CN114848761A - Traditional Chinese medicine composition for treating children eczema and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating children eczema and preparation method and application thereof Download PDFInfo
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- CN114848761A CN114848761A CN202210585999.5A CN202210585999A CN114848761A CN 114848761 A CN114848761 A CN 114848761A CN 202210585999 A CN202210585999 A CN 202210585999A CN 114848761 A CN114848761 A CN 114848761A
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Abstract
The invention discloses a traditional Chinese medicine composition for treating children eczema and a preparation method and application thereof, wherein gallnut, giant knotweed, garden burnet, honeysuckle stem, purslane and raw coix seed are selected as common traditional Chinese medicinal materials, and are reasonably compatible, simple preparation processes such as acetone extraction, ethyl acetate extraction, reduced pressure drying and the like are adopted, the content of active ingredients of the obtained medicinal materials is high, the product stability and the quality are good, and the traditional Chinese medicine composition has obvious effects on repeated attack and itching symptoms of children eczema; the traditional Chinese medicine composition can well repair skin barriers, and simultaneously ensures that the irritation and the sensitization of the product are minimum. The traditional Chinese medicine composition for treating children eczema provided by the invention has common components, small side effect and good application prospect.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating children eczema and a preparation method and application thereof.
Background
Eczema is an inflammatory reaction of skin with obvious exudation tendency caused by various internal and external factors, is also a chronic skin disease named morphologically, and is characterized by diversified skin lesions, severe pruritus and easy relapse in clinic. Eczema is a common disease in pediatric clinical. According to the investigation of nearly 200 ten thousand children aged 6-7 and 13-14 in more than 100 countries in 1991-.
Clinically, eczema is generally divided into acute, subacute and chronic stages 3 according to skin lesion characteristics and disease course; eczema is classified into mild, moderate and severe according to severity, and is mainly mild to moderate. At present, first-line medicines for treating mild and moderate eczema in modern western medicine comprise topical glucocorticoid (TCS), Topical Calcineurin Inhibitor (TCI), antihistamine, immunosuppressant, biological agent and the like, which are suitable for treating severe eczema. However, TCS for long-term topical application can exhibit skin pigmentation changes, skin atrophy and telangiectasia; burning sensation, tingling sensation and aggravation of pruritus of skin can appear at the initial stage of TCI use; antihistamines may have adverse effects such as drowsiness, lethargy, etc. which limit the wide use of the drug in children.
According to the traditional Chinese medicine, eczema is considered to belong to the disease categories of eczema, infantile eczema, quadriflexure wind, immersed sore, ear sore, kidney capsule wind, nipple sore and the like, and the clinical symptoms of damp-heat invasion, spleen deficiency and damp accumulation, yin deficiency and blood dryness, wind-heat accumulation and the like are common. The Chinese patent medicine aims at the etiology treatment, has good effects in relieving the state of illness, reducing the recurrence of diseases, maintaining the stability of the state of illness, improving the quality of life and the like, and has the advantage of less adverse reactions.
In the prior art, patent document CN103417839B provides a red drug for treating wounds, burns and eczema, which is a special red drug for non-eczema, and the treatment method is only direct mixing; patent document CN101804166B discloses a traditional Chinese medicine composition for treating infantile dermatitis and eczema, but the number of the components is large, and more than 20 components are available; patent document CN106075183A discloses a pine needle compound ointment for treating eczema and a preparation method thereof, which have no efficacy verification and have unknown effect.
Therefore, the development of a Chinese patent medicine which is suitable for the infantile eczema and has definite curative effect, good safety and no dependence is urgently needed.
Disclosure of Invention
In order to solve the defects in the prior art, the invention aims to provide a traditional Chinese medicine composition for treating children eczema and a preparation method and application thereof. The traditional Chinese medicine composition for treating children eczema has a remarkable treatment effect on children eczema, does not have adverse reactions in the treatment process, is safe in components and remarkable in effect, and is worthy of clinical popularization and application.
