CN118105425A - Heat-clearing and orifice-opening composition, preparation method and application thereof and navel patch - Google Patents

Abstract

The invention discloses a heat-clearing and resuscitation-inducing composition, a preparation method and application thereof, and an umbilical paste, belonging to the technical field of compositions, wherein the heat-clearing and resuscitation-inducing composition comprises the following active components in parts by weight: 100-200 parts of radix angelicae, 20-60 parts of fructus xanthii, 80-120 parts of wrinkled gianthyssop, 15-25 parts of pig gall powder, 20-30 parts of ligusticum wallichii, 70-110 parts of flos magnoliae, 15-25 parts of mint and 1-5 parts of borneol. The heat-clearing and orifice-opening composition consists of modified Xanthium sibiricum powder and Huobalt pill, and the synergistic effect is exerted on the aspect of treating rhinitis/sinusitis caused by lung heat through the mutual cooperation of angelica dahurica, xanthium sibiricum, wrinkled giant hyssop, pig gall powder, ligusticum wallichii, magnolia flower, peppermint and borneol. Compared with the prior art, the navel paste for clearing heat and opening orifices has better treatment effect on rhinitis/nasosinusitis.

Description

Heat-clearing and orifice-opening composition, preparation method and application thereof and navel patch

Technical Field

The invention relates to the technical field of compositions, in particular to a heat-clearing and orifice-opening composition, a preparation method and application thereof, and an umbilical patch.

Background

Rhinitis and sinusitis are all clinical common nasal diseases. Symptoms of rhinitis/sinusitis are mainly: runny nose, nasal obstruction, itching and pain, sneezing, hypertrophy of nasal septum, nasal polyp, swelling and thickening of nasal mucosa, hypertrophy of adenoids and nasal anosmia; western medicine believes that: the nasal mucosa is strong in sensitivity and weak in resistance after being damaged, and the allergen enters the body to induce allergy in the body, release histamine and act on the nasal mucosa, so that the nasal mucosa gland secretion is increased, the capillary permeability is increased, the lymphocyte is infiltrated, inflammatory factors are gathered, chronic inflammation is formed, and tissue edema is caused; at the same time, histamine can stimulate neurons of nasal mucosa to increase excitability, and relieve nasal itching, pain and sneeze.

Factors inducing rhinitis/sinusitis are as follows: genetic factors, allergen exposure (allergens are largely classified into inhaled allergens, which are the main cause of allergic rhinitis, and food allergens), environmental factors (low temperature, high temperature); the nasal mucosa can not be repaired for a long time, is influenced by various inducing factors, has abnormal endocrine disturbance of hypothalamus pituitary gland and water salt metabolism, has reduced secretion function regulating and controlling ability on nasal mucosa glands, and gradually forms a series of symptoms of chronic refractory rhinitis and nasosinusitis.

The disease parts of rhinitis/nasosinusitis are spleen, lung and kidney, and the exterior part is nasal orifice; the deficiency of primordial qi in the body of a patient causes deficiency of kidney qi, spleen qi and lung qi, cold and heat imbalance of organs such as kidney, spleen and lung, insecurity of defensive exterior, and bad nasal orifices, and rhinitis and sinusitis appear. Many patients alternate cold and heat, and the cold and heat are mingled, so that qi movement and body fluid are not smooth, and the patients are excessively sensitive to external cold and heat, so that four seasons are started; qi deficiency of spleen and kidney and yang qi dissipation can lead to lung failing to warm and nourish; lung governs nose, lung qi weakness, insecurity of defensive exterior, wind-cold and warp qi attacking nose and lung, adverse nose orifices, stagnation of body fluid, and stagnation of blood stasis in nose; liver, gall and spleen fire are accumulated in the lung, lung fire is overactive and sinking, and rise to nasal orifices, which cause rhinitis and nasosinusitis, and symptoms such as nasal obstruction, yellow nasal discharge, sticky nasal discharge, headache, glabrous bone pain and the like appear.

Clinically, medicines such as antibiotics, antihistamines, glucocorticoids and the like are commonly used for treating rhinitis and nasosinusitis, and the medicines have poor curative effects and are accompanied with adverse reactions such as central nervous system inhibition, cardiotoxicity and the like. The traditional Chinese medicine has high safety, wide action and other characteristics, is a research hot spot all the time, and has great potential in the aspect of treating nose diseases.

However, the traditional Chinese medicine rhinitis plaster sold in the market still has the problem of unsatisfactory treatment effect, and needs to be improved. The Siberian cocklebur fruit powder, which is also called Siberian cocklebur fruit powder, is prepared from Siberian cocklebur fruit, dahurian angelica root, magnolia flower and peppermint according to compatibility of the Siberian cocklebur fruit, dahurian angelica root, magnolia flower and peppermint, has the effects of clearing away heat and toxic materials, dispelling wind evil, clearing head and eyes, removing stasis and turbidity, and freeing nose orifices, and is a traditional prescription for treating rhinitis. The Huodan pill is derived from Qing dynasty 'Yizongjin Jiang' and consists of two components of patchouli leaf and pig gall powder, has the effects of removing turbid pathogen by aromatics and clearing heat and dredging orifices, and is a famous Chinese patent medicine for treating chronic rhinitis and chronic nasosinusitis. It is very challenging how to develop a composition for external use with better effect for clearing heat and inducing resuscitation based on the xanthium powder and the Huodan pill.

