CN114848761B - 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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- CN114848761B CN114848761B CN202210585999.5A CN202210585999A CN114848761B CN 114848761 B CN114848761 B CN 114848761B CN 202210585999 A CN202210585999 A CN 202210585999A CN 114848761 B CN114848761 B CN 114848761B
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- chinese medicine
- traditional chinese
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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 the traditional Chinese medicine composition is prepared from Chinese gall, giant knotweed rhizome, garden burnet root, honeysuckle stem, purslane and raw coix seed, and the traditional Chinese medicine composition is reasonably compatible, and simple preparation processes of acetone extraction, ethyl acetate extraction, decompression drying and the like are adopted, so that the obtained medicinal material has high active ingredient content, good product stability and quality, and has remarkable effects on repeated attacks and pruritus symptoms of children eczema; the traditional Chinese medicine composition can well repair skin barriers, and meanwhile ensures that the irritation and sensitization of the product are minimum. The traditional Chinese medicine composition for treating the children eczema provided by the invention has common components, small side effects 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 a skin inflammatory reaction with obvious exudation tendency caused by various internal and external factors, is also a type of chronic skin disease named by morphology, and is clinically characterized by various skin lesions, severe itching and easy recurrence. Eczema is now a common disease in the pediatric clinic. According to the investigation of nearly 200 ten thousand children aged 6-7 and 13-14 in more than 100 countries in 1991-2012, the overall prevalence of eczema is about 20%, and the recent prevalence has a tendency of increasing year by year, so that great inconvenience is caused to life and study of children.
Clinically, eczema is generally classified into acute, subacute and chronic 3 phases according to skin damage characteristics and disease course; eczema is classified as mild, moderate, severe according to severity, mostly in light to moderate. The first-line medicine for treating the light eczema and the moderate eczema by modern western medicine comprises external glucocorticoid (TCS), external calcineurin inhibitor (TCI) and antihistamine, and immunosuppressant, biological agent and the like, which are suitable for treating the severe eczema. However, long-term external TCS can exhibit skin pigmentation changes, skin atrophy and telangiectasia; the TCI can cause burning sensation, tingling sensation and itching aggravation of skin at the initial use stage; antihistamines can have drowsiness, somnolence, etc. adverse effects that limit the widespread use of the drug in children.
The traditional Chinese medicine considers that eczema belongs to the categories of dampness sores, tinea, four-bend wind, and symptoms such as maceration sores, spiracles, kidney capsule wind, nipple sores, and the like, and clinically, dampness-heat maceration, spleen deficiency dampness accumulation, yin deficiency and blood dryness, wind-heat accumulation and skin accumulation are common. The Chinese patent medicine aims at etiology treatment, has good effects in relieving illness state, reducing disease recurrence, maintaining illness state stability, improving life quality and the like, and has the advantage of less adverse reaction.
In the prior art, patent document CN103417839B provides a red medicine for treating wounds, burns and eczema, which is a non-eczematous special red medicine and the treatment method is only direct mixing; patent document CN101804166B discloses a traditional Chinese medicine composition for treating pediatric dermatitis and eczema, but the number of the components is large, and more than 20 are available; patent document CN106075183a discloses a pine needle compound ointment for treating eczema and a preparation method thereof, which has no efficacy verification and unknown effect.
Therefore, a Chinese patent medicine with definite curative effect, good safety and no dependence, which is applicable to children eczema, needs to be developed at present.
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 the children eczema has a remarkable treatment effect on the children eczema, no adverse reaction is caused in the treatment process, and the traditional Chinese medicine composition for treating the children eczema is safe in components, remarkable in effect and worthy of clinical popularization and application.
