CN110898125A - Donkey-hide gelatin and angelica blood-nourishing pill and preparation method thereof - Google Patents
Donkey-hide gelatin and angelica blood-nourishing pill and preparation method thereof Download PDFInfo
- Publication number
- CN110898125A CN110898125A CN201911249195.2A CN201911249195A CN110898125A CN 110898125 A CN110898125 A CN 110898125A CN 201911249195 A CN201911249195 A CN 201911249195A CN 110898125 A CN110898125 A CN 110898125A
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- Prior art keywords
- concentrating
- mixing
- pill
- corii asini
- colla corii
- Prior art date
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- Medicinal Preparation (AREA)
Abstract
The invention discloses an donkey-hide gelatin blood-nourishing pill and a preparation method thereof, the preparation is an improvement of the preparation form process on the basis of the existing granules, and the pill has the advantages of high drug release speed, high bioavailability, accurate divided dose, convenient taking and carrying, beautiful appearance and the like; overcomes the defects of large dosage, high sugar content and unsuitability for people with diabetes of the original dosage form of auxiliary materials, comprehensively improves the quality control standard and enriches the variety of the drugs. The composition has effects in invigorating qi and blood; the traditional Chinese medicine composition has obvious curative effects on deficiency of qi and blood, sallow complexion, dizziness and hypodynamia, muscle emaciation, amenorrhea, leucorrhea with reddish discharge and the like, is a clinically popular, safe, stable and effective medicine, and is widely applicable to modern traditional Chinese medicine enterprises.
Description
Technical Field
The invention relates to the technical field of preparation processes of Chinese patent medicine pills, in particular to an angelica sinensis blood-nourishing pill and a preparation method thereof.
Background
The pill is a traditional dosage form, because of the sound velocity development of modern science and technology, pharmaceutical machinery and equipment are continuously updated, a novel pill making machine is appeared, and new auxiliary materials are widely applied, the pill is an ancient dosage form of traditional Chinese medicine pill, and the pill has youthful vigor, changes the traditional prejudice of people on the blackness, the bulkiness and the thickness of the traditional Chinese medicine pill, and has the advantages of high medicine release speed, high bioavailability, small irritation, accurate dosage, convenient taking and carrying, attractive appearance and the like; according to the relevant pharmaceutical regulations in China, the dosage form is changed to be used as a new drug for research, and the original dosage form of the donkey-hide gelatin blood-nourishing pill is as follows: the aji blood-nourishing granule is listed in volume 12 of the drug Standard "Chinese medicine Chengfang preparation" of Ministry of public health of the people's republic of China. The process technology of the original preparation formulation is characterized in that: percolating and extracting eight materials except colla Corii Asini with 60% ethanol, recovering ethanol from percolate, concentrating to appropriate amount, standing, and collecting floating oily substance; extracting the residue with water, concentrating to appropriate amount, mixing with the above concentrated solution, adding dissolved colla Corii Asini solution, boiling, filtering, concentrating, adding sucrose and dextrin, granulating, drying, spraying the above oily substance, and mixing. The granule has large adjuvant dosage and high sugar content, and is not suitable for people with diabetes; and the quality standard control index is low, the dosage form is single, and the medicine requirement of people can not be met. Based on the fact that the modern pharmaceutical technology is applied to improve the product process, a new preparation is formed, the quality standard is comprehensively improved, the monitoring quality of the product is guaranteed, the drug effect is improved, the common people are benefited, and the method has great significance for inheriting and developing the ancestral Chinese medicine heritage.
Disclosure of Invention
The invention aims to provide the donkey-hide gelatin and angelica blood-nourishing pill and the preparation method thereof, so that the quality and the curative effect of the product are improved, the stability of the product is improved, and the medical needs are better met.
The purpose of the invention is realized as follows:
1. the donkey-hide gelatin and angelica blood-nourishing pill and the preparation method thereof comprise the following steps:
1.1 prescription composition of Agui blood-nourishing pill
1158 and 3088g of angelica sinensis, 72 to 192g of codonopsis pilosula, 72 to 192g of white paeony root
36-96g of liquorice (honey-fried), 72-192g of poria cocos, 72-192g of astragalus membranaceus
72-192g of prepared rehmannia root, rhizoma ligustici wallichii, 36-96g of donkey-hide gelatin, 72-792g
Proper amount of auxiliary materials, and the total weight is 1000 g.
