American ginseng and clove granules and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to American ginseng and clove granules and a preparation method thereof. The active ingredients comprise the following raw materials in parts by weight: 20 parts of American ginseng, 60 parts of clove, 90 parts of zaocys dhumnade, 60 parts of smoked plum, 60 parts of liquorice, 60 parts of radix angelicae, 60 parts of agastache rugosus, 40 parts of myristica fragrans and 60 parts of gastrodia elata; the auxiliary materials comprise 80 parts of honey and one or more of starch, dextrin and lactose; according to the invention, on the basis of the core pathogenesis of qi deficiency, yin deficiency and meridian stasis, the American ginseng is used as a monarch drug for tonifying qi and nourishing yin, and the root of qi deficiency and weakness after stroke is solved; clove, wrinkled gianthyssop herb and myristica fragrans have the effects of warming spleen and stomach for dispelling cold and breaking meridian dampness The zaocys dhumnades, the gastrodia elata and the radix angelicae dahuricae dispel wind, dredge collaterals, search and remove tendons and vessels, directly strike hand and foot numbness and hemiplegia; the traditional Chinese medicine composition has the effects of strengthening the body resistance without leaving evil and eliminating evil without hurting the body resistance, and can effectively improve the symptoms of numbness of limbs, unfavorable movement, pain in waist and legs and the like.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine preparation, in particular to a Panax quinquefolium clove granule and a preparation method thereof. BACKGROUND

[0002] Hemiplegia, facial asymmetry, numbness of hands and feet, and lumbar and leg pain are often secondary to stroke sequelae or caused by wind-cold-damp evil blocking meridians, blood circulation, liver and kidney deficiency, and are common and refractory diseases in clinical practice. Such diseases not only lead to limb dysfunction, such as hand numbness and inability to hold objects, lower extremity weakness and difficulty walking, which seriously affect the ability of daily life, but also easily cause psychological problems such as anxiety and depression, which brings heavy burden to the patient's family and society. At present, the clinical treatment mostly adopts symptomatic support therapy, such as western medicine to nourish nerves and analgesic drugs to relieve symptoms, but long-term use can easily produce side effects such as gastrointestinal irritation and drug resistance, and cannot fundamentally improve the pathogenesis of meridian obstruction and blood deficiency; traditional Chinese medicine treatment emphasizes syndrome differentiation and treatment, but the existing preparations have the problem of insufficient targeting - either emphasizing blood-activating and meridian-unblocking while ignoring tonifying and consolidating the body, leading to repeated efficacy, or the dosage form is a decoction, which is inconvenient to take, especially not suitable for patients with limited limb movement and poor swallowing function, and it is difficult to meet the clinical demand for "treating both the root and the branch and convenient to take" preparations.

[0003] According to traditional Chinese medicine theory, the core pathogenesis of hemiplegia, numbness of hands and feet, and other diseases is "root deficiency and branch excess", the root is qi deficiency and yin deficiency, liver and kidney deficiency, and the branch is wind-phlegm and blood stasis, and meridian obstruction. Panax quinquefolium can tonify qi and nourish yin, and consolidate the body, clove can warm the middle and dispel cold, and unblock meridians and relieve pain, and black turtle and snake can dispel wind and unblock meridians, and search for tendons and vessels, and the three can be combined to "tonify and expel evil, unblock meridians and relieve obstruction", and then assisted by plum to astringe yin and generate fluid, and licorice to harmonize various drugs, forming a complete compatibility system for the disease and pathogenesis. However, in the prior art, there is no related report on scientifically compounding the above-mentioned medicinal materials into granules, and the traditional decoction has the problems of inconvenient taking, difficult dosage control, and poor stability of active ingredients, while granules have the advantages of rapid absorption, convenient taking, and easy storage, etc. Therefore, a Panax quinquefolium clove granule and a preparation method thereof are proposed. SUMMARY

[0004] Therefore, the present application provides a Panax quinquefolium clove granule and a preparation method thereof to solve or alleviate the technical problems in the prior art, and at least provide a beneficial choice.

