CN111375019A - Aloe microcapsule preparation for relieving constipation and preparation method thereof - Google Patents
Aloe microcapsule preparation for relieving constipation and preparation method thereof Download PDFInfo
- Publication number
- CN111375019A CN111375019A CN202010201199.XA CN202010201199A CN111375019A CN 111375019 A CN111375019 A CN 111375019A CN 202010201199 A CN202010201199 A CN 202010201199A CN 111375019 A CN111375019 A CN 111375019A
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- CN
- China
- Prior art keywords
- aloe
- fine powder
- extract
- microcapsule
- laxative
- Prior art date
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Abstract
The invention belongs to the field of traditional Chinese medicine preparations, and discloses a aloe cathartic microcapsule preparation and a preparation method thereof. The aloe cathartic microcapsule of the invention is spherical or quasi-spherical, has good fluidity and small hygroscopicity, and is not easy to agglomerate; the obtained microcapsule preparation has obvious slow release and targeting effects, the medicine is mainly released in a target area of small intestine and large intestine, and directly acts on an effective part, the bioavailability is high, and the best effect of treating constipation can be achieved; meanwhile, by embedding the capsule wall material, the inherent bad smell of the aloe cathartic preparation can be covered up, the taste is improved, and the medication compliance of patients is improved.
Description
Technical Field
The invention relates to a Chinese medicinal microcapsule preparation and a preparation method thereof, in particular to a aloe catharsis microcapsule preparation and a preparation method thereof, belonging to the field of Chinese medicinal 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., is a unique product, has independent intellectual property rights of core technologies such as prescription, process, quality standard and application, obtains a production lot (Chinese medicine standard Z20150041) and a new medicine certificate (Chinese medicine certificate Z20150005) 5 and 6 days 2015, is successfully marketed and has a trade name of
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 of the product is guided by the theory of traditional Chinese medicine, combines 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, has reasonable prescription, precise and appropriate compatibility, simultaneous tonifying of qi and yin, concurrent application of tonifying and purging, no retention of tonifying, no harm to body resistance of purging, and achieves the purpose of treating constipation by tonifying qi, nourishing yin and improving physique. 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 particularly suitable for the old and weak patients to take, and is well received by doctors and patients.
The microencapsulation technology is characterized in that natural or synthetic polymer encapsulating materials (generally called capsule materials) are used as capsule wall shells, solid medicines or liquid medicines (generally called core materials) are wrapped in tiny, semi-permeable or sealed capsules to form drug-reservoir type microcapsules, and the microcapsules are named because the particle size is 1-250 mu m and belongs to the micron grade. Microencapsulation allows the contents to be released at a controlled rate under specific conditions, providing controlled or targeted drug delivery. There are many methods for microencapsulating drugs, which can be roughly classified into three types, namely, physicochemical methods, physical mechanical methods, and chemical methods, and among them, the spray drying method in the physical mechanical methods is one of the methods for preparing microcapsules that are widely used and practical. Spray drying (also known as droplet spray drying) can be used to directly dry emulsion and suspension into powder or granule, and can be used for microencapsulation of solid or liquid medicine without further evaporation and pulverization. The principle is that the core material is uniformly dispersed in the capsule material solution, further emulsified to form suspension or emulsion, and then fed into nozzle by means of sample-feeding pump, and under the action of compressed air flow it is atomized by means of spray in the hot air flow of drying chamber to form micro liquid drop, and its specific surface area is obviously increased, and the solvent in the liquid drop can be quickly volatilized by means of contact with hot air so as to make the capsule material be separated out into capsule, and then separated by means of vortex separator so as to obtain the invented medicine microcapsule. The spray drying method has the advantages of continuous operation, rapid drying, simple and convenient operation control, suitability for thermosensitive substances and the like, is widely applied to the industrial batch production of microcapsule products in the field of food and medicines, has excellent performance of the obtained microcapsule products, basically keeps the spherical particles, shows better dispersibility and fluidity, and simultaneously adopts an aqueous solution system to avoid the residue of organic solvents.
The spray drying process is a rather complicated process for preparing microcapsules, which is determined on the one hand by the diversity of the core material and the capsule material, and on the other hand by the diversification of the parameters in the preparation of the emulsion and the spray drying process. The aloe cathartic is a Chinese herbal compound preparation, and the prescription of the aloe cathartic is prepared by compatibility of a plurality of Chinese herbal medicines, can fully reflect the characteristics of differential treatment of diseases by Chinese medical science, and has better clinical advantages and practical value. However, the complexity of the chemical components of the aloe laxative extract is determined by the diversity of the basis of the traditional Chinese medicine compound materials, and is influenced by the inherent properties of the aloe laxative extract, such as large cream output, high clear paste viscosity and the like, in the process of preparing the aloe laxative extract into the micro-capsules, the types and the use amounts of the capsule wall materials, the anti-sticking agents and the plasticizing agents are slightly changed, the properties of the emulsion type material liquid containing the core materials and the capsule wall materials are often greatly changed, the problems of small drug loading amount, low encapsulation rate, poor fluidity, unstable preparation and the like of the micro-capsules can be caused, and even the situations of empty capsules and incapability of forming the capsules can be caused. In addition, in the preparation of the microcapsule, factors such as the preparation of the capsule wall material and the capsule core material, the operation of the spray drying process, the collection of products and the like all influence the microcapsule. Therefore, various influencing factors are required to be paid attention to in the preparation of the microcapsule by the spray drying method, and the process flow and parameters are optimized simultaneously, so that a good microcapsule product is obtained.
The existing research on traditional Chinese medicine microcapsules mainly focuses on traditional Chinese medicine monomeric compounds, and few researches on single traditional Chinese medicine active ingredient extracts and traditional Chinese medicine compounds with relatively complex ingredients are carried out. The effective components of the Chinese herbal compound are complex and various, and the mechanism for exerting the curative effect is not clear, so that great difficulties are faced in the aspects of capsule material selection, prescription design, preparation stability improvement, quality detection indexes, method establishment and the like. In the preparation process of the aloe laxative microcapsules, the inventor tries to prepare the aloe laxative microcapsules by referring to the existing preparation process of the microcapsules, but the forming effect of the aloe laxative microcapsules is not ideal due to the difference of prescription composition and the difference of the preparation process of the traditional Chinese medicine extract.
Disclosure of Invention
Aiming at the defects of the existing aloe laxative capsules and the requirement of upgrading and updating the products, the preparation sequence of the aloe laxative products is increased to fully exert the clinical treatment value of the products, and the invention is necessary to invent a microencapsulated product which is different from the characteristics and the release mechanism of the common capsules and is more suitable for the constitution and the functional indication of the aloe laxative prescription.
The aloe laxative microcapsule preparation comprises the following components in percentage by weight:
A. 13.5 to 27.5 percent of aloe laxative extract fine powder
B. 67-81 percent of capsule wall material
C. 0.9 to 2.5 percent of antisticking agent
D. 3.6 to 5.0 percent of plasticizer
The capsule wall material is one or more of acacia, maltodextrin, modified starch, octenyl succinate starch, starch syrup dry powder, sodium caseinate, β -lactoglobulin, soybean protein isolate and xanthan gum;
the anti-sticking agent is one or more of glyceryl monostearate, octadecanol, micropowder silica gel and titanium dioxide;
the plasticizer is one or more of glycerol, polyethylene glycol 6000, polyethylene glycol 400, propylene glycol and citric acid.