Disclosure of Invention

In order to solve the technical problems, the invention provides a heat-clearing and resuscitation-inducing composition, a preparation method and application thereof, and an umbilical paste.

In order to achieve the above purpose, the present invention adopts the following technical scheme:

A composition for clearing heat and inducing resuscitation comprises the following active components: radix Angelicae Dahuricae, fructus Xanthii preparata, herba Agastaches, pulvis Fellis suis, rhizoma Ligustici Chuanxiong, flos Magnoliae, herba Menthae and Borneolum Syntheticum.

The angelica dahurica, the fried fructus xanthil, the herba pogostemonis and the pig gall powder are monarch drugs, the angelica dahurica has warm nature and pungent taste, and enters the stomach, the large intestine and the lung channels, has the effects of dispelling wind-cold, eliminating dampness and relieving swelling, and the nasosinusitis and the forehead headache can be caused by the angelica dahurica, not only enter the lung channels to dispel wind-cold, but also enter the stomach channels of the yangming, and disperse wind, cold and damp evils at the circulation position of the forehead yangming channels of the face, the pain and swelling are relieved, the water extract of the angelica dahurica has obvious antibacterial effect, and the volatile oil of the angelica dahurica has strong antibacterial effect, especially drug-resistant bacteria and can also improve the immunity; fructus Xanthii, warm in nature, pungent and bitter in taste, enters lung meridian, has the effects of dispelling cold and relieving stuffy nose, is a key medicine for relieving stuffy nose, is toxic in fructus Xanthii components and is water-soluble glycosides, the content of glycosides is greatly reduced after being fried, water extracts and volatile oil of the fructus Xanthii have obvious antibacterial and anti-inflammatory effects, and the content of volatile oil of the fried fructus Xanthii is increased; herba Pogostemonis, with warm nature and pungent taste, has effects of invigorating spleen, stomach and lung channel, relieving exterior syndrome, eliminating dampness and relieving vomit, and its extract has effects of inducing sweat, relieving fever and pain, resisting bacteria, resisting virus and resisting inflammation, and improving immunity, and its volatile oil has effects of resisting bacteria and fungi, improving digestive system function, invigorating spleen and removing dampness; pig gall powder, which is cold in nature and bitter in taste, enters liver, gall, lung and large intestine channels, has the effects of clearing internal heat, clearing heat and moistening dryness, relieving cough and asthma, relaxing bowels and detoxifying, and has the effect of relaxing bowels and clearing large intestine stagnation, accelerating lung heat to flow downwards and discharging out of body, and can be effectively anti-inflammatory. Rhinitis and sinusitis are mostly caused by exogenous wind-cold, long-term heat removal and heavy damp turbidity, so that the combination of dahurian angelica root, cocklebur fruit and patchouli not only can relieve exterior syndrome by pungent temperature and remove wind-cold, but also can reduce swelling and relieve pain, strengthens the effect of removing yangming meridian damp evil, and the typical symptom of sinusitis is pain at the head and face positions of forehead, eyebrow bones and the like, is the position of yangming stomach meridian circulation, the root cause of damp turbidity comes from spleen and stomach and can be scattered to the head and face along the meridian, and the common use of dahurian angelica root and patchouli can strengthen the effect of removing the damp turbidity at the stomach meridian circulation position. The pig gall powder has the effects of dredging large intestine, clearing internal heat, and simultaneously dispersing and clearing other three medicines, and effectively removes wind, cold, dampness and turbidity, so that qi movement is smooth, and symptoms such as nasal obstruction, turbid nasal discharge, headache and the like are treated.

The ligusticum wallichii and the magnolia flower are ministerial drugs, the ligusticum wallichii is warm in nature and pungent in taste, and enters liver, gall and pericardium channels, so that the ligusticum wallichii has the effects of dispelling wind and activating blood circulation, the ligusticum wallichii enters the gall channels and can guide various drugs to ascend to the head and face, the ligusticum wallichii tea dispersion is a classical prescription for treating headache by taking the ligusticum wallichii as a main drug, the powder formulation is a use mode for protecting volatile components in a traditional Chinese medicine formulation, and meanwhile, the ligusticum wallichii has the effect of activating blood circulation, long-term illness is caused to be stasis, and rhinitis and nasosinusitis are frequently repeated, so that the upper respiratory tract is often caused to have local blood stasis due to chronic inflammation, the ligusticum wallichii can assist the monarch drug to dispel wind and remove stasis, the effects of detumescence and analgesia are enhanced, the volatile oil in the ligusticum wallichii can calm, nerve cells are protected, and vascular functions are improved; the magnolia flower has warm nature, and the taste is octyl, the lung and stomach are returned, the effects of dispelling wind-cold and relieving stuffy nose are achieved, the angelica dahurica and the fructus xanthil can be assisted, the wind-cold is dispersed, the relieving stuffy nose can be achieved, the nasal mucosa is contracted, the nasal mucosa is protected, the absorption of mucous membrane secretion is promoted, the inflammation is lightened, the nasal cavity is smooth, the inhibition effect on various pathogenic bacteria is achieved, the volatile oil has the effects of calming, easing pain, resisting allergy and inhibiting various pathogenic bacteria, and researches show that the volatile oil of the magnolia flower and fructus xanthil drug pair can obviously inhibit histamine type anaphylactic reaction.

