CN111202793A - Traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains and preparation method thereof - Google Patents

Traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains and preparation method thereof Download PDF

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CN111202793A
CN111202793A CN202010056275.2A CN202010056275A CN111202793A CN 111202793 A CN111202793 A CN 111202793A CN 202010056275 A CN202010056275 A CN 202010056275A CN 111202793 A CN111202793 A CN 111202793A
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blood stasis
traditional chinese
chinese medicine
treating heart
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蓝保强
农云开
饶伟源
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Guangxi Institute Of Chinese Medicine & Pharmaceutical Science
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Guangxi Institute Of Chinese Medicine & Pharmaceutical Science
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    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/62Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236Ligusticum (licorice-root)
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286Carthamus (distaff thistle)
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/89Cyperaceae (Sedge family)
    • A61K36/8905Cyperus (flatsedge)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention discloses a traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains, which is prepared from the following raw materials: peach kernel, Chinese angelica, bitter orange, Szechuan lovage rhizome, safflower, tangerine peel, earthworm, nutgrass galingale rhizome and dextrin; on the other hand, the invention also provides a preparation method of the traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains. The traditional Chinese medicine formula optimizes the proportion of each component on the basis of considering the content of each component, and improves the effect of promoting blood circulation to remove blood stasis; meanwhile, the main effective components of the medicinal materials in the formula have certain water solubility, so that the formula is unified with the traditional medicine, the quality is not changed, and the curative effect is not influenced; the prepared traditional Chinese medicine preparation not only keeps the characteristics of quick absorption and quick action of the decoction, but also overcomes the defects of inconvenient decoction, large dosage, easy deterioration and the like when the decoction is used temporarily, and the product quality is stable.

Description

Traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains and preparation method thereof
Technical Field
The invention relates to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains and a preparation method thereof.
Background
The chest stuffiness, heart pain and heart blood stasis syndrome refers to the condition of chest pain, such as stabbing like twisting, pain in fixed places, even in the night, chest pain involving the back, back pain involving the heart, or pain involving the shoulder and back, accompanied by chest distress, not healing after a long time, aggravated by violence and fatigue, dark purple tongue with ecchymosis and the like. It is equivalent to coronary heart disease and angina pectoris in Western medicine. The following symptoms and accompanying symptoms are different from qi deficiency and blood stasis, qi stagnation and blood stasis, phlegm turbidity and blood stasis, yin deficiency and blood stasis.
The prior patent documents disclose a plurality of Chinese patent medicines for treating heart blood stasis type thoracic obstruction. Such as:
chinese patent CN105663416A discloses a traditional Chinese medicine composition for treating heart blood stasis type thoracic obstruction, which is prepared from the following raw materials in parts by weight: 6-8 parts of ligusticum wallichii, 10-12 parts of angelica sinensis, 13-14 parts of safflower, 3-5 parts of red paeony root, 6-8 parts of achyranthes bidentata, 10-13 parts of radix rehmanniae, 3-4 parts of folium lycii and 1-3 parts of stiff silkworm. The preparation method of the traditional Chinese medicine composition for treating heart blood stasis type chest stuffiness is also provided. The traditional Chinese medicine composition for treating heart blood stasis type thoracic obstruction has the cure rate of 87.5% and the total effective rate of 96.9% for patients with heart blood stasis type thoracic obstruction.
Chinese patent CN103610965B discloses a medicament for treating heart blood stasis type thoracic obstruction, which is prepared from the following raw material medicines: mallotus japonicus, green bamboo shoot slices, blue flower shallot, yellow water branches, esculent sword, lobster sauce grass, giant boxing, Shunjiang wood, tiger trifoliate, zornia gibbosa, Dazhugu and Diedacao.
Chinese patent CN105079505B discloses a traditional Chinese medicine for treating heart-lung qi deficiency and heart blood stasis type thoracic obstruction, which is prepared from the following raw materials: radix codonopsitis, radix pseudostellariae, angelica, polygala root, poria, exocarpium citri rubrum, pinellia tuber, rhizoma atractylodis macrocephalae, rhizoma gastrodiae, almond, peach kernel, salvia miltiorrhiza, red paeony root, cortex moutan, fructus trichosanthis, allium macrostemon, pseudo-ginseng, cortex magnoliae officinalis, ganoderma lucidum, blackberry lily, asarum, honey-fried licorice root and cassia twig.