In order to achieve the above purpose, the present 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:
according to the invention, the above 6 raw materials are selected for compatibility, and the compatibility is mainly based on the result of the existing research on the constitution of the infant suffering from eczema, namely lung heat and yang excess, damp heat mass, phlegm dampness mass, yin deficiency and dryness red mass, and specific intrinsic mass are the high-altitude constitution of the infant suffering from eczema, wherein the lung heat and yang excess, the damp heat mass and the phlegm dampness mass are the main constitution types of the attack of the eczema. The traditional Chinese medicine composition is prepared according to the theory of viscera and channels and theory of qi and blood of traditional Chinese medicine by adopting a treatment method of clearing heat and detoxicating, eliminating dampness and healing sores.
In the recipe, chinese gall is mainly used for eliminating dampness, promoting wound healing and stopping bleeding, and can be used for treating sores, furuncles, swelling and toxin and unhealed ulcers as monarch drugs. The giant knotweed can clear heat and detoxify, and can treat carbuncle swelling and sore toxicity; the sanguisorba officinalis has the effects of cooling blood, stopping bleeding, relieving swelling and healing sore, and the two medicines are used as ministerial medicines together to assist the Chinese gall in astringing dampness and healing sore, and detoxify and relieve swelling. Honeysuckle stem is sweet and cold in nature and bitter in taste, and is good at clearing heat and removing toxicity, dispelling wind and dredging collaterals; purslane is cold in nature and bitter in taste, can clear heat and detoxify, cool blood and stop bleeding, and can be used for eczema and pruritus; raw myotonin, slightly cold, enters lung meridian, is stronger than clearing heat, promoting diuresis and relieving itching, and can dispel wind and relieve itching when being externally used; it is used together with adjuvant drugs to clear blood heat, dispel blood poison, and dispel toxin. The mutual assistance of the six medicines plays the roles of clearing heat and detoxicating, eliminating dampness and healing sore.
The raw medicines used by the invention can be purchased from common medical shops, and the specification of the raw medicines accords with the national medical standard.
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:
still 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 coarse powder;
(2) Extracting 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) 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 to disperse to obtain a suspension; extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: distilling the ethyl acetate extract liquid 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 process flow of acetone extraction, concentrated extraction and drying, mainly because: the Chinese medicinal composition contains a large amount of tannins, the content of tannins in Chinese gall which is a monarch drug is about 60-80%, the tannins have a precipitation effect on proteins, and after skin ulceration surfaces and mucous membranes are contacted with the tannins, tissue proteins are coagulated to cause secretion inhibition mucous membrane drying, so that a protective film is formed to play a role in astringing.
Preferably, in the step (1), the granularity of the crude drug powder is not more than 40 meshes.
Preferably, in the step (2), the mass fraction of the acetone in the acetone-water is 50-70%; the extraction adopts an immersion method, and the feed liquid ratio is 1g: 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 of the invention adopts 50-70% aqueous acetone (acid condition), has the strongest dissolving capacity to tannins, can open the connecting chain of the tannins and proteins in the traditional Chinese medicine tissues, improves the extraction rate of the tannins, has lower boiling point of the acetone, and is easy to recycle to obtain the aqueous solution of the tannins; the immersion method is adopted for cold extraction, so that the tannin is prevented from being damaged, and the tannin of the gallnut is kept in a dissociated state under the low-temperature condition, so that the extraction efficiency is improved.
Preferably, in the step (3), the temperature of the reduced pressure concentration is 70-80 ℃, the vacuum degree is-0.06 MPa to-0.08 MPa, and the concentration specific gravity is 1.1-1.2 (70-80 ℃).
In the step (3), the ethyl acetate extraction is adopted to sufficiently remove fat-soluble impurities, so that purer tannins are obtained, and the extraction efficiency is further improved.
It will be appreciated that the extraction of the suspension with ethyl acetate in step (3) is a common process, and the amount of ethyl acetate used in the present invention is not particularly limited, 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 to 50: any number within the range of 1.