The optimal formula is as follows:
radix Angelicae sinensis 1930-
60-84g of liquorice (honey-fried), 120 g of tuckahoe, 120-168g of astragalus root, 120-168g
Prepared rehmannia root 120-
Proper amount of auxiliary materials, and the total weight is 1000 g.
1.2 preparation process of pill containing donkey-hide gelatin, angelica and blood
The first process is to clean and select the nine medicines respectively, remove impurities and check the nine medicines to be qualified for later use. Pulverizing the rest materials except colla Corii Asini into coarse powder or cutting into pieces, extracting with 50-95% ethanol, recovering ethanol from the extractive solution, concentrating, standing, collecting oily matter, and storing in another container; decocting the residue in water for 1-2 times, filtering, concentrating the filtrate to appropriate amount, mixing with the above concentrated solution, adding water-dissolved colla Corii Asini solution, stirring, boiling for 30 min, hot filtering, concentrating into soft extract/concentrating and drying to obtain dry extract powder, mixing with adjuvant, making pill, drying, spraying the above oily substance, and mixing.
And in the second process, the nine medicines are respectively cleaned and selected, impurities are removed, and the nine medicines are qualified for standby after inspection. Pulverizing colla Corii Asini into fine powder; pulverizing the rest materials into coarse powder or cutting into pieces, extracting with 50-95% ethanol, recovering ethanol from the extractive solution, concentrating, standing, collecting floating oily substance, and storing in another container; decocting the residue in water for 1-2 times, filtering, concentrating the filtrate to appropriate amount, mixing with the above concentrated solution, concentrating into soft extract or concentrating and drying to obtain dry extract powder, mixing with colla Corii Asini fine powder and adjuvant, making pill, drying, spraying the above oily substance, and mixing.
And in the third process, the nine medicines are respectively cleaned and selected, impurities are removed, and the nine medicines are qualified for standby after inspection. Pulverizing colla Corii Asini into fine powder; extracting volatile oil from radix Angelicae sinensis, and collecting the residue; clathrating the above volatile oil with appropriate amount of cyclodextrin or dissolving with anhydrous alcohol solution; pulverizing the rest seven materials into coarse powder or cutting into pieces, extracting with 50-95% ethanol, and recovering ethanol from the extractive solution; mixing the residue with above radix Angelicae sinensis residue, decocting in water for 1-2 times, filtering decoction, mixing with the ethanol extractive solution obtained after recovering ethanol, concentrating into soft extract/concentrating and drying to obtain dry extract powder, mixing the soft extract/dry extract powder with the colla Corii Asini fine powder, volatile oil cyclodextrin clathrate and appropriate amount of adjuvant, making pill, and drying. Or mixing the soft extract/dry extract powder with the fine powder of colla Corii Asini and adjuvant, making pill, drying, and spraying the above anhydrous alcohol solution of volatile oil.
1.3 the pill prepared by the first, second and third processes is the pill for nourishing blood of the angelica.
The pill obtained in the process can be coated with film coating, wherein the film coating material is one or more of gastric soluble film coating premix (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, and methylcellulose.
The adjuvants used in the process can be one or more of sucrose, lactose, starch, β -cyclodextrin, hydroxypropyl- β -cyclodextrin, microcrystalline cellulose, hydroxypropyl cellulose, carboxymethyl starch sodium, aspartame, crospovidone, polyvidone K30, etc.
The obtained pill has particle diameter of 0.5-6mm, preferably 1-4 mm.
The pills obtained in the process can be directly used or filled into empty capsules for use.
The pill drying process can be vacuum drying, fluidized bed drying, freeze drying, etc.
The process comprises pulverizing the above Chinese medicinal materials into coarse powder or cutting into pieces, or pulverizing into coarse powder of 5-30 meshes or cutting into pieces, preferably 10-20 meshes.
The traditional Chinese medicinal materials are crushed into fine powder, usually into fine powder which passes through 80-160 meshes, and optimally into fine powder which passes through 200-300 meshes in an ultramicro way.
