A kind of ear drops for suppurative otitis media and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to an ear drop for suppurative otitis media and a preparation method thereof. The ear drop comprises the following raw materials: houttuynia cordata, patrinia salviae, thorns of Gleditsia sinensis, fresh calamus tatarinowii, coptis chinensis, xanthium sibiricum, white scutellaria baicalensis, red ochre and cuttlefish bone; the preparation method comprises the following steps: pre-treating red ochre; pre-treating xanthium sibiricum; mixing the treated red ochre with the treated xanthium sibiricum and houttuynia cordata, patrinia salviae, thorns of Gleditsia sinensis, fresh calamus tatarinowii, coptis chinensis, white scutellaria baicalensis and cuttlefish bone, repeatedly decocting three times, combining the three filtrates, filtering after standing, taking the filtrate, and preparing the ear drop for suppurative otitis media. The prepared ear drop for suppurative otitis media has the advantages of small toxic and side effects and low drug resistance, and the research and development of the traditional Chinese medicine compound ear drop is helpful to reduce the abuse of antibiotics, and provides a new treatment method for clinical decision-making of patients with suppurative otitis media.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, in particular to an ear drop for suppurative otitis media and a preparation method thereof. Background Art

[0002] Purulent otitis media is a common infectious disease in otolaryngology with a high incidence rate. Patients often suffer from severe ear pain, fever and other symptoms. If not treated in time, it may cause serious complications such as mastoiditis and labyrinthitis, endangering the patient's hearing health.

[0003] At present, the clinical treatment of suppurative otitis media is mainly based on the results of bacterial culture to select appropriate antibiotics for targeted treatment. However, with the widespread use of antibiotics, the problem of drug resistance has become increasingly prominent, leading to the phenomenon of prolonged illness and increasing the risk of complications. Summary of the invention

[0004] The purpose of the present invention is to provide an ear drop for suppurative otitis media and a preparation method thereof, aiming to solve the technical problem in the prior art that with the widespread use of antibiotics, the problem of drug resistance becomes increasingly prominent, leading to the phenomenon of clinical protracted disease and increased risk of complications.

[0005] To achieve the above object, the present invention adopts a suppurative otitis media ear drop, which is prepared from the following raw materials in parts by weight:

[0006] 15-35 parts of Houttuynia cordata, 15-35 parts of Patrinia scabra, 15-35 parts of Gleditsia sinensis, 15-35 parts of fresh Acorus calamus, 15-35 parts of Coptis chinensis, 5-15 parts of Xanthium sibiricum, 15-35 parts of Bletilla striata, 15-35 parts of Oleaster ochre, and 15-35 parts of Cuttlefish bone.

[0007] The present invention also provides a method for preparing a suppurative otitis media ear drop, comprising the following steps:

[0008] Pre-treating red ochre;

[0009] Pre-treating Xanthium sibiricum;

[0010] The processed red ochre is mixed with the processed Xanthium sibiricum and Houttuynia cordata, Patrinia scabra, Gleditsia sinensis, fresh Acorus calamus, Coptis chinensis, Bletilla striata and Sepia sepia, and the mixture is decocted three times, the three filtrates are combined, allowed to stand and then filtered, and the filtrate is taken to prepare the suppurative otitis media ear drops.

[0011] Wherein, in the step of pre-treating red ochre:

[0012] Take red ochre, add it to the boiling water, continue heating over high heat, and after boiling, switch to low heat and simmer. The simmering time is 1 to 4 hours. Filter the cooked liquid, remove the residue and set aside.

[0013] Wherein, in the step of pre-treating the Fructus Xanthii:

[0014] Wash and dry the Xanthium sibiricum. Preheat the pan and stir-fry over medium heat until the surface turns yellow-brown and the thorns are charred.

[0015] Among them, after the step of heating and frying over medium heat until the surface turns yellow-brown and the spines on the surface are charred and then removing from the pan:

[0016] Wait for the Xanthium sibiricum to cool to room temperature, then grind and remove the thorns.

