CN112386582B - Solid-liquid dual-phase capsule containing astragalus membranaceus and angelica sinensis and preparation method of capsule - Google Patents
Solid-liquid dual-phase capsule containing astragalus membranaceus and angelica sinensis and preparation method of capsule Download PDFInfo
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Abstract
The invention relates to a solid-liquid dual-phase capsule containing astragalus mongholicus and angelica sinensis and a preparation method thereof. The capsule comprises a capsule shell, a capsule cavity surrounded by the capsule shell and a filler filled in the capsule cavity, wherein the filler comprises a liquid-phase filler and a solid-phase filler surrounded by the liquid-phase filler, the liquid-phase filler contains angelica volatile oil, and the solid-phase filler is a coated astragalus aqueous extract solid preparation. The invention takes the coated astragalus aqueous extract solid preparation as a solid phase filler and the angelica volatile oil as a liquid phase filler, and after the solid phase filler and the liquid phase filler are filled in a capsule, the solid phase filler is surrounded by the liquid phase filler, but based on the physical separation effect of the coating material, the invention reduces the chemical and physical changes possibly caused by the mixing of the solid phase filler and the liquid phase filler, and is beneficial to maintaining the stability of the active ingredients. The capsule provided by the invention is easy to carry and use.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a solid-liquid dual-phase capsule containing astragalus membranaceus and angelica sinensis and a preparation method thereof.
Background
Dang Gui has the actions of tonifying blood, activating blood, regulating menstruation, alleviating pain, moistening intestines and relaxing bowels. It is commonly used for blood deficiency and sallow complexion, vertigo and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency cold and abdominal pain, rheumatic arthralgia, traumatic injury, superficial infection, pyocutaneous disease, intestinal dryness and constipation. The wine angelica sinensis can activate blood and promote menstruation. Can be used for treating amenorrhea, dysmenorrhea, rheumatalgia, and traumatic injury.
The astragalus root has the main functions of: tonify qi, strengthen superficies, expel toxin, expel pus, induce diuresis, and promote granulation. Can be used for treating deficiency of vital energy, asthenia, chronic diarrhea, proctoptosis, spontaneous perspiration, edema, uterine prolapse, albuminuria due to chronic nephritis, diabetes, and unhealed wound.
Dang Gui and Huang Qi are combined together to have the effect of tonifying qi and blood. For example, dang Gui Bu Xue Tang is famous prescription in the golden period, which is from Nei Wai Shang Bian Huo Lun (treatise on differentiation of internal injury and trauma) by Li Dongyuan of famous medicine. The formula contains astragalus and angelica, the main effective components of the astragalus are polysaccharide and saponin substances, and the astragalus has the effects of tonifying qi and invigorating yang, consolidating superficial resistance and arresting sweating, inducing diuresis and reducing edema, promoting the production of body fluid and nourishing blood, activating stagnancy and dredging paralysis, detoxifying and expelling pus, healing sore and promoting granulation, and has the effects of enhancing immunity, relieving nutritional anemia and the like under a modern scientific theoretical system. The main effective components of the angelica comprise volatile oil, ferulic acid and the like, have the effects of enriching and activating blood, regulating menstruation and relieving pain, and relaxing bowel, can be used for treating blood deficiency and chlorosis, irregular menstruation, amenorrhea and dysmenorrheal, deficiency cold and abdominal pain, and has the effects of enhancing immunity, relieving nutritional anemia and the like under the modern scientific theory system. At present, the compatibility of Chinese angelica and astragalus is mainly used for treating various diseases such as low immunity, anemia and the like clinically. However, decoction is troublesome and laggard, and has the defects of unchanged carrying and storage and the like, so that the popularization and clinical application of the angelica decoction are not facilitated; in addition, the effective components of the angelica are difficult to extract in the traditional decoction, thereby greatly reducing the efficacy of the angelica. In view of the above, it is urgent to develop a portable radix astragali and radix angelicae sinensis blood-enriching product, and a conventional method for producing an integrated new formulation of an radix angelicae sinensis blood-enriching decoction comprises the following steps: the method comprises the following steps: pretreating each Chinese medicinal decoction piece, weighing, pulverizing into 80-200 mesh powder, and supersonic airflow pulverizing into 1-10 μm powder to obtain different Chinese medicinal micropowder. Step two: soaking 60% radix astragali micropowder in 6-12 times of 30-90% ethanol water solution for 1-2 days, reflux extracting for 3 times, simultaneously extracting water soluble, alcohol soluble, and ester soluble three effective medicinal components, and recovering ethanol to obtain extract. Step three: taking 60% of angelica sinensis and millet flour, and respectively carrying out dispersion extraction by adopting independently developed ultrasonic dispersion crushing extraction equipment, wherein the ultrasonic power is as follows: 800-3000W, ultrasonic frequency: extracting at 28-120KHz for 10-100 min to obtain extract. Step four: and (4) grinding the traditional Chinese medicine extract obtained in the second step and the third step for 4-16 hours by adopting a nano ball mill which is independently developed to obtain nano powder with the