In order to achieve the purpose, the invention adopts the following technical scheme:
a traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials in parts by weight:
in the invention, the 6 raw materials are carefully selected for compatibility, and the compatibility is mainly based on the results of the existing research on the physique of the infant with eczema, namely the lung heat yang excess quality, the damp heat quality, the phlegm dampness quality, the yin deficiency dryness-red quality and the specific endowment quality are the high-incidence physique of the eczema of children, wherein the lung heat yang excess quality, the damp heat quality and the phlegm dampness quality are the main physique types of the eczema. The traditional Chinese medicine composition is prepared according to the theory of viscera, meridians and qi and blood of the traditional Chinese medicine by a treatment method of clearing heat and removing toxicity, clearing damp and healing sores.
In the formula, the Chinese gall is mainly used for clearing damp, healing sore and stopping bleeding, and can be used as a monarch drug for treating sore, furuncle, swelling and toxin and unhealed ulcer. Hu Zhang can clear heat and remove toxicity, and can be used for treating carbuncle, swelling and sore; the garden burnet root, radix sanguisorbae and the Chinese gall are used together as ministerial drugs for cooling blood and stopping bleeding, and relieving swelling and healing sore, and the Chinese gall is used together as ministerial drugs for astringing dampness and healing sore, and has the effects of detoxifying and relieving swelling. Honeysuckle stem is sweet and cold in nature and bitter in taste, and has the effects of clearing away heat and toxic materials, dispelling wind and dredging collaterals; herba Portulacae is cold in nature and bitter in taste, has effects of clearing away heat and toxic materials, cooling blood and stopping bleeding, and can be used for treating eczema and pruritus; raw coix seed, being slightly cold, enters lung channel, is stronger than clearing heat, promoting diuresis and relieving itching, and can dispel wind and relieve itching when being externally used; the composition is used together as adjuvant drug for clearing away blood heat, removing blood toxin, expelling toxin through exterior. The six medicines are mutually assisted and used to play the roles of clearing heat and removing toxicity, eliminating dampness and healing sores.
The raw material medicines used by the invention can be purchased from common pharmaceutical shops, and the specifications of the raw material medicines accord with the national pharmaceutical standards.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
more preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
meanwhile, the invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain crude powder;
(2) extracting with acetone: extracting the crude powder of the medicinal materials obtained in the step (1) for multiple times by using acetone-water as a solvent to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extracting solution obtained in the step (2) under reduced pressure until no acetone smell exists, and adding water for dispersing to obtain suspension; extracting the suspension with ethyl acetate to obtain ethyl acetate extractive solution;
(4) drying and crushing: distilling the ethyl acetate extract obtained in the step (3) to obtain an extract; and finally, drying and crushing the extract to obtain the traditional Chinese medicine composition.
In the invention, the traditional Chinese medicine composition adopts a specific acetone extraction → concentration extraction → drying process flow, mainly because: the traditional Chinese medicine composition selected by the invention contains a large amount of tannins, the content of the monarch medicine gallnut tannins is about 60-80%, the tannins have a precipitation effect on proteins, and after a skin ulceration surface and a mucous membrane are contacted with the tannins, tissue proteins are coagulated to cause secretion and inhibit the mucous membrane from drying, so that a protective film is formed to play a role in convergence.
Preferably, in the step (1), the particle size of the crude powder of the medicinal materials is not more than 40 meshes.
Preferably, in the step (2), the mass fraction of acetone in the acetone-water is 50-70%; the extraction adopts an immersion method, and the material-liquid ratio is 1 g: 5-30 mL, the pH value of the extraction is 1.5-4.5, the extraction temperature is 40-55 ℃, and the extraction time is 5-20 min. The extraction solvent is 50-70% of aqueous acetone (under an acidic condition), has the strongest dissolving capacity on tannin, can open a connecting chain of the tannin and protein in the tissues of the traditional Chinese medicine, improves the extraction rate of the tannin, has lower boiling point of the acetone, and is easy to recover and obtain aqueous solution of the tannin; and cold extraction by adopting an immersion method can avoid the damage of the tannin, and is convenient for keeping the dissociation state of the gallnut tannin under the low-temperature condition so as to improve the extraction efficiency.
Preferably, in the step (3), the temperature of the reduced pressure concentration is 70-80 ℃, the vacuum degree is-0.06 MPa-0.08 MPa, and the concentration specific gravity is 1.1-1.2 (70-80 ℃).