Chinese patent CN102302741B discloses a preparation method of a traditional Chinese medicine for treating heart blood stasis type thoracic obstruction. The technical scheme of the invention is as follows: soaking rhizoma ligustici wallichii, China rose, salvia miltiorrhiza, impatiens balsamina, leech, fructus polygoni orientalis, humifuse euphorbia herb, rhizoma corydalis, native copper, artemisia anomala, safflower, azalea, sappan wood, spina gleditsiae, myrrh, caulis spatholobi, frankincense, herba lycopi, selaginella tamariscina, rosewood heart wood, resina draconis, motherwort fruit, winged euonymus twig, turmeric, peach kernel, campsis grandiflora, trichosanthes kirilowii maxim, allium macrostemon, tangerine seed, orange peel, buckeye, tobacco, citron, rhizoma cyperi, mangnolia officinalis, lychee seed, lychee, saffron and liquorice in water, decocting the above traditional Chinese medicines with slow fire, filtering and removing dregs, wherein the decocted liquid medicine is the traditional Chinese medicine for treating the heart blood.
Although most of the traditional Chinese medicines for treating heart blood stasis type thoracic obstruction are decoction, the decoction has good clinical effect and wide market demand, but the decoction needs to be newly prepared, is inconvenient to carry, cannot form scale, and is not beneficial to popularization and application. If the preparation is prepared into oral liquid, the precipitation is easy to appear, and the preparation is not stable.
Disclosure of Invention
The invention provides a traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains and a preparation method thereof, aiming at the problems of uncertain curative effect, unstable preparation and the like in the prior art. The purpose of the invention is realized by the following scheme:
a traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains is prepared from the following raw materials in parts by weight: 15-21 parts of peach kernel, 7-13 parts of angelica sinensis, 7-13 parts of fructus aurantii, 8-14 parts of ligusticum wallichii, 3-9 parts of safflower, 3-9 parts of pericarpium citri reticulatae, 7-13 parts of earthworm, 7-13 parts of rhizoma cyperi and 50-75 parts of dextrin;
preferably, the preparation consists of the following raw materials in parts by weight: 17-19 parts of peach kernel, 9-11 parts of angelica sinensis, 9-11 parts of fructus aurantii, 9-12 parts of ligusticum wallichii, 5-7 parts of safflower, 5-7 parts of pericarpium citri reticulatae, 8-11 parts of earthworm, 9-11 parts of rhizoma cyperi and 57-68 parts of dextrin;
preferably, the preparation consists of the following raw materials in parts by weight: 18 parts of peach kernel, 10 parts of angelica, 10 parts of fructus aurantii, 10 parts of ligusticum wallichii, 6 parts of safflower, 6 parts of dried orange peel, 10 parts of earthworm, 10 parts of rhizoma cyperi and 65 parts of dextrin;
the invention also provides a preparation method of the traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains, which comprises the following steps:
the method comprises the following steps: taking peach kernel, Chinese angelica, bitter orange, Szechuan lovage rhizome, safflower, tangerine peel, earthworm and nutgrass galingale rhizome, adding 4 to E
Decocting with 10 times of water for 1-4 times, 0.5-3 hours each time;
step two: merging the decoctions, filtering, and concentrating the filtrate to a relative density of 1.2-1.3;
step three: adding dextrin, granulating, and drying;
preferably, 5-7 times of water is added in the first step;
preferably, the decocting times in the step one are 2-3 times;
preferably, the decocting time in the first step is 1-2 hours;
preferably, the relative density in the second step is 1.25-1.28;
preferably, the concentration temperature in the second step is 65-75 ℃.
The sources and standards of the medicinal materials used in the invention are as follows:
1. peach kernel: the product is dried mature seed of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch of Rosaceae. Quality standard: it should meet the regulations of "Tao ren" on pages 277 to 278 in the first part of the 2015 edition of Chinese pharmacopoeia.
2. Safflower: the product is dried flower of Carthamus tinctorius L. Quality standard: it should meet the regulation of "hong Hua" item on page 151 of the first part of the book "Chinese pharmacopoeia" 2015 edition.