particle size distribution of 50-1000 nanometers for later use. Step five: soaking 40% of each traditional Chinese medicine micropowder in water for two hours, decocting with traditional Chinese medicine decocting machine for 3 times, mixing decoctions, filtering, and concentrating the filtrate to obtain extract or concentrated water decoction. Step six: and (3) preparing the traditional Chinese medicine extract and the nano powder obtained in the second step, the third step and the fourth step respectively by adopting the technologies of delamination, macroporous adsorption, gel molecular screening, mold separation, ultracentrifugation and the like according to the requirements and different medicinal properties and pharmacological actions of the traditional Chinese medicine extract and the nano powder, so as to obtain different medicinal raw materials such as medicinal monomers, effective parts, effective substance groups and the like. Step seven: the obtained medicinal raw materials are respectively prepared into the raw material medicaments of nano-particles, micro-liposomes, nano-liposomes, solid lipid nano-particles, nano-polymer micelles, pharmacosomes, nano-emulsions, lipid microspheres, micro-capsules, micro-emulsions, lipid liquids, nano-membranes, nano-suspensions, micro-capsules and the like by adopting different medicinal auxiliary materials and carriers according to the requirements of related preparation part standard specifications in 2010 version Chinese pharmacopoeia and the requirements of appendix XIXE' micro-capsules, micro-spheres, liposome preparation guiding principles and the like in 2005 version Chinese pharmacopoeia and adopting the technologies of a high-pressure emulsion homogenizing method, an inclusion technology, a solid technology, a grinding method, a solvent-melting method, an extrusion method, a complex coacervation method, an emulsion cross-linking method, a polymerization dispersion method, a melting method, a freeze-drying method and the like. The particle size of the raw material medicine is between 10 nanometers and 10 micrometers; step eight: mixing the Chinese medicinal extract or water decoction concentrated solution obtained in the fifth step and one or more of the raw material medicaments of nanoparticles, liposomes, nano-emulsions, microcapsules and the like obtained in the seventh step according to the requirements of part standard specifications of preparations in Chinese pharmacopoeia of 2010 edition. Step nine: and respectively filling the mixed raw materials into hard capsules and soft capsules by a full-automatic capsule filling machine in a GMP10000 clean room. Other types of the terminal products can be prepared according to the relevant preparation standard specification of Chinese pharmacopoeia 2010 edition. Step ten: and (4) respectively carrying out internal and external packaging on the prepared terminal product, such as counting, bottling, boxing, sealing, sticking a label, printing a code, boxing and the like. And (4) transporting the packaged products to a specified place according to production batches for uniform instant sterilization, and making a sterilization report. The traditional Chinese angelica and astragalus membranaceus capsule preparation is formed by mixing the effective components of Chinese angelica and astragalus membranaceus and then encapsulating the mixture. However, when the volatile oil of angelica and the water-soluble components of astragalus are mixed together, chemical and physical reactions are easy to occur, and the stability of the effective components is influenced.
Disclosure of Invention
Based on the above, the invention provides a solid-liquid dual-phase capsule containing astragalus membranaceus and angelica sinensis and a preparation method thereof. The invention fills the coated radix astragali aqueous extract solid preparation and the angelica volatile oil into the capsule, reduces chemical and physical changes possibly caused by mixing the water-soluble ingredients of the radix astragali and the angelica volatile oil based on the physical separation effect of the coating material, and is beneficial to maintaining the stability of the active ingredients.
The purpose of the invention is realized by the following technical scheme:
the capsule comprises a capsule shell, a capsule cavity surrounded by the capsule shell and fillers filled in the capsule cavity, wherein the fillers comprise liquid-phase fillers and solid-phase fillers surrounded by the liquid-phase fillers, the liquid-phase fillers comprise angelica volatile oil, and the solid-phase fillers are coated astragalus aqueous extract solid preparations.
In one embodiment, the astragalus membranaceus and angelica sinensis solid-liquid dual-phase capsule comprises the following raw material medicines in parts by mass: 10-20 parts of astragalus and 5-15 parts of angelica.
In one embodiment, the astragalus membranaceus and angelica sinensis solid-liquid dual-phase capsule comprises the following raw material medicines in parts by mass: 12-18 parts of astragalus and 8-12 parts of angelica.
In one embodiment, the liquid-phase filler comprises the angelica volatile oil and a soft capsule filling agent, and the raw materials for preparing the astragalus aqueous extract solid preparation comprise an astragalus aqueous extract, a binding agent and an excipient.
In one embodiment, the mass ratio of the angelica volatile oil to the soft capsule filler is (0.5-2): 200, the weight ratio of the astragalus aqueous extract to the adhesive to the excipient is (0.5-1.5): (0.5-1.5): (0.5-1.5).
In one embodiment, the soft capsule filler is olive oil.
In one embodiment, the adhesive is selected from water or ethanol water solution.
In one embodiment, the excipient is microcrystalline cellulose.
In one embodiment, the dosage form of the astragalus aqueous extract solid preparation is pills.
In one embodiment, the particle size of the astragalus aqueous extract solid preparation is 18-24 meshes.
