CN113058014A

CN113058014A - Preparation method of traditional Chinese medicine composition, traditional Chinese medicine composition and application thereof

Info

Publication number: CN113058014A
Application number: CN201911294908.7A
Authority: CN
Inventors: 石丽; 李卉
Original assignee: Xi'an Beilin Pharmaceutical Co ltd
Current assignee: Xi'an Beilin Pharmaceutical Co ltd
Priority date: 2019-12-16
Filing date: 2019-12-16
Publication date: 2021-07-02

Abstract

The invention provides a preparation method of a traditional Chinese medicine composition, the traditional Chinese medicine composition and an application thereof, wherein vinegar zedoary, honeysuckle, blanched peach seed, figwort root, vinegar rhizoma sparganii, safflower, salvia miltiorrhiza, isatis root, dwarf lilyturf tuber, oriental waterplantain rhizome, cicada slough, fried chicken's gizzard-membrane, oroxylum indicum and dandelion are subjected to reflux extraction by ethanol to obtain clear paste, and then puffball and thunberg fritillary bulb are added into the clear paste to be crushed into fine powder, and the medicinal preparation is prepared according to: granules, capsules, tablets, pills and lozenges; the composition has effects of clearing away heat and toxic materials, promoting blood circulation, removing blood stasis, promoting diuresis, and eliminating phlegm; is mainly used for hoarseness, vocal cords congestion and swelling caused by heat-toxin accumulation, qi stagnation and blood stasis; chronic laryngitis, vocal nodule, and polyp of vocal cord. The invention improves the preparation process, obviously improves the clinical pharmacodynamics test effect and has small toxic and side effects. The preparation is stable and has obvious curative effect.

Description

Preparation method of traditional Chinese medicine composition, traditional Chinese medicine composition and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a preparation method of a traditional Chinese medicine composition, the traditional Chinese medicine composition and application thereof.

Background

The Jinsangsanjie is a traditional Chinese medicine formula for treating throat diseases, the disease rate of throat diseases is relatively high due to the change of the existing environmental quality, but the extraction rate of effective components of different Jinsangsanjie preparations is relatively low due to the difference of preparation process means of the existing traditional Chinese medicine formula, and the curative effect is not high. Therefore, the development of a preparation process of a medicament for treating throat diseases, which has the advantages of stable preparation, obvious curative effect and small toxic and side effect after long-term administration, is urgently needed.

The prior art is as follows: 1. in the invention patent with the application number of CN200610009169.9, a Jinsangsanjie preparation and a preparation method thereof are disclosed; 2. the invention patent with the application number of CN200410038253.4 discloses a traditional Chinese medicine for treating chronic aphonia and a preparation method thereof; 3. in the invention patent with the application number of CN201110330345.X, a Chinese medicinal composition for throat and resolving masses and a preparation method thereof are disclosed; 4. in the invention patent with the application number of CN200610043108.4, a preparation process and application of a traditional Chinese medicine for treating vocal nodule and vocal cord polyp symptoms are disclosed; 5. in the invention patent with the application number of CN200510087283.9, a Jinsangsanjie fast dispersion solid preparation and a preparation method thereof are disclosed; 6. a prescription component of Jinsangsanjie capsule and a preparation process thereof are disclosed under page 96 of the twelfth book of Chinese patent medicine Chengfang preparation; 7. the prescription component of Jinsangsanjie pill and the preparation process thereof are disclosed under the item 1090 page of the Chinese pharmacopoeia (2015 edition I).

Through the research of the applicant in recent years, the following findings are obtained: the prior art 1-7 has the defects that the process is thick, the effective components in the traditional Chinese medicine formula cannot be extracted, and the traditional Chinese medicine formula has unsatisfactory curative effect in the actual application process. Therefore, the applicant improves the product process by combining a large amount of traditional Chinese medicine formula theories and clinical pharmacodynamic researches and applying modern pharmaceutical technology to improve the clinical pharmacodynamic test effect.

Disclosure of Invention

In order to solve the technical problems, the invention aims to provide a preparation method of a traditional Chinese medicine composition, the traditional Chinese medicine composition and application thereof, the traditional Chinese medicine composition is improved by the prior art to improve the content of effective components, and has the advantages of stable preparation, remarkable curative effect, small toxic and side effects and good market application value.

