Traditional Chinese medicine compound preparation based on antibiosis and anti-inflammation and preparation method thereof

Abstract

The invention provides an antibacterial and anti-inflammatory traditional Chinese medicine compound preparation and a preparation method thereof. The compound preparation is prepared from the following raw materials in parts by weight: 10 to 30 parts of fructus forsythiae, 10 to 25 parts of flos chrysanthemi, 15 to 40 parts of rhizoma imperatae, 5 to 10 parts of herba menthae, 0.5 to 3 parts of borneol and 0.1 to 3 parts of camphor. The main innovation point of the formula is that triple mechanisms of clearing away heat and toxic materials, repairing mucous membranes and rapidly relieving pain are innovatively fused; instantaneous mucous membrane permeation is realized through volatile components (borneol, mint and camphor), and itching and pain are quickly relieved; forsythia suspense-chrysanthemum-couch grass root synergistically inhibit release of inflammatory factors and radically diminish swelling, and the specific functions are as follows: forsythia suspense has antibacterial and antiviral effects and inhibits streptococcus in throat; chrysanthemum has the effects of clearing liver fire, relieving heat toxin and eliminating mucosal hyperemia; the couch grass root can promote salivation, moisten dryness and repair damaged mucosa; mint is capable of quickly relieving itching and promoting transmembrane absorption of the medicine; borneol is used for instantly cooling and easing pain and opening a cell channel; and camphor and local anesthesia enhance the pain relieving time efficiency.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine compound preparation for treating and relieving acute and chronic pharyngitis and sore throat and a preparation method thereof. BACKGROUND

[0002] The pharynx connects the esophagus to the stomach and the larynx to the trachea and lungs. Pain in the throat is mainly caused by inflammation, except for trauma. Any substance that irritates the mucous membranes of the throat and mouth can cause throat pain. They include: viral and bacterial infections, allergic reactions, dust, cigarettes, exhaust fumes, hot beverages or food, tooth or gum infections that sometimes also involve the throat, chronic cough, extremely dry environments, acid reflux, and loud talking can also irritate the throat. Hoarseness is a common side effect.

[0003] Throat pain is often caused by viral / bacterial infection, overuse of the voice or environmental irritation, which can be caused by a variety of factors. The following are some common causes: Inflammation: Most throat pain is considered to be inflammation of the pharynx and inflammation of the larynx, and some is caused by a sore throat.

[0004] Allergy: It is considered that the patient has an allergic reaction after eating a certain substance, which causes congestion and edema of the pharyngeal mucosa, so the pain is particularly obvious.

[0005] Bacterial infection: such as streptococcal pharyngitis, tonsillitis, epiglottitis, and uvulitis; in rare cases, sexually transmitted diseases such as gonorrhea and chlamydia infection can also cause throat pain.

[0006] Viral infection: Most throat pain is caused by viral infection.

[0007] Other factors: Prolonged loud talking can also cause throat pain.

[0008] If the throat pain does not decrease or is accompanied by severe symptoms such as high fever and difficulty breathing, medical treatment should be sought as soon as possible for professional examination and treatment.

[0009] Existing western medicines contain antibiotics or hormones, which are prone to drug resistance. Traditional Chinese medicine preparations such as sprays and lozenges have certain effects, but they generally have the problems of slow onset and poor durability.

[0010] Existing traditional Chinese medicines have the following problems: traditional prescriptions such as Zhicuo Powder and Xingsu Powder are not specific enough for treating phlegm-heat obstructing the lung or wind-dryness damaging the lung type of cough.

[0011] Therefore, there is an urgent need for a traditional Chinese medicine compound preparation for treating and relieving acute and chronic pharyngitis and sore throat and a preparation method thereof. SUMMARY

[0012] In order to solve the above problems, the application provides an anti-bacterial and anti-inflammatory traditional Chinese medicine compound preparation for treating and relieving acute and chronic pharyngitis and sore throat and a preparation method thereof.