In one embodiment, the coating material used for the coating is an opadry film coating premix.
The preparation method of the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule comprises the following steps:
and taking the liquid-phase filler and the solid-phase filler, filling the liquid-phase filler and the solid-phase filler into capsules, and sealing the capsules.
In one embodiment, the preparation method further comprises the step of drying the solid-liquid dual-phase capsule obtained after sealing.
In one embodiment, the drying is carried out at a temperature of 22-25 ℃.
The beneficial effects of the invention include:
the invention takes the coated astragalus aqueous extract solid preparation as a solid-phase filler and the angelica volatile oil as a liquid-phase filler, and the solid-phase filler and the liquid-phase filler are filled in capsules, although the solid-phase filler is surrounded by the liquid-phase filler, the chemical and physical changes possibly caused by the mixing of the two are reduced based on the physical separation effect of the coating material, and the stability of the active ingredients is maintained. The capsule provided by the invention is easy to carry and use.
Furthermore, the invention can effectively avoid the permeation of the water-soluble component and/or the volatile oil of the astragalus to the coating material in the storage process by integrally optimizing the liquid-phase filler and the solid preparation of the aqueous extract of the astragalus contained in the solid-liquid dual-phase capsule of the astragalus and the angelica.
Detailed Description
In order that the invention may be more fully understood, reference will now be made to the following description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
The embodiment of the invention provides an astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule which is characterized by comprising a capsule shell, a capsule cavity surrounded by the capsule shell and fillers filled in the capsule cavity, wherein the fillers comprise a liquid-phase filler and a solid-phase filler surrounded by the liquid-phase filler, the liquid-phase filler contains angelica sinensis volatile oil, and the solid-phase filler is a coated astragalus mongholicus aqueous extract solid preparation.
The invention takes the coated astragalus aqueous extract solid preparation as a solid-phase filler and the angelica volatile oil as a liquid-phase filler, and the solid-phase filler and the liquid-phase filler are filled in capsules, although the solid-phase filler is surrounded by the liquid-phase filler, the chemical and physical changes possibly caused by the mixing of the two are reduced based on the physical separation effect of the coating material, and the stability of the active ingredients is maintained. The capsule provided by the invention is easy to carry and use. And after coating, the bad smell can be covered, the stability is increased, and the capsule filling and the dosage division are easy.
The astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule provided by the embodiment of the invention has the following pharmacological effects: astragalus root: sweet and warm. It enters lung and spleen meridians. Tonify qi, strengthen superficies, induce diuresis, expel pus, heal wound and promote tissue regeneration. Can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, metrorrhagia, superficial deficiency, spontaneous perspiration, qi deficiency, edema, carbuncle, cellulitis, intractable ulcer, blood deficiency, debility with yellowish complexion, internal heat, and diabetes; proteinuria due to chronic nephritis and diabetes. Chinese angelica: sweet, pungent and warm. It enters liver, heart and spleen meridians. Tonify blood, activate blood, regulate menstruation, alleviate pain, moisten intestines to relieve constipation. Can be used for treating blood deficiency, sallow complexion, giddiness, palpitation, menoxenia, amenorrhea, dysmenorrhea, asthenia cold, abdominal pain, constipation due to intestinal dryness, rheumatic arthralgia, traumatic injury, superficial infection, pyocutaneous disease.
Preferably, the astragalus membranaceus and angelica sinensis solid-liquid dual-phase capsule comprises the following raw material medicines in parts by mass: 10-20 parts of astragalus and 5-15 parts of angelica. Further preferably, the astragalus membranaceus and angelica sinensis solid-liquid dual-phase capsule is prepared from the following raw materials in parts by mass: 12-18 parts of astragalus and 8-12 parts of angelica. More preferably, the raw materials for preparing the astragalus mongholicus-angelica sinensis solid-liquid dual-phase capsule comprise: 15 parts of astragalus and 10 parts of angelica.
Preferably, the liquid-phase filler comprises the angelica volatile oil and a soft capsule filling agent, and the raw materials for preparing the astragalus aqueous extract solid preparation comprise an astragalus aqueous extract, an adhesive and an excipient.
Preferably, the mass ratio of the angelica volatile oil to the soft capsule filler is (0.5-2): 200, the weight ratio of the astragalus aqueous extract to the adhesive to the excipient is (0.5-1.5): (0.5-1.5): (0.5-1.5).
The coating material generally has a certain slow release effect and the like, so that for the dual-phase capsule of the invention, the drug permeation effect exists in long-term storage, for example, the components in the astragalus aqueous extract solid preparation can permeate the coating agent to enter the liquid-phase filler, and in order to avoid the situation, the embodiment of the invention can avoid the permeation of the water-soluble components and/or the volatile oil to the coating material by integrally optimizing the astragalus aqueous extract solid preparation and the liquid-phase filler.
It is understood that the specific types of the soft capsule fillers in the embodiments of the present invention are not particularly limited, and include, but are not limited to: olive oil, peanut oil, corn oil, etc. Preferably, the olive oil is selected as the filler in the embodiment of the invention, which is beneficial to improving the appearance stability of the liquid phase part of the angelica volatile oil and is embodied in more clarification.