[0017] Among them, after mixing the processed red ochre with the processed Xanthium sibiricum and Houttuynia cordata, Patrinia scabra, Gleditsia sinensis, fresh Acorus calamus, Coptis chinensis, Ampelopsis pilosula, and Sepia ocellaris, the decoction is repeated three times, the three filtrates are combined, filtered after standing, and the filtrate is taken to prepare the suppurative otitis media ear drops, and the decoction process is:

[0018] Add the mixed herbs into water, bring to a boil, and then simmer for 1 to 4 hours.

[0019] The invention discloses an ear drop for treating suppurative otitis media and a preparation method thereof. The ear drops are prepared by using the following raw materials in parts by weight: 15-35 parts of houttuynia cordata, 15-35 parts of patrinia herb, 15-35 parts of thorns of honey locust, 15-35 parts of fresh calamus, 15-35 parts of coptis chinensis, 5-15 parts of xanthium sibiricum, 15-35 parts of white scutellaria, 15-35 parts of red ochre and 15-35 parts of cuttlefish; pre-treating red ochre; pre-treating xanthium sibiricum; mixing the treated red ochre with the treated xanthium sibiricum and houttuynia cordata, patrinia herb, thorns of honey locust, fresh calamus, coptis chinensis, white scutellaria and cuttlefish, repeating the decoction three times, combining the three filtrates, filtering after standing, taking the filtrate and finally obtaining the ear drop for treating suppurative otitis media and a preparation method thereof. The ear drops for suppurative otitis media have the advantages of small toxic and side effects and low drug resistance, and the research and development of Chinese medicine compound ear drops helps to reduce the abuse of antibiotics and provide a new treatment method for clinical decision-making of patients with suppurative otitis media. The extraction technique adopted by the invention can extract and utilize the effective active ingredients of each medicine to the maximum extent, maximize the efficacy of each medicine and the efficacy of health products, improve their bioavailability, and correspondingly reduce the dosage of native medicinal materials. The ear drops for suppurative otitis media and the preparation method thereof can be applied to the preparation of pharmaceutical tablets, pharmaceutical granules, pharmaceutical capsules and pharmaceutical injections. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0021] Figure 1 It is a step flow chart of Example 1 of the present invention.

[0022] Figure 2 It is a step flow chart of Example 2 of the present invention.

[0023] Figure 3 It is a step flow chart of Example 3 of the present invention. DETAILED DESCRIPTION

[0024] The present invention provides an ear drop for suppurative otitis media, which is prepared from the following raw materials in parts by weight:

[0025] 15-35 parts of Houttuynia cordata, 15-35 parts of Patrinia scabra, 15-35 parts of Gleditsia sinensis, 15-35 parts of fresh Acorus calamus, 15-35 parts of Coptis chinensis, 5-15 parts of Xanthium sibiricum, 15-35 parts of Bletilla striata, 15-35 parts of Oleaster ochre, and 15-35 parts of Cuttlefish bone.

[0026] Houttuynia cordata clears away heat and detoxifies, reduces swelling and treats sores, Patrinia patriniae removes blood stasis and discharges pus, Gleditsia sinensis reduces swelling and promotes pus, fresh Acorus calamus clears the nine orifices and improves the eyes and ears, Coptis chinensis clears away heat and detoxifies, Bletilla striata disperses nodules and relieves pain, Red ochre promotes tissue growth and heals sores, and Sepia sepia astringes and stops bleeding. The suppurative otitis media ear drops have significant effects of clearing away heat and detoxifying, eliminating sores and astringing muscles, have good effects on treating suppurative otitis media, are low in cost, and have no toxic side effects.

