CN112137973A - A Chinese medicinal pill and its preparation method - Google Patents

A Chinese medicinal pill and its preparation method Download PDF

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Publication number
CN112137973A
CN112137973A CN202010977108.1A CN202010977108A CN112137973A CN 112137973 A CN112137973 A CN 112137973A CN 202010977108 A CN202010977108 A CN 202010977108A CN 112137973 A CN112137973 A CN 112137973A
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traditional chinese
chinese medicine
pill
microcrystalline cellulose
parts
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舒加菊
李周
汪小东
孙杨杨
李梦
庄东芳
李润
王转红
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Dongguan dongyangguang Cordyceps research and Development Co., Ltd
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Dongguan Dongyangguang Health Product Research And Development Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2068Compounds of unknown constitution, e.g. material from plants or animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

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Abstract

The invention relates to a traditional Chinese medicine pill, wherein the active ingredients of the traditional Chinese medicine pill comprise traditional Chinese medicine extracts; the auxiliary materials of the traditional Chinese medicine pill comprise edible vegetable oil, and the edible vegetable oil is preferably sesame oil. The invention can overcome the defects caused by the characteristics of easy moisture absorption, large viscosity and the like of the traditional Chinese medicine extract, and obtain the traditional Chinese medicine pill with smooth and round appearance. The traditional Chinese medicine pill provided by the invention is simple in preparation process, low in cost and easy for large-scale production.

Description

A Chinese medicinal pill and its preparation method
Technical Field
The invention relates to the field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine pill and a preparation method thereof.
Background
At present, the traditional Chinese medicine clinical proved recipe is often changed from decoction to pills. However, the clinical proved recipe is often large in prescription amount, and if the decoction pieces are directly used as the medicine, the daily dose is large, and the patient compliance is poor. The concentrated pill is prepared by extracting decoction pieces or part of decoction pieces, concentrating, adding appropriate adjuvant or fine powder of the rest decoction pieces, and adding binder. The concentrated pill has small dosage, easy administration and absorption, and convenient storage and carrying.
However, in order to reduce the dosage, the traditional Chinese medicine extract is often in a large proportion, and due to the fact that the traditional Chinese medicine extract is easy to absorb moisture and has large viscosity, the prepared pills have the phenomena of beading, lentil, tailing, cracks and cutting marks, so that the pill making fails or a process is required to be added to improve the appearance. The process steps are increased, and the cost of manpower and material resources is increased.
Disclosure of Invention
The invention aims to overcome the defect of poor appearance of the traditional Chinese medicine pill caused by the characteristics of easy moisture absorption, large viscosity and the like of the traditional Chinese medicine extract in the prior art, and provides the traditional Chinese medicine pill which has smooth and round appearance and simple preparation process.
Specifically, the first purpose of the invention is to provide a traditional Chinese medicine pill, wherein the active ingredients of the traditional Chinese medicine pill comprise traditional Chinese medicine extracts; the auxiliary materials of the traditional Chinese medicine pills comprise edible vegetable oil.
In a preferred embodiment of the present invention, the edible vegetable oil is sesame oil. Sesame oil is a yellow transparent liquid, the sesame fragrance is obvious, but the sesame oil has no odor after being made into pills.
The active ingredients mainly comprise traditional Chinese medicine extracts, can also comprise fine powder of part of traditional Chinese medicine decoction pieces, and can also further comprise other active substances with similar or synergistic effects with the traditional Chinese medicine extracts.
The traditional Chinese medicine extract is powder, and is preferably prepared by extracting traditional Chinese medicine raw materials with water, concentrating, drying and crushing. The traditional Chinese medicine raw materials can be single traditional Chinese medicine raw materials or compound raw materials formed by mixing multiple traditional Chinese medicines. As a preferred scheme of the invention, the traditional Chinese medicine raw materials are prepared by mixing traditional Chinese medicinal materials adopted in a traditional Chinese medicine classic formula.
As a specific embodiment of the present invention, the raw materials of the traditional Chinese medicine are traditional Chinese medicinal materials adopted in the classic traditional Chinese medicine formula "eight-treasure decoction", including ginseng, atractylodes macrocephala koidz, poria cocos, angelica sinensis, ligusticum wallichii, radix paeoniae alba, prepared rehmannia root and radix glycyrrhizae preparata. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 8-12 parts of ginseng, 8-12 parts of bighead atractylodes rhizome, 8-12 parts of poria cocos, 8-12 parts of angelica sinensis, 8-12 parts of ligusticum wallichii, 8-12 parts of radix paeoniae alba, 8-12 parts of prepared rehmannia root and 4-6 parts of honey-fried licorice root. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 10 parts of ginseng, 10 parts of bighead atractylodes rhizome, 10 parts of poria cocos, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of prepared rehmannia root and 10 parts of honey-fried licorice root.