Peppermint is an adjuvant drug, peppermint is cool in nature, pungent in taste, and enters lung and liver channels, has the effects of dispelling wind-heat and pungent in cool and penetrating exterior, the monarch drug is ministerial drug of pungent in taste and warm in nature, and the ministerial drug of the prescription is effective in dispelling wind-heat while the pig gall powder is effective in removing internal heat of large intestine, but the monarch drug is focused on clearing internal heat, and rhinitis and nasosinusitis are mostly initial exogenous wind-cold and further are internal heat, so the treatment principle is to dispel exterior and cold while the internal heat is cleared, but patients also have wind-heat attack on the surface, so the monarch drug is added to dispel wind-heat while the wind-cold is dispelled by the ministerial drug of the peppermint, and the volatile oil of the peppermint has the effects of sweating and fever as well as diminishing inflammation and pain and itching.

Borneol is used as a guiding drug; borneol has the effects of clearing heat and relieving pain, inducing resuscitation and refreshing mind, clearing heat and relieving pain, guiding the medicines to directly reach the superficial orifices and promoting medicine absorption, and has the advantages of slightly cold nature, pungent and bitter taste, lung, spleen and heart meridian. Meanwhile, peppermint and borneol can be used as transdermal absorbent to promote the transdermal absorption of medicines, and researches show that volatile oils of various medicines have the same function.

The invention discloses a heat-clearing and orifice-opening composition which comprises the following active components in parts by weight: 100-200 parts of radix angelicae, 20-60 parts of fructus xanthii, 80-120 parts of wrinkled gianthyssop, 15-25 parts of pig gall powder, 20-30 parts of ligusticum wallichii, 70-110 parts of flos magnoliae, 15-25 parts of mint and 1-5 parts of borneol.

In some preferred embodiments, the amount of dahurian angelica root in the heat-clearing and resuscitation-inducing composition of the present invention is 100-200 parts by weight, preferably 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200 or any value between the above values.

In some preferred embodiments, the fructus Xanthii is used in the heat clearing and resuscitation inducing composition of the present invention in an amount of 20-60 parts by weight, preferably 20, 25, 30, 35, 40, 45, 50, 55, 60 or any value therebetween.

In some preferred embodiments, the amount of wrinkled giant hyssop in the heat clearing and resuscitation inducing composition of the present invention is 80-120 parts by weight, preferably 80, 85, 90, 95, 100, 105, 110, 115, 120 or any value in between.

In some preferred embodiments, the amount of pig gall powder in the heat-clearing and resuscitation-inducing composition of the present invention is 15-25 parts by weight, preferably 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 or any value therebetween.

In some preferred embodiments, the amount of Ligusticum wallichii in the heat clearing composition of the present invention is 20-30 parts by weight, preferably 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 or any value therebetween.

In some preferred embodiments, the flos Magnoliae is used in the heat clearing and resuscitation inducing composition of the present invention in an amount of 70-110 parts by weight, preferably 70, 75, 80, 85, 90, 95, 100, 105, 110 or any value therebetween.

In some preferred embodiments, the mint is used in the heat clearing composition of the present invention in an amount of 15-25 parts by weight, preferably 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 or any value therebetween.

In some preferred embodiments, the amount of borneol in the heat clearing and resuscitation composition of the present invention is 1-5 parts by weight, preferably 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 or any value in between.

In a more preferred embodiment, the heat-clearing and orifice-opening composition comprises the following active components in parts by weight: 130 parts of dahurian angelica root, 40 parts of cocklebur fruit, 110 parts of wrinkled gianthyssop herb, 20 parts of pig gall powder, 25 parts of szechuan lovage rhizome, 90 parts of magnolia flower, 20 parts of peppermint and 2 parts of borneol.

The invention also provides a preparation method of the heat-clearing and orifice-opening composition, which comprises the following steps:

(1) Mixing radix Angelicae Dahuricae, herba Agastaches and fructus Xanthii, soaking, extracting to obtain volatile oil I, and separating solid from liquid to obtain filtrate;

(2) Concentrating the filtrate obtained in the step (1), and adding ethanol for ethanol precipitation to obtain supernatant;

(3) Concentrating the supernatant obtained in the step (2) to obtain a thick extract, drying and crushing to obtain an extract;

(4) Mixing and soaking rhizoma Ligustici Chuanxiong and herba Menthae, and extracting to obtain volatile oil II;

(5) Mixing the volatile oil I obtained in the step (1), the extract obtained in the step (3) and the volatile oil II obtained in the step (4), adding the pig gall powder and the borneol with the formula amount, mixing, and stirring to obtain the heat-clearing and orifice-opening composition.

Preferably, the soaking in steps (1) and (4) is: soaking at 60-80deg.C for 1-2 hr.

Preferably, the extraction in step (1) and step (4) comprises at least one of distillation, extraction, cold pressing, extraction and supercritical fluid extraction.

Preferably, the solid-liquid separation in step (1) comprises centrifugation and/or filtration.

Preferably, the concentrating in step (2) is: concentrating under reduced pressure at 65-75deg.C to relative density of 1.03-1.07.

Preferably, the alcohol precipitation in step (2) is: ethanol is added to make the concentration of ethanol be 60-70v/v%.

Preferably, the concentrating in step (3) is: concentrating under reduced pressure at 65-75deg.C to relative density of 1.09-1.12.

Further preferably, after the soaking in any one of the steps (1) and (4), the method further comprises ultrasonic treatment at 60-80 ℃ for 5-15min, wherein the ultrasonic power is 300-500W.

The invention also provides application of the heat-clearing and orifice-opening composition in preparing a product for treating rhinitis and/or nasosinusitis.

