water extractive solution of step C, concentrating into soft extract with relative density of 1.30-1.35(70 deg.C), belt vacuum drying, pulverizing into fine powder, and sieving;

E. mixing the colla Corii Asini micropowder of step A and the fine powder of step D to obtain Aloe laxative extract fine powder;

preferably, the belt vacuum drying in step D has the parameter conditions of vacuum degree of-0.08 MPa-0.10 MPa and drying temperature of 50-60 ℃.

The preparation method of the fleece-flower root and aloe pellet preparation comprises the following preparation processes:

F. respectively weighing the fine powder of the aloe cathartic extract in the step E, the pelleting accelerant and the viscosity modifier, uniformly mixing, adding an ethanol solution, kneading to prepare a soft material, and extruding to obtain strips;

G. and (D) opening the spheronizer, putting the strip-shaped objects in the step (F) into the spheronizer, preparing pellets, drying and screening to obtain the finished product.

Preferably, the formulation process comprises the following steps:

F. respectively weighing the fine powder of the aloe cathartic extract in the step E, the pelleting accelerant and the viscosity modifier, fully and uniformly mixing, adding 35-55 wt% of ethanol solution with the concentration of 15-40% according to the prescription amount, kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 0.9-1.3 mm of an extruder;

G. and D, opening the spheronizer, putting the strip-shaped objects obtained in the step F into the spheronizer, preparing a pellet semi-finished product, taking out the pellet semi-finished product, drying at 50-60 ℃, and screening to obtain the pellet with 20-30 meshes.

Preferably, a 40% by weight, 40% strength by weight, 25% strength ethanol solution is added as wetting agent in step F.

Preferably, the rotating speed of the rounding machine in the step G is 900-1150 prm, and the rounding time is 4-7 min; preferably, the rotation speed of the rounding machine in the step 2) H is 1050prm, and the rounding time is 6 min.

The aloe bowel-relaxing pellet preparation is spherical or quasi-spherical, has regular appearance, smooth and round surface, good fluidity, large drug-loading capacity and small dosage, and reduces the administration times of patients; the medicine has the advantages of rapid release, high bioavailability, good stability, and no influence from gastrointestinal rhythm; can improve the problems of easy moisture absorption and instability of the finished product of the aloe catharsis capsule. In addition, the pellet of the present invention can be used as common granules, and can be further used as an intermediate to be filled into capsules, compressed into tablets, etc., so as to obtain aloe laxative pellet tablets and aloe laxative pellet capsules.

In-vitro cumulative dissolution rate tests show that the aloe cathartic pellet tablet and the aloe cathartic pellet capsule of the invention reach more than 80% dissolution within 40min and more than 90% dissolution within 60min, and compared with the traditional aloe cathartic capsule, the aloe cathartic pellet preparation of the invention obviously improves the dissolution rate of the medicine.

The accelerated stability test result shows that the aloe laxative pellet tablet is grey white after being placed for 6 months under the accelerated test conditions (40 +/-2 ℃ and RH 75% +/-5), the content of the aloe laxative pellet tablet is not obviously changed, and all examination indexes of moisture, dissolution time limit and hygiene meet the requirements. According to the experimental data, the prepared aloe laxative pellet preparation has good stability and controllable quality.

Experimental example 1 dissolution test

Examples 6, 12 and 07518001 of the present invention were prepared by dissolution test (the third method of 0931, four Provisions of the national pharmacopoeia 2015 edition) using 200ml of distilled water as dissolution medium, water bath temperature 37 ℃. + -. 0.5 ℃ and rotation speed 100 r.min^-1In vitro dissolution test with 2, 3, 5, 4' -tetrahydroxystilbene-2-0-beta-D-glucoside (C)₂₀H₂₂O₉) And (5) inspecting indexes.

The chromatographic condition and the system applicability test use octadecyl bonded silica gel as a filler; acetonitrile-methanol-water at a ratio of 20: 8: 72 as a mobile phase; the detection wavelength was 320 nm. The number of theoretical plates is not less than 2000 calculated according to the peak of 2, 3, 5, 4' -tetrahydroxystilbene-2-0-beta-D-glucoside.

Preparation of reference solution A proper amount of 2, 3, 5, 4' -tetrahydroxystilbene-2-0-beta-D-glucoside reference is precisely weighed, and diluted ethanol is added to prepare a solution containing 0.06mg per 1ml, so as to obtain the product.