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 raw materials:
120 parts of polygonum multiflorum, 160 parts of aloe and 140 parts of cassia seed
50 parts of ginseng, 75 parts of wolfberry fruit and 75 parts of donkey-hide gelatin
120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.
Preferably, the formulation comprises the following components in percentage by weight:
A. 17.5 to 23.5 percent of aloe laxative extract fine powder
B. 71.5 to 77.5 percent of capsule wall material
C. 1.1 to 1.9 percent of antisticking agent
D. 3.8% -4.7% of plasticizer;
preferably, the formulation comprises the following components in percentage by weight:
A. 19.7 to 22.5 percent of aloe laxative extract fine powder
B. 72.3 to 74.1 percent of capsule wall material
C. 1.3 to 1.8 percent of antisticking agent
D. 3.9% -4.4% of plasticizer;
the capsule wall material comprises one of sodium curdlin, starch syrup dry powder, maltodextrin, β -lactoglobulin, 3:2, maltodextrin, soybean protein isolate, modified starch, Arabic gum, 5:3:2:1 or octenyl succinate starch, β -lactoglobulin, 3: 2;
the anti-sticking agent is octadecanol: titanium dioxide 2:1 or glyceryl monostearate;
the plasticizer comprises polyethylene glycol 6000: 2-6: 1 or propylene glycol.
The invention also aims to provide a preparation method of the aloe cathartic microcapsule preparation, which mainly comprises the steps of preparing fine powder of aloe cathartic extract, preparing emulsion and spray drying.
A method for preparing HUI TONG XIAO JIAO NANG (Aloe Vera and Aloe Vera microcapsule) comprises the following steps:
1) extraction and purification process
A. Weighing colla Corii Asini according to formula ratio, pulverizing into superfine powder, and sieving;
B. reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 50% -70% ethanol twice, 10 times the amount of the first time and 8 times the amount of the second time, each time for 2 hr, filtering respectively, and mixing filtrates;
C. 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 to obtain 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% (25 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. mixing the colla Corii Asini micropowder of step A and the fine powder of step D to obtain Aloe laxative extract fine powder;
2) preparation process
F. Weighing the fine powder of the aloe vera laxative extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step E according to the formula, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 45-58 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 22-42%, cooling to room temperature, adding the fine powder of the aloe vera laxative extract and the emulsifier in a stirring state, and homogenizing and emulsifying to obtain an emulsion for later use;
G. and F, carrying out spray drying on the emulsion in the step F under the conditions of air inlet temperature of 165-175 ℃, spray pressure of 0.36-0.42 MPa and feeding speed of 15-25 ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
Preferably, the step 1) extraction and purification process comprises the following steps:
A. weighing the donkey-hide gelatin according to the formula ratio, crushing the donkey-hide gelatin into superfine powder, and sieving the superfine powder with a sieve of 150-200 meshes for later use;
B. 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;
C. 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 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 concentration of 60% (at 25 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(70 deg.C), belt vacuum 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 parameter conditions of belt type vacuum drying in the step D of the 1) extraction and purification process are that the vacuum degree is-0.08 Mpa to-0.10
Mpa, drying temperature 50-60 deg.C.
Preferably, the step 2) formulation process comprises the following steps:
F. weighing the fine powder of the aloe vera laxative extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step E according to the formula, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 52 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 36%, cooling to room temperature, adding the fine powder of the aloe vera laxative extract and the emulsifier in a stirring state, and homogenizing and emulsifying to obtain an emulsion for later use;
G. and F, carrying out spray drying on the emulsion in the step F under the conditions of the air inlet temperature of 172 ℃, the spray pressure of 0.39MPa and the feeding speed of 22.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
Preferably, the emulsifier in step 2) F is one or more of Tween80, soybean lecithin, poloxamer and sucrose fatty acid ester, and the using amount of the emulsifier is 0.4-1.2% of the total amount of the preparation formula by mass fraction;
preferably, the emulsifier in step F is soybean phospholipid: the dosage of the compound emulsifier is 0.9 percent of the total amount of the preparation formula according to the mass fraction, wherein the sucrose fatty acid ester is 4: 6.
Further, the preparation method of the aloe laxative microcapsule preparation comprises the following steps:
1) extraction and purification process
A. Weighing the donkey-hide gelatin according to the formula ratio, crushing the donkey-hide gelatin into superfine powder, and sieving the superfine powder with a sieve of 150-200 meshes for later use;
B. 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;
C. 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 concentration of 60% (25 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 to-0.09 pa, 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;
2) preparation process
F. Taking the fine powder of the aloe vera laxative extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step E, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 52 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 36%, cooling to room temperature, adding the fine powder of the aloe vera laxative extract and the soybean lecithin in a stirring state: the dosage of the compound emulsifier is 0.9 percent of the total amount of the preparation formula according to the mass fraction, wherein the sucrose fatty acid ester is 4: 6. Homogenizing and emulsifying to obtain emulsion for later use;
G. and F, carrying out spray drying on the emulsion in the step F under the conditions of the air inlet temperature of 172 ℃, the spray pressure of 0.39MPa and the feeding speed of 22.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
The microcapsules of the present invention can be used as common powders or granules, and can be further used as an intermediate to fill capsules, compress tablets, etc., thereby obtaining aloe laxative microcapsule capsules and aloe laxative microcapsule tablets.
The aloe laxative microcapsule preparation has the following characteristics and beneficial effects:
1) the aloe cathartic microcapsule preparation is a drug storage type microcapsule, is spherical or quasi-spherical, has good fluidity, small hygroscopicity, good stability and difficult agglomeration, and can improve the problems of easy moisture absorption, instability and the like of finished products of the aloe cathartic capsule;
2) the aloe cathartic microcapsule preparation has obvious slow release and targeting effects, is mainly concentrated in the target area release of the small intestine and the large intestine, directly acts on the effective part, has high bioavailability, is not influenced by gastrointestinal rhythm, and can exert the optimal effect of treating constipation;
3) the aloe laxative extract fine powder can cover the inherent bad smell and taste of the aloe laxative preparation by embedding and covering the capsule wall material, and the patient has good medication compliance.
The aloe cathartic microcapsule preparation is white or grey white powder, is loose, has no bad smell, and has high flowability, high dispersivity and high stability. Except for the existence of dents on the surfaces of the microcapsule particles, the particles are round and nearly spherical, the surfaces of the microcapsule particles are compact and have no pores, basically no adhesion exists, the capsule particle size distribution is relatively uniform, the particle size distribution is narrow, most of the particles are concentrated near 20 mu m, and the particles are in approximate normal distribution. The encapsulation efficiency test result shows that the aloe cathartic microcapsule preparation prepared by the preparation formula and the preparation process has the encapsulation efficiency of over 80 percent and the highest encapsulation efficiency of 93.8 percent and has better microencapsulation effect.