In order to achieve the purpose, the technical scheme of the invention is as follows:

a preparation method of a traditional Chinese medicine composition comprises the following steps in parts by weight:

s1, weighing 20-30 parts of puffball, 120-130 parts of vinegar curcuma zedoary, 120-130 parts of honeysuckle, 50-60 parts of blanched peach kernels, 50-60 parts of radix scrophulariae, 50-60 parts of vinegar rhizoma sparganii, 50-60 parts of safflower, 70-80 parts of salvia miltiorrhiza, 120-130 parts of isatis roots, 90-100 parts of radix ophiopogonis, 70-80 parts of thunberg fritillary bulb, 70-80 parts of rhizoma alismatis, 70-80 parts of cicada slough, 50-60 parts of fried chicken' S gizzard-membrane, 70-80 parts of oroxylum indicum and 120-130 parts of dandelion;

s2, pulverizing Bulbus Fritillariae Thunbergii and Lasiosphaera Seu Calvatia into fine powder, sieving, and mixing to obtain component A;

s3, mixing the rest components in S1, adding ethanol for reflux extraction, mixing the extractive solutions, filtering, concentrating the filtrate to obtain clear paste, drying, and pulverizing into dry extract powder to obtain component B;

s4, uniformly mixing the component B obtained in the step S3 with the component A obtained in the step S2, adding auxiliary materials, and preparing the medicine preparation.

Further, in S3, the reflux extraction frequency is 2 times, and the extraction time is 2-3 h each time.

Further, in the process of two times of reflux extraction in S3, 70% -80% ethanol with the weight of 10 times of the raw materials is added for the first time, and 70% -80% ethanol with the weight of 8 times of the raw materials is added for the second time.

Further, in S3, the temperature of the two reflux extractions is 70-80 ℃.

Further, in S3, the relative density of the clear paste measured at 60 ℃ is 1.05-1.10.

Further, in S4, the pharmaceutical preparation includes granules, capsules, tablets and pills.

Further, in S4, the auxiliary material is one or more of dextrin, sugar powder, starch, and refined honey.

The invention also provides a traditional Chinese medicine composition which is prepared according to the preparation method.

In addition, the invention also provides application of the preparation method of the traditional Chinese medicine composition in preparing a medicinal preparation for treating children vocal nodule and vocal cord polyp.

The invention has the beneficial effects that:

1. the preparation method of the invention is an improvement of the prior art, and the thunberg fritillary bulb and the puffball are independently crushed and then mixed with ethanol extracts of the other components, and proper auxiliary materials are added to prepare the oral convenient medicinal preparation. The method is simple to operate, compared with the prior art, the method has the advantages that the process steps are reduced, the adopted solvent is wide in source and low in cost, the solvent can be recycled, and with the increase of production batches, the production cost of each batch can be reduced to 75.41% of the original production cost, namely the cost is saved by 24.86%. In addition, the method can obviously improve the content of the effective components and the clinical pharmacodynamic test effect, and has small toxic and side effects.

2. The oral medicinal preparation prepared by the preparation method has the effects of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, removing dampness by diuresis and reducing phlegm, and is mainly used for hoarseness, vocal cord congestion and swelling caused by heat toxin accumulation, qi stagnation and blood stasis; the preparation is stable and has obvious curative effect for patients with chronic laryngitis, vocal nodule and polyp of vocal cord with the above symptoms, and better meets the domestic medical needs.

3. The preparation method of the invention not only makes great progress in preparing the pharmaceutical preparation for treating adult throat diseases, but also has very wide application prospect in preparing the pharmaceutical preparation for treating children vocal nodule and vocal cord polyp.

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. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the embodiment of the present invention, the material and the equipment can be purchased in the market without specific description.