[0005] The technical scheme of the present application is implemented as follows: a ginseng clove granule is composed of active ingredient raw materials and auxiliary materials; the active ingredient raw materials are proportioned by weight as follows: 20 parts of ginseng, 60 parts of clove, 90 parts of black snake, 60 parts of Chinese plum, 60 parts of liquorice, 60 parts of white peony root, 60 parts of agastache, 40 parts of mace, and 60 parts of Gastrodia elata; the auxiliary materials include 80 parts of honey and one or more of starch, dextrin, and lactose, and the total amount of the auxiliary materials is 10-30% of the total weight of the active ingredient raw materials.

[0006] A preparation method of a ginseng clove granule, comprising the following steps:

[0007] Step one, preparation of medicinal materials: select genuine medicinal materials, remove impurities and moldy parts;

[0008] Step two, treatment of medicinal materials: clean the medicinal materials and then dry them in the shade, crush the black snake, Gastrodia elata, white peony root, and mace into 20-40 mesh coarse powder, and keep the rest of the medicinal materials intact;

[0009] Step three, extraction of effective components: decoct and extract ginseng, clove, Chinese plum, liquorice, agastache, and Gastrodia elata and white peony root coarse powder with water for 2-3 times, and combine the water-soluble extract; extract the black snake and mace coarse powder with 70-80% ethanol by reflux for 2 times, and combine the fat-soluble extract; mix the two kinds of extracts;

[0010] Step four, filtration, concentration, and purification: sequentially filter the extract, concentrate under reduced pressure, then add ethanol for alcohol precipitation, concentrate the supernatant to remove the alcohol taste, and obtain a purified concentrated paste;

[0011] Step five, addition of auxiliary materials: add melted honey and other auxiliary materials to the purified concentrated paste, and mix to form a soft material;

[0012] Step six, granulation, drying, and packaging: place the soft material in a fluidized bed device, and simultaneously perform hot air drying and granulation, check the quality of the granulated material, and package it according to a dosage of 8 grams each time.

[0013] Further preferably, in the water-soluble component extraction in step three, the amount of water added is 8-10 times the total weight of the medicinal materials, and the extraction is performed under micro-boiling for 2 hours the first time and 1-1.5 hours for subsequent times; in the fat-soluble component extraction, the amount of ethanol added is 6-8 times the total weight of the medicinal materials, and the extraction is performed by reflux for 1-1.5 hours each time.

[0014] Further preferably, in step four, the reduced pressure concentration is performed at a vacuum degree of -0.08 to -0.09 MPa and a temperature of 60-70°C, and the relative density of the concentrated liquid reaches 1.20-1.25 (hot measurement at 60°C); in the alcohol precipitation, ethanol is added to make the alcohol content of the solution reach 60%, and the solution is left to stand for 24 hours.

[0015] Further preferably, in the step six, the fluidized bed equipment parameters are: inlet air temperature 60-70 DEG C, outlet air temperature 40-50 DEG C, atomization pressure 0.25-0.3 MPa, and the granulation is performed through 10-20 mesh screen.

[0016] The embodiment of the present application has the following advantages due to the adoption of the above technical solutions:

[0017] Firstly, the present application focuses on the core pathogenesis of "qi deficiency and yin depletion, meridian obstruction", uses American ginseng as the monarch drug to tonify qi and nourish yin, solves the root of post-stroke qi deficiency and weakness; uses clove, agastache, nutmeg to warm the middle and dispel cold, breaks the stagnation of meridian dampness; uses black-brown snake, gastrodia, white pyrethrum to dispel wind and dredge collaterals, directly attacks the symptoms of hand and foot numbness and hemiplegia; uses Fructus Mume to astringe yin and generate fluid, uses licorice to harmonize all drugs, the whole prescription "supports the healthy qi and expels the pathogenic factors without damaging the healthy qi", can effectively improve the symptoms of limb numbness, difficulty in movement, waist and leg pain, etc.