[0013] In one aspect, the application discloses an anti-bacterial and anti-inflammatory traditional Chinese medicine compound preparation, which is composed of the following raw materials in parts by weight: forsythia suspense 10-30 parts, chrysanthemum 10-25 parts, sedge root 15-40 parts, mint 5-10 parts, borneol 0.5-3 parts, and camphor 0.1-3 parts.

[0014] Preferably, the compound preparation is further composed of the following raw materials in parts by weight: forsythia suspense 15-25 parts, chrysanthemum 12-20 parts, sedge root 20-30 parts, mint 6-8 parts, borneol 0.6-2 parts, and camphor 0.2-2 parts.

[0015] Preferably, the compound preparation is an oral liquid, a syrup, a mixture or a spray.

[0016] In another aspect, the application discloses a preparation method of the compound preparation, which comprises the following steps: S1, prescription amount of medicinal materials forsythia suspense, chrysanthemum and mint are put into an extraction tank, a proper amount of water is added, and volatile oil is extracted by heating for 3-5 hours, and the water extract after distillation is collected in another device after filtration; S2, the filtrate is transferred to a concentrator, concentrated under reduced pressure to a clear paste with a relative density of 1.02-1.06, the temperature is ≤80℃, the vacuum degree is -0.03--0.10Mpa, and the post-2-8℃ cold storage is 12-24 hours; S3, the clear paste is centrifuged, and then the centrifugal liquid is heated to micro-boiling under normal pressure and kept for 0.5-1 hour, and then filtered to obtain the extract; S4, the volatile oil is added to a stabilizer, stirred and dispersed to obtain a mixture; borneol and camphor are completely dissolved in a proper amount of ethanol to obtain a mixture, and the two kinds of mixtures are mixed with each other and stirred uniformly, then a bacteriostatic agent, a flavoring agent and other stabilizers are added, stirred and dissolved, and then purified water is added to the total amount of the prescription, and stirred uniformly; S5, the liquid after constant volume is first filtered through a 2-3μm plate and frame filter for primary filtration, and then filtered through a 0.22-0.45μm plate and frame filter for fine filtration.

[0017] Preferably, the stabilizer is one or more of hydroxypropyl β-cyclodextrin, β-cyclodextrin, sulfobutyl β-cyclodextrin, polysorbate 80, PEG400, gum arabic, agar, methyl cellulose and hydroxypropyl methyl cellulose.

[0018] Preferably, the amount of the stabilizer is 5-10% of the amount of the volatile oil.

[0019] Preferably, the bacteriostatic agent is one or both of potassium sorbate and sodium benzoate.

[0020] Preferably, the flavoring agent is one or more of sucrose, single sugar syrup, aromatic sugar syrup, stevioside, sodium saccharin, aspartame.

[0021] Compared with the prior art, the present application has the following advantages: The main innovation of the present application is the use of the innovative triple mechanism of "clearing heat and detoxifying-mucosa repair-rapid analgesia"; the volatile components (bitter orange peel, mint, camphor) achieve instantaneous mucosa penetration, rapid itching and pain relief; Forsythia suspensa-chrysanthemum-maigan synergistically inhibit the release of inflammatory factors, and the root cause of swelling is eliminated. The specific functions are as follows: Forsythia suspensa has antibacterial and antiviral properties and inhibits streptococcus in the throat; chrysanthemum clears liver fire and removes heat and toxins, and eliminates mucosal hyperemia; maigan restores damaged mucosa; mint rapidly relieves itching and promotes drug transmembrane absorption; bitter orange peel provides instantaneous cooling and analgesia, and opens cell channels; camphor provides local anesthesia and enhances the analgesic effect. DETAILED DESCRIPTION

[0022] The technical solutions of the present application will be described below in conjunction with the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments.

[0023] Embodiment 1 The compound preparation provided in this embodiment is an oral liquid, and a preparation method of the oral liquid is also provided.

[0024] The prescription of the oral liquid is as follows: Forsythia suspensa 15 parts, chrysanthemum 12 parts, maigan 20 parts, mint 6 parts, bitter orange peel 0.6 parts, and camphor 0.2 parts. The parts refer to the weight parts of the raw materials in grams.