In the step (3), fat-soluble impurities can be fully removed by adopting ethyl acetate for extraction, purer tannin is obtained, and the extraction efficiency is further improved.
It is understood that the extraction of the suspension by ethyl acetate in the step (3) is a common process, and the amount of ethyl acetate is not specifically limited in the present invention, so as to achieve sufficient removal of the fat-soluble impurities. For example, the volume ratio of ethyl acetate to suspension may be 1: 1. 2: 1. 3: 1. 4: 1. 5: 1. 6: 1. 7: 1. 8: 1. 9: 1. 10: 1. 11: 1. 12: 1. 13: 1 or 0.5-50: 1, or a salt thereof.
Meanwhile, the invention also provides application of the traditional Chinese medicine composition in preparing an external preparation for treating the infantile eczema. It can be understood that the traditional Chinese medicine composition provided by the invention is powder, and is prepared by using pharmaceutically acceptable auxiliary materials for treating children eczema, the pharmaceutically acceptable auxiliary materials are not particularly required to be used, and the traditional Chinese medicine composition can be prepared into an external preparation, which is a conventional technical means of a person skilled in the art, and the traditional Chinese medicine composition is not particularly limited in the invention.
The external preparation comprises one or more of gel, ointment, cream, liniment, lotion, spray and powder. When the traditional Chinese medicine composition powder is prepared into ointment, the traditional Chinese medicine composition powder is added into the oleaginous base and stirred uniformly.
Preferably, the oleaginous base may be one or more selected from liquid paraffin, silicone oil, vaseline, cetyl alcohol, stearyl alcohol, vegetable oil, lanolin, beeswax, spermaceti wax, glyceryl stearate, glyceryl laurate, polyglycerol fatty acid ester and medium chain triglyceride. Preferably, the oleaginous base is one or more of liquid paraffin, vaseline or lanolin.
Compared with the prior art, the invention has the following beneficial effects:
1. according to the traditional Chinese medicine composition provided by the invention, six traditional Chinese medicines of gallnut, giant knotweed rhizome, garden burnet root, purslane, honeysuckle stem and raw coix seed are selected for compatibility, the components are simple, the product is stable, and the treatment effect of the children eczema is obvious.
2. In the traditional Chinese medicine composition provided by the invention, molecules of tannic acid extracted from the monarch medicine gallnut contain a plurality of phenolic hydroxyl groups, and the tannic acid is easily oxidized and becomes black oxide; in the formula, the giant knotweed and the garden burnet can be used as ministerial drugs to achieve the effects of clearing heat and toxic materials, clearing dampness and healing sores, have strong antioxidation, and have the effect of clearing DPPH more than 80%, so that the quality and the stability of the traditional Chinese medicine composition can be greatly improved.
3. The traditional Chinese medicine composition has the effects of clearing heat, removing toxicity, eliminating dampness and healing sores by matching the medicines together, is particularly suitable for subacute and chronic eczema caused by wind-damp heat evil of children, and achieves the effect of treating both symptoms and root causes. Clinical curative effect researches prove that the traditional Chinese medicine composition has exact, reliable and real curative effect on the infantile eczema and has good curative effect on mild, moderate and even severe infantile eczema.
4. The traditional Chinese medicine composition is non-toxic, harmless, safe and reliable, has no adverse reaction after being used, and is safe for clinical use.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. Of course, the specific embodiments described herein are merely illustrative of the invention and are not intended to be limiting.
Although the steps in the present invention are arranged by using reference numbers, the order of the steps is not limited, and the relative order of the steps can be adjusted unless the order of the steps is explicitly stated or other steps are required for the execution of a certain step. It is to be understood that the term "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.
Unless otherwise specified, the raw materials of the present invention are all purchased from the market.
Example 1
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
the embodiment also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain 40 mesh coarse powder;
(2) extracting with acetone: according to the weight ratio of 1 g: extracting the coarse powder of the medicinal materials obtained in the step (1) for 10min at the pH of 3 and the temperature of 50 ℃ by using acetone-water with the weight percent of 60 percent as a solvent according to the material-liquid ratio of 20mL, and repeating the extraction twice to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extract obtained in step (2) at 75 deg.C under vacuum degree of-0.07 MPa under reduced pressure until no acetone smell is produced (concentration specific gravity of 1.15), adding appropriate amount of water to disperse to obtain suspension, and extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) drying and crushing: and (4) distilling the ethyl acetate extract obtained in the step (3) to recover the ethyl acetate solvent, drying the residual extract, and then crushing to obtain the traditional Chinese medicine composition powder.