[0018] Secondly, the present application uses "water decoction + ethanol" classification extraction according to the different properties of the active ingredients of black-brown snake (such as protein, polypeptide) and saponins of American ginseng, ensures that the water-soluble and fat-soluble effective components are fully dissolved, especially the extraction rate of the anti-rheumatism and meridian-dredging active ingredients in black-brown snake is increased by more than 40%; the subsequent alcohol precipitation purification step removes polysaccharides and other invalid impurities, so that the effective components are more concentrated, and after taking, they can quickly act on the diseased meridians through blood circulation, accelerate the relief of limb numbness and pain relief.

[0019] The above summary is merely intended to illustrate the present application and is not intended to limit in any way. Further aspects, embodiments and features of the present application will be readily apparent from the following detailed description, taken in conjunction with the accompanying drawings and the following detailed description. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, brief introductions to the drawings needed in the embodiments or prior art descriptions will be given in the following. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort on the basis of these drawings.

[0021] Figure 1 The flow chart of the method of the present application. DETAILED DESCRIPTION

[0022] In the following, only some exemplary embodiments are simply described. As those skilled in the art can recognize, the described embodiments can be modified in various different ways without departing from the spirit or scope of the present application. Therefore, the drawings and the description are considered to be exemplary in nature rather than limiting.

[0023] The embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0024] As shown in the formula (I), the present application provides a ginseng clove granule, which is composed of active ingredient raw materials and excipients; the active ingredient raw materials are proportioned by weight as follows: 20 parts of ginseng, 60 parts of clove, 90 parts of black snake, 60 parts of Fructus Mume, 60 parts of licorice, 60 parts of radix angelicae dahuricae, 60 parts of agastache, 40 parts of myristica, and 60 parts of Gastrodia elata Blume; the excipients include 80 parts of honey, and one or more of starch, dextrin, and lactose, and the total amount of the excipients is 10% to 30% of the total weight of the active ingredient raw materials. Figure 1

[0025] A preparation method of a ginseng clove granule, which comprises the following steps:

[0026] Step one, preparation of medicinal materials: select genuine medicinal materials, remove impurities and moldy parts;

[0027] Step two, treatment of medicinal materials: clean the medicinal materials and dry them in the shade, crush the black snake, Gastrodia elata Blume, radix angelicae dahuricae, and myristica into 20-40 mesh coarse powder, and keep the rest of the medicinal materials intact;

[0028] Step three, extraction of active ingredients: decoct and extract ginseng, clove, Fructus Mume, licorice, and agastache, and the coarse powder of Gastrodia elata Blume and radix angelicae dahuricae 2-3 times with water, and combine the water-soluble extract; extract the coarse powder of black snake and myristica 2 times with 70%-80% ethanol by reflux, combine the lipid-soluble extract, and mix the two kinds of extracts;

[0029] Step four, filtration, concentration, and purification: sequentially filter the extract by coarse filtration and fine filtration, add ethanol after concentration under reduced pressure, and take the supernatant to concentrate to no alcohol taste, to obtain a purified concentrated paste;

[0030] Step five, addition of excipients: add melted honey and other excipients to the purified concentrated paste, and mix to form a soft material;

[0031] Step six, granulation, drying, and packaging: place the soft material in a fluidized bed device, and simultaneously perform hot air drying and granulation, and after the granulation, perform quality inspection, and package according to a dosage of 8 grams each time.

[0032] In one embodiment, in the step three, when the water-soluble ingredients are extracted, the amount of water added is 8-10 times the total weight of the medicinal materials, and the extraction is performed under micro-boiling for 2 hours the first time and 1-1.5 hours the following times; when the lipid-soluble ingredients are extracted, the amount of ethanol used is 6-8 times the total weight of the medicinal materials, and the extraction is performed by reflux for 1-1.5 hours each time.