As a specific implementation mode of the invention, the traditional Chinese medicine raw materials are traditional Chinese medicinal materials adopted in a traditional Chinese medicine classic formula 'four-ingredient decoction', and comprise angelica sinensis, ligusticum wallichii, white peony root and prepared rehmannia root. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 7-11 parts of angelica sinensis, 4-8 parts of ligusticum wallichii, 7-11 parts of radix paeoniae alba and 13-17 parts of prepared rehmannia root. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 9 parts of angelica, 6 parts of ligusticum wallichii, 9 parts of radix paeoniae alba and 15 parts of prepared rehmannia root.
As a specific implementation mode of the invention, the traditional Chinese medicine raw materials are traditional Chinese medicinal materials adopted in a traditional Chinese medicine classic formula 'Sijunzi decoction', and comprise ginseng, bighead atractylodes rhizome, poria cocos and honey-fried licorice root. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 7-11 parts of ginseng, 7-11 parts of bighead atractylodes rhizome, 7-11 parts of poria cocos and 4-8 parts of honey-fried licorice root. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 9 parts of ginseng, 9 parts of bighead atractylodes rhizome, 9 parts of poria cocos and 6 parts of honey-fried licorice root.
As a specific embodiment of the invention, the traditional Chinese medicine raw materials are traditional Chinese medicinal materials adopted in a traditional Chinese medicine classic formula of 'gui pi decoction', and comprise bighead atractylodes rhizome, poria with hostwood, astragalus mongholicus, arillus longan, spina date seed, ginseng, elecampane, honey-fried licorice root, angelica sinensis and polygala tenuifolia. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 4-8 parts of bighead atractylodes rhizome, poria with hostwood, astragalus membranaceus, arillus longan and spina date seed, 2-4 parts of ginseng and elecampane, 1-3 parts of honey-fried licorice root and 0.5-1.5 parts of angelica and polygala tenuifolia. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 6 parts of bighead atractylodes rhizome, poria with hostwood, astragalus, arillus longan and spina date seed respectively, 3 parts of ginseng and costustoot respectively, 2 parts of honey-fried licorice root and 1 part of angelica and polygala tenuifolia respectively.
As a specific embodiment of the invention, the traditional Chinese medicine raw materials are traditional Chinese medicinal materials adopted in a traditional Chinese medicine classic formula 'Liuwei Dihuang pill', and comprise prepared rehmannia root, pulp of dogwood fruit, Chinese yam, rhizoma alismatis, tree peony bark and tuckahoe. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 6-10 parts of prepared rehmannia root, 3-5 parts of cornus officinalis and Chinese yam respectively, and 2-4 parts of rhizoma alismatis, tree peony bark and poria cocos respectively. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 8 parts of prepared rehmannia root, 4 parts of cornus fruit and Chinese yam respectively, and 3 parts of alisma orientale, moutan bark and poria cocos respectively. The traditional preparation process of the pill of six ingredients with rehmannia is to pulverize all the medicines in the formula into fine powder, pulverize into fine powder, sieve, mix, then use ethanol to make pill, dry and make into watered pill, or powder adds refined honey and right amount of water, pill, dry and make into watered honeyed pill, or add refined honey and make into small honeyed pill or big honeyed pill. Compared with the traditional preparation process, the method provided by the invention can greatly reduce the dosage and is easy to take and absorb the medicine.
As a specific embodiment of the present invention, the raw materials of the traditional Chinese medicine are traditional Chinese medicinal materials adopted in a traditional Chinese medicine classic formula of "zuogui pill", and include prepared rehmannia root, Chinese yam, medlar, dogwood, deerhorn glue, tortoise-plastron glue, dodder and cyathula root. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 6-10 parts of prepared rehmannia root, 3-5 parts of Chinese yam, medlar, dogwood, deerhorn glue, tortoise-plastron glue and dodder, and 2-4 parts of medicinal cyathula root. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 8 parts of prepared rehmannia root, 4 parts of each of Chinese yam, medlar, dogwood, deerhorn glue, tortoise-plastron glue and dodder, and 3 parts of medicinal cyathula root. The traditional 'ZUOGUI pill' is prepared by steaming raw materials, grinding into paste, and making into honeyed pill with large dosage. Compared with the traditional preparation process, the method provided by the invention can greatly reduce the dosage and is easy to take and absorb the medicine.