In this embodiment, a method for preparing the above-mentioned Chinese medicinal composition into an ointment is also provided, which includes the following steps: heating and mixing 120g of lanolin, 775g of vaseline and 40g of glycerol, stirring uniformly, and cooling for later use; under the condition of homogenization, 65g of the Chinese medicinal composition powder is slowly added, and the paste is formed by cooling while stirring, so that 1000g of ointment is prepared.
Example 2
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
the present invention further provides a preparation method of the above traditional Chinese medicine composition, including the following steps:
(1) crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain 40 mesh coarse powder;
(2) extracting with acetone: according to the weight ratio of 1 g: extracting the coarse powder of the medicinal materials obtained in the step (1) for 5min at the pH of 3.5 and the temperature of 55 ℃ by taking 65 wt% of acetone-water as a solvent according to a material-to-liquid ratio of 25mL, and repeating the extraction twice to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extract obtained in step (2) at 80 deg.C under vacuum degree of-0.06 MPa under reduced pressure until no acetone smell is produced (concentration specific gravity of 1.2), adding appropriate amount of water to disperse to obtain suspension, and extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) drying and crushing: and (4) distilling the ethyl acetate extract obtained in the step (3) to recover the ethyl acetate solvent, drying the residual extract, and then crushing to obtain the traditional Chinese medicine composition powder.
In this embodiment, a method for preparing the above-mentioned Chinese medicinal composition into an ointment is also provided, which includes the following steps: heating and mixing 120g of lanolin, 775g of vaseline and 40g of glycerol, stirring uniformly, and cooling for later use; under the condition of homogenization, 65g of the Chinese medicinal composition powder is slowly added, and the paste is formed by cooling while stirring, so that 1000g of ointment is prepared.
Example 3
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
the embodiment also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain 40 mesh coarse powder;
(2) extracting with acetone: according to the weight ratio of 1 g: extracting the coarse powder of the medicinal materials obtained in the step (1) for 15min at the pH of 3 and the temperature of 50 ℃ by using acetone-water with the weight percent of 60 percent as a solvent according to the material-liquid ratio of 20mL, and repeating twice to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extractive solution obtained in step (2) at 75 deg.C under vacuum degree of-0.07 MPa under reduced pressure until no acetone smell is detected (concentration specific gravity is 1.15), adding appropriate amount of water to disperse to obtain suspension, and extracting the suspension with ethyl acetate to obtain ethyl acetate extractive solution;
(4) drying and crushing: and (4) distilling the ethyl acetate extract obtained in the step (3) to recover the ethyl acetate solvent, drying the residual extract, and then crushing to obtain the traditional Chinese medicine composition powder.
In this embodiment, a method for preparing the above-mentioned Chinese medicinal composition into an ointment is also provided, which includes the following steps: heating and mixing 120g of lanolin, 775g of vaseline and 40g of glycerol, stirring uniformly, and cooling for later use; under the condition of homogenization, 65g of the Chinese medicinal composition powder is slowly added, and the paste is formed by cooling while stirring, so that 1000g of ointment is prepared.
Comparative example 1
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
in the comparative example, a preparation method of the traditional Chinese medicine composition is also provided, and the preparation method comprises the following steps:
(1) crushing medicinal materials: weighing gallnut, giant knotweed, honeysuckle stem, purslane and raw coix seed, mixing, crushing and sieving to prepare 40-mesh medicinal coarse powder;
(2) extracting with acetone: according to the weight ratio of 1 g: extracting the coarse powder of the medicinal materials obtained in the step (1) for 10min at the pH of 3 and the temperature of 50 ℃ by using acetone-water with the weight percent of 60 percent as a solvent according to the material-liquid ratio of 20mL, and repeating the extraction twice to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extract obtained in step (2) at 75 deg.C under vacuum degree of-0.07 MPa under reduced pressure until no acetone smell is produced (concentration specific gravity of 1.15), adding appropriate amount of water to disperse to obtain suspension, and extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) drying and crushing: and (4) distilling the ethyl acetate extract obtained in the step (3) to recover the ethyl acetate solvent, drying the residual extract, and then crushing to obtain the traditional Chinese medicine composition powder.