The invention also provides a navel patch for clearing heat and inducing resuscitation, which comprises the composition for clearing heat and inducing resuscitation.

Preferably, the navel patch for clearing heat and inducing resuscitation further comprises a matrix, a surfactant, a humectant and an antioxidant. Wherein, the matrix, the surfactant, the humectant and the antioxidant are all conventional auxiliary materials in the field, and are not particularly limited herein. For example, the matrix may comprise at least one of semisynthetic coconut butter, lanolin, polyethylene glycols, glycerogelatin, and cocoa butter; the surfactant may include at least one of polyethylene glycol, ethylene glycol, glycerol pentaerythritol, and sorbitan; the humectant may include at least one of glycerol, butylene glycol, propylene glycol, and sorbitol; the antioxidant may include at least one of butylated hydroxyanisole, t-butyl-p-cresol, vitamin C, and gallic acid esters.

The invention also provides a preparation method of the navel patch for clearing heat and inducing resuscitation, which comprises the following steps:

S1, preparing extracts and volatile oil:

(1) Mixing and soaking radix Angelicae Dahuricae, herba Agastaches and fructus Xanthii in the formula amount, extracting to obtain volatile oil I, and separating solid from liquid to obtain filtrate;

(2) Concentrating the filtrate obtained in the step (1), and adding ethanol for ethanol precipitation to obtain supernatant;

(3) Concentrating the supernatant obtained in the step (2) to obtain a thick extract, drying and crushing to obtain an extract;

(4) Mixing flos Magnoliae, rhizoma Ligustici Chuanxiong and herba Menthae, soaking, and extracting to obtain volatile oil II;

s2, adding pig gall powder, a surfactant and an antioxidant in a formula amount into the extract obtained in the step S1, and stirring to obtain a material 1;

S3, adding ethanol into the borneol with the formula amount, stirring and dissolving, adding a humectant, and stirring and homogenizing to obtain a material 2;

s4, mixing the volatile oil I and the volatile oil II obtained in the step S1 to obtain a material 3;

s5, melting the substrate, pouring the material 1 obtained in the step S2 and the material 2 obtained in the step S3, and pouring the material 3 obtained in the step S4 into the substrate to be uniformly mixed to obtain a material 4;

s6, pouring the material 4 obtained in the step S5 into a mold for cooling to obtain an umbilical patch tablet;

s7, placing the navel patch tablet obtained in the step S6 into a rubberized fabric patch to obtain the navel patch for clearing heat and dredging orifices.

Preferably, the extraction method in steps (1) and (4) is a distillation method.

The beneficial effects of the invention are as follows:

(1) The heat-clearing and orifice-opening composition consists of modified Xanthium sibiricum powder and Huobalt pill, and the synergistic effect is exerted on the aspect of treating rhinitis/sinusitis caused by lung heat through the mutual cooperation of angelica dahurica, xanthium sibiricum, wrinkled giant hyssop, pig gall powder, ligusticum wallichii, magnolia flower, peppermint and borneol.

(2) The original prescription of the fructus xanthil powder and the Huodan pill in the traditional prescription is the whole medicine component, namely, the original prescription is not decocted, is a measure for protecting volatile components in the medicine, the volatile components in the traditional Chinese medicine have the effects of fragrance channeling and direct resultants, and are important components for treating upper respiratory diseases, but most of modern pharmaceutical processes are water extraction and alcohol extraction, and the loss of the volatile components in the decoction and concentration process greatly influences the efficacy. The invention not only effectively reserves volatile components in the medicine, but also changes the prescription into external use by utilizing the characteristic that volatile oil can quickly enter channels and collaterals through skin barriers, and particularly, most of the volatile oil of the traditional Chinese medicine can promote the percutaneous absorption of other active ingredients, and menthol is widely used as a percutaneous absorbent, so that the external effect is better than oral administration. By adopting navel administration, not only is the navel the most accurate position in all acupuncture points not found out, but also because the navel tissue is the only tissue without fat layer in the place of the human body, is the only way for the human embryo to absorb nutrition from the matrix, twelve channels and collaterals of the human body can be achieved through the navel, by utilizing the effects of the medicament channel tropism and the medicament guiding medicament in the formula, the medicament active ingredient can directly reach the head and the face through the channels and collaterals by utilizing the characteristic of aromatic channeling of the volatile oil, thereby rapidly relieving symptoms, and the concentrated use of the volatile components of the Chinese medicament is the key that the rhinitis can be treated through the navel administration.

(3) The navel patch for clearing heat and inducing resuscitation has good safety, no toxic or side effect and can be used for treating rhinitis and/or nasosinusitis of adults and children.

Detailed Description

The method of the invention and its core ideas are illustrated below by means of specific examples. Any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials being described herein. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Example 1 Heat clearing and resuscitation inducing composition and navel paste for clearing heat and resuscitation

The formula (in parts by weight) of the heat-clearing and orifice-opening composition is as follows: 130 parts of dahurian angelica root, 40 parts of cocklebur fruit, 110 parts of wrinkled gianthyssop herb, 20 parts of pig gall powder, 25 parts of szechuan lovage rhizome, 90 parts of magnolia flower, 20 parts of peppermint and 2 parts of borneol.