Example 1

A Chinese medicinal composition comprises Lasiosphaera Seu Calvatia 25g, Curcumae rhizoma 125g, flos Lonicerae 125g, semen Persicae 50g, radix scrophulariae 50g, rhizoma Sparganii 50g, Carthami flos 50g, Saviae Miltiorrhizae radix 75g, radix Isatidis 125g, radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Alismatis rhizoma 75g, periostracum Cicadae 75g, endothelium corneum Gigeriae Galli 50g, semen Oroxyli 75g, and herba Taraxaci 125 g; the preparation method comprises the following steps:

s1, weighing 25g of puffball, 125g of vinegar-treated curcuma zedoary, 125g of honeysuckle, 50g of semen persicae, 50g of radix scrophulariae, 50g of vinegar-treated rhizoma sparganii, 50g of safflower, 75g of salvia miltiorrhiza, 125g of radix isatidis, 100g of radix ophiopogonis, 75g of thunberg fritillary bulb, 75g of rhizoma alismatis, 75g of periostracum cicada, 50g of fried chicken' S gizzard-membrane, 75g of semen oroxyli and 125g of dandelion;

s3, mixing the rest components in S1 uniformly, adding 70% ethanol, extracting twice at 75 ℃, adding 10 times of ethanol by weight of the raw materials for the first time and 8 times of ethanol by weight of the raw materials for the second time, wherein the extraction time is 2 hours each time, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.05 at 60 ℃, drying, and crushing to obtain a dry paste powder to obtain a component B;

s4, uniformly mixing the component B obtained in the step S3 and the component A obtained in the step S2, adding 1g of dextrin and 4g of powdered sugar, uniformly mixing, performing spray granulation, and finishing granules to obtain the granules.

Example 2

A Chinese medicinal composition comprises Lasiosphaera Seu Calvatia 20g, Curcumae rhizoma 120g, flos Lonicerae 120g, semen Persicae 50g, radix scrophulariae 50g, rhizoma Sparganii 50g, Carthami flos 50g, Saviae Miltiorrhizae radix 70g, radix Isatidis 120g, radix Ophiopogonis 90g, Bulbus Fritillariae Thunbergii 70g, Alismatis rhizoma 70g, periostracum Cicadae 70g, endothelium corneum Gigeriae Galli 50g, semen Oroxyli 70g, and herba Taraxaci 120 g; the preparation method comprises the following steps:

s1, weighing 20g of puffball, 120g of vinegar-treated curcuma zedoary, 120g of honeysuckle, 50g of semen persicae, 50g of radix scrophulariae, 50g of vinegar-treated rhizoma sparganii, 50g of safflower, 70g of salvia miltiorrhiza, 120g of radix isatidis, 90g of radix ophiopogonis, 70g of thunberg fritillary bulb, 70g of rhizoma alismatis, 70g of periostracum cicada, 50g of fried chicken' S gizzard-membrane, 70g of semen oroxyli and 120g of dandelion;

s3, mixing the rest components in S1 uniformly, adding 80% ethanol, extracting twice at 70 ℃, adding 10 times of ethanol by weight of the raw materials for the first time and 8 times of ethanol by weight of the raw materials for the second time, wherein the extraction time is 3 hours each time, combining the extracting solutions, filtering, concentrating the filtrate to a clear paste with the relative density of 1.10 at 60 ℃, drying, and crushing to obtain a dry extract powder, thus obtaining a component B;

s4, uniformly mixing the component B obtained in the step S3 and the component A obtained in the step S2, adding 5g of starch, uniformly mixing, granulating, drying, grading, and encapsulating to obtain the capsule.

Example 3

A Chinese medicinal composition comprises Lasiosphaera Seu Calvatia 30g, Curcumae rhizoma 130g, flos Lonicerae 130g, semen Persicae preparata 60g, radix scrophulariae 60g, rhizoma Sparganii 60g, Carthami flos 60g, Saviae Miltiorrhizae radix 80g, radix Isatidis 130g, radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 80g, Alismatis rhizoma 80g, periostracum Cicadae 80g, endothelium corneum Gigeriae Galli 60g, semen Oroxyli 80g, and herba Taraxaci 130 g; the preparation method comprises the following steps:

s1, weighing 30g of puffball, 130g of vinegar-treated curcuma zedoary, 130g of honeysuckle, 60g of semen persicae, 60g of radix scrophulariae, 60g of vinegar-treated rhizoma sparganii, 60g of safflower, 80g of salvia miltiorrhiza, 130g of radix isatidis, 100g of radix ophiopogonis, 80g of thunberg fritillary bulb, 80g of rhizoma alismatis, 80g of periostracum cicada, 60g of fried chicken' S gizzard-membrane, 80g of semen oroxyli and 130g of dandelion;