Preparing a sample solution for a test sample, taking 10ml of the sample at each time point, simultaneously adding 10ml of isothermal distilled water, filtering the sample through a 0.45-micron microporous membrane, taking 5ml of subsequent filtrate, transferring the subsequent filtrate into a separating funnel, extracting with diethyl ether for 2 times, 15ml each time, discarding the diethyl ether solution, adjusting the pH value to 1-2 with dilute hydrochloric acid, extracting with ethyl acetate (15ml, 15ml, 15ml, 10ml) for 4 times, combining the ethyl acetate solutions, evaporating to dryness, dissolving the residue with dilute ethanol, transferring the residue into a 2ml measuring flask, fixing the volume, shaking up, and filtering to obtain the test sample.

The determination method comprises the steps of taking a standard solution and a sample solution, injecting 20ul of the standard solution and the sample solution respectively, calculating the content of 2, 3, 5, 4 '-tetrahydroxystilbene-2-O-beta-D-glucoside in the sample by adopting an external standard two-point method logarithmic equation, and calculating the cumulative dissolution percentage of 2, 3, 5, 4' -tetrahydroxystilbene-2-O-beta-D-glucoside at each time point, wherein the results are shown in Table 1.

TABLE 1 cumulative percent dissolution for different samples

The dissolution curve was plotted with the dissolution time (min) as abscissa and the cumulative dissolution percentage (%) as ordinate, as shown in FIG. 1.

As can be seen from figure 1, the aloe vera pellet tablet and the aloe vera pellet capsule can be dissolved by more than 80% within 40min and 90% within 60 min; the aloe laxative capsule can be dissolved out by 68.76% within 40min and 82.29% within 60 min. Therefore, compared with the traditional aloe constipation relieving capsule, the aloe constipation relieving pellet preparation of the invention has rapid and comprehensive dissolution, which shows that the prepared pellet has good in-vitro dissolution effect.

Experimental example 2 pellet roundness and yield investigation

The rounding degree of the micro-pill is expressed by a plane critical angle, a certain amount of micro-pills are placed on a flat plate, one side of the flat plate is lifted, the included angle (phi) between the inclined plane and the horizontal plane before the micro-pills start rolling is measured, namely the plane critical angle, and the smaller the plane critical angle is, the higher the rounding degree of the micro-pills is. The yield is the proportion of the screened qualified pellets in the total pellets. The results are shown in Table 2.

TABLE 2 roundness and yield of HUI TONG WEI WAN

As can be seen from Table 2, the rounding of the Hui Po pellets and the yield of acceptable pellets changed with the concentration of the ethanol solution of the wetting agent when the amount of the ethanol solution of the wetting agent was fixed at 40% by weight of the prescribed amount, and from the experimental results, the rounding was the best and the yield was the highest at a concentration of 25% of the ethanol solution of the wetting agent, which was significantly higher than those of comparative examples 1 to 4 and examples 10 and 11.

The pellets of comparative examples 5 and 6 have poor roundness, the critical angles are 21.42 and 18.78 respectively, the yield is low, 48.9 percent and 67.6 percent respectively, the aloe constipation relieving capsule is prepared by the pellet preparation formula and the pellet preparation method in the prior art, the roundness and the yield of the pellets can not meet the corresponding requirements, and the industrial production is also realized.

Experimental example 3 accelerated stability study

To verify the stability of the hui-laxative pellet formulation of the present invention, the inventors conducted a related stability test study, and conducted an accelerated stability test study on the hui-laxative pellet capsule of example 6 and the hui-laxative pellet tablet of example 12. It should be noted that the sample of the aloe laxative pellet formulation used in this test is a representative formulation of the present invention and the sample obtained by the preparation method thereof, and the other formulations and samples obtained by the preparation method included in the present invention relate to the test and the results thereof, which are not intended to be exhaustive due to space limitations.

Two batches of samples (pellet capsules of example 6, pellet tablets of example 12) of the invention were stored in an accelerated tester (40 ± 2 ℃, RH 75% ± 5) under an aluminum-plastic package (6 pellets/plate) for 6 months (04 months in 2018 to 09 months in 2018, and sampled at 0 months, 1 month, 2 months, 3 months, and 6 months, respectively) for accelerated stability examination. The accelerated stability test data of the two batches of products are shown in tables 3 and 4.

Table 3 example 6 aloe laxative pellet capsule accelerated stability study results

Table 4 example 12 results of accelerated stability studies of aloe laxative pellets

The results of accelerated stability tests in tables 3 and 4 show that the properties of the aloe-laxative pellet capsules and pellets are not changed and the content is not obviously changed after the aloe-laxative pellet capsules and pellets are placed for 6 months under accelerated test conditions (40 +/-2 ℃ and RH 75% +/-5), and all investigation indexes of water content, dissolution time limit and hygiene meet the requirements. According to the accelerated stability test result, the aloe laxative pellet preparation prepared by the invention has good stability and controllable quality.