3. Chinese angelica: the product is dried root of Angelica sinensis (Oliv.) Diels) of Umbelliferae. Quality standard: it should meet the regulations of the term "Dang Gui" from page 133 to page 134 of the first part of the "Chinese pharmacopoeia" 2015 edition.
4. Ligusticum wallichii: the product is dried rhizome of Ligusticum chuanxiong Hort of Umbelliferae. Quality standard: it should meet the regulation of Chuan Xiong from pages 40 to 41 of the first part of the book "Chinese pharmacopoeia" 2015 edition.
5. Earthworm: the product is dried body of Pheretima aspergillum (E.Perrier), Pheretima vulgaris Chen, Pheretima guillellimi (Michaelsen), or Pheretima pictoria pectinifera Michaeken. Quality standard: it should meet the stipulations of "earthworm" from page 122 to page 123 of the first part of the "Chinese pharmacopoeia" 2015 edition.
6. Fructus aurantii: the product is dried immature fruit of Citrus aurantium L.A.graveolens L.and its cultivar. Quality standard: it should meet the regulation of Zhi Qiao on page 246 of the first part of the book "Chinese pharmacopoeia" 2015 edition.
7. Rhizoma cyperi: the product is dried rhizome of Cyperus rotundus L. Quality standard: it should meet the stipulations of "Xiang Fu" item at page 258 of the first part of the book of Chinese pharmacopoeia 2015.
8. Dried orange peel: the product is dry mature pericarp of Citrus reticulata Blanco of Rutaceae and its cultivar. Quality standard: it should meet the regulations of "Chenpi" item at page 191 of the first part of the book 2015 of Chinese pharmacopoeia.
The traditional Chinese medicine for treating heart blood stasis type chest stuffiness and pains is a clinical proved formula, the traditional preparation method is to add water for decoction for 2 times and combine decoction to prepare decoction for taking in a divided manner, the traditional Chinese medicine particles for treating heart blood stasis type chest stuffiness and pains are developed into hospital preparations on the basis, most main active ingredients of all medicinal materials in the formula have certain water solubility, most of the traditional Chinese medicines are decocted with water for extraction, and therefore, in order to ensure uniformity with the traditional medicine, cause no qualitative change and influence on curative effect, a water decoction extraction method is adopted for extraction, and an orthogonal test method is adopted to optimize extraction process conditions.
The invention has the beneficial effects that:
1. the traditional Chinese medicine formula disclosed by the invention has the effects of promoting blood circulation to remove blood stasis, dredging collaterals and relieving pain and the like, is mainly used for treating heart blood stasis, and has the cure rate of more than 96%; the traditional Chinese medicine formula optimizes the proportion of each component on the basis of considering the content of each component, and improves the effects of promoting blood circulation and removing blood stasis; the traditional Chinese medicine formula is prepared by compatibility of various traditional Chinese medicinal materials, but has clear main treatment and no toxic or side effect.
2. Most main effective components of the medicinal materials in the formula have certain water solubility, and most of the main effective components are extracted by decocting in water in most of traditional Chinese medicines, so that the formula is unified with the traditional medicines, the quality is not changed, and the curative effect is not influenced.
3. The traditional Chinese medicine granules not only keep the characteristics of quick absorption and quick action of the decoction, but also overcome the defects of inconvenient decoction, large dosage, easy rot and deterioration and the like when the decoction is used; the preparation process of the granules is suitable for standardized production, and the product quality is stable; convenient administration, carrying, storage and transportation, and is popular with patients.
Detailed Description
The present invention will be further illustrated with reference to the following specific examples.
Example 1
The method comprises the following steps: taking 15 parts of peach kernel, 7 parts of angelica, 7 parts of fructus aurantii, 8 parts of ligusticum wallichii, 3 parts of safflower, 3 parts of dried orange peel, 7 parts of earthworm and 7 parts of rhizoma cyperi, adding 4 times of water, and decocting for 1 time, 3 hours each time;
step two: merging the decoctions, filtering, and concentrating the filtrate at 65-75 ℃ until the relative density is 1.2-1.3;
step three: adding 50 parts of dextrin, granulating, and drying at 60 ℃.