[0025] The preparation method of the oral liquid is as follows: S1, the prescription amount of medicinal materials Forsythia suspensa, chrysanthemum, and mint are put into an extraction tank, and a proper amount of water is added to extract volatile oil for 3-5 hours. The water extract after distillation is collected in another device after filtration; S2, the filtrate is transferred to a concentrator, and concentrated under reduced pressure to a clear paste with a relative density of 1.02-1.06 (60℃), a temperature ≤80℃, a vacuum degree of -0.03--0.10Mpa, and then placed in a 2-8℃ cold storage for 12-24 hours; S3, the clear paste is centrifuged using a tubular centrifuge, and then the centrifugal liquid is heated under normal pressure and kept at a slight boil for 0.5-1 hour, and filtered to obtain an extract; S4, add volatile oil into stabilizer polysorbate 80 three parts, stir and disperse to get mixture; dissolve menthol and camphor completely in two parts of 95% ethanol to get mixture, mix the two mixtures together, stir evenly, then add potassium sorbate, flavoring agent sucrose 0.01 part, aromatic syrup 2 parts, stevioside 0.01 part, and other stabilizer sulfobutyl β-cyclodextrin, stir and dissolve, then add purified water to the total amount of the batch prescription, stir evenly; S5, the drug solution after constant volume is first filtered through a 2 μm plate and frame filter, then filtered through a 0.22 μm plate and frame filter, then filled with a filling machine, the container is a high-density polyethylene bottle for oral liquid medicine, each bottle contains 10 ml, and the preparation is completed.

[0026] Example 2 The compound preparation provided by the embodiment is a spray, and a preparation method of the spray is also provided.

[0027] The prescription of the spray is: forsythia 25 parts, chrysanthemum 20 parts, sedge 30 parts, mint 8 parts, menthol 1 part, and camphor 1 part. The part refers to the weight of the raw material in grams.

[0028] The preparation method of the spray is: S1, put the prescription amount of medicinal materials forsythia, chrysanthemum, and mint into an extraction tank, add an appropriate amount of water, and heat to extract volatile oil for 3-5 hours. The distilled water extract is collected in another container after filtration; S2, transfer the filtrate to a concentrator, concentrate under reduced pressure to a clear paste with a relative density of 1.02-1.06 (60℃), temperature ≤80℃, vacuum degree -0.03--0.10 Mpa, and then store at 2-8℃ for 12-24 hours; S3, centrifuge the clear paste using a tubular centrifuge, then heat the centrifuged liquid to micro-boiling under normal pressure and keep it for 0.5-1 hour, and filter to obtain the extract; S4, add volatile oil into stabilizer polysorbate 80 three parts, stir and disperse to get mixture; dissolve menthol and camphor completely in two parts of 95% ethanol to get mixture, mix the two mixtures together, stir evenly, then add potassium sorbate, flavoring agent sucrose 0.01 part, aromatic syrup 2 parts, stevioside 0.01 part, and other stabilizer sulfobutyl β-cyclodextrin, stir and dissolve, then add purified water to the total amount of the batch prescription, stir evenly; S5, the drug solution after constant volume is first filtered through a 2 μm plate and frame filter, then filtered through a 0.22 μm plate and frame filter, then filled with a filling machine, the container is a high-density polyethylene bottle for oral liquid medicine, each bottle contains 10 ml, and the preparation is completed.

[0029] Example 3 The compound preparation provided by the embodiment is a syrup, and a preparation method of the syrup is also provided.

[0030] The prescription of the syrup is: 25 parts of forsythia, 20 parts of chrysanthemum, 30 parts of horsetail, 8 parts of mint, 1 part of borneol, and 1 part of camphor. The part refers to the weight part of the raw material in grams.