In the comparative example, a method for preparing the traditional Chinese medicine composition into ointment is also provided, and the method comprises the following steps: heating and mixing 120g of lanolin, 775g of vaseline and 40g of glycerol, stirring uniformly, and cooling for later use; under the condition of homogenization, 65g of the Chinese medicinal composition powder is slowly added, and the paste is formed by cooling while stirring, so that 1000g of ointment is prepared.
Comparative example 2
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
the comparative example also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) crushing medicinal materials: weighing gallnut, garden burnet, honeysuckle stem, purslane and raw coix seed, mixing, crushing and sieving to prepare 40-mesh medicinal coarse powder;
(2) extracting with acetone: according to the weight ratio of 1 g: extracting the coarse powder of the medicinal materials obtained in the step (1) for 10min at the pH of 3 and the temperature of 50 ℃ by using acetone-water with the weight percent of 60 percent as a solvent according to the material-liquid ratio of 20mL, and repeating the extraction twice to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extract obtained in step (2) at 75 deg.C under vacuum degree of-0.07 MPa under reduced pressure until no acetone smell is produced (concentration specific gravity of 1.15), adding appropriate amount of water to disperse to obtain suspension, and extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) drying and crushing: and (4) distilling the ethyl acetate extract obtained in the step (3) to recover the solvent ethyl acetate, drying the residual extract, and then crushing to obtain the traditional Chinese medicine composition powder.
In the comparative example, a method for preparing the traditional Chinese medicine composition into ointment is also provided, and the method comprises the following steps: heating and mixing 120g of lanolin, 775g of vaseline and 40g of glycerol, stirring uniformly, and cooling for later use; under the condition of homogenization, 65g of the Chinese medicinal composition powder is slowly added, and the paste is formed by cooling while stirring, so that 1000g of ointment is prepared.
Comparative example 3
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
the comparative example also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain 40 mesh coarse powder;
(2) extracting with acetone: according to the weight ratio of 1 g: extracting the coarse powder of the medicinal materials obtained in the step (1) for 10min at the pH of 3 and the temperature of 70 ℃ by using 40 wt% of acetone-water as a solvent according to a material-liquid ratio of 20mL, and repeating the extraction twice to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extract obtained in step (2) at 75 deg.C under vacuum degree of-0.07 MPa under reduced pressure until no acetone smell is produced (concentration specific gravity of 1.15), adding appropriate amount of water to disperse to obtain suspension, and extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) drying and crushing: and (4) distilling the ethyl acetate extract obtained in the step (3) to recover the ethyl acetate solvent, drying the residual extract, and then crushing to obtain the traditional Chinese medicine composition powder.
Comparative example 4
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
the comparative example also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain 40 mesh coarse powder;
(2) extracting with acetone: according to the weight ratio of 1 g: extracting the coarse powder of the medicinal materials obtained in the step (1) for 10min at the pH of 3 and the temperature of 50 ℃ by taking pure water as a solvent according to a material-liquid ratio of 20mL, and repeating twice to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extract obtained in step (2) at 75 deg.C under reduced pressure to specific gravity of 1.15 under vacuum degree of-0.07 MPa, adding appropriate amount of water to disperse to obtain suspension, and extracting with ethyl acetate to obtain ethyl acetate extract;
(4) drying and crushing: and (4) distilling the ethyl acetate extract obtained in the step (3) to recover the ethyl acetate solvent, drying the residual extract, and then crushing to obtain the traditional Chinese medicine composition powder.
First, the effect of different extraction processes on the product quality was examined, specifically for comparative example 1 and comparative examples 3 and 4. The quality of the powder of the Chinese medicinal composition prepared in the above examples and comparative examples was measured, and the measurement results are shown in Table 1.