The alcohol extraction conditions in the process are as follows: heating reflux/percolation extracting with 50-95% ethanol as solvent; preferably, 60% ethanol is used as solvent, soaking for 24 hr, slowly percolating, and collecting 8 times of percolate.
In the process, the cyclodextrin inclusion compound is prepared by adopting one of β -cyclodextrin and hydroxypropyl- β -cyclodextrin as cyclodextrin, the ratio of the volatile oil to the β -cyclodextrin is 1: 5-15(ml/g), the optimal ratio is 1: 9(ml/g), the ratio of the volatile oil to the hydroxypropyl- β -cyclodextrin is 1: 3-10(ml/g), and the optimal ratio is 1: 6 (ml/g).
The process comprises the following water decocting conditions: decocting for 1-2 times, with water amount 4-12 times of the amount of the medicinal materials for 0.5-3 hr; the best is as follows: decocting for 1 time, with water amount 10 times of the amount of the medicinal materials, and the time is 1 hr.
The relative density of the thick paste in the process is 1.10-1.45(75-80 ℃), and the optimal relative density is 1.30(75-80 ℃).
The extract can be dried by vacuum drying or spray drying at 50-80 deg.C, preferably 60 deg.C. The relative density of the spray-dried concentrated solution is 1.05-1.15 (55-60 ℃); the air inlet temperature is 100-200 ℃ and the air outlet temperature is 50-150 ℃; the optimal relative density of the concentrated solution is 1.08-1.10(60 ℃), the air inlet temperature is 160-180 ℃, and the air outlet temperature is 80-100 ℃.
The filtration in the process can adopt the conventional filtration, centrifugation, ultrafiltration, filtration/centrifugation/ultrafiltration after adding a clarifying agent and the like.
2. The quality control of the product is mainly as follows: identification, inspection and content measurement.
The quality standard of the product is comprehensively improved, the original preparation formulation only has the thin layer identification of angelica, and the thin layer identification of codonopsis pilosula, astragalus and white paeony root is added; the limit of heavy metals is not over ten parts per million and the arsenic salt is not over two parts per million; the amount of angelica was quantified in the assay.
Compared with the prior art, the invention has the advantages that: the production process is more perfect and reasonable, the quality standard is greatly improved, the product has a scientific qualitative and quantitative control method, and the quality and the curative effect of the product are guaranteed.
Detailed Description
Example 1: the nine medicines are respectively cleaned and selected, impurities are removed, and the nine medicines are qualified for standby after inspection. Pulverizing the rest materials except colla Corii Asini into coarse powder, mixing, soaking with 60% ethanol as solvent for 24 hr, slowly percolating, collecting percolate of 8 times, recovering ethanol, concentrating to appropriate amount, standing, collecting floating oily substance, and storing in another container; decocting the residue in water for 1 time for 1 hr, filtering, concentrating the filtrate to appropriate amount, and standing for 24 hr. Pouring the two concentrated liquid medicines, mixing, adding water-dissolved colla Corii Asini solution, stirring, boiling for 30 min, filtering while hot, concentrating to relative density of 1.08-1.10(55-60 deg.C), spray drying to obtain dry extract powder, adding appropriate amount of adjuvant, mixing, making pill, drying, spraying the above oily substance, and mixing.
Example 2: the nine medicines are respectively cleaned and selected, impurities are removed, and the nine medicines are qualified for standby after inspection. Pulverizing colla Corii Asini into fine powder; pulverizing the rest eight materials into coarse powder, soaking in 60% ethanol for 24 hr, slowly percolating, collecting percolate 8 times, recovering ethanol, concentrating to appropriate amount, standing, collecting floating oily substance, and storing in another container; decocting the residue in water for 1 time for 1 hr, filtering, concentrating the filtrate to appropriate amount, and standing for 24 hr. Pouring the two concentrated liquid medicines, mixing, adding water-soluble colla Corii Asini solution, stirring, boiling for 30 min, filtering while hot, concentrating to relative density of 1.08-1.10(55-60 deg.C), spray drying to obtain dry extract powder, adding the above colla Corii Asini fine powder and appropriate amount of adjuvants, mixing, making pill, drying, spraying the oily substance, and mixing.