In-vitro cumulative dissolution tests show that the aloe laxative microcapsule capsules and aloe laxative microcapsule tablets have the cumulative dissolution percentage of less than 55 percent within 1 hour, reach the dissolution of more than 80 percent within 2 hours and are basically and completely released within 3 hours. Compared with the traditional capsule, the aloe cathartic microcapsule preparation has certain slow release effect.
The accelerated stability test result shows that the aloe cathartic microcapsule tablet and the microcapsule capsule have no change in properties and content and meet the requirement of various investigation indexes of water content, dissolution time and hygiene after being placed for 6 months under the accelerated test conditions (40 +/-2 ℃ and RH 75% +/-5). According to the experimental data, the aloe cathartic microcapsule preparation prepared by the invention has good stability and controllable quality.
Experimental example 1 microcapsule form and particle size distribution
First, form
A proper amount of the microcapsule samples of example 5 and example 11 were placed in an evaporation dish, and the color and shape thereof were observed in a room with or without natural light. The microcapsule sample is observed to be white or grey white powder by naked eyes, is loose, has no bad smell, and has good fluidity, dispersibility and stability.
And (2) adding a small amount of acetone into the samples respectively, performing ultrasonic treatment for 2min (dispersing overlapped and adhered microcapsules), dipping and dripping the samples on a glass slide, covering the glass slide, and placing the glass slide on a Winner99C type static particle imager (Jinan micro-nano particle instrument, Inc.) for observation under the magnification of 1000 times, wherein the surfaces of the microcapsule particles are round and nearly spherical except for individual dents, the surfaces are compact and have no pores, the microcapsules are basically not adhered, and the microcapsule requirements are met.
II, particle size distribution
About 0.03g of the microcapsule samples of examples 5 and 11 were taken, and the particle size (D) was measured by a Winner2005B smart laser particle size analyzer (micronano particle instruments ltd) using 50% ethanol as a dispersion medium, and the results are shown in table 1 (in the table, D10, D50, and D90 respectively indicate equivalent diameters of the largest particles at 10%, 50%, and 90% cumulative distribution in the distribution curve, and Dav indicates an average particle size, the same is shown in the following table) and fig. 1 and 2.
TABLE 1 particle size measurement of HUI TONG MICROCAPSULE
As can be seen from the accompanying drawings 1 and 2, the Huilu laxa microcapsules have relatively uniform particle size distribution, most of which are concentrated around 20 μm, wherein the average particle size of the microcapsules of example 5 is 22.69 μm, the average particle size of the microcapsules of example 11 is 23.03 μm, the particle size distribution of the microcapsules of the two samples is narrow and approximately normal, and the microencapsulation effect is better.
Experimental example 2 measurement of encapsulation efficiency of Hhui cathartic microcapsule
The encapsulation efficiency refers to the percentage of the actual drug content in the microcapsule to the total drug content (i.e. drug loading) in the microcapsule sample, i.e. the percentage of the drug content in the prepared microcapsule to the total drug content of the system. The higher the encapsulation efficiency, the better the drug is encapsulated, and the specific method for determining the encapsulation efficiency of the aloe laxative microcapsules is as follows.
Chromatographic conditions and system applicability tests show that octadecyl bonded silica gel is used as a filler, acetonitrile-methanol-water (20: 8: 72) is used as a mobile phase, the detection wavelength is 320nm, and the number of theoretical plates is not less than 2000 according to the peak calculation of 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside.
Preparation of reference substance solution A proper amount of 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside reference substance is precisely weighed, and diluted ethanol is added to prepare a solution containing 0.06mg per 1 ml.
Preparation of test solution A proper amount of aloe vera laxative microcapsule sample is precisely weighed, placed in a 100mL volumetric flask, the volume is determined to be 100mL by 75% ethanol, shaken up to completely dissolve the aloe vera laxative extract on the outer surface of the microcapsule in the ethanol solution, 10mL of the solution is precisely transferred to another 25mL volumetric flask, the volume is determined to be a scale by 75% ethanol solution, 5mL of the sample solution is taken, transferred to a separating funnel, extracted with diethyl ether for 2 times, 15mL each time, the ethyl ether solution is discarded, the pH value is adjusted to 1-2 by dilute hydrochloric acid, extracted with ethyl acetate (15mL, 10mL) for 4 times, the ethyl acetate solution is combined, evaporated to dryness, the residue is dissolved with dilute ethanol and transferred to a 2mL volumetric flask, the volume is determined, shaken up and filtered, and the test solution of 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside outside the microcapsule is obtained.
Another appropriate amount of aloe vera microcapsule sample is precisely weighed, placed in a 100mL volumetric flask, dissolved by potassium dihydrogen phosphate-sodium hydroxide buffer solution with pH 7.6 and constant volume to 100mL, shaken up to completely dissolve the outer surface of the microcapsule and the aloe vera microcapsule extract in the buffer solution, and the rest operations are the same as above, thus obtaining the microcapsule 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside test solution.
The determination method comprises sampling standard solution and test solution respectively, injecting 20ul, calculating the content of 2, 3, 5, 4 '-tetrahydroxystilbene-2-O- β -D-glucoside in the sample by adopting external standard two-point method logarithmic equation, and calculating the amount (M) of microcapsule external surface extract fine powder and the amount (M) of microcapsule total extract fine powder by the content of 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside.
The encapsulation efficiency (total drug M in the microcapsule sample-the amount of drug M outside the microcapsule) is × 100%/total drug M in the microcapsule sample.
TABLE 2 Aloe Vera microencapsulated rate and yield for purgation
As can be seen from table 2, when the plasticizer is a polyethylene glycol 6000 and citric acid complex and the amount is fixed to be 3.9% of the total amount of the formulation, the encapsulation efficiency of the aloe laxative microcapsules and the yield of the qualified microcapsules are changed along with the change of the ratio of the amount of polyethylene glycol 6000 to the amount of citric acid, and from the experimental results, the ratio of polyethylene glycol 6000: when the citric acid is 3:1, the encapsulation efficiency is best, the yield of the finished product is highest, and the yield is obviously higher than that of the comparative example 1 with the plasticizer of single-taste polyethylene glycol 6000 and that of the comparative example 2 with the plasticizer of single-taste citric acid.
The microcapsule encapsulation efficiencies of comparative example 7 and comparative example 8, which are obtained by carrying out microcapsule preparation by the traditional Chinese medicine compound microcapsule preparation process described in the prior art patents and documents, are respectively 44.1% and 37.6%; the yield is low, and is respectively 24.5 percent and 32.9 percent. Therefore, when the formulation of the microcapsule preparation and the preparation method of the microcapsule in the prior art are used for preparing the aloe laxative capsule, the encapsulation efficiency and the product yield can not meet the corresponding requirements, and the industrial production can not be realized.
EXAMPLE 3 in vitro cumulative dissolution test
Inventive example 5, the aloe vera micro-capsule, example 11, and the aloe vera micro-capsule (lunan pacho pharmaceutical limited, specification: 0.35 g/capsule × 6/capsule, lot # 26190032) were prepared by referring to dissolution test method (slow release or controlled release formulation 0931 in the four pharmacopoeia 2015 edition) using 250ml of phosphate buffer (pH6.8) as dissolution medium, at a water bath temperature of 37 ℃. + -. 0.5 ℃ and a rotation speed of 100 rpm-1In vitro dissolution test with 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside (C)20H22O9) And (5) inspecting indexes.