The preparation method of the navel patch for clearing heat and inducing resuscitation comprises the following steps:

S1, preparing an extract and volatile oil:

(1) Pulverizing radix Angelicae Dahuricae, herba Agastaches and fructus Xanthii, mixing, soaking at 70deg.C for 1.5 hr, distilling for 4 hr to obtain volatile oil I, and filtering to obtain filtrate;

(2) Concentrating the filtrate obtained in the step (1) under reduced pressure at 70 ℃ until the relative density is 1.03-1.07 (50 ℃), adding ethanol to ensure that the concentration of the ethanol is 65v/v% ethanol precipitation to obtain supernatant;

(3) Concentrating the supernatant obtained in the step (2) under reduced pressure at 70deg.C until the relative density is 1.09-1.12 (50deg.C) to obtain soft extract, drying and pulverizing to obtain extract;

(4) Pulverizing flos Magnoliae, rhizoma Ligustici Chuanxiong and herba Menthae, mixing, soaking at 70deg.C for 1.5 hr, ultrasonic treating at 70deg.C under 400W for 10min, and distilling for 4 hr to obtain volatile oil II;

s2, adding pig gall powder, 5 parts by weight of polyethylene glycol and 0.1 part by weight of butyl hydroxy anisol into the extract obtained in the step S1, and stirring to obtain a material 1;

s3, adding ethanol into the borneol with the formula amount, stirring and dissolving, adding 5 parts by weight of glycerol, and stirring and homogenizing to obtain a material 2;

s4, mixing the volatile oil I and the volatile oil II obtained in the step S1 to obtain a material 3;

S5, melting 50 parts by weight of glycerogelatin (the volume ratio of glycerol to gelatin to water is 1:1:2) at a constant temperature, pouring the material 1 obtained in the step S2 and the material 2 obtained in the step S3, and pouring the material 3 obtained in the step S4 into a matrix to be uniformly mixed to obtain a material 4;

s6, pouring the material 4 obtained in the step S5 into a mold, and cooling to obtain an umbilical patch tablet;

s7, placing the navel patch tablet obtained in the step S6 into a rubberized fabric patch to obtain the navel patch for clearing heat and dredging orifices.

Example 2 Heat clearing and resuscitation inducing composition and navel Patch for clearing heat and resuscitation

The formula (in parts by weight) of the heat-clearing and orifice-opening composition is as follows: 100 parts of dahurian angelica root, 20 parts of cocklebur fruit, 80 parts of wrinkled gianthyssop herb, 15 parts of pig gall powder, 20 parts of szechuan lovage rhizome, 70 parts of magnolia flower, 15 parts of peppermint and 1 part of borneol.

The preparation method of the navel patch for clearing heat and inducing resuscitation is the same as that of the embodiment 1.

Example 3 Heat clearing and resuscitation inducing composition and navel Patch for clearing heat and resuscitation

The formula (in parts by weight) of the heat-clearing and orifice-opening composition is as follows: 200 parts of dahurian angelica root, 60 parts of cocklebur fruit, 120 parts of wrinkled gianthyssop herb, 25 parts of pig gall powder, 30 parts of szechuan lovage rhizome, 110 parts of magnolia flower, 25 parts of peppermint and 5 parts of borneol.

The preparation method of the navel patch for clearing heat and inducing resuscitation is the same as that of the embodiment 1.

Comparative example 1 Heat clearing and resuscitation inducing composition and navel paste for clearing and resuscitation inducing

The comparative example differs from example 1 only in the preparation method, specifically, the preparation method of the navel patch for clearing heat and inducing resuscitation is as follows:

S1, preparing an extract and volatile oil:

(1) Pulverizing radix Angelicae Dahuricae, herba Agastaches, rhizoma Ligustici Chuanxiong and fructus Xanthii, mixing, soaking at 70deg.C for 1.5 hr, distilling for 4 hr to obtain volatile oil I, and filtering to obtain filtrate;

(2) Concentrating the filtrate obtained in the step (1) under reduced pressure at 70deg.C until the relative density is 1.09-1.12 (50deg.C) to obtain soft extract, drying and pulverizing to obtain extract;

(3) Pulverizing flos Magnoliae and herba Menthae, mixing, soaking at 70deg.C for 1.5 hr, ultrasonic treating at 70deg.C and 400W for 10min, and distilling for 4 hr to obtain volatile oil II;

S2, adding pig gall powder, polyethylene glycol and butylated hydroxyanisole with the formula amount into the extract obtained in the step S1, and stirring to obtain a material 1;

s3, adding ethanol into the borneol with the formula amount, stirring and dissolving, adding glycerol, and stirring and homogenizing to obtain a material 2;

s4, mixing the volatile oil I and the volatile oil II obtained in the step S1 to obtain a material 3;

S5, melting glycerogelatin at a constant temperature, pouring the material 1 obtained in the step S2 and the material 2 obtained in the step S3, and pouring the material 3 obtained in the step S4 into a matrix to be uniformly mixed to obtain a material 4;

s6, pouring the material 4 obtained in the step S5 into a mold, and cooling to obtain an umbilical patch tablet;

S7, placing the navel patch tablet obtained in the step S6 into a rubberized fabric patch to obtain the navel patch for clearing heat and dredging orifices. Comparative example 2 Heat clearing and resuscitation inducing composition and navel paste for clearing and resuscitation inducing

The comparative example differs from example 1 only in that it does not contain Ligusticum wallichii, specifically, the formula (in parts by weight) of the heat-clearing and orifice-opening composition is: 130 parts of dahurian angelica root, 40 parts of cocklebur fruit, 110 parts of wrinkled gianthyssop herb, 20 parts of pig gall powder, 90 parts of magnolia flower, 20 parts of peppermint and 2 parts of borneol.