As a specific embodiment of the present invention, the raw materials of the traditional Chinese medicine are traditional Chinese medicinal materials adopted in a classic traditional Chinese medicine formula of lily solid-golden decoction, and include prepared rehmannia root, radix rehmanniae, angelica, white peony root, liquorice, platycodon root, figwort, fritillaria, ophiopogon root and lily. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 2-4 parts of prepared rehmannia root, raw rehmannia root and angelica, 0.5-1.5 parts of white peony root, liquorice, platycodon root and figwort and 1-3 parts of fritillary bulb, dwarf lilyturf tuber and lily. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: prepared rehmannia root, dried rehmannia root, angelica root each 3 parts, root of herbaceous peony, licorice root, root of ballon flower, scrophularia root each 1 part, fritillary bulb, lilyturf root, lily each 2 parts.
As a specific implementation mode of the invention, the traditional Chinese medicine raw materials are traditional Chinese medicinal materials adopted in a traditional Chinese medicine classic formula of 'Ganmai Dazao decoction', and comprise honey-fried licorice root, light wheat and Chinese date. Preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 7-11 parts of honey-fried licorice root, 13-17 parts of light wheat and 28-32 parts of Chinese date. More preferably, the traditional Chinese medicine raw materials comprise the following components in parts by weight: 9 parts of honey-fried licorice root, 15 parts of light wheat and 30 parts of Chinese date.
The traditional Chinese medicine adopts ginseng, largehead atractylodes rhizome, tuckahoe, angelica, Szechuan lovage rhizome, white paeony root, prepared rehmannia root, honey-fried licorice root, cordyceps sinensis and the like, the ginseng, radix pseudostellariae, radix scrophulariae, astragalus mongholicus, codonopsis pilosula, pericarpium citri reticulatae, Chinese yam, Chinese dates, wheat, acanthopanax senticosus, gynostemma pentaphylla, rhodiola rosea, white hyacinth beans, platycodon grandiflorum, elecampane, pilose antler, cistanche, cynomorium songaricum, epimedium herb, morinda officinalis, rhizoma curculiginis, fructus psoraleae, fructus alpiniae oxyphyllae, eucommia ulmoides, teasel roots, dogwood, semen cuscutae, semen astragali complanati, walnut kernels, radix rehmanniae, polygonum multiflorum, polygala tenuifolia, rhizoma alismatis, moutan barks, donkey-hide gelatin, arillus longan, radix glehniae, adenophora tetraphylla, radix polygonati officinalis, rhizoma polygonati, dendrobium nobilis, radix ophiopogonis, asparagus coc. The above herbs have tonifying effect, and most of the extracts have strong hygroscopicity and high viscosity.
As a specific embodiment of the present invention, the Chinese medicinal extract is prepared by a method comprising the following steps: soaking the raw materials in water, extracting under heating for several times, filtering, mixing filtrates, concentrating under reduced pressure to obtain soft extract, vacuum drying, and pulverizing. The reduced pressure concentration can be carried out at the temperature of 60-70 ℃ and the pressure of-0.08-0.09 MPa. The vacuum drying can be carried out at 60-70 ℃. The Chinese medicinal extract has the characteristics of easy moisture absorption, agglomeration and high viscosity. Specifically, the viscosity of the traditional Chinese medicine extract at 20 ℃ is within the range of 1000 cP-3000 cP.
As a preferable scheme of the invention, the mass of the active ingredients accounts for 40-65% of the total mass of the traditional Chinese medicine pill. Specifically, the mass of the active ingredient accounts for 40-45%, 45-50%, 50-55%, 55-60% or 60-65% of the total mass of the traditional Chinese medicine pill.
Because the active ingredients adopted by the invention are mainly powdery traditional Chinese medicine extracts which are easy to absorb moisture and agglomerate and have viscosity, the invention adds specific auxiliary materials to relieve the viscosity, reduce the resistance in the preparation process and improve the smoothness and the roundness of the ball.