Meanwhile, the invention also provides application of the traditional Chinese medicine composition in preparation of external preparations for treating children eczema. It is understood that the traditional Chinese medicine composition provided by the invention is powder, and is prepared by using pharmaceutically acceptable auxiliary materials for treating eczema of children, wherein the pharmaceutically acceptable auxiliary materials have no specific requirements, and the traditional Chinese medicine composition can be prepared into an external preparation, which is a conventional technical means for those skilled in the art, and the invention is not particularly limited.
The external preparation comprises one or more of gel, ointment, cream, liniment, lotion, spray and powder. When the Chinese medicinal composition powder is prepared into ointment, the Chinese medicinal composition powder is added into a greasy matrix and stirred uniformly.
Preferably, the oleaginous base is one or more selected from liquid paraffin, silicone oil, vaseline, cetyl alcohol, stearyl alcohol, vegetable oil, lanolin, beeswax, spermaceti, glyceryl stearate, glyceryl laurate, polyglyceryl fatty acid ester, and medium chain triglyceride. Preferably, the oleaginous base is one or more of liquid paraffin, vaseline or lanoline.
Compared with the prior art, the invention has the following beneficial effects:
1. the traditional Chinese medicine composition provided by the invention is prepared by carefully selecting the six traditional Chinese medicines of gallnut, giant knotweed, garden burnet, purslane, honeysuckle stem and raw coix seed, has simple components, stable product and obvious treatment effect on children eczema.
2. In the traditional Chinese medicine composition provided by the invention, molecules of tannic acid extracted from the Chinese gall serving as a monarch drug contain a plurality of phenolic hydroxyl groups, so that the tannic acid is easily oxidized and changed into black oxide; the polygonum cuspidatum and the sanguisorba officinalis in the formula can be used as ministerial drugs to play roles of clearing heat and detoxicating, eliminating dampness and healing sores, have a strong antioxidation effect, and have a DPPH clearing effect of more than 80%, so that the quality and stability of the traditional Chinese medicine composition can be greatly improved.
3. The medicines in the formula are combined together to have the effects of clearing heat and detoxicating, eliminating dampness and healing sore, and are particularly suitable for subacute and chronic eczema caused by wind dampness and heat evil of children, so that the effect of treating both symptoms and root causes is achieved. Clinical curative effect researches prove that the traditional Chinese medicine composition disclosed by the invention has definite, reliable and real curative effect on children eczema and has good curative effect on light, moderate and even severe children eczema.
4. The traditional Chinese medicine composition is nontoxic and harmless, safe and reliable, has no adverse reaction after use, 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 will be described in further detail with reference to the following examples. Of course, the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
Although the steps of the present invention are arranged by reference numerals, the order of the steps is not limited, and the relative order of the steps may be adjusted unless the order of the steps is explicitly stated or the execution of a step requires other steps as a basis. It is to be understood that the term "and/or" as used herein relates to and encompasses any and all possible combinations of one or more of the associated listed items.
Unless otherwise specified, the raw materials in the invention are all purchased from 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 acetone: according to 1g: extracting the crude powder of the medicinal material obtained in the step (1) with 60wt% of acetone-water as a solvent for 10min at the pH of 3 and the temperature of 50 ℃ according to the feed-liquid ratio of 20mL, and repeating the steps for two times to obtain an extracting solution;
(3) Concentrating and extracting under reduced pressure: concentrating the extract obtained in the step (2) under reduced pressure at 75 ℃ and a vacuum degree of-0.07 MPa until no acetone smell exists (the concentration specific gravity is 1.15), adding a proper amount of water for dispersion to obtain a suspension, and extracting the suspension by using ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: and (3) taking ethyl acetate extract liquid obtained in the step (3), distilling to recover solvent ethyl acetate, drying the residual extractum, and then crushing to obtain the traditional Chinese medicine composition powder.