The preparation method of the navel patch for clearing heat and inducing resuscitation is the same as in example 1.

Comparative example 3 navel Patch for clearing heat and inducing resuscitation

The comparative example differs from example 1 only in that it does not contain a heat-clearing and resuscitation-inducing composition, specifically, the preparation method of the navel patch for clearing heat and resuscitation is as follows:

S1, stirring polyethylene glycol and butyl hydroxy anisol to obtain a material 1;

S2, melting glycerogelatin at a constant temperature, adding glycerol and uniformly mixing the glycerol with the material 1 obtained in the step S1 to obtain a material 2;

S3, pouring the material 2 obtained in the step S2 into a mold, and cooling to obtain an umbilical patch tablet;

S4, placing the navel patch tablet obtained in the step S3 into a rubberized fabric patch to obtain the navel patch for clearing heat and dredging orifices. 1. Therapeutic effect of heat-clearing and orifice-opening composition on rhinitis

The therapeutic effect of the heat-clearing and resuscitation-inducing composition on rhinitis is examined by using an ovalbumin-sensitized SD rat allergic rhinitis model.

1. Experimental materials

1.1, Laboratory animals

SPF-grade SD rats, male, weighing 180-220g, supplied by the laboratory animal center, guangdong province, using license number for laboratory units: SYXK (yue) 2022-0125, license number: SCXK (Yue) 2022-0002.

1.2 Experimental reagents

Ovalbumin OVA, CAS number 9006-59-1; al (OH) ₃, CAS number 21645-51-2; physiological saline

Rat ovalbumin specific IgE (OVA sIgE) ELISA detection kit and rat interleukin 6 (IL-6) ELISA detection kit; the rat interleukin 10 (IL-10) ELISA detection kit was purchased from Shanghai enzyme-linked biotechnology Co.

1.3 Laboratory apparatus

Multifunctional microplate reader, model SpectraMax i3X, available from the molecular instruments of america, shanghai, inc.

2. Experimental method

2.1, Experimental grouping and administration

The molding method comprises the following steps: 200. Mu.L of the mixture (30. Mu. gOVA +5mg of Al (OH) 3+1mL of physiological saline) was injected into the abdominal cavity of SD rats, and the mixture was administered once every other day for 14 days. On day 15, 20. Mu.L of OVA solution (50. Mu. gOVA +1mL of physiological saline) was dropped on both sides of SD rats, and the administration was continued for 7 days 1 time a day. Normal groups were dosed with the same amount of physiological saline.

Symptoms such as nasal grabbing, sneezing and nasal discharge of the rats within 10 minutes after the last nasal drop excitation are recorded, and when the cumulative score is greater than 5 minutes, the modeling success is indicated, and the scoring standard is shown in table 1.

TABLE 1

Score of	Nose grabbing/scratching device	Sneeze/time	Runny nose
				0	Never less than or equal to 1 time	0	Without any means for
1	Occasionally, 2-10 times	1-3	Nasal discharge flowing to anterior nares
				2	Repeatedly, frequently, 11-20 times	4-10	Nasal discharge flowing out anterior naris
3	Continuously, not less than 20 times	≥11	Nasal discharge filling up face

SD rats successfully modeled were randomly divided into 6 groups of 10 animals each, each of examples 1-3 was given the heat-clearing and resuscitation-inducing navel patches prepared in examples 1,2 and 3, respectively, each of comparative example 1 was given the heat-clearing and resuscitation-inducing navel patch prepared in comparative example 1, each of comparative example 2 was given the heat-clearing and resuscitation-inducing navel patch prepared in comparative example 2, and each of the model groups was given the heat-clearing and resuscitation-inducing navel patch prepared in comparative example 3 (placebo patch). 1 patch per day for 5 days.

Meanwhile, 10 SD rats without modeling were used as normal groups, and the navel patch (placebo patch) for clearing heat and inducing resuscitation prepared in comparative example 3 was administered. 1 patch per day for 5 days.

Before treatment, the Shenque acupoint area and its peripheral hair are removed, the rat is fixed on the back during administration, and the tablet for clearing heat and inducing resuscitation is applied to the Shenque acupoint area.

After 2h of 5 th administration, the symptoms of nasal grasping, sneezing, runny nose, and the like of the rat were observed within 10 minutes.

2.2 Sample collection

After the treatment is finished, the animals are anesthetized by isoflurane, the heart is used for blood sampling under negative pressure, centrifugation is carried out for 10min at 8000r/min, the supernatant is collected, and the serum is stored in a refrigerator at-80 ℃.

2.3 Detection of

Serum IgE, IL-6 and IL-10 content was measured according to ELISA kit instructions.

2.4 Statistical analysis

Data were analyzed using GraphPad prism9.0 statistical software, results were expressed as mean ± standard deviation, independent sample t-test was used for group-to-group comparisons, single factor analysis of variance was used for group-to-group comparisons, and LSD was used for pairwise comparisons. P <0.05 is statistically significant for differences, and P > 0.05 is statistically insignificant for differences.

3. Experimental results

3.1 Symptoms of nasal grabbing and sneezing in rats

As can be seen from table 2, there was no significant difference between the number of nasal grabs/scratchs, sneezes, and the like in the rats of each group, except the normal group, before the treatment.