Generally, in the field of preparation, in order to ensure pill forming, auxiliary materials including water, alcohol, vinegar, honey, sugar solution, medicinal juice and the like are conventionally adopted, but the problems of rough surface and non-uniform shape of the traditional Chinese medicine pill caused by high viscosity and large pill forming resistance of traditional Chinese medicine extracts are difficult to overcome by the components. The invention adopts the edible vegetable oil, particularly the edible vegetable oil used in the granulating step of preparing the pills, can alleviate the viscosity of the traditional Chinese medicine extract, reduce the resistance in the preparation process and improve the smoothness and the roundness of the pills.
As a preferable scheme of the invention, the edible vegetable oil accounts for 1-4% of the total mass of the traditional Chinese medicine pills.
In the actual production process of the traditional Chinese medicine pill, conventional excipients (water, alcohol, vinegar, honey, sugar solution, medicinal juice and the like, preferably water) are added on the basis of active ingredients for primary granulation, the edible vegetable oil is added for secondary granulation, the dosage of the vegetable oil is preferably 1/10 to 1/3 of the mass of the excipients for primary granulation, and the prepared granules are prepared for pill making. Drying after the pill making is finished, removing water, and finally controlling the water content in the pill to be below 6%.
The excipients in a traditional Chinese medicine pill generally include diluents in addition to the ingredients (such as the excipients mentioned above) used for the purpose of shaping. The traditional Chinese medicine pill is prepared by diluting active ingredients including traditional Chinese medicine extracts by adopting a diluent with low or no hygroscopicity on the basis of using edible vegetable oil.
As a preferable scheme of the invention, the diluent adopted by the traditional Chinese medicine pill contains microcrystalline cellulose or a mixture of the microcrystalline cellulose and the cordyceps sinensis powder. Microcrystalline cellulose is a white, odorless and tasteless substance, is crystalline powder composed of porous microparticles, has low hygroscopicity, is insoluble in water, and can dilute and moderate the viscosity of Chinese medicinal extract, increase the hardness of pill, and promote pill disintegration. The cordyceps sinensis serving as a precious fine medicinal material is pulverized into powder, preferably to be pulverized into 150-180 mu m, and can equally replace microcrystalline cellulose. When the cordyceps sinensis powder is adopted, the mass ratio of the microcrystalline cellulose to the cordyceps sinensis powder is preferably (8-12): 1; specifically, the ratio of the two may be (8-9): 1. (9-10): 1. (10-11): 1 or (11-12): 1.
in a preferred embodiment of the present invention, the diluent may further comprise lactose, such as lactose monohydrate. Lactose monohydrate is white crystal or crystalline powder, has no odor, can be dissolved in water, has stable property and no hygroscopicity, and can be diluted to moderate extract viscosity, increase pill softness, and promote pill disintegration. According to the invention, the mass ratio of microcrystalline cellulose or a mixture of microcrystalline cellulose and cordyceps sinensis powder in the diluent to the lactose monohydrate is preferably (1.5-2.5): 1.
as a preferable scheme of the invention, the dosage of the diluent accounts for 30-50% of the total mass of the traditional Chinese medicine pill.
In a preferred embodiment of the present invention, the mass ratio of the active ingredient to the diluent is (1 to 2): 1. specifically, the mass ratio of the two may be (1-1.2): 1. (1.2-1.5): 1. (1.5-1.8): 1 or (1.8-2): 1.
since the diluent preferably used in the present invention has low or no hygroscopicity, the viscosity is not increased but decreased. Therefore, when the diluent is applied, the adhesive can be added, so that the viscosity requirement is met, and the preparation is convenient. The invention preferably uses as binder a component having a certain hygroscopicity and viscosity, such as maltodextrin, or a mixture of maltodextrin with other excipients having similar hygroscopicity and viscosity.
As a preferable scheme of the invention, the dosage of the adhesive accounts for 0-10% of the total mass of the traditional Chinese medicine pills. Under the condition of using the adhesive, the dosage of the adhesive is preferably 5-10% of the total mass of the traditional Chinese medicine pills.
In a preferred embodiment of the present invention, the mass ratio of the active ingredient to the binder is (5 to 8): 1, and/or the mass ratio of the diluent to the adhesive is (5-8): 1.
as a preferable scheme of the invention, the traditional Chinese medicine pill comprises the following components in parts by weight: 45-65 parts of active ingredients, 30-50 parts of diluents and 1-5 parts of edible vegetable oil; wherein the active ingredients comprise Chinese medicinal extracts, preferably Chinese medicinal extracts.