It is understood that the examples of the present invention do not specifically limit the types of the adhesives, including but not limited to: water, aqueous ethanol, and the like. The ethanol aqueous solution has, for example, ethanol content of 30% by volume, 60% by volume, or the like. Preferably, the embodiment of the invention selects water as the adhesive, and the water is used as the adhesive, so that the appearance stability of the astragalus aqueous extract solid preparation is favorably improved, and the astragalus aqueous extract solid preparation is more smooth and has no loose powder.
It is understood that the examples of the present invention do not specifically limit the types of the excipients, and include, but are not limited to, microcrystalline cellulose, powdered cellulose, chitosan, and the like. Preferably, the embodiment of the invention selects microcrystalline cellulose as an excipient, and the microcrystalline cellulose is used as the excipient, so that the appearance stability of the astragalus aqueous extract solid preparation is favorably improved, and the astragalus aqueous extract solid preparation is better in formability and free of loose powder.
It is understood that the specific dosage form of the solid preparation of the astragalus aqueous extract provided by the embodiments of the present invention is not particularly limited, and includes, but is not limited to, pills, provided that the solid preparation is suitable for filling capsules.
It is understood that the size of the solid preparation of the astragalus aqueous extract is not particularly limited in the embodiments of the present invention provided that it is suitable for filling capsules, and includes, but is not limited to, setting the particle size to 18-24 mesh.
It is understood that the coating material used in the coating of the present invention is not particularly limited in kind, and is a common film coating material, including but not limited to, coating premix with opadry film. Preferably, the opadry film coating premix is selected as the coating agent, and the opadry film coating premix is used as the coating agent, so that the stability of the whole capsule is improved, less solid components and oil phase components penetrate, and the capsule is clearer and less turbid.
The embodiment of the invention also provides a preparation method of the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule, which comprises the following steps:
and taking the liquid-phase filler and the solid-phase filler, filling the liquid-phase filler and the solid-phase filler into capsules, and sealing the capsules.
Preferably, the preparation method further comprises the step of drying the solid-liquid dual-phase capsule obtained after sealing.
Preferably, the drying is carried out at a temperature of 22 to 25 ℃. The preferred drying temperature helps to reduce the leakage rate of the capsules.
It is understood that the preparation steps of the angelica volatile oil in the embodiment of the present invention are not particularly limited, and include, but are not limited to, the reflux method, for example, the following steps: soaking radix Angelicae sinensis in water, connecting volatile oil detector and reflux condenser tube, and collecting radix Angelicae sinensis volatile oil. It can be understood that the angelica needs to be cleaned before extraction, and for the convenience of extraction, the angelica can be cut into slices and the like, and the thickness of the slices can be controlled to be 1-2mm. It can be understood that, in order to facilitate the soaking of the angelica medicinal material by water, glass beads can be added when the water is added to the angelica, and the mixture is shaken and mixed. Preferably, the weight of water is 10-15 times of that of radix Angelicae sinensis, the soaking time can be 1.5-2.5h, and the extraction time is controlled at 3-5h.
It is understood that the preparation of the astragalus aqueous extract solid preparation in the embodiment of the present invention is not particularly limited, and includes, but is not limited to, the following steps: extracting radix astragali with water to obtain extractive solution; concentrating the extracting solution to prepare a concentrated solution; drying the concentrated solution, and pulverizing to obtain dry extract powder; taking the dry paste powder, and preparing the solid preparation. It is understood that, the embodiment of the present invention does not specifically limit the parameters in the above steps, and includes but is not limited to:
in the step of preparing the extracting solution, the mass of water is 8-12 times of that of the astragalus, the extracting mode adopts decoction, the extracting times are 1-3 times, and each time is 1.5-2.5 hours. It can be understood that, in this step, before water extraction, the astragalus needs to be cleaned, and for convenience of extraction, the astragalus can be cut into slices (for example, the thickness is 2-4 mm) and the like; after the water extraction, the water extraction product is filtered, and the obtained filtrate is an extraction liquid for the subsequent step, and the filtering can adopt a 300-mesh sieve for example. If the extraction is carried out for multiple times, the filtrates obtained by each extraction are combined. If the pill is prepared, the parameters for preparing the pill are controlled as follows: extruding at 55-65r/min, rolling at 1100-1300r/min for 3.5-4.5min, and sieving to obtain 18-24 mesh micropills.
In the preparation step of the concentrated solution, the relative density of the concentrated solution is 1.20-1.25 (65-75 ℃), and the dry solid content of the concentrated solution is 55-65%.
In the preparation step of the dry paste powder, the drying adopts vacuum belt drying, such as: the concentrate was transferred to a feed tank and the batch was preheated to 40-60 ℃. The set temperature of the heating section is adjusted to be less than or equal to 130 ℃ in the drying process, and the cooling temperature is 20-30 ℃. And adjusting the frequency of the feeding pump and the speed of the conveyor belt according to the drying condition of the materials. Pulverizing the dried extract into fine powder.