In this embodiment, there is also provided a method for preparing the above-mentioned Chinese medicinal composition into an ointment, comprising the steps of: 120g of lanolin, 775g of vaseline and 40g of glycerol are heated and mixed, stirred uniformly and cooled for standby; under the condition of homogenization, 65g of traditional Chinese medicine composition powder is slowly added, and the ointment is prepared by stirring and cooling to form ointment.
Example 2
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 acetone: according to 1g: extracting the crude powder of the medicinal material obtained in the step (1) with 65wt% of acetone-water as a solvent for 5min at the pH of 3.5 and the temperature of 55 ℃ at the feed-liquid ratio of 25mL, and repeating the steps for two times to obtain an extracting solution;
(3) Concentrating and extracting under reduced pressure: concentrating the extract obtained in the step (2) under reduced pressure at 80 ℃ and a vacuum degree of-0.06 MPa until no acetone smell exists (concentration specific gravity is 1.2), adding a proper amount of water for dispersion to obtain a suspension, and extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: and (3) taking ethyl acetate extract liquid obtained in the step (3), distilling to recover solvent ethyl acetate, drying the residual extractum, and then crushing to obtain the traditional Chinese medicine composition powder.
In this embodiment, there is also provided a method for preparing the above-mentioned Chinese medicinal composition into an ointment, comprising the steps of: 120g of lanolin, 775g of vaseline and 40g of glycerol are heated and mixed, stirred uniformly and cooled for standby; under the condition of homogenization, 65g of traditional Chinese medicine composition powder is slowly added, and the ointment is prepared by stirring and cooling to form ointment.
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 acetone: according to 1g: extracting the crude powder of the medicinal material obtained in the step (1) with 60wt% of acetone-water as a solvent for 15min at the pH of 3 and the temperature of 50 ℃ according to the feed-liquid ratio of 20mL, and repeating the steps for two times to obtain an extracting solution;
(3) Concentrating and extracting under reduced pressure: concentrating the extract obtained in the step (2) under reduced pressure at 75 ℃ and a vacuum degree of-0.07 MPa until no acetone smell exists (the concentration specific gravity is 1.15), adding a proper amount of water for dispersion to obtain a suspension, and extracting the suspension by using ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: and (3) taking ethyl acetate extract liquid obtained in the step (3), distilling to recover solvent ethyl acetate, drying the residual extractum, and then crushing to obtain the traditional Chinese medicine composition powder.
In this embodiment, there is also provided a method for preparing the above-mentioned Chinese medicinal composition into an ointment, comprising the steps of: 120g of lanolin, 775g of vaseline and 40g of glycerol are heated and mixed, stirred uniformly and cooled for standby; under the condition of homogenization, 65g of traditional Chinese medicine composition powder is slowly added, and the ointment is prepared by stirring and cooling to form ointment.
Comparative example 1
A traditional Chinese medicine composition for treating children eczema is prepared from the following raw materials:
in this comparative example, there is also provided a method for preparing the above-mentioned Chinese medicinal composition, comprising the steps of:
(1) Crushing medicinal materials: weighing Galla chinensis, rhizoma Polygoni Cuspidati, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain 40 mesh coarse powder;
(2) Extracting acetone: according to 1g: extracting the crude powder of the medicinal material obtained in the step (1) with 60wt% of acetone-water as a solvent for 10min at the pH of 3 and the temperature of 50 ℃ according to the feed-liquid ratio of 20mL, and repeating the steps for two times to obtain an extracting solution;
(3) Concentrating and extracting under reduced pressure: concentrating the extract obtained in the step (2) under reduced pressure at 75 ℃ and a vacuum degree of-0.07 MPa until no acetone smell exists (the concentration specific gravity is 1.15), adding a proper amount of water for dispersion to obtain a suspension, and extracting the suspension by using ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: and (3) taking ethyl acetate extract liquid obtained in the step (3), distilling to recover solvent ethyl acetate, drying the residual extractum, and then crushing to obtain the traditional Chinese medicine composition powder.