Further preferably, the diluent is microcrystalline cellulose, or the mass ratio of the microcrystalline cellulose to the diluent is (8-12): 1, or the mass ratio of the microcrystalline cellulose to the cordyceps powder is (1.5-2.5): 1 of microcrystalline cellulose and lactose monohydrate, or the mass ratio of (1.5-2.5): (0.15-0.25): 1 microcrystalline cellulose, cordyceps powder and lactose monohydrate.
As a preferable scheme of the invention, the traditional Chinese medicine pill comprises the following components in parts by weight: 45-65 parts of active ingredients, 30-50 parts of diluents, 5-10 parts of adhesives and 1-5 parts of edible vegetable oil; wherein the active ingredients comprise Chinese medicinal extracts, preferably Chinese medicinal extracts.
Further preferably, the diluent is microcrystalline cellulose, or the mass ratio of the microcrystalline cellulose to the diluent is (8-12): 1, or the mass ratio of the microcrystalline cellulose to the cordyceps powder is (1.5-2.5): 1 of microcrystalline cellulose and lactose monohydrate, or the mass ratio of (1.5-2.5): (0.15-0.25): 1 microcrystalline cellulose, cordyceps powder and lactose monohydrate; and/or the binder is maltodextrin.
The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine pill. Specifically, the preparation method adopts the active ingredients provided by the invention and the auxiliary materials including the edible vegetable oil to prepare pills.
As a preferable scheme of the invention, the preparation method comprises the following steps: mixing the active ingredient with diluent, or mixing the active ingredient with diluent and adhesive, adding excipient, granulating, adding edible vegetable oil, and granulating; making the obtained granules into pills, shaping and drying.
In the invention, the excipient adopted in the primary granulation is preferably one or more of water, alcohol, vinegar, honey, sugar solution and medicinal juice, and is preferably water. The invention further preferably selects the amount of the excipient adopted in the primary granulation to be 3-10 times of the mass of the edible vegetable oil added subsequently. The granulation may be performed in a high efficiency mixing granulator. In the granulating process, parameters such as stirring speed, cutting knife speed, atomizing pressure and the like of a proper granulator can be adjusted according to requirements.
The pelleting can be carried out in a traditional Chinese medicine pelleting machine. In the process of making the pills, parameters such as strip conveying speed, pill making speed and the like are adjusted, and the speed that the pills are not stretched, the thickness is consistent and the appearance of the pills is round is suitable. Preferably, 95% ethanol can be sprayed for anti-sticking in the pelleting process.
The invention preferably carries out the shaping in a sugar coating machine, and primarily rolls, dries and shapes the balls.
In the invention, hot air drying is preferably adopted for drying, and the drying is preferably carried out until the water content is below 6%.
Compared with the prior art, the invention selects the specific auxiliary materials, further adjusts the active ingredients in the traditional Chinese medicine pill and the proportion among the auxiliary materials, can overcome the defects caused by the characteristics of easy moisture absorption, large viscosity and the like of the traditional Chinese medicine extract, and obtains the traditional Chinese medicine pill with smooth and round appearance. The traditional Chinese medicine pill provided by the invention is simple in preparation process, low in cost and easy for large-scale production.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.
The information of the raw materials and auxiliary materials used in the following examples is shown in table 1, and the information of the instruments used is shown in table 2.
Table 1: information of raw and auxiliary materials
Figure BDA0002686092370000081
Figure BDA0002686092370000091
Table 2: instrument information
Name of instrument Manufacturer of the product Model number
Electronic balance Mettler ME4002E
High-efficiency mixing granulator Shenzhen xinyite G10
Full-automatic quick-control traditional Chinese medicine pill making machine Tianshuihua Yuan (circle of flowers) YUJ-10A
Sugar-coating machine Guangzhou Yangying eagle BY-400
Electric heating blowing dry box Tianjin Tester 101-3AB
Preparation example 1
The eight-treasure soup extract is prepared according to the following method:
weighing 1224g of medicinal materials according to the proportion of 10 parts of ginseng, 10 parts of bighead atractylodes rhizome, 10 parts of poria cocos, 10 parts of angelica sinensis, 10 parts of ligusticum wallichii, 10 parts of radix paeoniae alba, 10 parts of prepared rehmannia root and 5 parts of honey-fried licorice root, adding 8 times of water, soaking for 1h, decocting and extracting for 2 times, filtering while hot, combining filtrates, concentrating under reduced pressure at 65 ℃ and-0.08 to-0.09 MPa to obtain thick paste, drying under vacuum at 65 ℃, and crushing dry paste into fine powder to obtain the eight-treasure decoction extract.