In the embodiment of the present invention, when coating, distilled water may be selected as the dispersing agent, and the parameter settings of coating include but are not limited to: the temperature is 35-40 ℃, the frequency of a fan is 25-35Hz, the atomization air pressure is 0.15-0.25mPa, and the flow rate of a peristaltic pump is 0.8-1mL/min.
The capsules selected by the embodiment of the invention include but are not limited to No. 0 capsules, the filling amount of the solid phase filling material can be 0.5g, and the filling amount of the liquid phase filling material can be 0.5mL.
The detection method for the roundness, the bulk density and the appearance of the capsule of the pellet in the embodiment of the invention is as follows:
the roundness detection method comprises the following steps: placing 2g pellet on a flat plate, lifting one side of the flat plate, and measuring the included angle between the inclined plane and the horizontal plane before the pellet starts to roll
Smaller indicates better rounding.
The bulk density detection method comprises the following steps: a100 mL measuring cylinder is taken, 20g of pellets are poured into the measuring cylinder at a constant speed by a funnel, the pellets fall from a position 5cm away from a table top, the volume of the pellets is recorded, and the operation is continuously carried out for 3 times.
Appearance: 10g of the pellets were placed in a clean white enamel dish and the appearance was visually observed under natural light.
Example 1
The embodiment provides a solid-liquid dual-phase capsule containing astragalus mongholicus and angelica sinensis and a preparation method thereof, and the solid-liquid dual-phase capsule comprises the following steps:
1. the solid-liquid dual-phase capsule comprises the following medicinal raw materials in parts by mass: 15 parts of astragalus and 10 parts of angelica.
2. The preparation method of the solid-liquid dual-phase capsule containing astragalus and angelica comprises the following steps:
2.1 preparation process of radix astragali paste powder and pellet
Cleaning radix astragali, cutting into 2-4mm thick pieces, extracting with 10 times of water for 2 times (2 hr each time), filtering with 300 mesh sieve, mixing filtrates, concentrating to relative density of 1.20-1.25 (65-75 deg.C), vacuum drying, and pulverizing into fine powder.
Selecting purified water as a binder, taking microcrystalline cellulose (MCC) as an excipient, mixing the purified water with the radix astragali paste powder according to the proportion of 1. Extruding at 60r/min, rolling at 1200r/min for 4min, and sieving to obtain 18-24 mesh micropills.
An opadry film coating premix is selected as a coating material, and distilled water is used as a dispersion. Coating the pellet in a fluidized coating machine. The coating temperature is 35-40 ℃, the frequency of a fan is 30Hz, the atomization air pressure is 0.2mPa, and the flow rate of a peristaltic pump is 0.8-1.0mL/min. Taking out the coated pellets, placing the coated pellets in a special container, and cooling the coated pellets.
2.2 preparation of volatile oil of Chinese angelica
Cleaning radix Angelicae sinensis, and cutting into slices with thickness of 1-2mm. Adding water 12 times of the amount of the medicinal materials into the radix Angelicae sinensis tablets, adding several glass beads, shaking, mixing, connecting with a volatile oil tester and a reflux condenser tube, soaking for 2h, extracting for 4h, and collecting volatile oil. Mixing the volatile oil and olive oil according to a ratio of 1.
2.3 filling of capsules
Selecting No. 0 capsule as carrier, and filling solid and liquid content with liquid capsule filling machine. The solid content in the capsule is astragalus extract pellet, and the filling amount is 0.5g. The liquid content is a mixed solution of angelica and olive oil, and the filling amount is 0.5mL. After the filling of the capsules is finished, the capsules are laid on white paper and are kept stand at room temperature overnight, the leakage situation of the capsules is checked the next day, and the leakage capsules are removed. Sealing with a capsule sealing machine, and drying the sealed capsule with blower for 30min at 22-25 deg.C. And (4) after sealing, flatly paving the capsule on a tray, standing overnight at room temperature, checking the leakage condition of the capsule the next day, and removing the leakage capsule to obtain the astragalus and angelica solid-liquid dual-phase capsule.
Example 2
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the adhesive of the astragalus mongholicus micro-pill 2.1 in the example 1 is changed into 30% ethanol by purified water, and the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is prepared by the rest processes.
Example 3
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the adhesive of the 2.1 astragalus mongholicus pellets in the example 1 is changed into 60% ethanol from purified water, and the other processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is prepared.
Example 4
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the adhesive of the 2.1 astragalus mongholicus pellets in the example 1 is changed into 90% ethanol from purified water, and the other processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is prepared.
Samples of the biphasic capsules obtained in examples 1-4 were taken and tested for pellet roundness, bulk density and capsule stability. The results are shown in Table 1.
TABLE 1 pellet roundness, bulk Density and Capsule stability results
As is clear from the results in table 1, in the above examples, example 1 was the most preferable, and therefore, purified water was selected as a binder for the astragalus mongholicus pellets.
Example 5
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the excipient of the astragalus mongholicus micro-pill 2.1 in the example 1 is changed from microcrystalline cellulose to powdery cellulose, and the other processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is prepared.