[0027] Example 1, please refer to Figure 1 The present invention provides a method for preparing an ear drop for suppurative otitis media, comprising the following steps:

[0028] S101: Take 30 parts of red ochre, add 1L of water after boiling, continue to heat with high heat, turn to low heat after boiling, and boil for 1 hour. Filter the boiled liquid, remove the residue and set aside;

[0029] S102: Take 15 portions of Xanthium sibiricum, wash and dry them, preheat a pan, stir-fry over medium heat until the surface turns yellow-brown and the thorns on the surface are charred, then remove from the pan, wait for the Xanthium sibiricum to cool to room temperature, and grind to remove the thorns;

[0030] S103: Mix the processed red ochre with the processed Xanthium sibiricum and 30 parts of Houttuynia cordata, 30 parts of Patrinia scabra, 30 parts of Gleditsia sinensis, 30 parts of fresh Acorus calamus, 30 parts of Coptis chinensis, 30 parts of Bletilla striata and 30 parts of Cuttlefish bone, repeat the decoction three times, combine the three filtrates, let stand and then filter, take the filtrate, and prepare the suppurative otitis media ear drops; wherein the decoction process is: add the mixed medicinal materials into water with an amount of 6 times the total weight of the medicinal materials, boil, and then simmer for 3 hours.

[0031] In this embodiment, first take 30 parts of red ochre, add 1L of water after boiling, continue to heat with high heat, and turn to low heat for decoction after boiling. The decoction time is 1 hour, filter the cooked medicinal liquid, remove the residue and set aside; then take 15 parts of Xanthium sibiricum, wash and dry them, preheat the pot, stir-fry with medium heat until the surface is yellowish brown and the thorns on the surface are coked, then take out of the pot, wait for the Xanthium sibiricum to cool to room temperature, grind and remove the thorns; then mix the processed red ochre with the processed Xanthium sibiricum and 30 parts of Houttuynia cordata, 30 parts of Patrinia scabra, 30 parts of Gleditsia sinensis, 30 parts of fresh Acorus calamus, 30 parts of Coptis chinensis, 30 parts of Scutellaria baicalensis, and 30 parts of cuttlefish bones, repeat the decoction three times, and combine The three filtrates are allowed to stand and then filtered, and the filtrate is taken to prepare the suppurative otitis media ear drops; wherein the decoction process is: the mixed medicinal materials are added into water of 6 times the total weight of the medicinal materials, boiled, and then simmered for 3 hours, and finally the suppurative otitis media ear drops are obtained, and the suppurative otitis media ear drops are filled to prepare health oral liquid A, and the prepared health oral liquid A has the advantages of small toxic and side effects and low drug resistance, and the research and development of Chinese medicine compound ear drops helps to reduce the abuse of antibiotics, and provides a new treatment method for clinical decision-making of patients with suppurative otitis media, and can be used in the preparation of pharmaceutical tablets, pharmaceutical granules, pharmaceutical capsules and pharmaceutical injections.

[0032] Example 2, please refer to Figure 2 The present invention provides a method for preparing an ear drop for suppurative otitis media, comprising the following steps:

[0033] S201: Take 25 parts of red ochre, add 0.8L of water after boiling, continue to heat with high heat, turn to low heat after boiling, and boil for 1 hour. Filter the boiled liquid, remove the residue and set aside;

[0034] S202: Take 10 portions of Xanthium sibiricum, wash and dry them, preheat a pan, stir-fry over medium heat until the surface turns yellow-brown and the thorns on the surface are charred, then remove from the pan, wait for the Xanthium sibiricum to cool to room temperature, and grind to remove the thorns;

[0035] S203: Mix the processed red ochre with the processed Xanthium sibiricum and 25 parts of Houttuynia cordata, 25 parts of Patrinia scabra, 25 parts of Gleditsia sinensis, 25 parts of fresh Acorus calamus, 25 parts of Coptis chinensis, 25 parts of Bletilla striata and 25 parts of Cuttlefish bone, repeat the decoction three times, combine the three filtrates, let stand and then filter, take the filtrate, and prepare the suppurative otitis media ear drops; wherein the decoction process is: add the mixed medicinal materials into water with an amount of 4 times the total weight of the medicinal materials, boil, and then simmer for 2 hours.