s3, mixing the rest components in S1 uniformly, adding 75% ethanol, extracting twice at 80 ℃, adding 10 times of ethanol by weight of the raw materials for the first time and 8 times of ethanol by weight of the raw materials for the second time, wherein the extraction time is 2 hours each time, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.10 at 60 ℃, drying, and crushing to obtain a dry paste powder to obtain a component B;

s4, mixing the component B obtained in the step S3 and the component A obtained in the step S2 uniformly, adding 5g of starch, mixing uniformly, granulating, drying, grading, and tabletting to obtain the tablet.

Example 4

A Chinese medicinal composition comprises Lasiosphaera Seu Calvatia 28g, Curcumae rhizoma 128g, flos Lonicerae 128g, semen Persicae, radix scrophulariae 55g, rhizoma Sparganii 55g, Carthami flos 55g, Saviae Miltiorrhizae radix 75g, radix Isatidis 128g, radix Ophiopogonis 95g, Bulbus Fritillariae Thunbergii 75g, Alismatis rhizoma 75g, periostracum Cicadae 75g, endothelium corneum Gigeriae Galli 55g, semen Oroxyli 75g, and herba Taraxaci 128 g; the preparation method comprises the following steps:

s1, weighing 28g of puffball, 128g of vinegar-treated curcuma zedoary, 128g of honeysuckle, 55g of semen persicae, 55g of radix scrophulariae, 55g of vinegar-treated rhizoma sparganii, 55g of safflower, 75g of salvia miltiorrhiza, 128g of radix isatidis, 95g of radix ophiopogonis, 75g of thunberg fritillary bulb, 75g of rhizoma alismatis, 75g of periostracum cicada, 55g of fried chicken' S gizzard-membrane, 75g of semen oroxyli and 128g of dandelion;

s4, mixing the component B obtained in S3 and the component A obtained in S2 uniformly, adding a proper amount of refined honey, and making into pills.

Example 5

A Chinese medicinal composition comprises Lasiosphaera Seu Calvatia 22g, Curcumae rhizoma 120g, flos Lonicerae 120g, semen Persicae 55g, radix scrophulariae 55g, rhizoma Sparganii 55g, Carthami flos 55g, Saviae Miltiorrhizae radix 78g, radix Isatidis 120g, radix Ophiopogonis 98g, Bulbus Fritillariae Thunbergii 78g, Alismatis rhizoma 78g, periostracum Cicadae 78g, endothelium corneum Gigeriae Galli 55g, semen Oroxyli 78g, and herba Taraxaci 120 g; the preparation method comprises the following steps:

s1, weighing 22g of puffball, 120g of vinegar-treated curcuma zedoary, 120g of honeysuckle, 55g of semen persicae, 55g of radix scrophulariae, 55g of vinegar-treated rhizoma sparganii, 55g of safflower, 78g of salvia miltiorrhiza, 120g of radix isatidis, 98g of radix ophiopogonis, 78g of thunberg fritillary bulb, 78g of rhizoma alismatis, 78g of cicada slough, 55g of fried chicken' S gizzard-membrane, 78g of semen oroxyli and 120g of dandelion;

s4, mixing the component B obtained in the step S3 and the component A obtained in the step S2 uniformly, adding 1g of hydroxypropyl cellulose, 1g of magnesium stearate and 4g of powdered sugar, mixing uniformly, granulating, drying, grading and tabletting to obtain the buccal tablet.

Comparative example 1

A tablet prepared by the method of example 1 of the specification of patent application publication No. CN 1785406A.

Step one, weighing 25g of puffball, 125g of vinegar curcuma zedoary, 125g of honeysuckle, 50g of blanched peach seed, 50g of figwort root, 50g of vinegar rhizoma sparganii, 50g of safflower, 75g of salvia miltiorrhiza, 125g of isatis root, 100g of radix ophiopogonis, 75g of thunberg fritillary bulb, 75g of rhizoma alismatis, 75g of cicada slough, 50g of fried chicken's gizzard-membrane, 75g of oroxylum indicum and 125g of dandelion;

step two, primarily crushing the sixteen medicines, then carrying out superfine crushing, and sieving with a 400-mesh sieve;

and step three, uniformly mixing the powder obtained in the step two with auxiliary materials every 100g, pressing the powder into large tablets, and coating the tablets with a new film coating material to obtain the tablet.