Example 6
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the excipient of the astragalus mongholicus pellet 2.1 in the example 1 is changed from microcrystalline cellulose to chitosan, and the other processes are not changed, so that the astragalus mongholicus-angelica sinensis solid-liquid dual-phase capsule is prepared.
Samples of the biphasic capsules obtained in example 1, example 5 and example 6 were taken and tested for pellet roundness, bulk density and capsule stability. The results are shown in Table 2.
TABLE 2 pellet roundness, bulk Density and Capsule stability results
As can be seen from the results in table 2, the above examples have the best overall effect, while example 1 is the best, and therefore microcrystalline cellulose is selected as the excipient of the astragalus mongholicus pellet.
Example 7
The present embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the coating agent of the 2.1 astragalus mongholicus pellets in the example 1 is changed from an opadry film coating premix to a common film coating material (hydroxypropyl methyl cellulose, 99%, jiangxi Baiying biotechnology limited), and the rest processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid two-phase capsule is prepared.
Two-phase capsule samples obtained in example 1 and example 7 were sampled and left for 15 days to observe the appearance of the capsules, and the results are shown in Table 3.
TABLE 3 appearance comparison results of capsules
From the results in table 3, it can be seen that the above examples have the best overall effect, but example 1 is the best, so the opadry film coating premix is selected as the coating agent of the astragalus mongholicus pellet.
Example 8
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the filler in 2.2 of the example 1 is changed into peanut oil from olive oil, and the other processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is prepared.
Example 9
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the fillers in 2.2 of the embodiment 1 are changed from olive oil to corn oil, and the other processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is prepared.
Samples of the biphasic capsules obtained in example 1, example 8 and example 9 were taken and left for 15 days to observe the clarity of the liquid phase portion of the capsules, the results of which are shown in Table 4.
TABLE 4 comparison of liquid phase portion of capsules
| Serial number | Appearance of liquid phase part |
| Example 1 | Clear, transparent and no turbidity |
| Example 8 | Slightly turbid |
| Example 9 | Slightly turbid |
From the results in table 4, it is understood that the above examples have better overall effects, and example 1 is the best, so that the olive oil is selected as the filler of the liquid phase part.
Example 10
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the drying temperature after the capsule sealing in the 2.3 in the embodiment 1 is changed into the drying temperature of 18-22 ℃, and the other processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid two-phase capsule is prepared.
Example 11
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the drying temperature after the capsule sealing in 2.3 in the embodiment 1 is changed into the drying temperature of 26-30 ℃, and the other processes are not changed, so that the astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is prepared.
The two-phase capsule samples obtained in example 1, example 10 and example 11 were sampled for 200 pieces, and the leakage rate (%) of capsules were calculated as indicated in table 5, except that the number of leaking capsules was 100/200.
TABLE 5 leakage rate of the sealed capsules
| Leakage Rate (%) | |
| Example 1 | 0.5 |
| Example 10 | 2 |
| Example 11 | 0.8 |
From the results in Table 5, it is clear that in the above examples, the drying temperature after capsule sealing is selected to be 22 to 25 ℃ because example 2 is the most preferable.
Example 12
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1:
(1) 18 parts of astragalus membranaceus and 8 parts of angelica sinensis;
(2) The mass ratio of the angelica volatile oil to the soft capsule filler is 0.5:200; the mass ratio of the astragalus aqueous extract to the adhesive to the excipient is 0.5:0.5:1.5.
the rest is carried out according to the embodiment 1 to prepare the solid-liquid dual-phase capsule of the astragalus mongholicus and the angelica sinensis.
Example 13
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1:
(1) 12 parts of astragalus membranaceus and 12 parts of angelica sinensis;
(2) The mass ratio of the angelica volatile oil to the soft capsule filler is 2:200 of a carrier; the mass ratio of the astragalus aqueous extract to the adhesive to the excipient is 1.5:1.5:0.5.
the rest is carried out according to the embodiment 1 to prepare the solid-liquid dual-phase capsule of the astragalus mongholicus and the angelica sinensis.
Example 14
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1:20 parts of astragalus and 15 parts of angelica. The rest is carried out according to the embodiment 1 to prepare the solid-liquid dual-phase capsule of the astragalus mongholicus and the angelica sinensis.
Example 15
This embodiment is a modification of embodiment 1, and includes, in relation to the modification of embodiment 1: the mass ratio of the angelica volatile oil to the soft capsule filler is 0.3:200 of a carrier; the mass ratio of the astragalus aqueous extract to the adhesive to the excipient is 0.5:2:2. the rest is carried out according to the embodiment 1 to prepare the solid-liquid dual-phase capsule of the astragalus mongholicus and the angelica sinensis.
TABLE 6
The astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule prepared by the method is subjected to an accelerated test for 3 months under the conditions of temperature of 37 +/-2 ℃ and relative humidity of RH75 +/-5% and avoidance of direct light according to a health food stability test guiding principle, is sampled once at the end of 0, 1, 2 and 3 months of a test period, and is detected according to stability key investigation items so as to determine the optimal formula and quality stability of a product.