[0036] In this embodiment, first take 25 parts of red ochre, add 0.8L of water after boiling, continue to heat with high heat, turn to low heat after boiling, decoct for 1 hour, filter the cooked medicinal liquid, remove the residue for later use; then take 10 parts of Xanthium sibiricum, wash and dry, preheat the pot, stir-fry with medium heat until the surface is yellowish brown and the thorns on the surface are coked, then take out of the pot, wait for the Xanthium sibiricum to cool to room temperature, grind and remove the thorns; then mix the treated red ochre with the treated Xanthium sibiricum and 25 parts of Houttuynia cordata, 25 parts of Patrinia scabra, 25 parts of Gleditsia sinensis, 25 parts of fresh Acorus calamus, 25 parts of Coptis chinensis, 25 parts of Scutellaria baicalensis, and 25 parts of cuttlefish bones, repeat the decoction three times, combine the three filtrates, let stand and filter again, take the filtrate, and prepare the suppurative otitis media ear drops; wherein the decoction process is: add 4 The invention discloses a method for preparing a suppurative otitis media ear drop preparation method, wherein the ear drop preparation is prepared by filling the ear drop preparation with water having a weight of times the total weight of the medicinal materials, and then simmering the mixture over a low fire for 2 hours to obtain the suppurative otitis media ear drop preparation. The ear drop preparation is filled to prepare a health-care oral liquid B. The prepared health-care oral liquid B has the advantages of small toxic and side effects and low drug resistance. The research and development of the Chinese medicine compound ear drop preparation is helpful to reduce the abuse of antibiotics and provide a new treatment method for the clinical decision-making of patients with suppurative otitis media. The extraction method adopted by the invention can extract and utilize the effective active ingredients of each medicine to the maximum extent, maximize the efficacy of each medicine and the efficacy of health-care products, improve their bioavailability, and reduce the dosage of the original medicinal materials accordingly. The suppurative otitis media ear drop preparation and the preparation method thereof can be applied to the preparation of pharmaceutical tablets, pharmaceutical granules, pharmaceutical capsules and pharmaceutical injections.

[0037] Example 3, please refer to Figure 3 The present invention provides a method for preparing an ear drop for suppurative otitis media, comprising the following steps:

[0038] S301: Take 20 parts of red ochre, add 0.6L of water after boiling, continue to heat with high heat, turn to low heat after boiling, and boil for 1 hour. Filter the boiled liquid, remove the residue and set aside;

[0039] S302: Take 5 portions of Xanthium sibiricum, wash and dry them, preheat the pan, stir-fry over medium heat until the surface turns yellow-brown and the thorns on the surface are charred, then remove from the pan, wait for the Xanthium sibiricum to cool to room temperature, and grind to remove the thorns;

[0040] S303: Mix the processed red ochre with the processed Xanthium sibiricum and 20 parts of Houttuynia cordata, 20 parts of Patrinia scabra, 20 parts of Gleditsia sinensis, 20 parts of fresh Acorus calamus, 20 parts of Coptis chinensis, 20 parts of Bletilla striata and 20 parts of Cuttlefish bone, repeat the decoction three times, combine the three filtrates, let stand and then filter, take the filtrate, and fill it to obtain the suppurative otitis media ear drops; wherein the decoction process is: add the mixed medicinal materials into water with an amount of 2 times the total weight of the medicinal materials, boil, and then simmer for 1 hour.

[0041] In this embodiment, first take 20 parts of red ochre, add 0.6L of water after boiling, continue to heat with high heat, and turn to low heat for decoction after boiling. The decoction time is 1 hour, filter the cooked medicinal liquid, remove the residue and set aside; then take 5 parts of Xanthium sibiricum, wash and dry them, preheat the pot, stir-fry with medium heat until the surface is yellowish brown and the thorns on the surface are coked, then take out of the pot, wait for the Xanthium sibiricum to cool to room temperature, grind and remove the thorns; then mix the processed red ochre with the processed Xanthium sibiricum and 20 parts of Houttuynia cordata, 20 parts of Patrinia scabra, 20 parts of Gleditsia sinensis, 20 parts of fresh Acorus calamus, 20 parts of Coptis chinensis, 20 parts of Scutellaria baicalensis, and 20 parts of cuttlefish bones, repeat the decoction three times, and combine the three times. The filtrate is allowed to stand and then filtered, the filtrate is taken and filled to obtain the suppurative otitis media ear drops; wherein the decocting process is: the mixed medicinal materials are added into water with the weight of 2 times of the total weight of the medicinal materials, after boiling, decocted on a low fire for 1 hour, and finally the suppurative otitis media ear drops are obtained, and the suppurative otitis media ear drops are filled to obtain health oral liquid C, the prepared health oral liquid C has the advantages of small toxic and side effects and low drug resistance, and the research and development of Chinese medicine compound ear drops helps to reduce the abuse of antibiotics, provides a new treatment method for clinical decision-making of patients with suppurative otitis media, and can be used in the preparation of drug tablets, drug granules, drug capsules and drug injections.