Chromatographic conditions and system applicability tests show that octadecyl bonded silica gel is used as a filler, acetonitrile-methanol-water (20: 8: 72) is used as a mobile phase, the detection wavelength is 320nm, and the number of theoretical plates is not less than 2000 according to the peak calculation of 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside.
Preparation of reference substance solution A proper amount of 2, 3, 5, 4' -tetrahydroxystilbene-2-O- β -D-glucoside reference substance is precisely weighed, and diluted ethanol is added to prepare a solution containing 0.06mg per 1 ml.
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- β -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- β -D-glucoside at each time point, wherein the results are shown in Table 3.
TABLE 3 cumulative percent dissolution for different samples
The dissolution curve was plotted with the dissolution time (min) as the abscissa and the cumulative dissolution percentage (%) as the ordinate, as shown in FIG. 3. As can be seen from figure 3, the aloe laxative micro-capsule and the aloe laxative micro-capsule tablet have the cumulative dissolution percentage of less than 54 percent within 1 hour, achieve the dissolution of more than 82 percent within 2 hours, and are basically and completely released within 3 hours, and the aloe laxative micro-capsule preparation has certain slow release effect.
Experimental example 4 accelerated stability examination
To verify the stability of the aloe vera microcapsule formulations of the present invention, the inventors conducted accelerated stability test studies on the aloe vera microcapsule capsules of example 5 and the aloe vera microcapsule tablets of example 11. It should be noted that the selected samples of the aloe laxative microencapsulated formulations used in this test are representative formulations and the preparation thereof, and the other formulations and preparation thereof involved in the present invention are not intended to be exhaustive due to space limitations.
Two batches of samples (microcapsule capsules in example 5 and microcapsule tablets in example 11) are stored for 6 months in an acceleration test box (40 +/-2 ℃ and RH 75% +/-5) under an aluminum-plastic package (6 capsules/version), and are sampled for 0 month, 1 month, 2 months, 3 months and 6 months respectively to carry out accelerated stability examination, wherein the content determination method of the stilbene glucoside is the same as that of the experiment example 2, and the detection methods of other indexes refer to the four parts of the 2015 year version of Chinese pharmacopoeia. The accelerated stability test data of the two batches of products are shown in tables 4 and 5.
Table 4 example 5 aloe laxative microcapsules accelerated stability study results
Table 5 example 11 the results of the accelerated stability study of aloe laxative microcapsules
The results of accelerated stability tests in tables 4 and 5 show that the aloe-laxative microcapsule capsule and microcapsule tablet have no change in properties and content, and meet the requirements of moisture, disintegration (dissolution) time limit and hygiene examination indexes after being placed for 6 months under accelerated test conditions (40 +/-2 ℃ and RH 75% +/-5). According to the accelerated stability test results, the aloe laxative micro-capsule preparation prepared by the invention has good stability and controllable quality.
Drawings
FIG. 1 is a distribution diagram of the particle size of the Hui Po microcapsules of example 5;
FIG. 2 is a distribution diagram of the particle size of the Hui Po microcapsules of example 11;
fig. 3 is a graph showing the cumulative dissolution rate percentage of the aloe vera laxative micro-capsule, the aloe vera laxative micro-capsule tablet and the aloe vera laxative capsule.
Detailed Description
The present invention is further described below by way of specific examples, but the present invention is not limited to the following examples, and any equivalent substitutions in any form will be apparent to those of ordinary skill in the art and are included in the present invention.
EXAMPLE 1 Aloe micro-capsules for laxation
1) Extraction and purification process
120g of polygonum multiflorum, 160g of aloe and 150g of cassia seed
Ginseng 20g and wolfberry fruit 50g and donkey-hide gelatin 40g
Immature bitter orange 120g white atractylodes rhizome 30g
Taking the above 8 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 180 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.10(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 70% (25 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 1.35(70 deg.C), vacuum drying at vacuum degree of-0.08 MPa-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 final product, QIHUITONGBIAO extract fine powder 243 g.
2) Preparation process
A. Aloe vera laxative extract fine powder: 135g
B. Gum arabic: 540g
Maltodextrin, 2: 270g
C. Glyceryl monostearate: 10g
Titanium dioxide: 5g
D. Polyethylene glycol 400: 40g of
Adding Arabic gum, maltodextrin, glyceryl monostearate, titanium dioxide and polyethylene glycol 400 into purified water, heating and stirring at 50 deg.C to dissolve, preparing into capsule wall material solution with mass fraction of 40%, cooling to room temperature, adding the above superfine powder of Aloe Vera extract and poloxamer 6g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 170 deg.C, spray pressure of 0.38MPa and feed rate of 17.5ml/min, collecting microcapsule, and cooling to obtain microcapsule 826 g.
And (3) adding 174g of starch into the microcapsules obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the microcapsule.
EXAMPLE 2 Aloe Vera microcapsule tablet 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 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 180 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.11(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 70% (25 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 1.30(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 micropowder to obtain final product, QIHUITONGBIAO extract fine powder 256 g.
2) Preparation process
A. Aloe vera laxative extract fine powder: 175g of
B. Octenyl succinylated starch: 775g
C. Silica gel micropowder: 13g
D. Propylene glycol: 37g
Adding octenyl succinate starch, silica gel micropowder and propylene glycol into purified water, heating and stirring at 48 deg.C to dissolve, preparing 28% capsule wall material solution, cooling to room temperature, adding the above superfine powder of Aloe Vera extract and Tween-8012 g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature 166 deg.C, spray pressure 0.40MPa, and feed rate 16ml/min, collecting microcapsule, and cooling to obtain 784g microcapsule.
And (3) adding 201g of sucrose powder into the microcapsules obtained in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 7g of magnesium stearate and 8g of talcum powder, uniformly mixing, and tabletting to obtain the finished product.
EXAMPLE 3 Aloe laxative microencapsulated capsules
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 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 200 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.17(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach 50% (25 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 1.32(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 331g of HUAIHUI TONGBIANG extract fine powder.
2) Preparation process
A. Aloe vera laxative extract fine powder: 217g
B. Starch syrup dry powder: 572g
β -lactoglobulin 143g
C. Octadecanol: 21g of
D. Glycerol: 28g
Citric acid: 19g of
Adding the above formula amount of starch syrup dry powder, β -lactoglobulin, octadecanol, glycerol and citric acid into purified water, heating and stirring at 46 deg.C to dissolve, preparing into 37% capsule wall material solution, cooling to room temperature, adding the above formula amount of Aloe Vera cathartica extract fine powder and 10g of sucrose fatty acid ester under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 168 deg.C, spray pressure of 0.42MPa, and feed rate of 15ml/min, collecting microcapsule, and cooling to obtain 796g microcapsule.
And (3) adding 204g of superfine silica gel powder into the microcapsules obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the microcapsule.
EXAMPLE 4 Aloe Vera microcapsule tablet for relaxing bowels
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 120g white atractylodes rhizome 80g
Taking the above 8 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 150 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.15(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 60% (25 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-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 the final product, QIHUITONGBIAO extract fine powder 311 g.