Preparation example 2
The four-ingredient decoction extract was prepared as follows:
weighing 1392g of medicinal materials according to the proportion of 9 parts of angelica, 6 parts of ligusticum wallichii, 9 parts of white peony root and 15 parts of prepared rehmannia root, adding 8 times of water, soaking for 1h, decocting and extracting for 2 times, 2h each time, filtering while hot, combining filtrates, concentrating under reduced pressure to thick paste at 65 ℃, drying under vacuum at 65 ℃, crushing the dry paste into fine powder to obtain the decoction of four ingredients.
Preparation example 3
The four monarch drug decoction extract was prepared as follows:
weighing 1400g of medicinal materials according to the proportion of 9 parts of ginseng, 9 parts of bighead atractylodes rhizome, 9 parts of poria cocos and 6 parts of honey-fried licorice root, adding 8 times of water, soaking for 1h, decocting and extracting for 2 times, 2h each time, filtering while hot, combining filtrates, concentrating under reduced pressure to thick paste at 65 ℃, drying under vacuum at 65 ℃ and-0.08 to-0.09 MPa, and crushing the dry paste into fine powder to obtain the sijunzi decoction extract.
Preparation example 4
Pulverizing 30g Cordyceps into 150-180 μm to obtain Cordyceps fine powder.
Example 1
Adding 465g of eight-treasure decoction extract, 30g of cordyceps sinensis fine powder, 240g of microcrystalline cellulose, 160g of lactose monohydrate and 70g of maltodextrin, uniformly mixing, putting into a high-efficiency mixing granulator, setting the stirring speed to be 3r/s, the cutting speed to be 20r/s, the atomizing pressure to be 0.3Mpa, spraying 135g of water for granulation, and adding 35g of sesame oil for granulation for 30 s. The wet granules are put into a full-automatic traditional Chinese medicine pill making machine, pill strips are made for 2 times, the strip conveying and pill making speed is adjusted, the speed that the pill strips are not stretched, the thickness is consistent, the appearance of pills is round and round is suitable, and 95% ethanol is sprayed for preventing sticking occasionally in the pill making process. Slowly putting the prepared balls into a sugar-coating machine for preliminary rounding, drying and shaping, and finally drying by hot air until the water content of the balls is lower than 6 percent to obtain 1000g of balls.
The traditional Chinese medicine pill obtained in the embodiment is smooth and round.
Example 2
Adding Cordyceps fine powder 30g and microcrystalline cellulose 315g into decoction of four ingredients 640g, mixing, feeding into high efficiency mixing granulator, setting stirring speed at 3r/s, cutter rotation speed at 20r/s, atomizing pressure at 0.3Mpa, spraying water 135g, granulating, and adding oleum Sesami 15g, and granulating. The pelleting and drying operations were the same as in example 1, to obtain 1000g pellets.
The traditional Chinese medicine pill obtained in the embodiment is smooth and round.
Example 3
Taking 490g of Sijunzi decoction extract, adding 30g of cordyceps sinensis fine powder, 300g of microcrystalline cellulose and 150g of lactose monohydrate, uniformly mixing, putting into a high-efficiency mixing granulator, setting the stirring speed to be 3r/s, the cutting knife speed to be 20r/s, the atomizing pressure to be 0.3Mpa, spraying 135g of water for granulation, and then adding 30g of sesame oil for granulation. The pelleting and drying operations were the same as in example 1, to obtain 1000g pellets.
The traditional Chinese medicine pill obtained in the embodiment is smooth and round.
Example 4
Mixing 640g of the decoction of four ingredients extract and 345g of microcrystalline cellulose, putting into a high-efficiency mixing granulator, setting the stirring speed at 3r/s, the cutter speed at 20r/s and the atomization pressure at 0.3Mpa, spraying 135g of water for granulation, and adding 15g of sesame oil for granulation. The wet granules are put into a full-automatic traditional Chinese medicine pill making machine, pill strips are made for 2 times, the strip conveying and pill making speed is adjusted, the speed that the pill strips are not stretched, the thickness is consistent, the appearance of pills is round and round is suitable, and 95% ethanol is sprayed for preventing sticking occasionally in the pill making process. Slowly putting the prepared balls into a sugar-coating machine for preliminary rounding, drying and shaping, and finally drying by hot air until the water content of the balls is lower than 6 percent to obtain 1000g of balls.
The traditional Chinese medicine pill obtained in the embodiment is smooth and round.