The items and the methods for the product focus investigation in the embodiment of the invention are as follows:
1. sensory: including appearance and content. The solid pellets contained were gray and the oil was tan.
2. The effective components are as follows: the product contains total saponin (calculated as ginsenoside Re) as effective component, and has effective component content not less than 50mg/100g (calculated as solid part of capsule content) according to method of total saponin item of 2003 edition of health food inspection and evaluation technical Specification.
3. Acid value: according to the method of GB 5009.229 determination of acid value in food safety national standard food, the acid value of the product is not more than 4mg/g (based on the liquid part of the capsule content).
4. Peroxide number: according to the method of GB 5009.227 determination of peroxide value in food safety national standard food, the peroxide value of the product is not more than 0.25g/100g (based on the liquid part of the capsule content).
The results of the accelerated test are shown in Table 7.
TABLE 7 stability results of accelerated testing
As can be seen from the results in Table 7, the formulation of example 1 is optimized, and the product has high content of effective components and stable quality.
Example 16
The embodiment provides a solid-liquid dual-phase capsule containing astragalus mongholicus and angelica sinensis and a preparation method thereof, and the solid-liquid dual-phase capsule comprises the following steps:
1. the solid-liquid dual-phase capsule comprises the following medicinal raw materials in parts by mass: 15 parts of astragalus and 10 parts of angelica.
2. The preparation method of the solid-liquid dual-phase capsule containing astragalus and angelica comprises the following steps:
2.1 preparation of Astragalus paste powder and micropill
Cleaning radix astragali, cutting into 2-4mm thick pieces, adding 8 times of water, extracting for 1 time (1.5 hr each time), filtering with 300 mesh sieve, mixing filtrates, concentrating to relative density of 1.20-1.25 (65-75 deg.C), vacuum drying, and pulverizing the obtained dry extract into fine powder.
Selecting purified water as a binder, taking microcrystalline cellulose (MCC) as an excipient, mixing the purified water with the radix astragali paste powder according to the proportion of 1. Extruding at 55r/min, rolling at 1100r/min for 3.5min, and sieving to obtain 18-24 mesh micropills.
An opadry film coating premix is selected as a coating material, and distilled water is used as a dispersion. Coating the pellet in a fluidized coating machine. The coating temperature is 35-40 ℃, the frequency of a fan is 25Hz, the atomization air pressure is 0.15mPa, and the flow rate of a peristaltic pump is 0.8mL/min. Taking out the coated micro-pill, placing in a special container, and cooling.
2.2 preparation of volatile oil of Chinese angelica
Cleaning radix Angelicae sinensis, and cutting into slices with thickness of 1-2mm. Adding water 10 times of the amount of the medicinal materials into the radix Angelicae sinensis tablets, adding several glass beads, shaking, mixing, connecting with a volatile oil tester and a reflux condenser tube, soaking for 1.5h, extracting for 3h, and collecting volatile oil. Mixing the volatile oil and olive oil according to a ratio of 1.
2.3 filling of capsules
Selecting No. 0 capsule as carrier, and filling solid and liquid content with liquid capsule filling machine. The solid content in the capsule is astragalus extract pellet, and the filling amount is 0.5g. The liquid content is a mixed solution of angelica and olive oil, and the filling amount is 0.5mL. After the filling of the capsules is finished, the capsules are laid on white paper and are kept stand at room temperature overnight, the leakage situation of the capsules is checked the next day, and the leakage capsules are removed. Sealing with a capsule sealing machine, and drying the sealed capsule with blower for 30min at 22-25 deg.C. And (4) after sealing, flatly paving the capsule on a tray, standing overnight at room temperature, checking the leakage condition of the capsule the next day, and removing the leakage capsule to obtain the astragalus and angelica solid-liquid dual-phase capsule.
Example 17
The embodiment provides a solid-liquid dual-phase capsule containing astragalus membranaceus and angelica sinensis and a preparation method of the solid-liquid dual-phase capsule, which comprises the following steps:
1. the solid-liquid dual-phase capsule comprises the following raw materials in parts by mass: 15 parts of astragalus and 10 parts of angelica.
2. The preparation method of the solid-liquid dual-phase capsule containing astragalus and angelica comprises the following steps:
2.1 preparation of Astragalus paste powder and micropill
Cleaning radix astragali, cutting into 2-4mm thick pieces, extracting with 12 times of water for 3 times (each for 2.5 hr), filtering with 300 mesh sieve, mixing filtrates, concentrating to relative density of 1.20-1.25 (65-75 deg.C), vacuum drying, and pulverizing into fine powder.
Selecting purified water as a binder, taking microcrystalline cellulose (MCC) as an excipient, mixing the purified water with the radix astragali paste powder according to the proportion of 1. Extruding at 65r/min, rolling at 1300r/min for 4.5min, and sieving to obtain 18-24 mesh micropills.