2) Preparation process
A. Aloe vera laxative extract fine powder: 275g
B. Isolated soy protein: 372g
Maltodextrin, 2: 224g of
Xanthan gum: 74g
C. Silica gel micropowder: 9g of
D. Polyethylene glycol 6000: 46g
Adding the soybean protein isolate, maltodextrin, xanthan gum, aerosil and polyethylene glycol 6000 into purified water according to the formula, heating and stirring at 51 ℃ to dissolve the soybean protein isolate, the maltodextrin, the xanthan gum, the aerosil and the polyethylene glycol 6000 to prepare a capsule material solution with the mass fraction of 27%, cooling to room temperature, adding the aloe cathartic extract fine powder and 5g of lecithin according to the formula under the stirring state, homogenizing and emulsifying to obtain an emulsion, carrying out spray drying at the air inlet temperature of 174 ℃, the spray pressure of 0.39MPa and the feeding speed of 20ml/min, collecting microcapsules, and cooling to obtain 806g of microcapsules.
And (3) adding 178g of dextrin into the microcapsule obtained in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, granulating, adding 8g of magnesium stearate and 8g of talcum powder, uniformly mixing, and tabletting to obtain the microcapsule.
EXAMPLE 5 Aloe micro-capsules for laxation
1) Extraction and purification process (10 times prescription amount)
1200g of polygonum multiflorum, 1600g of aloe and 1400g of cassia seed
500g ginseng, 750g medlar and 750g donkey-hide gelatin
Immature bitter orange 1200g white atractylodes rhizome 500g
Taking the above 8 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 200 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.15(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 60% (25 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 60 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain the final product, YIHUI TONGBIAO extract fine powder, 2650 g.
2) Preparation process
A. Aloe vera laxative extract fine powder: 225g
B. Sodium caseinate: 445g
Starch syrup dry powder: 296g of
C. Glyceryl monostearate: 13g
D. Polyethylene glycol 6000: 30g of
Citric acid: 9g of
Adding maltodextrin, β -lactoglobulin, glyceryl monostearate, polyethylene glycol 6000, and citric acid into purified water, heating and stirring at 52 deg.C to dissolve, preparing into capsule wall material solution with mass fraction of 36%, cooling to room temperature, adding Aloe Vera extract fine powder, soybean phospholipid 3.6g, sucrose fatty acid ester 5.4g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 172 deg.C, spray pressure of 0.39MPa, and feed rate of 22.5ml/min, collecting microcapsule, and cooling to obtain 867g microcapsule.
And (3) adding 133g of aerosil into the microcapsule obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the microcapsule.
EXAMPLE 6 Aloe Vera microcapsule tablets for relaxing bowels
1) Extraction and purification process
130g of polygonum multiflorum, 180g of aloe and 150g of cassia seed
Ginseng 70g and wolfberry fruit 60g and donkey-hide gelatin 70g
Immature bitter orange 120g white atractylodes rhizome 60g
Taking the above 8 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 150 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.19(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 60% (25 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 superfine powder 325g of HUIHUI TONGBIAN extract.
2) Preparation process
A. Aloe vera laxative extract fine powder: 260g of
B. Gum arabic: 510g
Isolated soy protein: 170g
C. Octadecanol: 8g
Silica gel micropowder: 4g
D. Polyethylene glycol 6000: 48g
Adding Arabic gum, soybean protein isolate, octadecanol, aerosil and polyethylene glycol 6000 in the above formula into purified water, heating and stirring at 58 deg.C to dissolve, preparing into 42% capsule material solution, cooling to room temperature, adding Aloe Vera extract fine powder and 7g sucrose fatty acid ester in the above formula under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature 166 deg.C, spray pressure 0.36MPa, and feed rate 20.5ml/min, collecting microcapsule, and cooling to obtain 798g microcapsule.
And (3) adding 180g of microcrystalline cellulose into the microcapsules obtained in the step 2), uniformly mixing, preparing coarse granules, drying, crushing, sieving, preparing granules, drying at low temperature, finishing granules, adding 10g of magnesium stearate and 12g of talcum powder, uniformly mixing, and tabletting to obtain the finished product.
EXAMPLE 7 Aloe Vera microcapsules
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 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 200 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.17(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach 50% (25 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 1.30(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 micropowder to obtain Aloe laxa extract fine powder 289 g.
2) Preparation process
A. Aloe vera laxative extract fine powder: 150g
B. Octenyl succinylated starch: 468g
β -lactoglobulin 312g
C. Glyceryl monostearate: 20g of
D. Propylene glycol: 50g
Adding octenyl succinate starch, β -lactoglobulin, glyceryl monostearate and propylene glycol into purified water, heating and stirring at 49 deg.C to dissolve, preparing 29% capsule wall material solution, cooling to room temperature, adding the above superfine powder of Aloe Vera cathartica extract and Tween-808 g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature 165 deg.C, spray pressure 0.41MPa, and feed rate 24ml/min, collecting microcapsule, and cooling to obtain 806g microcapsule.
EXAMPLE 8 Aloe laxative microencapsulated capsules
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 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 150 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.19(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 70% (25 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 60 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain 281g of radix Aloe bowel relaxing extract fine powder.
2) Preparation process
A. Aloe vera laxative extract fine powder: 190g of
B. Maltodextrin, 2: 474g
Isolated soy protein: 273g of
C. Octadecanol: 25g of
D. Propylene glycol: 41g
Adding maltodextrin, soybean protein isolate, octadecanol and propylene glycol into purified water, heating and stirring at 45 ℃ to dissolve, preparing 22% capsule wall material solution, cooling to room temperature, adding the aloe vera cathartic extract fine powder and 4g of poloxamer under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at the air inlet temperature of 174 ℃, the spray pressure of 0.42MPa and the feed speed of 25ml/min, collecting microcapsules, and cooling to obtain 839g of microcapsules.
And (3) adding 161g of aerosil into the microcapsules obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the microcapsule.
EXAMPLE 9 Aloe Vera microcapsule tablets 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 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 150 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.12(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 50% (25 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-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 fine powder 263g of HUIHUI TONGBIANG extract.
2) Preparation process
A. Aloe vera laxative extract fine powder: 183g
B. Gum arabic: 756g of
C. Glyceryl monostearate: 10g
Titanium dioxide: 6g
D. Citric acid: 45g of
Adding Arabic gum, glyceryl monostearate, titanium dioxide and citric acid into purified water, heating and stirring at 50 deg.C to dissolve, preparing into capsule wall material solution with mass fraction of 32%, cooling to room temperature, adding the above aloe extract fine powder and lecithin 5g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 175 deg.C, spray pressure of 0.38MPa, and feed rate of 18.5ml/min, collecting microcapsule, and cooling to obtain 811g microcapsule.
And (3) adding 173g of starch into the microcapsules obtained in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, granulating, adding 5g of magnesium stearate and 11g of talcum powder, uniformly mixing, and tabletting to obtain the finished product.
EXAMPLE 10 Aloe micro-capsules for laxation
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 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 180 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.16(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 70% (25 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-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 303g of HUAIHUI TONGBIANG extract fine powder.