Drawings

Fig. 1 is a graph showing the cumulative dissolution percentage of the hui defaecation pellet capsule, the hui defaecation pellet tablet and the hui defaecation pill.

Detailed Description

Example 1 Hui Tongbiang micro-pill tablet

1) Extraction and purification process

60g of polygonum multiflorum, 100g of aloe and 80g of cassia seed

Ginseng 80g, wolfberry fruit 100g and donkey-hide gelatin 100g

Immature bitter orange 80g white atractylodes rhizome 80g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 150-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 70% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.15(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol degree of 60% (20 deg.C), refrigerating, standing for 48 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.34(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 60 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain herba Aloe laxa extract fine powder 272 g;

2) preparation process

A. Aloe vera laxative extract fine powder: 272g

B. Microcrystalline cellulose: 438g

And (3) chitosan: 150g

C. Silica gel micropowder: 50g

Dextrin: 90g

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, superfine silica gel powder and dextrin according to the prescription amount, fully and uniformly mixing, adding 50 wt% of ethanol solution with the concentration of 35% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.2mm of an extruder; opening the spheronizer, selecting the rotation speed of 1110rpm, placing the strips in the spheronizer, spheronizing for 6min until the granules are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 887.3g of pellets with 20-30 meshes.

And (3) adding 96.7g of dextrin into the pellets obtained in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 8g of magnesium stearate and 8g of talcum powder, uniformly mixing, and tabletting to obtain the finished product.

EXAMPLE 2 HUI BIAN TONG WEI WAN CAPSULE

1) Extraction and purification process

150g of polygonum multiflorum, 200g of aloe and 180g of cassia seed

Ginseng 20g, wolfberry fruit 30g and donkey-hide gelatin 30g

Immature bitter orange 150g white atractylodes rhizome 20g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 200-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 50% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.17 (at 80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol content of 50% (at 20 deg.C), refrigerating and standing for 36 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating to obtain soft extract with relative density of 1.32(70 deg.C), vacuum drying under vacuum degree of-0.08 MPa to-0.10 MPa, drying at 55 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini superfine powder to obtain 340g of HUIHUI TONGBIAO extract fine powder;

2) preparation process

A. Aloe vera laxative extract fine powder: 340g

B. Microcrystalline cellulose: 400g

Starch: 160g

C. Silica gel micropowder: 50g

Sodium carboxymethyl starch: 50g

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, starch, micro silica gel and sodium carboxymethyl starch according to the prescription amount, fully and uniformly mixing, adding 40 percent (by weight) of ethanol solution with the concentration of 30 percent of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 0.9mm of an extruder; opening the spheronizer, selecting the rotation speed of 1150rpm, placing the strips in the spheronizer, spheronizing for 4min until the granules are rolled into pills, taking out the semi-finished pellets, drying at 50 ℃, and sieving to obtain 872.5g of pellets with 20-30 meshes.

And (3) adding 127.5g of micro silica gel powder into the pellet obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the compound micro-capsule.

EXAMPLE 3 Aloe pellet Capsule for relaxing bowels

1) Extraction and purification process

120g of polygonum multiflorum, 160g of aloe and 150g of cassia seed

Ginseng 20g, wolfberry fruit 50g, donkey-hide gelatin 40g

Immature bitter orange 120g white atractylodes rhizome 30g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 180-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.10(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach 70% (20 deg.C), refrigerating and standing for 36 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.35(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 50 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini superfine powder to obtain Aloe laxa extract fine powder 250 g;

2) preparation process

A. Aloe vera laxative extract fine powder: 250g

B. Microcrystalline cellulose: 660g

C. Silica gel micropowder: 70g

Sodium carboxymethyl starch: 20g of

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, micro silica gel powder and sodium carboxymethyl starch according to the prescription amount, fully and uniformly mixing, adding 45 wt% of ethanol solution with the concentration of 20% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 950rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 7min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 55 ℃, and screening to obtain 890.7g of pellets with 20-30 meshes.

And (3) adding 109.3g of starch into the pellets obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the finished product.