Example 3: the nine medicines are respectively cleaned and selected, impurities are removed, and the nine medicines are qualified for standby after inspection. Pulverizing colla Corii Asini into fine powder; extracting volatile oil from radix Angelicae sinensis, and collecting the residue; clathrating the above volatile oil with cyclodextrin; pulverizing the rest seven materials into coarse powder, soaking with 60% ethanol as solvent for 24 hr, slowly percolating, collecting 8 times of percolate, and recovering ethanol; mixing the residues with above radix Angelicae sinensis residues, decocting in water for 1 time 1 hr, filtering, mixing the filtrate with the ethanol extractive solution obtained after ethanol recovery, concentrating to relative density of 1.08-1.10(55-60 deg.C), spray drying to obtain dry extract powder, adding above colla Corii Asini fine powder, volatile oil cyclodextrin clathrate and appropriate amount of adjuvant, mixing, making pill, and drying.
Claims (2)
1. An donkey-hide gelatin and angelica blood-nourishing pill and a preparation method thereof are characterized in that: respectively cleaning and selecting nine medicines of angelica, codonopsis pilosula, white paeony root, liquorice, tuckahoe, astragalus, prepared rehmannia root, Szechuan lovage rhizome and donkey-hide gelatin, removing impurities, and inspecting for standby; pulverizing the rest eight medicines except colla Corii Asini into coarse powder, extracting with 50-95% ethanol, recovering ethanol from the extractive solution, concentrating to appropriate amount, standing, collecting floating oily substance, and storing in another container; decocting the residue in water for 1-2 times, filtering, concentrating the filtrate to appropriate amount, mixing with the concentrated solution, adding water-dissolved colla Corii Asini solution, stirring, boiling for 30 min, filtering while hot, concentrating into soft extract/concentrating and drying to obtain dry extract powder, mixing with appropriate amount of adjuvant, making into pill, drying, spraying with oily substance, and mixing;
(2) respectively cleaning radix Angelicae sinensis, radix Codonopsis, radix Paeoniae alba, Glycyrrhrizae radix, Poria, radix astragali, radix rehmanniae Preparata, rhizoma Ligustici Chuanxiong, and colla Corii Asini, removing impurities, and inspecting; pulverizing colla Corii Asini into fine powder; pulverizing the rest eight materials into coarse powder, extracting with 50-95% ethanol, recovering ethanol from the extractive solution, concentrating to appropriate amount, standing, collecting floating oily substance, and storing in another container; decocting the residue in water for 1-2 times, filtering, concentrating the filtrate to appropriate amount, mixing with the concentrated solution, concentrating into soft extract/concentrating and drying to obtain dry extract powder, mixing with colla Corii Asini fine powder and adjuvant, making pill, drying, spraying oil, and mixing;
(3) respectively cleaning radix Angelicae sinensis, radix Codonopsis, radix Paeoniae alba, Glycyrrhrizae radix, Poria, radix astragali, radix rehmanniae Preparata, rhizoma Ligustici Chuanxiong, and colla Corii Asini, removing impurities, and inspecting; pulverizing colla Corii Asini into fine powder; extracting volatile oil from radix Angelicae sinensis, and collecting the residue; clathrating the volatile oil with appropriate amount of cyclodextrin or dissolving with anhydrous alcohol solution; pulverizing the rest seven materials into coarse powder, extracting with 50-95% ethanol, and recovering ethanol from the extractive solution; mixing the residue with radix Angelicae sinensis residue, decocting in water for 1-2 times, filtering decoction, mixing with ethanol extractive solution obtained after recovering ethanol, concentrating into soft extract/concentrating and drying to obtain dry extract powder, mixing the soft extract/dry extract powder with colla Corii Asini fine powder, volatile oil cyclodextrin clathrate and appropriate amount of adjuvant, making pill, and drying; or mixing the soft extract/dry extract powder with colla Corii Asini fine powder and appropriate amount of adjuvant, making pill, drying, and spraying with anhydrous alcohol solution containing volatile oil.
2. The donkey-hide gelatin and angelica blood-nourishing pill as claimed in claim 1 and the preparation method thereof are characterized in that: the obtained pill can be coated with film coating, wherein the film coating material is selected from one or more of gastric soluble film coating premix (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, and methylcellulose.
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