Comparative example 2

Granules were prepared according to the method of the specification example 3 of the patent application publication No. CN 1899569A.

step two, taking honeysuckle, thunberg fritillary bulb and safflower with the prescription amount of 50 percent and puffball with the prescription amount of 2 percent, crushing the honeysuckle, the thunberg fritillary bulb and the safflower into fine powder, sieving the fine powder and uniformly mixing the fine powder for later use;

step three, crushing and remaining the vinegar curcuma zedoary, blanched peach seed, figwort root, vinegar rhizoma sparganii, salvia miltiorrhiza, isatis root, dwarf lilyturf tuber, alisma orientale, fried chicken's gizzard-membrane, cicada slough, oroxylum indicum, dandelion, honeysuckle, thunberg fritillary bulb, safflower and puffball, adding water for decocting twice, adding water with the weight of 10 times of the weight of the raw materials for decocting for the first time, adding water with the weight of 8 times of the weight of the raw materials for decocting for the second time, and decocting;

step four, combining the decoctions, filtering, concentrating the filtrate to thick paste with the relative density of 1.28-1.32 at 60 ℃, adding 95% ethanol to ensure that the ethanol content reaches 60%, uniformly stirring, standing for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating under reduced pressure at 60 ℃ to obtain clear paste with the relative density of 1.38-1.40;

and step five, mixing the clear paste obtained in the step four with the fine powder prepared in the step two and a proper amount of auxiliary materials, drying, crushing, preparing fine particles and packaging.

Comparative example 3

Granules were prepared according to the method of the specification example 4 of patent application publication No. CN 1544077A.

step two, taking half of honeysuckle, thunberg fritillary bulb and safflower respectively, taking one fifth of puffball, crushing into 120-140 fine powder, sieving, and uniformly mixing for later use;

step three, adding water into the rest 12 medicines and the rest of the four medicines, decocting twice, each time lasting for 2 hours, combining decoction liquids, filtering, concentrating filtrate to obtain extract with the relative density of 1.15-1.20 at the temperature of 65 ℃, adding ethanol to adjust the ethanol content to 60%, taking supernate, recovering ethanol, and concentrating to obtain thick paste with the relative density of 1.28-1.32 at the temperature of 85 ℃;

and step four, uniformly mixing the thick paste obtained in the step four with the fine powder prepared in the step three, 400g of cane sugar and 200g of starch, and granulating to obtain the compound.

Comparative example 4

Granules were prepared according to the method of the specification example 3 of the patent application publication No. CN 102363017A.

Weighing 25g of puffball, 125g of vinegar curcuma zedoary, 125g of honeysuckle, 50g of blanched peach kernel, 50g of figwort, 50g of vinegar rhizoma sparganii, 50g of safflower, 75g of salvia miltiorrhiza, 125g of isatis root, 100g of radix ophiopogonis, 75g of thunberg fritillary bulb, 75g of rhizoma alismatis, 75g of cicada slough, 50g of fried chicken's gizzard-membrane, 75g of oroxylum indicum and 125g of dandelion, and sixteen ingredients in total;

step two, crushing blanched semen persicae, half of thunberg fritillary bulb and half of safflower into fine powder for later use;

step three, adding water which is 10 times of the weight of the raw materials into the vinegar curcuma zedoary and the oroxylum indicum, extracting volatile oil for 2 times in a refluxing manner, collecting the volatile oil for later use, and combining the filtrates for later use;

step four, refluxing and extracting the cicada slough and the fried chicken gizzard membrane for 2 times by using 30 percent ethanol in an amount which is 8 times that of the cicada slough and the fried chicken gizzard membrane for 1 hour each time, combining the filtrates, and recovering the ethanol under reduced pressure to obtain an extracting solution for later use;

step five, reflux-extracting the salvia miltiorrhiza with 6 times of 80% ethanol for 2 times, wherein each time lasts for 1.5 hours, combining the two filtrates, and recovering the ethanol under reduced pressure to obtain an extracting solution for later use;