After continuous 5 days of umbilical administration, compared with the model group, the nasal grabbing/scratching times and sneezing times of the rats in the examples 1-3 are obviously reduced (P is less than 0.01), and the symptom scores of the rats are obviously reduced, which shows that the heat-clearing and resuscitation-inducing navel paste prepared in the examples 1-3 can effectively relieve the symptoms of nasal grabbing/scratching, sneezing and nasal discharge of the rats.

Compared with the model group, the number of times of grabbing and scratching the nose and the number of times of sneezing of the rats in the comparison examples 1 and 2 are not obviously different (P is more than 0.05), which indicates that the heat clearing and resuscitation navel patch prepared in the comparison examples 1 and 2 has no effect of relieving the symptoms of grabbing and scratching the nose, sneezing and the like of the rats.

Compared with the group of the example 1, the number of times of grabbing nose and scratching nose and the number of times of sneezing of the rats in the group of the example 1 and the group of the rats in the group of the example 2 have remarkable difference (P is less than 0.05), which shows that the heat-clearing and resuscitation navel plaster prepared in the example 1 has better effect than the heat-clearing and resuscitation navel plaster prepared in the examples 2 and 3.

TABLE 2

# P < 0.01 compared to the normal group, P < 0.01 compared to the model group, Δp < 0.05 compared to the example 1 group. 3.2 content of IgE, IL-6 and IL-10 in rat serum

As shown in Table 3, compared with the normal group, the serum of the rat in the model group has significantly increased IgE and IL-6 content (P < 0.01) and significantly reduced IL-10 content (P < 0.01), which indicates that the induced modeling of ovalbumin can lead to the increase of IgE and IL-6 content and the decrease of IL-10 content in the serum of the rat.

After the umbilical administration is carried out for 5 days continuously, compared with a model group, the serum content of IgE and IL-6 in the rat serum of the embodiment 1-3 group is obviously reduced (P is less than 0.05), and the IL-10 content is obviously increased (P is less than 0.05), which shows that the heat-clearing and resuscitation-inducing umbilical paste prepared in the embodiment 1-3 can relieve allergic rhinitis of the SD rat sensitized by ovalbumin by reducing the level of IgE and IL-6 in the serum, increasing the level of IL-10.

Compared with the model group, the serum of the rats in the comparative examples 1 and 2 has no obvious difference (P is more than 0.05) on the content of IgE, IL-6 and IL-10, which indicates that the heat clearing and resuscitation navel patch prepared in the comparative examples 1 and 2 can not relieve allergic rhinitis of SD rats sensitized by ovalbumin by reducing the level of IgE and IL-6 in the serum and increasing the level of IL-10.

Compared with the group of the example 1, the content of IgE and IL-6 in the serum of the rats in the groups of the examples 1 and 2 has a significant difference (P is less than 0.05), which indicates that the navel patch for clearing heat and inducing resuscitation prepared in the example 1 has better effect than the navel patch for clearing heat and inducing resuscitation prepared in the examples 2 and 3.

TABLE 3 Table 3

Group of	IgE(mg/L)	IL-6(mg/L)	IL-10(mg/L)
				Normal state	108.63±18.32	36.25±6.62	243.84±30.34
Model	226.32±23.18##	120.17±10.42##	89.75±13.05##
				Example 1	121.86±15.37**	56.20±6.03**	136.82±17.12*
Example 2	145.31±17.52*Δ	67.82±8.24*Δ	121.55±16.35*
				Example 3	140.74±16.60*Δ	63.27±7.06*Δ	125.28±18.67*
Comparative example 1	189.97±24.25	90.73±6.58	101.23±16.32
				Comparative example 2	192.10±25.19	92.26±7.75	102.59±16.90

# P < 0.01 compared to the normal group, P < 0.01 compared to the model group, P < 0.05 compared to the example 1 group, Δp < 0.05.

2. Clinical application of navel paste for clearing heat and dredging orifice

Clinical application proves that the navel paste for clearing heat and opening orifices has better treatment effect on rhinitis/nasosinusitis. Wherein the patch for therapeutic administration is the navel patch for clearing heat and inducing resuscitation prepared in example 1.

Case 1: zhao, a certain man, 4 years old, shandong shou hospital check is that the adenoid is hypertrophic, and the nostril is basically blocked up when most serious, and the repeated cold is snored at night, and open breath, operation is required to be performed by the hospital, and the symptoms are relieved after a treatment course 7 is pasted with the navel paste for clearing heat and opening orifices, and the symptoms completely disappear after four treatment courses 28 are pasted, the adenoid is contracted, and the follow-up visit is not repeated after one year.

Case 2: when a certain Qiu, a woman, ages 30 years, allergic rhinitis develops into nasosinusitis, the disease history is 6 years, the traditional Chinese medicine and western medicine treat the lack effect, the nasal obstruction and headache, the symptoms disappear after the medicine is applied to the medicine for 4 days, and the follow-up visit is not repeated after one year.

Case 3: when a woman is in a certain age, 8 years old, the adenoid hypertrophy accounts for 2/3 of the nostril, nasal obstruction, open mouth and breathing, night snoring, and the stool is once every three and four days, the symptom is relieved after one week of administration, the nose is completely ventilated after two weeks, the size of the adenoid is unchanged but the inflammatory reaction is disappeared after the nasal mucosa is changed from red to light powder, secretion is reduced, the symptom is completely disappeared after four weeks of administration, and the follow-up visit is not repeated after one year.