[0042] Example 4

[0043] The therapeutic effect of the preparation prepared in Test Example 1 on suppurative otitis media:

[0044] 40 healthy male SD rats were selected, each weighing 200±10 parts. They were randomly divided into 4 groups, marked as measurement group A, measurement group B, measurement group C and blank group. The rats in each group were required to have sensitive auricular reflexes, complete tympanic membranes and clear light cones under electric otoscope examination, and to exclude infections of the external auditory canal, tympanic membrane, and middle ear. After adaptive feeding for one week, the rats in each group were fasted for 24 hours, and then anesthetized with sodium pentobarbital as an anesthetic at a volume of 36 parts / (k parts·BW), and injected intraperitoneally with an injection volume of 3mL. After anesthetizing the rats in each group, the ears of the rats were disinfected, and 25μL of LPS (1.0 parts / ml) was injected into the middle ear of the rats through the tympanic membrane only in the right ear of the rats to construct an animal model of suppurative otitis media. The ear drops A prepared in Example 1 were used to measure group A, the ear drops B prepared in Example 2 were used to measure group B, the ear drops C prepared in Example 3 were used to measure group C, and normal saline was used in the blank group. The ear drops were administered once a day, 1 mL each time, for 14 consecutive days, and the rats were fed conventionally during the period. On the 7th day, each group of rats was fasted but not watered for 24 hours, and then the rats were killed, blood was collected from the abdominal aorta of the rats, and the supernatant was centrifuged and measured by radioimmunoassay according to the kit instructions for TNF-α, IL-1β, IL-6, INF-γ, and IL-4. The results are shown in Table 1.

[0045]

[0046] Note: Compared with the blank group, *p<0.05 indicates a significant difference, **p<0.01 indicates an extremely significant difference.

[0047] Table 1. Changes in serum inflammatory factor levels in rats in each group of Examples 1 to 3 ( p parts / mL -1 )

[0048] As shown in Table 1, compared with the blank, the levels of TNFα, IL-1β, IL-6 and INF-γ in the dosage groups A, B and C were reduced. It has a protective effect on suppurative otitis media. The preparation of the present invention has the effect of clearing away heat and detoxifying, and can be used for treatment.

[0049] Example 5

[0050] The in vitro antibacterial effects of the preparations prepared in Test Examples 1 to 3:

[0051] Take the ATCC standard strain with a bacterial age of 16 to 24 hours and dilute it to 1*10^6 CFU / ml with casein beef broth.

[0052] Take a 96-well sterile culture plate, set 12*3 wells for each strain, the first well is a negative control well (original concentration of Example 1, Example 2, Example 3 preparations, no bacteria), the 12th well is a positive control well (no drug), use a pipette to add 50 μl of bacteria-containing casein beef broth medium to each well from the 2nd to the 12th well, and make 3 rows for each strain to reduce experimental errors.

[0053] 50 μl of each example preparation of original concentration was added to wells 1 and 2, wells 2 were mixed, and then 50 μl of the mixture was pipetted from well 2 to well 3, and then 50 μl was pipetted to well 4 after mixing, and so on and so forth, and the mixture was continuously diluted to well 11, and 50 μl of the mixture was pipetted from well 11 and discarded. At this time, the dilution multiples of each example preparation in wells 1 to 12 were 1 times, 2 times, 4 times, 8 times, ..., 1024 times, and 0 times, respectively.