An opadry film coating premix is selected as a coating material, and distilled water is used as a dispersion. Coating the pellet in a fluidized coating machine. The coating temperature is 35-40 ℃, the frequency of a fan is 35Hz, the atomization air pressure is 0.25mPa, and the flow rate of a peristaltic pump is 1mL/min. Taking out the coated pellets, placing the coated pellets in a special container, and cooling the coated pellets.
2.2 preparation of volatile oil of Chinese angelica
Cleaning radix Angelicae sinensis, and cutting into slices with thickness of 1-2mm. Adding water 15 times the amount of the medicinal materials into the radix Angelicae sinensis slices, adding several glass beads, shaking, mixing, connecting with a volatile oil tester and a reflux condenser tube, soaking for 2.5h, extracting for 5h, and collecting volatile oil. Mixing the volatile oil and olive oil according to a ratio of 1.
2.3 filling of capsules
Selecting No. 0 capsule as carrier, and filling solid and liquid content with liquid capsule filling machine. The solid content in the capsule is astragalus extract pellet, and the filling amount is 0.5g. The liquid content is a mixed solution of angelica and olive oil, and the filling amount is 0.5mL. After the filling of the capsules is finished, the capsules are laid on white paper and are kept stand at room temperature overnight, the leakage situation of the capsules is checked the next day, and the leakage capsules are removed. Sealing with a capsule sealing machine, and drying the sealed capsule with blower for 30min at 22-25 deg.C. And (4) after sealing, flatly paving the capsule on a tray, standing overnight at room temperature, checking the leakage condition of the capsule the next day, and removing the leakage capsule to obtain the astragalus and angelica solid-liquid dual-phase capsule.
The sensory values, effective ingredients, acid values and peroxide values of example 16 and example 17 were determined as shown in Table 8.
Table 8, example 16 and example 17 results
| Examples | Active ingredient (mg/100 g) | Acid value (mg/g) | Peroxide number (g/100 g) |
| Example 16 | 58.9 | 3.1 | 0.17 |
| Example 17 | 58.8 | 3.2 | 0.18 |
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is specific and detailed, but not to be understood as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (8)
1. The astragalus mongholicus and angelica sinensis solid-liquid dual-phase capsule is characterized by comprising a capsule shell, a capsule cavity surrounded by the capsule shell and a filler filled in the capsule cavity, wherein the filler comprises a liquid-phase filler and a solid-phase filler surrounded by the liquid-phase filler, and the solid-phase filler is a coated astragalus mongholicus aqueous extract solid preparation;
the liquid phase filler comprises angelica volatile oil and a soft capsule filler;
the solid-liquid dual-phase capsule of astragalus mongholicus and angelica sinensis comprises the following medicinal raw materials: 15 parts of astragalus and 10 parts of angelica; the raw materials for preparing the astragalus aqueous extract solid preparation comprise an astragalus aqueous extract, an adhesive and an excipient;
the mass ratio of the angelica volatile oil to the soft capsule filler is 1:200 of a carrier;
the weight ratio of the astragalus aqueous extract to the adhesive to the excipient is 1:1:1;
the soft capsule filler is olive oil;
the coating material adopted by the coating is an Opadry film coating premix;
the adhesive is selected from water;
the excipient is microcrystalline cellulose.
2. The astragalus membranaceus-angelica sinensis solid-liquid dual-phase capsule according to claim 1, wherein the astragalus membranaceus aqueous extract solid preparation is in a pill form.
3. The astragalus membranaceus-angelica sinensis solid-liquid dual-phase capsule according to claim 1, wherein the particle size of the astragalus membranaceus aqueous extract solid preparation is 18-24 meshes.
4. The preparation method of the astragalus membranaceus-angelica sinensis solid-liquid dual-phase capsule as claimed in any one of claims 1 to 3, wherein the preparation method comprises the following steps:
and taking the liquid-phase filler and the solid-phase filler, filling the liquid-phase filler and the solid-phase filler into capsules, and sealing the capsules.
5. The method for preparing the solid-liquid dual-phase capsule of radix astragali and radix angelicae sinensis according to claim 4, wherein the method further comprises the step of drying the solid-liquid dual-phase capsule obtained after sealing.
6. The method for preparing the solid-liquid dual-phase capsule of astragalus membranaceus and angelica sinensis as claimed in claim 5, wherein the drying temperature is 22-25 ℃.
7. The preparation method of the solid-liquid dual-phase capsule of radix astragali and radix angelicae sinensis according to any one of claims 4 to 6, wherein the radix angelicae sinensis volatile oil is prepared by a reflux method, comprising the following steps: soaking radix Angelicae sinensis in water, reflux extracting, and collecting radix Angelicae sinensis volatile oil.
8. The preparation method of the solid-liquid dual-phase capsule of radix astragali and radix angelicae sinensis according to any one of claims 4 to 6, wherein the preparation of the solid preparation of the aqueous extract of radix astragali comprises the following steps: extracting radix astragali with water to obtain extractive solution; concentrating the extracting solution to prepare a concentrated solution; drying the concentrated solution, and pulverizing to obtain dry extract powder; taking the dry paste powder, and preparing the solid preparation.
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