In this comparative example, there is also provided a method of preparing an ointment from the above-mentioned Chinese medicinal composition, comprising the steps of: 120g of lanolin, 775g of vaseline and 40g of glycerol are heated and mixed, stirred uniformly and cooled for standby; under the condition of homogenization, 65g of traditional Chinese medicine composition powder is slowly added, and the ointment is prepared by stirring and cooling to form ointment.
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 Galla chinensis, radix Sangusorbae, caulis Lonicerae, herba Portulacae and Coicis semen, mixing, pulverizing, and sieving to obtain 40 mesh coarse powder;
(2) Extracting acetone: according to 1g: extracting the crude powder of the medicinal material obtained in the step (1) with 60wt% of acetone-water as a solvent for 10min at the pH of 3 and the temperature of 50 ℃ according to the feed-liquid ratio of 20mL, and repeating the steps for two times to obtain an extracting solution;
(3) Concentrating and extracting under reduced pressure: concentrating the extract obtained in the step (2) under reduced pressure at 75 ℃ and a vacuum degree of-0.07 MPa until no acetone smell exists (the concentration specific gravity is 1.15), adding a proper amount of water for dispersion to obtain a suspension, and extracting the suspension by using ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: and (3) taking ethyl acetate extract liquid obtained in the step (3), distilling to recover solvent ethyl acetate, drying the residual extractum, and then crushing to obtain the traditional Chinese medicine composition powder.
In this comparative example, there is also provided a method of preparing an ointment from the above-mentioned Chinese medicinal composition, comprising the steps of: 120g of lanolin, 775g of vaseline and 40g of glycerol are heated and mixed, stirred uniformly and cooled for standby; under the condition of homogenization, 65g of traditional Chinese medicine composition powder is slowly added, and the ointment is prepared by stirring and cooling to form ointment.
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 acetone: according to 1g: extracting the crude powder of the medicinal material obtained in the step (1) with 40wt% of acetone-water as a solvent for 10min at the pH of 3 and the temperature of 70 ℃ according to the feed-liquid ratio of 20mL, and repeating the steps for two times to obtain an extracting solution;
(3) Concentrating and extracting under reduced pressure: concentrating the extract obtained in the step (2) under reduced pressure at 75 ℃ and a vacuum degree of-0.07 MPa until no acetone smell exists (the concentration specific gravity is 1.15), adding a proper amount of water for dispersion to obtain a suspension, and extracting the suspension by using ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: and (3) taking ethyl acetate extract liquid obtained in the step (3), distilling to recover solvent ethyl acetate, drying the residual extractum, 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 acetone: according to 1g: extracting coarse powder of the medicinal materials obtained in the step (1) with pure water as a solvent at a pH of 3 and a temperature of 50 ℃ for 10min at a feed-liquid ratio of 20mL, and repeating the steps for two times to obtain an extracting solution;
(3) Concentrating and extracting under reduced pressure: concentrating the extract obtained in the step (2) under reduced pressure at 75 ℃ and a vacuum degree of-0.07 MPa until the specific gravity is 1.15, adding a proper amount of water for dispersion to obtain a suspension, and extracting the suspension by using ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: and (3) taking ethyl acetate extract liquid obtained in the step (3), distilling to recover solvent ethyl acetate, drying the residual extractum, and then crushing to obtain the traditional Chinese medicine composition powder.
First, the influence of different extraction processes on the product quality was examined, specifically comparative example 1 and comparative examples 3, 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 processes on the amount of extraction of powder from a pharmaceutical composition
| Sample of | Weight of Chinese medicinal composition powder (g) |
| Example 1 | 170.4 |
| Comparative example 3 | 146.4 |
| Comparative example 4 | 122.8 |
As is clear from table 1, the content of the effective components extracted in example 1 is higher, thus demonstrating that the aqueous acetone solution has a strong dissolving capacity for tannins, and can break the linkage of tannins-proteins in plants, so that tannins are leached out in large amounts, and acetone is easy to recover, is a good solvent and can avoid oxidation of tannins. In a word, experiments prove that the low-temperature extraction rate of 60% of acetonic acid 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 tannic acid serving as an active ingredient are greatly improved.