step six, decocting 10 puffball, honeysuckle, dandelion, isatis root, vinegar rhizoma sparganii, figwort root, rhizoma alismatis and radix ophiopogonis, half of safflower and half of thunberg fritillary bulb in weight by adding water for 2 times, adding 10 times of water for the first time, decocting for 2 hours, adding 8 times of water for the second time, decocting for 1.5 hours, combining filtrates of the two times, concentrating under reduced pressure to obtain clear paste with relative density of 1.08-1.10 (70 ℃),

and seventhly, mixing the clear paste obtained in the sixth step with the filtrate obtained after the volatile oil is extracted, the alcohol extract of the cicada slough, the fried chicken's gizzard-membrane and the alcohol extract of the salvia miltiorrhiza, concentrating the mixture under reduced pressure to clear paste with the relative density of 1.08-1.12 (70 ℃) at minus 0.08Mpa and 70 ℃, filtering the clear paste with a filter screen of more than 60 meshes, carrying out spray drying, uniformly mixing the obtained spray dried powder with the fine powder and a proper amount of dextrin, granulating, drying, finishing granules, spraying the volatile oil, and bagging to obtain the granules.

Main pharmacodynamic test

First, preparation of experimental medicine

1. Preparation of raw materials:

a Chinese medicinal composition comprises Lasiosphaera Seu Calvatia 25g, Curcumae rhizoma 125g, flos Lonicerae 125g, semen Persicae 50g, radix scrophulariae 50g, rhizoma Sparganii 50g, Carthami flos 50g, Saviae Miltiorrhizae radix 75g, radix Isatidis 125g, radix Ophiopogonis 100g, Bulbus Fritillariae Thunbergii 75g, Alismatis rhizoma 75g, periostracum Cicadae 75g, endothelium corneum Gigeriae Galli 50g, semen Oroxyli 75g, and herba Taraxaci 125 g; corresponding pharmaceutical preparations were prepared according to the methods of the present invention of example 1, comparative example 2, comparative example 3, and comparative example 4, respectively. Wherein:

group I: prepared according to the method of the invention specification example 1.

Group A is as follows: tablets were prepared according to the method of comparative example 1.

Group B is as follows: granules were prepared according to the method of comparative example 2.

Group C is: granules were prepared according to the method of comparative example 3.

Group D is: granules were prepared according to the method of comparative example 4.

Secondly, the following steps: test procedure and test results

2.1, purpose of experiment:

through pharmacological experimental researches on anti-inflammation, analgesia, phlegm reduction, organism immunity improvement and the like of the group I and the group A, B, C, D, the group I and the group A, B, C, D are compared, and the strength of the pharmacological action is observed.

2.2, test method:

effects of group I and group A, B, C, D on mouse skin capillary permeability;

group I and group A, B, C, D effects on radiation-induced thermal pain in mice;

effect of group I and group A, B, C, D on the amount of sputum excretion from rats;

group I and group A, B, C, D influence on phagocytic function of mouse macrophages.

2.3 Effect on mouse skin capillary Permeability

2.3.1 Experimental materials

Animals: the Kunming mouse has both male and female bodies and has the weight of 18-22 g.

Medicine preparation: group I and group A, B, C, D five dose groups. The medicine is prepared by distilled water before experiment and administered by intragastric administration.

2.3.2 Experimental methods

60 Kunming mice, half of male and female, with the weight of 18-22 g, were randomly divided into 6 groups of 10 mice each.

Control group: perfusing the normal saline with the same volume as the stomach;

experimental groups: the group I and the group A, B, C, D were administered by gavage with 4.8 g/kg. Continuously administering 7D, after 1h of last administration, injecting 0.5% Evans blue 0.2ml/10g per tail vein, smearing xylene 0.04 ml/mouse on abdomen depilatory after 15min, killing mouse after 20min, and cutting blue-stained skin. Placing acetone: soaking in normal saline (7: 3) solution for 48 h. After centrifugation, the supernatant was taken and the absorbance was measured colorimetrically at a spectrophotometer wavelength of 61 Onm.

2.3.3, experimental results: as shown in table 1.

TABLE 1 Effect on mouse skin capillary Permeability

P < 0.01 compared to control; the ratio of delta P to group I is less than 0.05; the ratio of group # P to group D is < 0.05.