Comparative example 1
640g of the decoction of four ingredients extract is taken, 350g of microcrystalline cellulose and 10g of silicon dioxide are added, mixed evenly and put into a high-efficiency mixing granulator, the stirring speed is set to be 3r/s, the cutting speed is set to be 20r/s, the atomization pressure is set to be 0.3Mpa, and 135g of water is sprayed for granulation. The pelleting and drying operations were the same as in example 1. 1000g of balls were obtained.
Most of the traditional Chinese medicine pills obtained by the comparative example have trailing phenomenon and are not round.
Comparative example 2
640g of the decoction of four ingredients is taken, 350g of microcrystalline cellulose and 10g of magnesium stearate are added into the decoction of four ingredients, the mixture is uniformly mixed and put into a high-efficiency mixing granulator, the stirring speed is set to be 3r/s, the cutting speed is set to be 20r/s, the atomization pressure is set to be 0.3Mpa, and 135g of water is sprayed for granulation. The pelleting and drying operations were the same as in example 1. 1000g of balls were obtained.
The traditional Chinese medicine pill obtained by the comparative example has a rough surface, most of the pills have trailing phenomenon and are not round.
Comparative example 3
640g of the four-ingredient decoction extract is taken, 350g of microcrystalline cellulose and 10g of sucrose fatty acid ester are added, mixed uniformly and put into a high-efficiency mixing granulator, the stirring speed is set to be 3r/s, the cutter speed is set to be 20r/s, the atomization pressure is set to be 0.3Mpa, and 135g of water is sprayed for granulation. The pelleting and drying operations were the same as in example 1.
The traditional Chinese medicine pill obtained in the comparative example is in a chain bead shape and is not round.
Comparative example 4
Taking 570g of the eight-treasure decoction extract, adding 380g of microcrystalline cellulose, and uniformly mixing; taking 50g of honey, adding 100g of water, heating to melt, and boiling to remove heat to obtain honey water; putting the uniformly mixed materials into a high-efficiency mixing granulator, setting the stirring speed to be 3r/s, the cutting knife speed to be 20r/s, the atomization pressure to be 0.3Mpa, adding 145g of honey water for granulation, putting wet granules into a full-automatic traditional Chinese medicine pill making machine, making pills into strips for 2 times, grading, rounding, primarily rolling, drying and shaping the pills, and finally drying by hot air until the moisture of the pills is lower than 6% to prepare 1000g of pills.
The surface of the traditional Chinese medicine pill obtained by the comparative example is rough and has fine cracks.
Comparative example 5
The ball of comparative example 4 was coated with a polish, as follows:
a part of the filtrate of the eight-treasure decoction (namely the filtrate filtered while hot in preparation example 1) is left, concentrated to a proper amount, added with sucrose and decocted to obtain a decocted extract (measured at 25 ℃) with the relative density of 1.25-1.30. 100g of the pellet sample of the comparative example 4 is placed in a sugar coating pan at 55 ℃, rotated and preheated, 3g of the decocted extract is added, fully wetted, 1g of talcum powder is added, the mixture is stirred until the powder is uniformly distributed, the mixture is heated to about 55 ℃ until the mixture is dried, and 3 layers are wrapped according to the method of adding 3g of the decocted extract, fully wetted, adding 1g of talcum powder, stirring until the powder is uniformly distributed, and heating to about 55 ℃ until the mixture is dried. Adding 3g of the above decocted extract, stirring well, adding 0.5-1g of activated carbon, heating to about 55 ℃ until drying, and packaging 3 layers according to the method of adding 3g of the above decocted extract, stirring well, adding 0.5-1g of activated carbon, heating to about 55 ℃ until drying. The inner wall of the sugar coating pan is continuously scrubbed by wet cloth dipped with warm boiled water in the coating process to ensure that the surface is smooth. The weight of the coated balls is 107g, and the weight is 7%.
In the coating process, the balls are easy to adhere and conglomerate, so the balls are black but not smooth and round, and the surface of the balls is like Chinese prickly ash. Therefore, the traditional polishing and coating method cannot solve the problem of rough surface of the traditional Chinese medicine concentrated pill.
Comparative example 6
The pellets of comparative example 4 were coated with a brown film coating premix of Carlekang 290F665144-CN, as follows:
1. preparing a coating solution: and weighing 30g of the film coating premix and 200mL of pure water, slowly pouring the film coating premix into the pure water in a stirring state, and continuously stirring for more than 45 minutes to obtain 15% coating solution. In the coating process, the coating liquid is kept uniform by stirring continuously.