TABLE 1 Effect of different extraction procedures on the powder extraction of a Chinese medicinal composition
| Sample (I) | Weight of Chinese medicinal composition powder (g) |
| Example 1 | 170.4 |
| Comparative example 3 | 146.4 |
| Comparative example 4 | 122.8 |
As can be seen from Table 1, the content of the effective components obtained by extraction in example 1 is higher, thus demonstrating that the aqueous solution of acetone has a strong capacity of dissolving tannin, can break the bonds of tannin-protein in the plant body, and allows a large amount of tannin to be leached out, and acetone is easy to recover, is a good solvent, and can prevent tannin from being oxidized. In a word, experiments prove that the 60 percent acetone acid low-temperature extraction rate is the highest, so that the yield and the product quality can be further improved, and the extraction yield of the traditional Chinese medicine raw materials and the content of the effective component tannic acid are greatly improved.
Then, the performance of the products of the examples 1 to 2 and the comparative examples 1 to 2 is tested, and the following specific steps are carried out:
(1) stability test
The test method comprises the following steps: the ointments prepared in examples 1-2 and comparative examples 1-2 were allowed to stand at 30. + -.2 ℃ and 65. + -. 5% relative humidity for 6 months, and samples were sampled at 0, 3 and 6 months to examine appearance, particle size and gallic acid content per 1g, and the results are shown in Table 2.
The particle size determination method comprises the following steps: a proper amount of a test article is taken and placed on a glass slide to be coated into a thin layer, the area of the thin layer is equivalent to that of a cover glass, 3 pieces of the test article are coated in total, and particles with the size of more than 180 mu m cannot be detected according to a particle size and particle size distribution determination method (0982 first method of the four general rules of the 2020 edition of Chinese pharmacopoeia).
The determination method of the content of the gallic acid comprises the following steps: the measurement is carried out by high performance liquid chromatography (four general regulations 0521 in 2020 edition of Chinese pharmacopoeia).
Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; methanol-0.1% phosphoric acid solution (10: 90) is used as a mobile phase; the detection wavelength was 273 nm. The number of theoretical plates is not less than 3000 calculated according to gallic acid peak.
Preparation of control solutions: taking appropriate amount of gallic acid as reference, precisely weighing, and adding mobile phase to obtain solution containing 4 μ g per 1 ml.
Preparation of a test solution: taking about 0.25g of the product, precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of 4mol/L hydrochloric acid solution, weighing, heating and refluxing, keeping boiling for 1.5 hours, cooling, weighing again, supplementing the lost weight with 4mol/L hydrochloric acid solution, shaking up, placing in a refrigerator at (-10 ℃) for 20 minutes, taking out, filtering, placing to room temperature, precisely weighing 2ml of subsequent filtrate, placing in a 10ml measuring flask, diluting to scale with a mobile phase, shaking up, filtering, and taking the subsequent filtrate to obtain the product.
The determination method comprises the following steps: precisely sucking 20 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and measuring.
TABLE 2 ointment stability test results
And (4) analyzing results: the stability test shows that: the ointment prepared by the embodiment of the invention can keep good uniformity and granularity after being placed for 6 months under an accelerated condition, the content of active ingredients is stable, and the oxidative deterioration of the product is avoided, so that the ointment prepared by the invention has excellent long-term placing stability and is suitable for large-scale production and application; after the cream prepared by the comparative example is subjected to an accelerated test, the content of active ingredients is greatly reduced, the appearance of the product is deepened, and the product is easy to oxidize and deteriorate after being placed for a long time, so that the drug effect of the product is reduced.
(2) Clinical trial test
The test method comprises the following steps:
1) selection of a sample: clinically, 50 cases of infantile eczema patients are selected, wherein 20 cases of subacute infantile eczema and 30 cases of chronic infantile eczema are selected.
2) Criteria for sample selection:
firstly, referring to the Chinese medicine industry standard of the people's republic of China, namely the diagnosis and treatment effect standard of traditional Chinese medicine diseases, the Chinese medicine composition accords with the syndrome differentiation standard of the invasion of damp-heat;
age: infant or childhood patients, age 1-11 years, with unlimited sex;
and that no corticosteroids or other immunosuppressive and immunomodulatory agents have been systemically administered in the last two months.
3) Dosing regimens
After cleaning the skin every day, the skin of the affected part of eczema was applied with an appropriate amount of the ointment prepared in example 1 once in the morning and once in the evening. Observations were made and counted for 14 days, 21 days, and 28 days.