[0031] The preparation method of the syrup is as follows: S1, the prescription amount of medicinal materials forsythia, chrysanthemum, and mint are put into an extraction tank, and a proper amount of water is added to extract volatile oil for 3-5 hours. The water extract after distillation is filtered and collected in another device; S2, the filtrate is transferred to a concentrator, and concentrated under reduced pressure to a clear paste with a relative density of 1.02-1.06 (60℃), a temperature ≤80℃, and a vacuum degree of -0.03--0.10Mpa. The paste is then placed in a 2-8℃ refrigerator for 12-24 hours; S3, the clear paste is centrifuged using a tubular centrifuge, and then the centrifugal liquid is heated under normal pressure and kept at a slight boil for 0.5-1 hour. After filtration, the extract is obtained; S4, the volatile oil is added to 3 parts of stabilizer polysorbate 80, stirred and dispersed to obtain a mixture. 2 parts of borneol and camphor are completely dissolved in a proper amount of 95% ethanol to obtain a mixture. The two mixtures are mixed with each other, stirred uniformly, and then 3 parts of potassium sorbate, 0.01 part of stevioside, and other stabilizers sulfobutyl β-cyclodextrin are added. After stirring and dissolving, a proper amount of syrup and honey is added, quantified, stirred uniformly, and filled into 100ml oral liquid bottles using a filling machine. Thus, the compound preparation is obtained.

[0032] Test Example 1: Treatment Efficacy Test Test Design: 96 SD rats were used, SPF level, half male and half female, body weight 160-200g, 5-6 weeks old, randomly divided into 4 groups according to gender and body weight, 24 animals in each group, namely control group, model group, Example 1 group, and Example 2 group (Example 1 group and Example 2 group are the compound preparations prepared in Examples 1 and 2, respectively). Except for the control group, the rest of the animals in each group were smeared with 2.5% ammonia water on the pharynx (morning modeling) using a sterile cotton swab, once a day for 10 consecutive days. The control group was smeared with normal saline on the pharynx using the same method. Before administration, the drugs were prepared into corresponding concentrations. At the same time of modeling, the animals in each group were administered orally at 8ml·kg-1 twice a day for 10 consecutive days. The control group and the model group were administered with the same volume of pure water.

[0033] Index Detection: General physiological observation: During the administration period, the general clinical observation of each group of animals was carried out daily, including the physiological conditions such as mental state and general behavior, and the weight was measured on the 5th and 10th day.

[0034] Cough detection: 1h after the last administration at 10 days, 6% ammonia solution was used to induce cough in rats (12 rats), and the cough frequency and cough latency of rats in each group within 10min were detected by cough induction instrument.

[0035] Detection of IL-6, TNF-α, COX-2 content and NF-κB, IκB protein expression in pharyngeal tissue: the next day after the last administration, the remaining animals (12) were euthanized by the same method, and two pharyngeal tissues were taken, one of which was homogenized by a high-speed homogenizer according to the ratio of pharyngeal mass (g): 0.9% sodium chloride injection (mL) = 1:9, and the homogenate was prepared, centrifuged at 12000r·min-1 for 12min in a 2-8℃ environment, and the supernatant was taken, and the IL-6, TNF-α, COX-2 content in the pharyngeal tissue was detected by ELISA kit. The specific data are shown in Tables 1, 2 and 3.

[0036] Table 1: Effect of the embodiment of the present application on the body weight of rats ±s) Note: compared with the model group, **P<0.01; compared with the control group, ##P<0.01.

[0037] It can be seen from the results that the body weight of the example 1 group and the example 2 group is heavier than that of the model group, which indicates that the examples provided by the present application have a significant therapeutic effect.

[0038] Table 2: Effect of the embodiment of the present application on cough of acute pharyngitis model of rats ±s) Note: compared with the model group, *P<0.01; compared with the control group, ## P<0.01.

[0039] As shown in Table 2, compared with the control group, the cough latency of the model group was significantly shortened (P<0.01), and the cough frequency was significantly increased (P<0.01). Compared with the model group, the cough latency of each group after administration was significantly prolonged (P<0.01), and the cough frequency was significantly reduced.