2) Preparation process
A. Aloe vera laxative extract fine powder: 176g
B. Maltodextrin, 2: 349g
Isolated soy protein: 210g
Modified starch: 140g
Gum arabic: 70g
C. Glyceryl monostearate: 16g
D. Glycerol: 39g
Adding maltodextrin, soybean protein isolate, modified starch, Arabic gum, glyceryl monostearate and glycerol into purified water, heating and stirring at 47 deg.C to dissolve, preparing into capsule wall material solution with mass fraction of 39%, cooling to room temperature, adding the above superfine powder of Aloe Vera extract and Tween-8011 g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at 169 deg.C, spray pressure of 0.41MPa and feed rate of 21ml/min, collecting microcapsule, and cooling to obtain 837g microcapsule.
Taking the microcapsule in the step 2), adding 163g of lactose, filling, polishing in a polishing machine, and removing damaged capsules to obtain the microcapsule.
EXAMPLE 11 Aloe laxative microcapsule tablets
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 5.
Preparation process
A. Aloe vera laxative extract fine powder: 197g
B. Maltodextrin, 2: 482g
β -lactoglobulin 241g
C. Octadecanol: 12g of
Titanium dioxide: 6g
D. Propylene glycol: 44g
Adding sodium caseinate, starch syrup dry powder, octadecanol, titanium dioxide and propylene glycol into purified water according to the formula, heating and stirring at 52 ℃ to dissolve, preparing a capsule wall material solution with the mass fraction of 36%, cooling to room temperature, adding aloe cathartic extract fine powder according to the formula, 3.6g of soybean phospholipid and 5.4g of sucrose fatty acid ester under stirring, homogenizing and emulsifying to obtain an emulsion, carrying out spray drying under the conditions of the air inlet temperature of 172 ℃, the spray pressure of 0.39MPa and the feed speed of 22.5ml/min, collecting microcapsules, and cooling to obtain 852g of microcapsules.
And (3) adding 131g of dextrin into the microcapsule obtained in the step 2), uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, granulating, adding 8g of magnesium stearate and 9g of talcum powder, uniformly mixing, and tabletting to obtain the microcapsule.
EXAMPLE 12 Hui Tongbian microcapsules
1) Extraction and purification process
110g of fleece-flower root, 140g of aloe and 140g of cassia seed
Ginseng 30g, wolfberry fruit 60g, donkey-hide gelatin 50g
Immature bitter orange 100g white atractylodes rhizome 40g
Taking the above 8 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 180 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.18(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach 50% (25 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-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 fine powder 272g of HUIHUI TONGBIANG extract.
2) Preparation process
A. Aloe vera laxative extract fine powder: 158g
B. Sodium caseinate: 595g
Xanthan gum: 198g
C. Glyceryl monostearate: 11g
D. Polyethylene glycol 6000: 25g of
Citric acid: 13g
Adding the sodium caseinate, the xanthan gum, the glyceryl monostearate, the polyethylene glycol 6000 and the citric acid into purified water according to the formula, heating and stirring at 54 ℃ to dissolve the sodium caseinate, the xanthan gum, the glyceryl monostearate, the polyethylene glycol 6000 and the citric acid to prepare a capsule material solution with the mass fraction of 41%, cooling to room temperature, adding the aloe vera extract fine powder and 8g of poloxamer according to the formula under the stirring state, homogenizing and emulsifying to obtain an emulsion, performing spray drying at the air inlet temperature of 171 ℃, the spray pressure of 0.37MPa and the feed speed of 15ml/min, collecting microcapsules, and cooling to obtain 797g of microcapsules.
EXAMPLE 13 Aloe laxative microencapsulated capsules
1) Extraction and purification process
100g of polygonum multiflorum, 130g of aloe and 110g of cassia seed
Ginseng 30g, wolfberry fruit 60g, donkey-hide gelatin 70g
Immature bitter orange 90g and white atractylodes rhizome 40g
Taking the above 8 ingredients, pulverizing colla Corii Asini into superfine powder, and sieving with 200 mesh sieve; 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 the decoction for the first time, soaking for 1 hr, decocting for 1.5 hr, adding 6 times of the decoction for the second time, decocting for 1.5 hr, filtering, mixing filtrates, concentrating to obtain fluid extract with relative density of 1.19(80 deg.C), cooling to room temperature, stirring, adding ethanol to reach concentration of 70% (25 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 55 deg.C, pulverizing into fine powder, sieving, and mixing with the above colla Corii Asini micropowder to obtain the final product, QIHUITONGBIAO extract fine powder 273 g.
2) Preparation process
A. Aloe vera laxative extract fine powder: 235g
B. Sodium caseinate: 353.5g
Maltodextrin, 2: 353.5g
C. Silica gel micropowder: 19g of
D. Polyethylene glycol 400: 21g of
Glycerol: 18g of
Adding sodium caseinate, maltodextrin, superfine silica gel powder, polyethylene glycol and glycerol into purified water according to the formula, heating and stirring at 53 ℃ to dissolve, preparing a capsule material solution with the mass fraction of 25%, cooling to room temperature, adding the superfine aloe cathartic extract powder, 4g of sucrose fatty acid ester and 3g of lecithin according to the formula under the stirring state, homogenizing and emulsifying to obtain an emulsion, performing spray drying at the air inlet temperature of 173 ℃, the spray pressure of 0.40MPa and the feed speed of 17ml/min, collecting microcapsules, and cooling to obtain 813g of microcapsules.
And (3) adding 187g of aerosil into the microcapsules obtained in the step 2), filling, polishing in a polishing machine, and removing damaged capsules to obtain the microcapsule.
COMPARATIVE EXAMPLE 1 HUI TONGBIAN MICROCAPSULE
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 5.
Preparation process
A. Aloe vera laxative extract fine powder: 225g
B. Maltodextrin, 2: 506g
β -lactoglobulin 217g
C. Glyceryl monostearate: 13g
D. Polyethylene glycol 6000: 39g
Adding maltodextrin, β -lactoglobulin, glyceryl monostearate, and polyethylene glycol 6000 into purified water, heating and stirring at 52 deg.C to dissolve, preparing into capsule material solution with mass fraction of 36%, cooling to room temperature, adding Aloe Vera extract fine powder, soybean phospholipid 3.6g, and sucrose fatty acid ester 5.4g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 172 deg.C, spray pressure of 0.39MPa, and feed rate of 22.5ml/min, collecting microcapsule, and cooling to obtain 785g microcapsule.
COMPARATIVE EXAMPLE 2 HUI TONGBIAN MICROCAPSULES
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 5.
Preparation process
A. Aloe vera laxative extract fine powder: 225g
B. Maltodextrin, 2: 506g
β -lactoglobulin 217g
C. Glyceryl monostearate: 13g
D. Citric acid: 39g
Adding maltodextrin, β -lactoglobulin, glyceryl monostearate, and polyethylene glycol 6000 into purified water, heating and stirring at 52 deg.C to dissolve, preparing into capsule material solution with mass fraction of 36%, cooling to room temperature, adding Aloe Vera extract fine powder, soybean phospholipid 3.6g, and sucrose fatty acid ester 5.4g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 172 deg.C, spray pressure of 0.39MPa, and feed rate of 22.5ml/min, collecting microcapsule, and cooling to obtain 794g microcapsule.
COMPARATIVE EXAMPLE 3 HUI TONGBIAN MICROCAPSULES
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 5.