As can be seen from the results in Table 1, the groups I and A, B, C, D have significant inhibitory effect on the hyperfiltration of the skin capillaries of the mice, and have very significant difference (P < 0.01) compared with the control group; the D dose group has significant difference (P < 0.05) compared with the I group; A. b, C dose groups showed significant differences compared to the D dose group (P < 0.05). It can be seen that the anti-inflammatory effect of the example I group of the present invention is stronger than that of the A, B, C, D group.

2.4 Effect on radiation-induced pain in mice

2.4.1 Experimental materials

2.4.2 Experimental methods

The mouse is fixed in a mouse barrel, a light beam is focused by a convex lens and then irradiates the junction of the middle and lower portions 1/3 of the rat tail, and the time from starting the light source to the rapid swing of the rat tail, namely the tail flicking latency period, which is also called pain threshold, is measured. The basal pain threshold of the mice before administration is determined, and the allergic or sluggish animals with the basal pain threshold less than 3s or more than 10s are rejected.

The screened mice were 60, half male and half female, randomly divided into 6 groups of 10 mice each.

Control group: perfusing the normal saline with the same volume as the stomach;

experimental groups: the group I and the group A, B, C, D were administered by gavage with 4.8 g/kg. The administration was continued for 7D 1 time a day, and 1h after the last administration, the mice were subjected to the radiant heat stimulation. Recording the time of tail flick reaction after 1h of administration, namely the pain threshold after administration.

2.4.3, experimental results: see table 2.

TABLE 2 Effect on radiation-induced thermal pain in mice

As can be seen from the results in Table 2, the pain threshold of the mice with radiation induced thermal pain can be significantly improved in the groups I and A, B, C, D, and the difference is very significant compared with the control group (P is less than 0.01); the D dose group has significant difference (P < 0.05) compared with the I group; A. b, C dose groups showed significant differences compared to the D dose group (P < 0.05). It can be seen that the analgesic effect of the group I of the present invention is stronger than that of the group A, B, C, D.

2.5 Effect on the amount of sputum discharged from rats

2.5.1 Experimental materials

Animals: SD rats have both male and female bodies, and the weight of the SD rats is 200-250 g.

2.5.2 Experimental methods

SD rats 60 in half of male and female, with a body weight of 200-250 g, were randomly divided into 6 groups of 10 rats each.

Control group: perfusing the normal saline with the same volume as the stomach;

experimental groups: the group I and the group A, B, C, D were administered by intragastric administration at 2.4 g/kg. Continuously administering 7D for 1 time every day, fasting for 8h after last administration, anesthetizing rat with urethane (1g/kg), fixing in a face-up position, cutting off fur in the middle of neck, separating trachea, pricking a small hole between two cartilages at the center of lower edge of thyroid cartilage with a sharp injection needle, inserting a glass capillary tube, and allowing the capillary tube to just contact with the bottom surface of trachea to absorb sputum at the rear part of trachea. When the capillary glass tube is filled with sputum, a capillary tube is replaced immediately. The tracheal secretion of each group of rats at 2h after administration was recorded, and the hourly sputum secretion of the rats was calculated.

2.5.3, experimental results: see table 3.

TABLE 3 Effect on the amount of sputum excretion from rats

As can be seen from the results in Table 3, the groups I and A, B, C, D significantly increased the amount of sputum excretion in rats, with a very significant difference (P < 0.01) compared to the control group; the D dose group has significant difference (P < 0.05) compared with the I group; A. b, C dose groups showed significant differences compared to the D dose group (P < 0.05). As can be seen, the group I of the present invention has a stronger expectorant effect than the group A, B, C, D.

2.6 Effect on phagocytic function of mouse macrophages

2.6.1 Experimental materials

2.6.2 Experimental methods

Control group: perfusing the normal saline with the same volume as the stomach;

experimental groups: the group I and the group A, B, C, D were administered by gavage with 4.8 g/kg. Continuously administering 7D, 1 time every day, and 2h after the last administration, injecting 0.4ml of 5% chicken red blood cells into the abdominal cavity of each mouse, killing the animal after 12 h by removing the cervical vertebra, injecting 2ml of physiological saline into the abdominal cavity, smearing with abdominal cavity liquid, staining, counting under an oil microscope, and calculating the phagocytosis index of chicken red blood cells phagocytized by abdominal cavity macrophages.