Example 2
The method comprises the following steps: taking 21 parts of peach kernel, 13 parts of angelica, 13 parts of fructus aurantii, 14 parts of ligusticum wallichii, 9 parts of safflower, 9 parts of dried orange peel, 13 parts of earthworm and 13 parts of rhizoma cyperi, adding 10 times of water, and decocting for 4 times, wherein each time lasts for 0.5 hour;
step two: mixing decoctions, filtering, and concentrating the filtrate at 75 deg.C to relative density of 1.3;
step three: adding 75 parts of dextrin, granulating, and drying at 60 ℃.
Example 3
The method comprises the following steps: taking 17 parts of peach kernel, 9 parts of angelica, 9 parts of fructus aurantii, 9 parts of ligusticum wallichii, 5 parts of safflower, 5 parts of dried orange peel, 8 parts of earthworm and 9 parts of rhizoma cyperi, adding 5 times of water, and decocting for 3 times, wherein each time lasts for 1 hour;
step two: mixing decoctions, filtering, and concentrating the filtrate at 70 deg.C to relative density of 1.25;
step three: adding 57 parts of dextrin, granulating, and drying at 70 ℃.
Example 4
The method comprises the following steps: taking 19 parts of peach kernel, 11 parts of angelica, 11 parts of fructus aurantii, 12 parts of ligusticum wallichii, 7 parts of safflower, 7 parts of dried orange peel, 11 parts of earthworm and 11 parts of rhizoma cyperi, adding 7 times of water, and decocting for 2 times, each time for 2 hours;
step two: mixing decoctions, filtering, and concentrating the filtrate at 72 deg.C to relative density of 1.28;
step three: adding 68 parts of dextrin, granulating, and drying at 65 ℃.
Example 5
The method comprises the following steps: 18 parts of peach kernel, 10 parts of angelica, 10 parts of fructus aurantii, 10 parts of ligusticum wallichii, 6 parts of safflower, 6 parts of dried orange peel, 10 parts of earthworm and 10 parts of rhizoma cyperi, and 6 times of water is added for decocting for 2 times, and each time lasts for 1.5 hours;
step two: mixing decoctions, filtering, and concentrating the filtrate at 70 deg.C to relative density of 1.26;
step three: adding 65 parts of dextrin, granulating, and drying at 65 ℃.
Example 6
The method comprises the following steps: 16 parts of peach kernel, 11 parts of angelica, 11 parts of fructus aurantii, 9 parts of ligusticum wallichii, 5 parts of safflower, 6 parts of dried orange peel, 10 parts of earthworm and 8 parts of rhizoma cyperi, and 7 times of water is added for decocting for 3 times, 2 hours each time;
step two: mixing decoctions, filtering, and concentrating the filtrate at 72 deg.C to relative density of 1.26;
step three: adding 63 parts of dextrin, granulating, and drying at 68 deg.C.
Example 7
The method comprises the following steps: 19 parts of peach kernel, 12 parts of angelica, 12 parts of fructus aurantii, 12 parts of ligusticum wallichii, 5 parts of safflower, 7 parts of dried orange peel, 9 parts of earthworm and 9 parts of rhizoma cyperi, and 5 times of water is added for decocting for 3 times, 2 hours each time;
step two: mixing decoctions, filtering, and concentrating the filtrate at 68 deg.C to relative density of 1.25;
step three: adding 68 parts of dextrin, granulating, and drying at 68 ℃.
Example 8
The method comprises the following steps: 20 parts of peach kernel, 12 parts of angelica, 8 parts of fructus aurantii, 7 parts of ligusticum wallichii, 8 parts of safflower, 8 parts of dried orange peel, 8 parts of earthworm and 12 parts of rhizoma cyperi, 8 times of water is added, and the mixture is decocted for 1 time and 3 hours each time;
step two: mixing decoctions, filtering, and concentrating the filtrate at 67 deg.C to relative density of 1.28;
step three: adding 68 parts of dextrin, granulating, and drying at 70 ℃.
Results and analysis
1. Optimization of water addition, decoction times and decoction time
According to the experience of water decoction extraction, the factors influencing the extraction efficiency of water decoction mainly include: water addition amount, decoction time, decoction times and the like. Therefore, the water addition amount (A), the decoction times (B) and the decoction time (C) are selected as investigation factors, the content of the salvianolic acid B is used as an assessment index, an orthogonal design method is adopted, and a three-level L is adopted9(34) The experiment is carried out, and the optimal process condition of water decoction extraction is preferred.