Preparation process
A. Aloe vera laxative extract fine powder: 225g
B. Maltodextrin, 2: 506g
β -lactoglobulin 217g
C. Glyceryl monostearate: 13g
D. Polyethylene glycol 6000: 26g
Citric acid: 13g
Adding maltodextrin, β -lactoglobulin, glyceryl monostearate, and polyethylene glycol 6000 into purified water, heating and stirring at 52 deg.C to dissolve, preparing into capsule material solution with mass fraction of 36%, cooling to room temperature, adding Aloe Vera extract fine powder, soybean phospholipid 3.6g, and sucrose fatty acid ester 5.4g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 172 deg.C, spray pressure of 0.39MPa, and feed rate of 22.5ml/min, collecting microcapsule, and cooling to obtain 791g microcapsule.
Comparative example 4 Aloe Vera microcapsules for laxation
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 5.
Preparation process
A. Aloe vera laxative extract fine powder: 225g
B. Maltodextrin, 2: 506g
β -lactoglobulin 217g
C. Glyceryl monostearate: 13g
D. Polyethylene glycol 6000: 31.2g
Citric acid: 7.8g
Adding maltodextrin, β -lactoglobulin, glyceryl monostearate and polyethylene glycol 6000 into purified water, heating and stirring at 52 deg.C to dissolve, preparing into capsule material solution with mass fraction of 36%, cooling to room temperature, adding Aloe Vera extract fine powder, soybean phospholipid 3.6g and sucrose fatty acid ester 5.4g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 172 deg.C, spray pressure of 0.39MPa and feed rate of 22.5ml/min, collecting microcapsule, and cooling to obtain 823g microcapsule.
COMPARATIVE EXAMPLE 5 HUI TONGBIAN MICROCAPSULES
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 5.
Preparation process
A. Aloe vera laxative extract fine powder: 225g
B. Maltodextrin, 2: 506g
β -lactoglobulin 217g
C. Glyceryl monostearate: 13g
D. Polyethylene glycol 6000: 32.5g
Citric acid: 6.5g
Adding maltodextrin, β -lactoglobulin, glyceryl monostearate and polyethylene glycol 6000 into purified water, heating and stirring at 52 deg.C to dissolve, preparing into capsule material solution with mass fraction of 36%, cooling to room temperature, adding Aloe Vera extract fine powder, soybean phospholipid 3.6g and sucrose fatty acid ester 5.4g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 172 deg.C, spray pressure of 0.39MPa and feed rate of 22.5ml/min, collecting microcapsule, and cooling to obtain microcapsule 817 g.
COMPARATIVE EXAMPLE 6 HUI TONGBIAN MICROCAPSULES
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 5.
Preparation process
A. Aloe vera laxative extract fine powder: 225g
B. Maltodextrin, 2: 506g
β -lactoglobulin 217g
C. Glyceryl monostearate: 13g
D. Polyethylene glycol 6000: 33.4g
Citric acid: 5.6g
Adding maltodextrin, β -lactoglobulin, glyceryl monostearate, and polyethylene glycol 6000 into purified water, heating and stirring at 52 deg.C to dissolve, preparing into capsule material solution with mass fraction of 36%, cooling to room temperature, adding Aloe Vera extract fine powder, soybean phospholipid 3.6g, and sucrose fatty acid ester 5.4g under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 172 deg.C, spray pressure of 0.39MPa, and feed rate of 22.5ml/min, collecting microcapsule, and cooling to obtain microcapsule 805 g.
Comparative example 7 preparation of Huilu laxative microcapsules
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 5. The best effect example 5 of the Chinese patent 'a compound mature vinegar microcapsule and its preparation method and application (grant publication No. CN 106036829B)' is referred to for the preparation method of the microcapsule, so as to examine the preparation effect of the preparation method of the microcapsule in the prior art when applied to the aloe laxative extract fine powder.
Preparation process
A. Aloe vera laxative extract fine powder: 222g
B. 3% sodium alginate solution: 778g
Adding the aloe vera laxative extract fine powder into a sodium alginate solution with the mass fraction of 3% to prepare a microcapsule capsule core mixed solution, wherein the weight ratio of the sodium alginate to the aloe vera laxative extract fine powder is 3.5: 1;
uniformly mixing the capsule core mixed solution, and dripping 1.5% of chitosan and 3.5% of calcium chloride mixed solution system under the stirring state for microencapsulation embedding;
and (3) conveying the prepared microcapsules to a spray dryer by using a pump for spray drying, controlling the temperature of an air inlet to be 185 ℃ and the spray pressure to be 0.185MPa, and finally leaching out the microcapsules to obtain 245g of finished microcapsules.
Comparative example 8 preparation of aloe vera microcapsules
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 5. The preparation method of the microcapsule refers to 'Hurui, Duckweed, Song Wei Chun', the preparation of the traditional Chinese medicine prebiotics microcapsule by a spray drying method and the in vitro controlled release analysis [ J ]. Anhui agricultural science, 2016, 44 (29): 89-94 ", namely the capsule material is gelatin: sodium alginate is 1:3, the mass fraction of the core material is 20%, the air inlet temperature is 187 ℃, the air outlet temperature is 60 ℃, and the feeding speed is 32 mL/min.
Preparation process
A. Aloe vera laxative extract fine powder: 200g
B. Gelatin: 200g
Sodium alginate: 600g
Adding purified water into gelatin and sodium alginate, heating and stirring at 50 deg.C to dissolve, making into capsule wall material solution with mass fraction of 4%, cooling to room temperature, adding Aloe Vera extract fine powder under stirring, homogenizing and emulsifying to obtain emulsion, spray drying at air inlet temperature of 187 deg.C, air outlet temperature of 60 deg.C, spray pressure of 0.39MPa, and feed speed of 32ml/min, collecting microcapsule, and cooling to obtain 329g of microcapsule.
Claims (10)
1. The aloe laxative microcapsule preparation is characterized by comprising the following components in percentage by weight:
A. 13.5 to 27.5 percent of aloe laxative extract fine powder
B. 67-81 percent of capsule wall material
C. 0.9 to 2.5 percent of antisticking agent
D. 3.6 to 5.0 percent of plasticizer
The capsule wall material is one or more of Arabic gum, maltodextrin, modified starch, octenyl succinate starch, starch syrup dry powder, sodium caseinate, β -lactoglobulin, soybean protein isolate and xanthan gum, the anti-sticking agent is one or more of glyceryl monostearate, octadecanol, aerosil and titanium dioxide, and the plasticizer is one or more of glycerol, polyethylene glycol 6000, polyethylene glycol 400, propylene glycol and citric acid.
2. The microcapsule formulation according to claim 1, wherein the fine powder of aloe vera extract 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 raw materials:
120 parts of polygonum multiflorum, 160 parts of aloe and 140 parts of cassia seed
50 parts of ginseng, 75 parts of wolfberry fruit and 75 parts of donkey-hide gelatin
120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.