[0040] Table 3: Effect of the embodiment of the present application on cytokines of acute pharyngitis model of rats ±s) Note: compared with the control group, # P<0.05, ## P<0.01.

[0041] As shown in Table 3, compared with the control group, the COX-2, IL-6 and TNF-α contents in the pharyngeal tissue of the model group rats were significantly increased (P<0.05 or P<0.01); compared with the model group, the example 1, 2 groups and the positive control group could significantly reduce the COX-2, IL-6 and TNF-α levels (P<0.05 or P<0.01).

[0042] The above detailed description is only for the specific implementation of the feasible embodiments of the present application, and is not intended to limit the protection scope of the present application. Any equivalent embodiments or changes made without departing from the spirit of the present application shall be included in the protection scope of the present application.

[0043] It is obvious for those skilled in the art that the present application is not limited to the details of the above exemplary embodiments, and can be realized in other specific forms without departing from the spirit or essential characteristics of the present application. Therefore, the embodiments should be regarded as exemplary and non-limiting, and the scope of the present application is defined by the appended claims rather than the above description, and all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present application.

[0044] In addition, it should be understood that although the present specification is described in terms of embodiments, not every embodiment contains only one independent technical solution, and the description manner of the specification is only for clarity, and those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be properly combined to form other implementation forms which can be understood by those skilled in the art.

Claims

1. An antibacterial and anti-inflammatory traditional Chinese medicine compound preparation, characterized in that, The compound preparation is composed of the following raw materials in parts by weight: forsythia 10-30 parts, chrysanthemum 10-25 parts, sedge root 15-40 parts, mint 5-10 parts, borneol 0.5-3 parts, camphor 0.1-3 parts.

2. The complex preparation according to claim 1, characterized in that, The compound preparation is composed of the following raw materials in parts by weight: forsythia 10-30 parts, chrysanthemum 10-25 parts, sedge root 15-40 parts, mint 5-10 parts, borneol 0.5-3 parts, camphor 0.1-3 parts.

3. The complex preparation according to claim 2, characterized in that, The compound preparation is oral liquid, syrup, mixture or spray.

4. The method of claim 1-3, wherein the preparation method is characterized in that, The method comprises the following steps: S1, put the prescribed amount of medicinal materials forsythia, chrysanthemum and mint into the extraction tank, add appropriate amount of water, heat and extract volatile oil for 3-5 hours, and collect the water extract after distillation in another device; S2, transfer the filtrate to the concentrator, concentrate under reduced pressure to a clear paste with a relative density of 1.02-1.06, temperature ≤80℃, vacuum degree -0.03--0.10Mpa, and then place in 2-8℃ cold storage for 12-24 hours; S3, centrifuge the clear paste, and then heat the centrifugate under normal pressure and keep it in a state of slight boiling for 0.5-1 hour, and filter to obtain the extract; S4, add the volatile oil to the stabilizer, stir and disperse to obtain a mixture; dissolve the borneol and camphor completely in appropriate amount of ethanol to obtain a mixture, mix the two mixtures, stir uniformly, then add the bacteriostatic agent, flavoring agent and other stabilizers, stir and dissolve, and then add purified water to the total amount of the batch prescription, and stir uniformly; S5, first filter the liquid after constant volume through a 2-3μm plate and frame filter, and then filter through a 0.22-0.45μm plate and frame filter, and then obtain the product.

5. The method of claim 4, wherein, The stabilizer is one or more of hydroxypropyl β-cyclodextrin, β-cyclodextrin, sulfobutyl β-cyclodextrin, polysorbate 80, PEG400, gum arabic, agar, methyl cellulose and hydroxypropyl methyl cellulose.

6. The method of claim 5, wherein, The amount of the stabilizer is 5-10% of the amount of volatile oil.

7. The method of claim 6, wherein, The bacteriostatic agent is one or both of potassium sorbate and sodium benzoate.

8. The method of claim 7, wherein, The flavoring agent is one or more of sucrose, monosaccharide syrup, aromatic sugar syrup, stevioside, sodium saccharin and aspartame.

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