EXAMPLE 4 Aloe pellet for relaxing bowels

1) Extraction and purification process

Polygonum multiflorum 80g aloe 120g cassia seed 100g

Ginseng 50g, wolfberry fruit 80g, donkey-hide gelatin 80g

Immature bitter orange 80g white atractylodes rhizome 50g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 180-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 70% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.11(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach 70% (20 deg.C), refrigerating and standing for 24 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.30(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 60 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini superfine powder to obtain Aloe laxa extract fine powder 265 g;

2) preparation process

A. Fine powder of aloe cathartic extract: 265g (g)

B. Ethyl cellulose: 200g

Microcrystalline cellulose: 402g

C. Sodium carboxymethyl starch: 50g

Silica gel micropowder: 23g

Dextrin: 60g of

Weighing the fine powder of the aloe cathartic extract in the step 1), ethyl cellulose, microcrystalline cellulose, sodium carboxymethyl starch, micro silica gel and dextrin according to the above formula amount, mixing uniformly, adding 35 wt% ethanol solution with the concentration of 15% as wetting agent, kneading continuously to prepare soft material, and extruding the soft material into strips through a sieve plate with the aperture of 1.1mm of an extruder; opening the spheronizer, selecting the rotation speed of 1000rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 5min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and sieving to obtain 907.8g of pellets with 20-30 meshes.

Taking the pellets in the step 2), adding 76.2g of sucrose powder, mixing uniformly, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 7g of magnesium stearate and 9g of talcum powder, mixing uniformly, and tabletting to obtain the finished product.

EXAMPLE 5 Aloe pellet for relaxing bowels

1) Extraction and purification process

70g of polygonum multiflorum, 110g of aloe and 90g of cassia seed

Ginseng 60g, wolfberry fruit 80g, donkey-hide gelatin 80g

Immature bitter orange 100g white atractylodes rhizome 30g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 150-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 50% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.12 (at 80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol content of 50% (at 20 deg.C), refrigerating, standing for 48 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.31(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 50 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain herba Aloe laxa extract fine powder 272 g;

2) preparation process

A. Aloe vera laxative extract fine powder: 272g

B. Hydroxypropyl methylcellulose: 258g

Starch: 450g

C. Dextrin: 110g

Weighing the fine powder of the aloe cathartic extract in the step 1), hydroxypropyl methylcellulose, starch and dextrin according to the prescription amount, fully and uniformly mixing, adding 50 wt% of ethanol solution with the concentration of 20% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.3mm of an extruder; opening the spheronizer, selecting the rotation speed of 900rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 4.5min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 50 ℃, and screening to obtain 917.4g of pellets with 20-30 meshes.

And (3) adding 66.6g of starch into the pellets obtained in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 5g of magnesium stearate and 11g of talcum powder, uniformly mixing, and tabletting to obtain the compound preparation.

EXAMPLE 6 Aloe pellet Capsule for relaxing bowels

1) Extraction and purification process (9 times prescription amount)

1080g of tuber fleeceflower root, 1440g of aloe, 1260g of cassia seed

Ginseng 450g medlar 675g donkey-hide gelatin 675g

Immature bitter orange 1080g white atractylodes rhizome 450g

Taking the donkey-hide gelatin with the above 8 ingredients, crushing the donkey-hide gelatin into superfine powder, and sieving the superfine powder with a 200-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.15(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol degree of 60% (20 deg.C), refrigerating, standing for 48 hr, and filtering; mixing the above ethanol extractive solution and water decoction, concentrating into soft extract with relative density of 1.32(70 deg.C), vacuum drying under vacuum degree of-0.08 MPa to-0.10 MPa, drying at 60 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain the fine powder 2520g of HUIHEITONG extract, examples 9 and 12 and comparative examples 1-6;

2) preparation process

A. Aloe vera laxative extract fine powder: 280g

B. Microcrystalline cellulose: 500g

And (3) chitosan: 150g

C. Silica gel micropowder: 35g of

Dextrin: 35g of

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, dextrin, superfine silica gel powder and dextrin according to the prescription amount, fully and uniformly mixing, adding 40 wt% of ethanol solution with the concentration of 25% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting rotation speed 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 926.6g of pellets of 20-30 meshes.

And (3) adding 73.4g of aerosil into the pellets obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the finished product.

EXAMPLE 7 HUI TONG WEI WAN CAPSULE

1) Extraction and purification process

Polygonum multiflorum 90g aloe 130g cassia seed 120g

Ginseng 40g, wolfberry fruit 70g and donkey-hide gelatin 50g

Immature bitter orange 90g and white atractylodes rhizome 40g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 180-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus, and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.16 (at 80 deg.C), cooling to room temperature, stirring, adding ethanol to reach 70% (at 20 deg.C), refrigerating, standing for 36 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.34(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 50 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain Aloe laxa extract fine powder 311 g;

2) preparation process

A. Aloe vera laxative extract fine powder: 311g

B. Cellulose acetate: 520g

And (3) chitosan: 100g

C. Sodium carboxymethyl starch: 69g

Weighing the fine powder of the aloe cathartic extract in the step 1), cellulose acetate, chitosan and sodium carboxymethyl starch according to the prescription amount, fully and uniformly mixing, adding 55 percent (by weight) of ethanol solution with the concentration of 15 percent of the prescription amount as a wetting agent, continuously kneading to prepare a soft material, and extruding the soft material into strips through a sieve plate with the aperture of 1.2mm of an extruder; opening the spheronizer, selecting the rotation speed of 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 5.5min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 50 ℃, and screening to obtain 885.4g of pellets with 20-30 meshes.