2.6.3, Experimental results: see table 4.

TABLE 4 Effect on phagocytic function of mouse macrophages

As can be seen from the results in Table 4, the groups I and A, B, C, D have significant effect in enhancing the phagocytic function of macrophages, and have a significant difference (P < 0.01) compared with the control group; the D dose group has significant difference (P < 0.05) compared with the I group; A. b, C dose groups showed significant differences compared to the D dose group (P < 0.05). Thus, the group I of the present invention has a stronger effect of enhancing the body immunity than the group A, B, C, D.

2.7 Experimental results and conclusions

2.7.1, experimental results:

the group I and the group A, B, C, D in the embodiment of the invention have obvious inhibition effect on hyperfiltration of the skin capillary vessel of the mouse; the pain threshold of the radiation-induced thermal pain mouse can be obviously improved; the sputum excretion of the rat is obviously increased; can obviously enhance the phagocytic function of macrophages.

2.7.2, conclusion:

compared with A, B, C, D group, group I of the invention has relatively strong pharmacological actions such as anti-inflammatory, analgesic, phlegm-resolving, immunity-improving, etc., so compared with A, B, C, D group, group I of the invention has relatively strong efficacies of clearing away heat and toxic material, promoting blood circulation by removing blood stasis, promoting diuresis and resolving phlegm.

In addition, the applicant evaluated the therapeutic effects of the Chinese medicinal compositions obtained in embodiments 1 to 5 of the present invention from four aspects, namely, the absorption value of the anti-inflammatory effect, the pain threshold after drug treatment of the analgesic effect, the sputum excretion amount of the phlegm-resolving effect, and the phagocytic index of the immunity of the organism, in the same manner as the above-mentioned main pharmacodynamic test methods, in the control group: and (5) irrigating the stomach with the same volume of normal saline. The comparative group was granules obtained by the method of comparative example 4. The results are shown in Table 5.

TABLE 5 pharmacological effects of the pharmaceutical compositions of the preparations obtained in examples 1 to 5 and comparative example 4

As can be seen from the results in Table 5, compared with the granules obtained by the method in comparative example 4, the Chinese medicinal composition obtained by the methods in examples 1 to 5 of the present invention has the optimal pharmacological effect, and the methods in examples 1 to 5 of the present invention have the advantages of simple process operation, low cost, meeting the requirements of industrial production, and having very broad application prospects.

In addition, multiple pharmacological tests and clinical tests prove that the preparation method disclosed by the embodiment 1 of the invention not only makes great progress in preparing a pharmaceutical preparation for treating adult throat diseases, but also has a very wide application prospect in preparing a pharmaceutical preparation for treating children vocal nodule and vocal cord polyp.

The present invention is not limited to the above preferred embodiments, and any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. The preparation method of the traditional Chinese medicine composition is characterized by comprising the following steps of:

2. The preparation method of the traditional Chinese medicine composition according to claim 1, wherein in S3, the reflux extraction times are 2 times, and the extraction time is 2-3 h.

3. The method for preparing a Chinese medicinal composition according to claim 1, wherein in the step of reflux extraction twice in S3, 70-80% ethanol is added in an amount 10 times the weight of the raw materials for the first time, and 70-80% ethanol is added in an amount 8 times the weight of the raw materials for the second time.

4. The method for preparing a Chinese medicinal composition according to claim 1, wherein in S3, the temperature of the two reflux extractions is 70-80 ℃.

5. The method of claim 1, wherein in S3, the relative density of the clear paste at 60 ℃ is 1.05-1.10.

6. The method for preparing a Chinese medicinal composition according to claim 1, wherein in S4, the pharmaceutical preparation comprises granules, capsules, tablets and pills.

7. The method for preparing a Chinese medicinal composition according to claim 1, wherein in S4, the adjuvant is one or more of dextrin, sugar powder, starch, and refined honey.

8. A Chinese medicinal composition prepared according to the preparation method of any one of claims 1-7.

9. Use of the Chinese medicinal composition of claim 1 for the preparation of a pharmaceutical preparation for the treatment of vocal nodule and vocal cord polyp in children.