Around example 5, three different levels of factors were set for the amount of water added, the duration of the decoction, and the number of times of decoction, and the levels of factors are shown in table 1.
TABLE 1 factor level table
Figure BDA0002372962700000071
Figure BDA0002372962700000081
(1) Survey index measuring method
Content determination: the determination is carried out by referring to high performance liquid chromatography (China pharmacopoeia 2015 edition general rules 0512).
Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; acetonitrile-1% formic acid (23:77) as mobile phase; the detection wavelength was 286 nm. The number of theoretical plates should not be less than 3000 calculated according to salvianolic acid B.
Preparation of control solutions: precisely weighing appropriate amount of salvianolic acid B as reference, adding 80% methanol to obtain solution containing 30 μ g of salvianolic acid B per 1ml, and shaking.
Preparation of a test solution: taking the concentrated solution of each process, shaking up, sucking 2ml, placing in a 25ml measuring flask, adding appropriate amount of methanol, performing ultrasonic treatment (power 300W, frequency 40kHz) for 30 minutes, cooling, adding methanol to scale, shaking up, filtering, and taking the subsequent filtrate to obtain the final product.
The determination method comprises the following steps: precisely sucking 10 μ l of each of the reference solution and the sample solution, respectively, injecting into a liquid chromatograph, and measuring to obtain the total amount of salvianolic acid B in 200ml of concentrated solution obtained by each extraction process.
(2) The test method comprises the following steps: weighing 9 parts of the same batch of medicinal materials according to the proportion of a prescription, wherein each part is 105g (1/10 of the prescription amount), decocting and extracting the medicinal materials in water according to the conditions shown in an orthogonal design table, filtering, concentrating 200ml, uniformly mixing, measuring the content of the salvianolic acid B, and calculating the total content (mg) of the salvianolic acid B in 200ml of concentrated solution. The results are shown in Table 2.
TABLE 2L9(34) Orthogonal test calculation table
Figure BDA0002372962700000091
TABLE 3 analysis of variance
Figure BDA0002372962700000092
The analysis of variance results show that the influences of A, B, C have no significant difference, and the most significant influence of the C factor, the second most significant influence of the A factor and the least significant influence of the B factor can be seen by comparing the extreme differences, and the best A factor is A1, the best B factor is B2 and the best C factor is C3 according to the numerical values of A, B, C three columns of K1, K2 and K3, so that the best process is A1B2C 3.
Orthogonal test results show that the optimal scheme for water decoction and extraction is A1B2C3, namely weighing the medicinal materials, adding 6 times of water, and decocting for 2 times, each time for 1.5 hours.
(4) Best protocol validation test for aqueous decoction extraction
Weighing 9 parts of the same batch of medicinal materials according to the proportion of a prescription, wherein each part is 105g (1/10 of the prescription amount), decocting and extracting the medicinal materials in water according to the conditions shown in an orthogonal design table, filtering, concentrating 200ml, uniformly mixing, measuring the content of the salvianolic acid B, and calculating the total content (mg) of the salvianolic acid B in 200ml of concentrated solution. The results are shown in Table 4.
TABLE 4 confirmation of optimal protocol for water decoction extraction
Figure BDA0002372962700000101
Test results show that the salvianolic acid B content is stabilized at a better level by extracting according to the preferably obtained extraction process conditions, which indicates that the preferably obtained extraction process conditions are reasonable and feasible.
2. Research on molding process
(1) Selection of auxiliary materials
The common adjuvants for granule include dextrin, soluble starch, mannitol, xylitol, etc. Soluble starch, mannitol, xylitol and the like have large viscosity after meeting water and are easy to be bonded into lumps. The thick paste obtained by the product according to the original extraction process contains a certain amount of moisture, and tests show that if soluble starch, mannitol, xylitol and the like are adopted as auxiliary materials, the thick paste is very easy to be bonded into a mass when being mixed with the thick paste due to high viscosity, is difficult to be uniformly mixed and is difficult to granulate. Dextrin has relatively good paste absorption, small viscosity and good forming, and can well solve the problem of granulation, so dextrin is selected as an auxiliary material.