Taking the pellets obtained in the step 2), adding 114.6g of micro-emulsion sugar, filling, polishing in a polishing machine, and removing damaged capsules to obtain the micro-emulsion capsule.

EXAMPLE 8 Aloe laxative pellet tablet

1) Extraction and purification process

130g of polygonum multiflorum, 180g of aloe and 150g of cassia seed

Ginseng, radix Ginseng, fructus Lycii, 60g Ejiao, 70g

Immature bitter orange 120g white atractylodes rhizome 60g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 150-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 70% ethanol twice (10 times and 8 times for 2 hr each time), filtering, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.19(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol degree of 60% (20 deg.C), refrigerating, standing for 24 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.33(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 55 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain 336g radix Aloe relaxing extract fine powder;

2) preparation process

A. Aloe vera laxative extract fine powder: 336g

B. Hydroxypropyl methylcellulose: 400g

Cellulose acetate: 100g

Microcrystalline cellulose: 80g of

C. Silica gel micropowder: 84g

Weighing the fine powder of the aloe cathartic extract in the step 1), hydroxypropyl methylcellulose, cellulose acetate, microcrystalline cellulose and superfine silica powder according to the prescription amount, fully and uniformly mixing, adding 35 wt% of ethanol solution with the concentration of 40% of the prescription amount as a wetting agent, continuously kneading to prepare a soft material, and extruding the soft material into strips through a sieve plate with the aperture of 0.9mm of an extruder; opening the spheronizer, selecting rotation speed of 1100rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and sieving to obtain 892.5g of pellets of 20-30 meshes.

And (3) adding 85.5g of microcrystalline cellulose into the pellets obtained in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 10g of magnesium stearate and 12g of talcum powder, uniformly mixing, and tabletting to obtain the compound preparation.

EXAMPLE 9 HUI BIAN TONG WEI WAN CAPSULE

The fine powder of the aloe vera laxative extract used in this example was the fine powder of the aloe vera laxative extract obtained in the extraction and purification process of step 1) of example 6.

Preparation process

A. Aloe vera laxative extract fine powder: 280g

B. Microcrystalline cellulose: 541.5g

And (3) chitosan: 108.3g

C. Dextrin: 43.8g

Silica gel micropowder: 26.2g

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, dextrin and superfine silica powder respectively according to the prescription amount, fully and uniformly mixing, adding 40% (weight) of ethanol solution with the concentration of 25% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 922.7g of pellets with 20-30 meshes.

And (3) adding 77.3g of aerosil into the pellets obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the finished product.

Example 10 Aloe laxative pellet tablet

1) Extraction and purification process

110g of fleece-flower root, 140g of aloe and 140g of cassia seed

Ginseng, radix Ginseng, fructus Lycii, 60g Ejiao, 50g

Immature bitter orange 100g white atractylodes rhizome 40g

Taking the donkey-hide gelatin with the above 8 ingredients, crushing the donkey-hide gelatin into superfine powder, and sieving the superfine powder with a 180-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 70% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.18(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol degree of 50% (20 deg.C), refrigerating, standing for 48 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.32(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 50 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain aloe and lax extract fine powder 279 g;

2) preparation process

A. Fine powder of aloe cathartic extract: 279g

B. Microcrystalline cellulose: 575g

And (3) chitosan: 75g of

C. Sodium carboxymethyl starch: 71g of

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan and sodium carboxymethyl starch according to the prescription amount, fully and uniformly mixing, adding 45 wt% of ethanol solution with the concentration of 20% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 950rpm, placing the strips in the spheronizer, spheronizing for 6.5min until the granules are rolled into pills, taking out the semi-finished pellets, drying at 50 ℃, and screening to obtain 906.7g of pellets with 20-30 meshes.

And (3) adding 76.3g of sodium hydroxymethyl starch into the micro-pills in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at a low temperature, finishing granules, adding 9g of magnesium stearate and 8g of talcum powder, uniformly mixing, and tabletting to obtain the compound magnesium stearate tablet.