[0033] ​In one embodiment, the reduced pressure concentration condition in the fourth step is a vacuum degree of -0.08 to -0.09 MPa, a temperature of 60-70°C, and the relative density of the concentrated solution reaches 1.20-1.25 (60°C hot measurement); the alcohol content of the solution reaches 60% when ethanol is added during alcohol precipitation, and the solution is left to stand for 24 hours.

[0034] In one embodiment, the fluidized bed equipment parameters in the sixth step are an inlet air temperature of 60-70°C, an outlet air temperature of 40-50°C, and an atomization pressure of 0.25-0.3 MPa, and the granules are sieved through a 10-20 mesh sieve after granulation.

[0035] The above is only a specific embodiment of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art can easily think of various changes or replacements within the technical range disclosed by the present application, which should be encompassed in the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A ginseng clove granule, characterized by: It is composed of active ingredient raw materials and adjuvants; the active ingredient raw materials are proportioned by weight parts as follows: American ginseng 20 parts, clove 60 parts, black snake 90 parts, dark plum 60 parts, liquorice 60 parts, white peony 60 parts, agastache 60 parts, mace 40 parts, and Gastrodia 60 parts; the adjuvants include honey 80 parts, and one or more of starch, dextrin, and lactose, and the total amount of the adjuvants is 10% to 30% of the total weight of the active ingredient raw materials.

2. A method for preparing the ginseng clove granules according to any one of claims 1, characterized in that: It comprises the following steps: Step one, preparation of medicinal materials: select genuine medicinal materials, remove impurities and moldy parts; Step two, treatment of medicinal materials: clean the medicinal materials and dry them in the shade, crush the black snake, Gastrodia, white peony, and mace into 20-40 mesh coarse powder, and keep the rest of the medicinal materials intact; Step three, extraction of effective components: decoct and extract American ginseng, clove, dark plum, liquorice, agastache, Gastrodia, and white peony coarse powder 2-3 times with water, and combine the water-soluble extract; extract the black snake and mace coarse powder 2 times with 70%-80% ethanol by reflux, combine the lipid-soluble extract, and mix the two kinds of extracts; Step four, filtration, concentration, and purification: sequentially filter the extract, concentrate under reduced pressure, add ethanol for alcohol precipitation, concentrate the supernatant to remove the alcohol taste, and obtain the purified concentrated paste; Step five, addition of adjuvants: add melted honey and other adjuvants to the purified concentrated paste, mix to form soft material; Step six, granulation, drying, and packaging: place the soft material in a fluidized bed device, simultaneously perform hot air drying and granulation, check the quality after granulation, and package according to the dosage of 8 grams each time.

3. The preparation method of the American ginseng clove granules according to claim 2, characterized in that: In the step three, when extracting the water-soluble components, add water to 8-10 times the total weight of the medicinal materials, extract under micro-boiling, extract for 2 hours the first time, and extract for 1-1.5 hours subsequently; when extracting the lipid-soluble components, add ethanol to 6-8 times the total weight of the medicinal materials, and extract by reflux for 1-1.5 hours each time.

4. The American ginseng clove granules and their preparation method according to claim 2, characterized in that: In the step four, the reduced pressure concentration conditions are vacuum degree-0.08 to-0.09 MPa and temperature 60-70℃, and the relative density of the concentrated solution reaches 1.20-1.25 (hot measurement at 60℃); when alcohol precipitation, add ethanol to make the alcohol content of the solution reach 60%, and stand for 24 hours.

5. The American ginseng clove granules and their preparation method according to claim 2, characterized in that: In the step six, the parameters of the fluidized bed device are inlet air temperature 60-70℃, outlet air temperature 40-50℃, and atomization pressure 0.25-0.3 MPa, and the granulation is performed through a 10-20 mesh screen.

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