Next, the products of examples 1 to 2 and comparative examples 1 to 2 were tested for performance, specifically as follows:
(1) Stability test
The testing method comprises the following steps: the ointments prepared in examples 1 to 2 and comparative examples 1 to 2 were left to stand at a temperature of 30.+ -. 2 ℃ and a relative humidity of 65%.+ -. 5% for 6 months, and samples were sampled and examined for appearance, particle size and gallic acid content per 1g at the time of 0, 3 and 6 months, respectively, and the results are shown in Table 2.
The particle size measurement method comprises the following steps: and (3) a proper amount of test sample is taken and placed on a glass slide to be coated into a thin layer, wherein the area of the thin layer is equal to that of a cover glass, 3 pieces of test sample are coated, and particles with the size and the size distribution are measured by a method (a first method of the four-part rule 0982 of the year 2020 edition of Chinese pharmacopoeia) and particles with the size of more than 180 microns cannot be detected.
The method for measuring the content of gallic acid comprises the following steps: the measurement was performed by high performance liquid chromatography (rule 0521 of four parts of chinese pharmacopoeia 2020 edition).
Chromatographic conditions and system suitability test: octadecylsilane chemically bonded silica is used as a filler; methanol-0.1% phosphoric acid solution (10:90) is taken as a mobile phase; the detection wavelength was 273nm. The theoretical plate number should be not less than 3000 calculated as gallic acid peak.
Preparation of a control solution: taking a proper amount of gallic acid reference substance, precisely weighing, adding mobile phase to prepare a solution containing 4 mug per 1 ml.
Preparation of test solution: taking about 0.25g of the product, precisely weighing, placing into 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 uniformly, placing into a refrigerator (-10 ℃) for freezing for 20 minutes, taking out, filtering, placing into room temperature, precisely measuring 2ml of the continuous filtrate, placing into a 10ml measuring flask, diluting to scale with mobile phase, shaking uniformly, filtering, and taking the continuous filtrate to obtain the product.
Assay: respectively precisely sucking 20 μl of the reference solution and the sample solution, and injecting into a liquid chromatograph for measurement.
TABLE 2 results of stability test of ointments
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Analysis of results: stability tests show that: the ointment prepared by the embodiment of the invention can keep good uniformity and granularity after being placed for 6 months under the acceleration condition, and the content of the active ingredients is stable, and the oxidative deterioration condition of the product does not occur, so that the ointment prepared by the embodiment of the invention has excellent long-term placement stability and is suitable for large-scale production and application; the cream prepared in the comparative example has greatly reduced content of active ingredients after accelerated test, and the appearance of the product is deepened, which indicates that the product is easy to oxidize and deteriorate after long-term placement, thereby reducing the drug effect of the product.
(2) Clinical trial test
The testing method comprises the following steps:
1) Sample selection: clinically, 50 pediatric eczema patients were selected, of which 20 subacute pediatric eczema and 30 chronic pediatric eczema.
2) Criteria for sample selection:
(1) referring to the traditional Chinese medicine industry standard of the people's republic of China, the traditional Chinese medicine disease diagnosis curative effect standard accords with the damp-heat infusion syndrome differentiation standard;
(2) age: patients in infancy or childhood, age 1-11 years, unlimited sex;
(3) corticosteroids or other immunosuppressants and immunomodulators have not been used systematically for nearly two months.
3) Dosing regimen
After skin is cleaned every day, a proper amount of the ointment prepared in the example 1 is smeared on the skin of the affected part of eczema, and each time in the morning and at night. Observations were made and statistics were made on days 14, 21, 28.