EXAMPLE 11 HUI TONG WEI WAN CAPSULE

1) Extraction and purification process

75g of polygonum multiflorum, 150g of aloe and 90g of cassia seed

Ginseng 50g, wolfberry fruit 70g and donkey-hide gelatin 80g

Immature bitter orange 120g white atractylodes rhizome 60g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 200-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 50% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.17 (at 80 deg.C), cooling to room temperature, stirring, adding ethanol to reach alcohol content of 50% (at 20 deg.C), refrigerating and standing for 36 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.30(70 deg.C), belt vacuum drying at vacuum degree of-0.08 MPa-0.10 MPa and drying temperature of 60 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini superfine powder to obtain herba Aloe laxative extract fine powder 298 g;

2) preparation process

A. Aloe vera laxative extract fine powder: 298g

B. Cellulose acetate: 132g

Starch: 510g

C. Dextrin: 60g of

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose acetate, starch and dextrin according to the prescription amount, fully and uniformly mixing, adding 40% (by weight) of ethanol solution with the concentration of 30% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.3mm of an extruder; opening the spheronizer, selecting the rotation speed of 1150rpm, placing the strips in the spheronizer, spheronizing for 7min until the granules are rolled into pills, taking out the semi-finished pellets, drying at 55 ℃, and sieving to obtain 911.3g pellets of 20-30 meshes.

And (3) adding 88.7g of lactose into the pellet obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the finished product.

EXAMPLE 12 Aloe laxative pellet tablet

Preparation process

A. Aloe vera laxative extract fine powder: 280g

B. Microcrystalline cellulose: 433.3g

And (3) chitosan: 216.7g

C. Dextrin: 31.8g

Silica gel micropowder: 38.2g

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, dextrin and superfine silica powder respectively according to the prescription amount, fully and uniformly mixing, adding 40% (weight) of ethanol solution with the concentration of 25% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 918.4g of pellets with 20-30 meshes.

And (3) adding 64.6g of dextrin into the micro-pills in the step 2), uniformly mixing, preparing coarse granules, drying, crushing, sieving, preparing granules, drying at a low temperature, finishing granules, adding 8g of magnesium stearate and 9g of talcum powder, uniformly mixing, and tabletting to obtain the compound capsule.

EXAMPLE 13 HUI TONG WEI WAN CAPSULE

1) Extraction and purification process

100g of polygonum multiflorum, 130g of aloe and 120g of cassia seed

Ginseng 40g, wolfberry fruit 70g, donkey-hide gelatin 60g

Immature bitter orange 100g white atractylodes rhizome 40g

Taking the above 8 medicines, pulverizing the donkey-hide gelatin into superfine powder, and sieving with a 150-mesh sieve to obtain the donkey-hide gelatin superfine powder for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol twice (10 times and 8 times for the first time and 2 hr for the second time), filtering respectively, and mixing filtrates; decocting fructus Lycii, fructus Aurantii Immaturus and Atractylodis rhizoma in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.19(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach 70% (20 deg.C), refrigerating and standing for 48 hr, and filtering; mixing the above alcoholic extractive solution and water decoction, concentrating into soft extract with relative density of 1.32(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 60 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain 288g radix Aloe laxative extract fine powder;

2) preparation process

A. Fine powder of aloe cathartic extract: 288g

B. Hydroxypropyl methylcellulose: 512g

And (3) chitosan: 90g

C. Sodium carboxymethyl starch: 55g

Silica gel micropowder: 55g

Weighing the fine powder of the aloe cathartic extract in the step 1), hydroxypropyl methylcellulose, chitosan, sodium carboxymethyl starch and superfine silica powder respectively according to the formula amount, fully and uniformly mixing, adding 55 wt% of ethanol solution with the concentration of 30% of the formula amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.2mm of an extruder; opening the spheronizer, selecting the rotation speed of 900rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 4min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and sieving to obtain 883.7g of pellets with 20-30 meshes.

Taking the pellets obtained in the step 2), adding 116.3g of micro silica gel powder, filling, polishing in a polishing machine, and removing damaged capsules to obtain the compound preparation.

Comparative example 1 Hui Tongbiang micro pill

2) Preparation process

A. Fine powder of aloe cathartic extract: 280g

B. Microcrystalline cellulose: 500g

And (3) chitosan: 150g

C. Silica gel micropowder: 35g of

Dextrin: 35g of

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, micro silica gel and dextrin according to the prescription amount, fully and uniformly mixing, adding ethanol solution with the concentration of 15 percent of the prescription amount of 40 percent (by weight) as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 895.1g of pellets with 20-30 meshes.