[0054] After covering, the plates were placed in a 37°C constant temperature incubator for 24 h and then taken out for preliminary evaluation of bacterial growth in each well using turbidimetry.

[0055] In a biological safety cabinet, Haemophilus chocolate agar selective medium was used to culture each well of Haemophilus influenzae and Moraxella catarrhalis, and Columbia blood agar medium was used to culture each well of the other 9 bacteria. After incubation in a 37°C constant temperature incubator for 24h-48h, the medium was taken out and observed for bacterial growth, so as to determine the in vitro antibacterial concentration of each example preparation against common pathogens.

[0056] The lowest drug concentration at which no bacteria grow in the wells and on the corresponding culture medium is the minimum inhibitory concentration. The experiment is meaningful only when bacteria grow significantly in the positive control well (well 12). The test results are shown in Table 2.

[0057]

[0058]

[0059] * indicates that the preparation has no antibacterial effect on the bacteria

[0060] Table 2. Minimum inhibitory concentration test results of suppurative otitis media drops

[0061] As shown in Table 2, the preparations prepared in Examples 1 to 3 have good inhibitory effects on most bacteria.

[0062] What is disclosed above is only a preferred embodiment of the present invention, and it certainly cannot be used to limit the scope of rights of the present invention. Ordinary technicians in this field can understand that all or part of the processes of the above embodiment and equivalent changes made according to the claims of the present invention still fall within the scope of the invention.

Claims

1. An ear drop for suppurative otitis media, characterized in that: It is prepared from the following raw materials in parts by weight: 15-35 parts of Houttuynia cordata, 15-35 parts of Patrinia scabra, 15-35 parts of Gleditsia sinensis, 15-35 parts of fresh Acorus calamus, 15-35 parts of Coptis chinensis, 5-15 parts of Xanthium sibiricum, 15-35 parts of Bletilla striata, 15-35 parts of Oleaster ochre, and 15-35 parts of Cuttlefish bone.

2. A method for preparing an ear drop for suppurative otitis media, comprising preparing the ear drop for suppurative otitis media as claimed in claim 1, characterized in that: The steps include: Pre-treating red ochre; Pre-treating Xanthium sibiricum; The processed red ochre is mixed with the processed Xanthium sibiricum and Houttuynia cordata, Patrinia scabra, Gleditsia sinensis, fresh Acorus calamus, Coptis chinensis, Bletilla striata and Sepia sepia, and the mixture is decocted three times, the three filtrates are combined, allowed to stand and then filtered, and the filtrate is taken to prepare the suppurative otitis media ear drops.

3. The method for preparing the suppurative otitis media ear drops as claimed in claim 2, characterized in that: In the step of pre-treating red ochre: Take red ochre, add it to the boiling water, continue heating over high heat, and after boiling, switch to low heat and simmer for 1 to 4 hours. Filter the cooked liquid, remove the residue and set aside.

4. The method for preparing the suppurative otitis media ear drops as claimed in claim 2, characterized in that: In the step of pre-treating Xanthium sibiricum: Wash and dry the Xanthium sibiricum. Preheat the pan and stir-fry over medium heat until the surface turns yellow-brown and the thorns are charred.

5. The method for preparing the suppurative otitis media ear drops as claimed in claim 4, characterized in that: After frying over medium heat until the surface turns yellow-brown and the spines are charred, remove from the pan: Wait for the Xanthium sibiricum to cool to room temperature, then grind and remove the thorns.

6. The method for preparing the suppurative otitis media ear drops as claimed in claim 2, characterized in that: After mixing the processed red ochre with the processed Xanthium sibiricum and Houttuynia cordata, Patrinia scabra, Gleditsia sinensis, fresh Acorus calamus, Coptis chinensis, Ampelopsis radix and Sepia sepia, the decoction is repeated three times, the three filtrates are combined, filtered after standing, and the filtrate is taken to prepare the suppurative otitis media ear drops, wherein the decoction process is: Add the mixed herbs into water, bring to a boil, and then simmer for 1 to 4 hours.

Images