3. The microcapsule formulation according to claim 1 or 2, wherein the formulation comprises the following ingredients in percent by weight:
A. 17.5 to 23.5 percent of aloe laxative extract fine powder
B. 71.5 to 77.5 percent of capsule wall material
C. 1.1 to 1.9 percent of antisticking agent
D. 3.8% -4.7% of plasticizer;
preferably, the preparation formula comprises the following components in percentage by weight:
A. 19.7 to 22.5 percent of aloe laxative extract fine powder
B. 72.3 to 74.1 percent of capsule wall material
C. 1.3 to 1.8 percent of antisticking agent
D. 3.9% -4.4% of plasticizer;
the capsule wall material comprises one of sodium curdlin, starch syrup dry powder, maltodextrin, β -lactoglobulin, 3:2, maltodextrin, soybean protein isolate, modified starch, Arabic gum, 5:3:2:1 or octenyl succinate starch, β -lactoglobulin, 3: 2;
the anti-sticking agent is octadecanol: titanium dioxide 2:1 or glyceryl monostearate;
the plasticizer comprises polyethylene glycol 6000: 2-6: 1 or propylene glycol.
4. A process for the preparation of the aloe laxative microencapsulated formulations according to any one of claims 1 to 3, characterized by the following steps:
1) extraction and purification process
A. Weighing colla Corii Asini according to formula ratio, pulverizing into superfine powder, and sieving;
B. reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 50% -70% ethanol twice, 10 times the amount of the first time and 8 times the amount of the second time, each time for 2 hr, filtering respectively, and mixing filtrates;
C. 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 to obtain 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% (25 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. mixing the colla Corii Asini micropowder of step A and the fine powder of step D to obtain Aloe laxative extract fine powder;
2) preparation process
F. Weighing the fine powder of the aloe vera laxative extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step E according to the formula, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 45-58 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 22-42%, cooling to room temperature, adding the fine powder of the aloe vera laxative extract and the emulsifier in a stirring state, and homogenizing and emulsifying to obtain an emulsion for later use;
G. and F, carrying out spray drying on the emulsion in the step F under the conditions of air inlet temperature of 165-175 ℃, spray pressure of 0.36-0.42 MPa and feeding speed of 15-25 ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
5. The method according to claim 4, wherein the extraction and purification process of step 1) comprises the following steps:
A. weighing the donkey-hide gelatin according to the formula ratio, crushing the donkey-hide gelatin into superfine powder, and sieving the superfine powder with a sieve of 150-200 meshes for later use;
B. 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;
C. 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 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 concentration of 60% (at 25 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(70 deg.C), belt vacuum 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.
6. The method as claimed in claim 5, wherein the belt type vacuum drying condition in the step 1) D is a vacuum degree of-0.08 MPa to-0.10 MPa, and the drying temperature is 50 ℃ to 60 ℃.
7. The method according to any one of claims 4 to 6, wherein the formulation process of step 2) comprises the steps of:
F. weighing the fine powder of the aloe vera laxative extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step E according to the formula, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 52 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 36%, cooling to room temperature, adding the fine powder of the aloe vera laxative extract and the emulsifier in a stirring state, and homogenizing and emulsifying to obtain an emulsion for later use;
G. and F, carrying out spray drying on the emulsion in the step F under the conditions of the air inlet temperature of 172 ℃, the spray pressure of 0.39MPa and the feeding speed of 22.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
8. The method of claim 7, wherein the emulsifier in step F is one or more of Tween80, soybean phospholipid, lecithin, poloxamer and sucrose fatty acid ester, and the amount of the emulsifier is 0.4-1.2% of the total amount of the preparation formulation by mass fraction.
9. The method of claim 8, wherein step F said emulsifier comprises, by weight, soy phospholipid: the dosage of the compound emulsifier is 0.9 percent of the total amount of the preparation formula according to the mass fraction, wherein the sucrose fatty acid ester is 4: 6.
10. The method according to claim 1, wherein the extraction and purification process of step 1) comprises the following steps:
1) extraction and purification process
A. Weighing the donkey-hide gelatin according to the formula ratio, crushing the donkey-hide gelatin into superfine powder, and sieving the superfine powder with a sieve of 150-200 meshes for later use;
B. 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;
C. 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 concentration of 60% (25 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 to-0.09 pa, 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;
2) preparation process
F. Taking the fine powder of the aloe vera laxative extract, the capsule wall material, the anti-sticking agent and the plasticizer in the step E, adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 52 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 36%, cooling to room temperature, adding the fine powder of the aloe vera laxative extract and the soybean lecithin in a stirring state: the dosage of the compound emulsifier is 0.9 percent of the total amount of the preparation formula according to the mass fraction, wherein the sucrose fatty acid ester is 4: 6. Homogenizing and emulsifying to obtain emulsion for later use;
G. and F, carrying out spray drying on the emulsion in the step F under the conditions of the air inlet temperature of 172 ℃, the spray pressure of 0.39MPa and the feeding speed of 22.5ml/min, collecting the microcapsules, and cooling to obtain the microcapsule.
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| CN202010201199.XA CN111375019A (en) | 2020-03-20 | 2020-03-20 | Aloe microcapsule preparation for relieving constipation and preparation method thereof |
| PCT/CN2020/105564 WO2021184636A1 (en) | 2020-03-20 | 2020-07-29 | Shouhui tongbian microcapsule preparation and preparation method therefor |
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| CN112426468A (en) * | 2020-12-22 | 2021-03-02 | 王焜 | Traditional Chinese medicine composition and preparation for constipation and preparation method thereof |
| WO2021184636A1 (en) * | 2020-03-20 | 2021-09-23 | 鲁南厚普制药有限公司 | Shouhui tongbian microcapsule preparation and preparation method therefor |
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| CN115944667B (en) * | 2022-12-29 | 2023-09-22 | 江中药业股份有限公司 | Poria, cassia bark, rhizoma atractylodis and sweet soup extract and preparation method thereof |
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| CN1748765A (en) * | 2004-09-17 | 2006-03-22 | 鲁南制药集团股份有限公司 | Composition with catharsis and toxin expelling, fat reducing and weight reducing function and preparing method |
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| CN1965944A (en) * | 2006-03-03 | 2007-05-23 | 上海中医药大学 | Microsphere of dried tangerine peel oil and method for preparing same |
| CN106123496A (en) * | 2016-06-30 | 2016-11-16 | 鲁南制药集团股份有限公司 | A kind of drying means of Chinese medical concrete |
| CN109464570B (en) * | 2018-11-23 | 2022-06-14 | 鲁南制药集团股份有限公司 | Preparation process of fleece-flower root and aloe capsule for relaxing bowels |
| CN111375019A (en) * | 2020-03-20 | 2020-07-07 | 鲁南制药集团股份有限公司 | Aloe microcapsule preparation for relieving constipation and preparation method thereof |
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| CN1748765A (en) * | 2004-09-17 | 2006-03-22 | 鲁南制药集团股份有限公司 | Composition with catharsis and toxin expelling, fat reducing and weight reducing function and preparing method |
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| 张超云等: "《药剂学》", 30 November 2013, 辽宁大学出版社 * |
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| WO2021184636A1 (en) * | 2020-03-20 | 2021-09-23 | 鲁南厚普制药有限公司 | Shouhui tongbian microcapsule preparation and preparation method therefor |
| CN112426468A (en) * | 2020-12-22 | 2021-03-02 | 王焜 | Traditional Chinese medicine composition and preparation for constipation and preparation method thereof |
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