Case 4: zhang Mou, men, 10 years old, repeated exogenous infection caused nasal obstruction, occasional sneeze, once daily sticky stool, feeling of nasal obstruction symptom relief after one patch, obvious symptom relief after 10 patches, complete disappearance of symptom after 14 patches, and no repeated follow-up after one year.

Case 5: ouyang A certain, 6 years old, and symptoms of rhinitis are more than one month, mainly nasal obstruction, clear nasal discharge and yellow nasal discharge, the stool is shaped every day, the symptoms disappear after 3 patches are applied, 2 patches are applied again for consolidation, and follow-up visit is not repeated after two weeks.

The invention has been further described above in connection with specific embodiments, which are exemplary only and do not limit the scope of the invention in any way. It will be understood by those skilled in the art that various changes and substitutions of details and forms of the technical solution of the present invention may be made without departing from the spirit and scope of the present invention, but these changes and substitutions fall within the scope of the present invention.

Claims (10)

1. The heat-clearing and orifice-opening composition is characterized by comprising the following active components in parts by weight: 100-200 parts of radix angelicae, 20-60 parts of fructus xanthii, 80-120 parts of wrinkled gianthyssop, 15-25 parts of pig gall powder, 20-30 parts of ligusticum wallichii, 70-110 parts of flos magnoliae, 15-25 parts of mint and 1-5 parts of borneol.

2. The external antipyretic traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following active components in parts by weight: 130 parts of dahurian angelica root, 40 parts of cocklebur fruit, 110 parts of wrinkled gianthyssop herb, 20 parts of pig gall powder, 25 parts of szechuan lovage rhizome, 90 parts of magnolia flower, 20 parts of peppermint and 2 parts of borneol.

3. A method for preparing a heat clearing and resuscitation composition according to any one of claims 1 to 2, comprising the steps of:

(1) Mixing radix Angelicae Dahuricae, herba Agastaches and fructus Xanthii, soaking, extracting to obtain volatile oil I, and separating solid from liquid to obtain filtrate;

(2) Concentrating the filtrate obtained in the step (1), and adding ethanol for ethanol precipitation to obtain supernatant;

(3) Concentrating the supernatant obtained in the step (2) to obtain a thick extract, drying and crushing to obtain an extract;

(4) Mixing flos Magnoliae, rhizoma Ligustici Chuanxiong and herba Menthae, soaking, and extracting to obtain volatile oil II;

(5) Mixing the volatile oil I obtained in the step (1), the extract obtained in the step (3) and the volatile oil II obtained in the step (4), adding the pig gall powder and the borneol with the formula amount, mixing, and stirring to obtain the heat-clearing and orifice-opening composition.

4. A method according to claim 3, wherein the soaking in steps (1) and (4) is: soaking at 60-80deg.C for 1-2 hr.

5. A method according to claim 3, wherein the concentration in step (2) is: concentrating under reduced pressure at 65-75deg.C to relative density of 1.03-1.07;

the alcohol precipitation in the step (2) is as follows: ethanol is added to make the concentration of ethanol be 60-70v/v%.

6. A method according to claim 3, wherein the concentration in step (3) is: concentrating under reduced pressure at 65-75deg.C to relative density of 1.09-1.12.

7. Use of a heat-clearing and resuscitation-inducing composition according to any one of claims 1 to 2 or a heat-clearing and resuscitation-inducing composition prepared by a preparation method according to any one of claims 3 to 6 in the preparation of a product for the treatment of rhinitis and/or sinusitis.

8. A navel patch for clearing heat and inducing resuscitation, which is characterized by comprising the heat clearing and inducing resuscitation composition according to any one of claims 1 to 2 or the heat clearing and inducing resuscitation composition prepared by the preparation method according to any one of claims 3 to 6.

9. The navel patch for clearing heat and inducing resuscitation according to claim 8, further comprising a base, a surfactant, a humectant and an antioxidant.

10. The preparation method of the navel patch for clearing heat and inducing resuscitation according to claim 8 or 9, comprising the following steps:

S1, preparing extracts and volatile oil:

(1) Mixing and soaking radix Angelicae Dahuricae, herba Agastaches and fructus Xanthii in the formula amount, extracting to obtain volatile oil I, and separating solid from liquid to obtain filtrate;

(2) Concentrating the filtrate obtained in the step (1), and adding ethanol for ethanol precipitation to obtain supernatant;

(3) Concentrating the supernatant obtained in the step (2) to obtain a thick extract, drying and crushing to obtain an extract;

(4) Mixing flos Magnoliae, rhizoma Ligustici Chuanxiong and herba Menthae, soaking, and extracting to obtain volatile oil II;

s2, adding pig gall powder, a surfactant and an antioxidant in a formula amount into the extract obtained in the step S1, and stirring to obtain a material 1;

S3, adding ethanol into the borneol with the formula amount, stirring and dissolving, adding a humectant, and stirring and homogenizing to obtain a material 2;

s4, mixing the volatile oil I and the volatile oil II obtained in the step S1 to obtain a material 3;

s5, melting the substrate, pouring the material 1 obtained in the step S2 and the material 2 obtained in the step S3, and pouring the material 3 obtained in the step S4 into the substrate to be uniformly mixed to obtain a material 4;

s6, pouring the material 4 obtained in the step S5 into a mold for cooling to obtain an umbilical patch tablet;

s7, placing the navel patch tablet obtained in the step S6 into a rubberized fabric patch to obtain the navel patch for clearing heat and dredging orifices.