Comparative example 2 Hui Tongbiang micro pill

2) Preparation process

A. Fine powder of aloe cathartic extract: 280g

B. Microcrystalline cellulose: 500g

And (3) chitosan: 150g

C. Silica gel micropowder: 35g of

Dextrin: 35g of

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, micro silica gel and dextrin according to the prescription amount, fully and uniformly mixing, adding 40% (by weight) of ethanol solution with the concentration of 20% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 907.3g of pellets with 20-30 meshes.

Comparative example 3 Hui Tongbiang micro pill

Preparation process

A. Fine powder of aloe cathartic extract: 280g

B. Microcrystalline cellulose: 433.3g

And (3) chitosan: 216.7g

C. Dextrin: 31.8g

Silica gel micropowder: 38.2g

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, dextrin and superfine silica powder respectively according to the prescription amount, fully and uniformly mixing, adding 40% (by weight) of ethanol solution with the concentration of 30% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 910.4.g of pellets of 20-30 meshes.

Comparative example 4 Hui Tongbiang micro pill

Preparation process

A. Aloe vera laxative extract fine powder: 280g

B. Microcrystalline cellulose: 433.3g

And (3) chitosan: 216.7g

C. Dextrin: 31.8g

Silica gel micropowder: 38.2g

Weighing the fine powder of the aloe cathartic extract in the step 1), microcrystalline cellulose, chitosan, dextrin and superfine silica powder respectively according to the prescription amount, fully and uniformly mixing, adding 40 wt% of ethanol solution with the concentration of 40% of the prescription amount as a wetting agent, continuously kneading to prepare soft materials, and extruding the soft materials into strips through a sieve plate with the aperture of 1.0mm of an extruder; opening the spheronizer, selecting the rotation speed of 1050rpm, placing the strip-shaped objects in the spheronizer, spheronizing for 6min until the particles are rolled into pills, taking out the semi-finished pellets, drying at 60 ℃, and screening to obtain 897.7g of pellets with 20-30 meshes.

Comparative example 5 preparation of aloe laxative pellets

The fine powder of the aloe vera laxative extract used in this example was the fine powder of the aloe vera laxative extract obtained in the extraction and purification process of step 1) of example 6. The best effect example 3 of the Chinese patent 'a traditional Chinese medicine pellet preparation for treating cervical spondylosis and lumbar spondylosis and a preparation method thereof (grant publication No. CN 100546596C)' is referred to for the preparation method of the pellet, so that the effect of forming the pellet when the pellet preparation method in the prior art is applied to the aloe laxative extract fine powder is examined.

Preparation process

A. Aloe vera laxative extract fine powder: 280g

B. Microcrystalline cellulose: 140g

Sieving the fine powder of the aloe cathartic extract and the microcrystalline cellulose with a 100-mesh sieve respectively, mixing the fine powder of the aloe cathartic extract and the microcrystalline cellulose according to the weight ratio of 1: 0.5, adding distilled water according to the weight ratio of the fine powder of the aloe cathartic extract and the distilled water of 1: 0.5 to prepare a mixed soft material, extruding and rounding the obtained mixed soft material by using an extruding and rounding granulator, wherein the conditions of the extruding and rounding granulator are as follows: the aperture of the sieve plate is 1.6mm, the extrusion speed is 30rpm, the spheronization time is 6min, the pellet with the particle size of 1.6mm is obtained, the pellet is placed in a drying oven for drying for 8 hours at the temperature of 60 ℃, and finally 204.9g of 20-30 meshes of the aloe constipation relieving pellet preparation is obtained by sieving.

Comparative example 6 preparation of aloe vera pellet

The fine powder of the aloe vera laxative extract used in this example was the fine powder of the aloe vera laxative extract obtained in the extraction and purification process of step 1) of example 6. The preparation method of the pellet refers to the control standard of the optimal quality and yield of the pellet in the prescription A for the drug-loading rate, wherein the control standard is the optimal quality and yield of the pellet in the 'research on the effect of the extrusion spheronization method for preparing the traditional Chinese medicine pellet (J. journal of mathematical and medical science, 2004, (27) 6: 723-724.)', and the drug-loading rate is 20%, and the preparation method is carried out according to the method in the '1.2.1 preparation process' of the document. Since the literature does not relate to the dosage ratio of the micro-powder silica gel and the microcrystalline cellulose as auxiliary materials and the dosage ratio of the wetting agent 95% ethanol, in the test process, the micro-powder silica gel and the microcrystalline cellulose are 1: 1, and the first aloe cathartic extract fine powder and the 95% ethanol are 1: 0.5 in percentage by weight, the pill forming effect of the preparation method of the micro-pill in the prior art when applied to the first aloe cathartic extract fine powder is examined.