2. 200g of the ball sample of the comparative example 4 is taken and placed in a high-efficiency coating machine, the rotating speed of a main machine is set to be 3rpm, the air inlet temperature is set to be 55 ℃, the air inlet rotating speed is set to be 1200rpm, the air outlet rotating speed is set to be 900rpm, and the ball sample is rotated and preheated for 10 min; adjusting the rotating speed of the main machine to 8rpm, the atomizing pressure to 0.08MPa, the thimble pressure to 0.1MPa and the spray speed to 1g/min, and starting spray coating; when the weight is increased to a proper degree, stopping spraying liquid, adjusting the rotating speed of the main machine to 5rpm, starting drying, stopping the machine after 10min, and taking out the balls. When the coating is increased to 3% and 7%, the coating is sampled and observed respectively.
The coating can cover the original color of the ball, but cannot fill cracks, and the condition of rough surface is not effectively improved.
Although the invention has been described in detail hereinabove by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that many modifications and improvements can be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims (10)

1. A traditional Chinese medicine pill is characterized in that the active ingredients of the traditional Chinese medicine pill comprise traditional Chinese medicine extracts; the auxiliary materials of the traditional Chinese medicine pills comprise edible vegetable oil; preferably, the edible vegetable oil is sesame oil.
2. The traditional Chinese medicine pill according to claim 1, wherein the mass of the active ingredient is 40-65% of the total mass of the traditional Chinese medicine pill.
3. The traditional Chinese medicine pill according to claim 1 or 2, wherein the traditional Chinese medicine extract is obtained by extracting traditional Chinese medicine raw materials with water, concentrating, drying and crushing;
preferably, the viscosity of the traditional Chinese medicine extract at 20 ℃ is within the range of 1000 cP-3000 cP; and/or the traditional Chinese medicine raw materials are prepared by mixing traditional Chinese medicines adopted in a traditional Chinese medicine classic formula.
4. The traditional Chinese medicine pill according to claim 1, wherein the edible vegetable oil accounts for 1-4% of the total mass of the traditional Chinese medicine pill.
5. A traditional Chinese medicine pill according to claim 1 or 4, wherein the edible vegetable oil is added during the granulation step of the pill preparation process.
6. The traditional Chinese medicine pill of claim 1, wherein the adjuvant of the traditional Chinese medicine pill further comprises a diluent; the diluent contains microcrystalline cellulose, or a mixture of the microcrystalline cellulose and the cordyceps powder, or a mixture of the microcrystalline cellulose and lactose, or a mixture of the microcrystalline cellulose, the cordyceps powder and the lactose;
preferably, the diluent contains microcrystalline cellulose or contains the following components in a mass ratio of (8-12): 1 or a mixture of microcrystalline cellulose and cordyceps powder, wherein the mass ratio of the microcrystalline cellulose to the cordyceps powder is (1.5-2.5): 1, or the mixture of microcrystalline cellulose and lactose monohydrate, wherein the mass ratio of the microcrystalline cellulose to the lactose monohydrate is (1.5-2.5): (0.15-0.25): 1 microcrystalline cellulose, cordyceps powder and lactose monohydrate.
7. The traditional Chinese medicine pill according to claim 1 or 6, wherein the diluent is used in an amount of 30-50% by mass of the total mass of the traditional Chinese medicine pill, and/or the mass ratio of the active ingredient to the diluent is (1-2): 1.
8. a traditional Chinese medicine pill according to claim 1, 6 or 7, wherein the adjuvant of the traditional Chinese medicine pill further comprises a binder, the binder comprising maltodextrin;
preferably, the dosage of the adhesive accounts for 5-10% of the total mass of the traditional Chinese medicine pills, and/or the mass ratio of the active ingredients to the adhesive is (5-8): 1, and/or the mass ratio of the diluent to the adhesive is (5-8): 1.
9. a method for preparing a traditional Chinese medicine pill according to any one of claims 1 to 8, which is characterized in that the pill is prepared by using the active ingredient according to any one of claims 1 to 8 and an auxiliary material including the edible vegetable oil.
10. The method of claim 9, comprising the steps of: mixing the active ingredient with diluent, or mixing the active ingredient with diluent and adhesive, adding excipient, granulating, adding edible vegetable oil, and granulating; making the obtained granules into pills, shaping and drying;
preferably, the excipient is water, and the using amount of the excipient is 3-10 times of the weight of the edible vegetable oil; and/or the water content of the dried pill is below 6%.
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