(2) Selection of dextrin adjuvant dosage
After dextrin is determined to be selected as an auxiliary material, in order to facilitate production operation and ensure granule forming and yield, a comparative test is carried out on different dextrin dosage around example 5, concentrated thick paste is added with dextrin according to different proportions for mixing and granulating, and the dextrin dosage is determined according to forming difficulty and yield. From the test results (see table 5), the ratio of thick paste to dextrin was 1: 2.3, mixing, granulating and obtaining good finished product rate, wherein according to the extraction process, the concentration thick paste obtained according to each prescription amount is about 280ml, and the ratio of the thick paste to dextrin is 1: 2.3 calculated, the amount of dextrin was 653g, and the total amount of the obtained granules was about 900g, and finally, 655g-705g of dextrin was added to prepare 900g by trial and error.
TABLE 5 comparative test for dextrin dosage
Figure BDA0002372962700000111
Through a plurality of small batches of tests and 3 batches of pilot plant tests, finally, the amount of dextrin added in each prescription amount is determined to be 655g-705 g.
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 (9)

1. The traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains is characterized by comprising the following raw materials in parts by weight: 15-21 parts of peach kernel, 7-13 parts of angelica, 7-13 parts of fructus aurantii, 8-14 parts of ligusticum wallichii, 3-9 parts of safflower, 3-9 parts of pericarpium citri reticulatae, 7-13 parts of earthworm, 7-13 parts of rhizoma cyperi and 50-75 parts of dextrin.
2. The traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains according to claim 1, which is prepared from the following raw materials in parts by weight: 17-19 parts of peach kernel, 9-11 parts of angelica sinensis, 9-11 parts of fructus aurantii, 9-12 parts of ligusticum wallichii, 5-7 parts of safflower, 5-7 parts of pericarpium citri reticulatae, 8-11 parts of earthworm, 9-11 parts of rhizoma cyperi and 57-68 parts of dextrin.
3. The traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains according to claim 1, which is prepared from the following raw materials in parts by weight: 18 parts of peach kernel, 10 parts of angelica, 10 parts of fructus aurantii, 10 parts of ligusticum wallichii, 6 parts of safflower, 6 parts of dried orange peel, 10 parts of earthworm, 10 parts of rhizoma cyperi and 65 parts of dextrin.
4. The preparation method of the traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains as claimed in any one of claims 1 to 3, characterized by comprising the following steps:
the method comprises the following steps: taking peach kernel, Chinese angelica, bitter orange, ligusticum wallichii, safflower, dried orange peel, earthworm and rhizoma cyperi, adding 4-10 times of water, and decocting for 1-4 times, 0.5-3 hours each time;
step two: merging the decoctions, filtering, and concentrating the filtrate to a relative density of 1.2-1.3;
step three: adding dextrin, granulating, and drying.
5. The method for preparing the traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains according to claim 4, wherein 5-7 times of water is added in the first step.
6. The method for preparing a Chinese medicinal preparation for treating heart blood stasis type chest stuffiness and pains according to claim 4, wherein the number of times of decoction in the first step is 2-3.
7. The method for preparing a Chinese medicinal preparation for treating heart blood stasis type chest stuffiness and pains according to claim 4, wherein the decoction time in the first step is 1-2 hours.
8. The method for preparing the traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains according to claim 4, wherein the relative density in the second step is 1.25-1.28.
9. The method for preparing the Chinese medicinal preparation for treating heart blood stasis type chest stuffiness and pains according to claim 4, wherein the temperature of the concentration in the second step is 65-75 ℃.
CN202010056275.2A 2020-01-18 2020-01-18 Traditional Chinese medicine preparation for treating heart blood stasis type chest stuffiness and pains and preparation method thereof Pending CN111202793A (en)

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CN115252739A (en) * 2022-07-11 2022-11-01 山东中医药大学附属医院 Traditional Chinese medicine composition for treating cardiovascular diseases and application thereof

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CN109464565A (en) * 2018-12-27 2019-03-15 玉林市中医医院 A kind of Chinese medicine composition and its preparation for treating chest impediment and cardialgia

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109464565A (en) * 2018-12-27 2019-03-15 玉林市中医医院 A kind of Chinese medicine composition and its preparation for treating chest impediment and cardialgia

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115252739A (en) * 2022-07-11 2022-11-01 山东中医药大学附属医院 Traditional Chinese medicine composition for treating cardiovascular diseases and application thereof

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