2) Preparation process

A. Aloe vera laxative extract fine powder: 200g

B. Microcrystalline cellulose: 400g

Silica gel micropowder: 400g

The fine powder of the aloe cathartic extract of example 9, microcrystalline cellulose and aerosil are weighed according to the above prescription amount, stirred evenly, added with 500g of 95% ethanol and kneaded to prepare soft materials. Extruding the soft material into smooth and compact strips with the same diameter by using an extrusion sieve plate (the aperture of the sieve plate is 1.6mm), then opening the rounding machine, placing the strips in the high-speed rotating rounding machine, and continuously rolling until the particles are rolled into pills. Taking out the pellet, drying properly, and sieving to obtain 676.3g of 20-30 mesh YIHUITONGBIAN pellet.

Claims

1. The aloe pellet preparation is characterized in that the pellet preparation formula comprises the following components:

A. 28 percent of aloe laxative extract fine powder by weight;

B. 65% of pelleting accelerant by weight;

C. 7% by weight of a viscosity modifier;

the aloe laxative extract fine powder is prepared from the following raw materials:

50 parts by weight of ginseng, 75 parts by weight of barbary wolfberry fruit and 75 parts by weight of donkey-hide gelatin

120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome;

the pelleting accelerant is a mixture of microcrystalline cellulose and chitosan, and the viscosity regulator is a mixture of dextrin and superfine silica gel powder; the weight ratio of the microcrystalline cellulose: chitosan = 1: 0.2-0.5, silica gel micropowder: dextrin = 1: 0.6-1.2;

a 40% by weight, 25% strength ethanol solution is used as a wetting agent.

2. The pellet formulation of claim 1, wherein the ratio of microcrystalline cellulose: chitosan = 1: 0.3, silica gel micropowder: dextrin = 1: 1.

3. the pellet formulation according to claim 1 or 2, wherein the extraction and purification process of the fine powder of the aloe vera extract comprises the steps of:

A. weighing colla Corii Asini, pulverizing into superfine powder, and sieving;

C. weighing fructus Lycii, fructus Aurantii Immaturus, and Atractylodis rhizoma, decocting with water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating into fluid extract with relative density of 1.10-1.20 at 80 deg.C, cooling to room temperature, stirring, adding ethanol to ethanol concentration of 50% -70% at 20 deg.C, refrigerating, standing for 24-48 hr, and filtering;

D. mixing the ethanol extractive solution of step B and the water extractive solution of step C, concentrating to obtain soft extract with relative density of 1.30-1.35 at 70 deg.C, drying, pulverizing into fine powder, and sieving;

4. The pellet formulation according to claim 1 or 2, wherein the extraction and purification process of the fine powder of the aloe vera extract comprises the steps of:

C. weighing fructus Lycii, fructus Aurantii Immaturus, and Atractylodis rhizoma, decocting in water twice, adding 8 times of water for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of water for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.10-1.20 at 80 deg.C, cooling to room temperature, stirring, adding ethanol to reach ethanol degree of 60 at 20 deg.C, refrigerating, standing for 36 hr, and filtering;

D. mixing the ethanol extractive solution of step B and the water extractive solution of step C, concentrating into soft extract with relative density of 1.30-1.35 at 70 deg.C, vacuum drying, pulverizing into fine powder, and sieving;

5. The pellet formulation of claim 4, wherein the belt vacuum drying conditions in step D are vacuum degree of-0.08 MPa-0.10 MPa, and drying temperature of 50-60 ℃.

6. The pellet formulation of claim 1 or 2, wherein the formulation process of said aloe laxative pellets comprises the steps of:

F. respectively weighing fine powder of the aloe cathartic extract, a pelleting accelerant and a viscosity regulator, uniformly mixing, adding an ethanol solution, kneading to prepare a soft material, and extruding to obtain strips;

G. and (4) opening the spheronizer, putting the strip-shaped objects in the step (F) into the spheronizer, preparing pellets, drying and screening to obtain the finished product.

7. The pellet formulation of claim 6, wherein the formulation process comprises the steps of:

F. respectively weighing the fine powder of the aloe cathartic extract, the pelleting accelerant and the viscosity modifier in the step E according to the prescription amount, fully and uniformly mixing, adding 40 percent of ethanol solution with the concentration of 25 percent according to the prescription amount by weight, kneading to prepare soft material, and extruding the soft material into strips through a sieve plate with the aperture of 0.9mm-1.3mm of an extruder;

8. The Hui Tong Wan preparation according to claim 7, wherein the speed of the spheronizer in step G is 900-1150 rpm and the spheronization time is 4-7 min.

9. The Hui Tong Wan preparation of claim 8, wherein in step G, the rotational speed of the spheronizer is 1050prm and the spheronization time is 6 min.