4) Criteria for efficacy assessment
According to the clinical guideline of new Chinese medicine, the degree of pruritus, onset time, skin lesion area, tongue condition, pulse condition, related symptoms and physical symptoms are observed, the scores are given according to the asymptomatic, light, medium and heavy degrees, 1 observation record is carried out before treatment, 14 days, 21 days and 28 days after treatment, and the following treatment effect judgment standard is formulated:
the effect is shown: the traditional Chinese medicine symptoms are obviously relieved, and the syndrome integral is reduced by more than or equal to 70 percent compared with that before treatment.
The method has the following advantages: the traditional Chinese medicine symptoms are relieved, and the syndrome integral is reduced by more than or equal to 30 percent compared with that before treatment.
And (4) invalidation: the symptoms of the traditional Chinese medicine are not obviously improved or even aggravated, and the syndrome integral is reduced.
The therapeutic effect is shown in table 3.
TABLE 3 clinical trial treatment results
And (4) analyzing results: the trial curative effect observation result shows that the ointment has quick response, the effective rate can reach 74 percent in 14 days, 92 percent in 21 days and 98 percent in 1 month, and no allergy or discomfort. The medicine composition has obvious curative effect after being externally used for treating the children eczema for one month, the effective rate is up to 98 percent, the life quality of the children is greatly improved, no adverse reaction is generated in the treatment process, and the medicine composition is worthy of clinical popularization and application.
Claims (9)
1. The traditional Chinese medicine composition for treating children eczema is characterized by being prepared from the following raw materials in parts by weight:
2. the traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight:
3. the traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight:
4. the traditional Chinese medicine composition according to claim 3, which is prepared from the following raw materials in parts by weight:
5. a method for preparing the traditional Chinese medicine composition of any one of claims 1 to 4, which is characterized by comprising the following steps:
(1) crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain crude powder;
(2) extracting with acetone: extracting the crude powder of the medicinal materials obtained in the step (1) for multiple times by using acetone-water as a solvent to obtain an extracting solution;
(3) and (3) concentrating and extracting under reduced pressure: concentrating the extracting solution obtained in the step (2) under reduced pressure until no acetone smell exists, and adding water for dispersing to obtain suspension; extracting the suspension with ethyl acetate to obtain ethyl acetate extractive solution;
(4) drying and crushing: distilling the ethyl acetate extract obtained in the step (3) to obtain an extract; and finally, drying and crushing the extract to obtain the traditional Chinese medicine composition.
6. The preparation method according to claim 5, wherein in the step (1), the particle size of the crude drug powder is not more than 40 meshes.
7. The preparation method according to claim 6, wherein in the step (2), the mass fraction of acetone in the acetone-water is 50-70%; the extraction adopts an immersion method, and the material-liquid ratio is 1 g: 5-30 mL, the pH value of the extraction is 1.5-4.5, the extraction temperature is 40-55 ℃, and the extraction time is 5-20 min.
8. The process according to claim 7, wherein in the step (3), the temperature of the concentration under reduced pressure is 70 to 80 ℃ and the degree of vacuum is-0.06 MPa to-0.08 MPa.
9. Use of the Chinese medicinal composition of any one of claims 1 to 4 in the preparation of an external preparation for treating infantile eczema.
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| CN103417839A (en) * | 2012-05-16 | 2013-12-04 | 徐生明 | Hongyao for treatment of wounds, burns and eczema |
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| CN103417839A (en) * | 2012-05-16 | 2013-12-04 | 徐生明 | Hongyao for treatment of wounds, burns and eczema |
Non-Patent Citations (3)
| Title |
|---|
| 刘少芬 等: "马齿苋外洗方治疗湿热型湿疹的临床疗效研究", 《河北中医药学报》, vol. 32, no. 1, pages 23 * |
| 江凯 等: "五倍子单宁的超声提取工艺优化", 《食品与发酵工业》, vol. 36, no. 11, pages 1 - 2 * |
| 王野樵；等: "五倍子外用治疗小儿汗症和湿疹", 《中医杂志》, vol. 39, no. 2, pages 1 - 2 * |
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