4) Efficacy assessment criteria
Referring to the clinical guidelines of new Chinese medicine, the itching degree, the onset time, the skin damage area, the tongue appearance, the pulse appearance, the related symptoms and the body symptoms are observed, the symptoms are scored according to the asymptomatic degree, the light degree, the medium degree and the heavy degree, the observation records are carried out for 1 time before treatment, 14 days after treatment, 21 days and 28 days respectively, and the following curative effect judgment standard is formulated:
the effect is shown: the symptoms of the traditional Chinese medicine are obviously relieved, and the integral of symptoms is reduced by more than or equal to 70 percent compared with the integral before treatment.
The method is effective: the symptoms of the traditional Chinese medicine are relieved, and the integral of symptoms is reduced by more than or equal to 30 percent compared with the integral before treatment.
Invalidation: the symptoms of traditional Chinese medicine are not obviously improved or even aggravated, and the integral of symptoms is reduced.
The therapeutic effect is shown in table 3.
TABLE 3 clinical trial treatment results
Analysis of results: the trial curative effect observation results show that the ointment of the invention has quick response, the effective rate of 14 days can reach 74%, the effective rate of 21 days can reach 92%, the effective rate of 1 month can reach 98%, and no allergy and discomfort phenomenon can occur. The medicine composition disclosed by the invention has the advantages that the curative effect is very obvious after the external use is used for treating the children eczema for one month, the effective rate is up to 98%, the life quality of children is greatly improved, no adverse reaction is found in the treatment process, and the medicine composition is worthy of clinical popularization and application.
Claims (5)
1. An external traditional Chinese medicine composition for treating children eczema is characterized by being prepared from the following raw materials in parts by weight:
100-300 parts of Chinese gall
50-200 parts of giant knotweed
40-200 parts of garden burnet
40-200 parts of purslane
40-150 parts of honeysuckle stem
50-80 parts of raw myotonin;
the preparation method of the external traditional Chinese medicine composition 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 coarse powder;
(2) Extracting 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) 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 to disperse to obtain a suspension; extracting the suspension with ethyl acetate to obtain ethyl acetate extract;
(4) Drying and crushing: distilling the ethyl acetate extract liquid obtained in the step (3) to obtain an extract; finally, drying and crushing the extract to obtain a traditional Chinese medicine composition;
in the step (2), the mass fraction of acetone in the acetone-water is 50-70%; the extraction adopts an immersion method, and the feed liquid ratio is 1g: 5-30 mL, wherein 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.
2. The external traditional Chinese medicine composition for treating children eczema according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight:
200 parts of Chinese gall
Giant knotweed rhizome 100 parts
100 parts of garden burnet
Purslane 100 parts
80 parts of honeysuckle stem
60 parts of raw myotonin.
3. The topical Chinese medicinal composition for treating infantile eczema according to claim 1, wherein in step (1), the particle size of the crude medicinal powder is not more than 40 mesh.
4. The external traditional Chinese medicine composition for treating children eczema according to claim 3, wherein in the step (3), the temperature of reduced pressure concentration is 70-80 ℃, and the vacuum degree is-0.06 MPa to-0.08 MPa.
5. The application of the external traditional Chinese medicine composition according to any one of claims 1-4 in preparing external preparations for treating eczema of children.
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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 |
|---|
| 五倍子单宁的超声提取工艺优化;江凯 等;《食品与发酵工业》;第36卷(第11期);第194页左栏1-2段和右栏4段、第197页左栏2段 * |
| 五倍子外用治疗小儿汗症和湿疹;王野樵；等;《中医杂志》;第39卷(第2期);第70页右栏第1-2段 * |
| 马齿苋外洗方治疗湿热型湿疹的临床疗效研究;刘少芬 等;《河北中医药学报》;第32卷(第1期);第23页右栏最后1段——第24页左栏1段，第24页右栏最后1段——第25页右栏1段 * |
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