CN112006987A - Cold compress gel for treating rhinitis and preparation method thereof - Google Patents

Cold compress gel for treating rhinitis and preparation method thereof Download PDF

Info

Publication number
CN112006987A
CN112006987A CN201911283886.4A CN201911283886A CN112006987A CN 112006987 A CN112006987 A CN 112006987A CN 201911283886 A CN201911283886 A CN 201911283886A CN 112006987 A CN112006987 A CN 112006987A
Authority
CN
China
Prior art keywords
percent
chloramphenicol
cold compress
collagen
balance
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201911283886.4A
Other languages
Chinese (zh)
Other versions
CN112006987B (en
Inventor
王悦欣
王怀伟
吕超
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jilin Jianfu Nose Technology Co ltd
Original Assignee
Jilin Jianfu Nose Technology Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jilin Jianfu Nose Technology Co ltd filed Critical Jilin Jianfu Nose Technology Co ltd
Priority to CN201911283886.4A priority Critical patent/CN112006987B/en
Publication of CN112006987A publication Critical patent/CN112006987A/en
Application granted granted Critical
Publication of CN112006987B publication Critical patent/CN112006987B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local antiseptics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Otolaryngology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Virology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention provides chloramphenicol-containing cold compress gel which is prepared from the following raw materials in percentage by weight: 0.01-80% of chloramphenicol, 0.001-10% of hydrogel resin, 0.001-10% of collagen, 0.001-10% of hyaluronic acid and the balance of water; the hydrogel resin is polyacrylic acid; the chloramphenicol is chloramphenicol eye drops with the concentration of 2.5 mg/ml.

Description

Cold compress gel for treating rhinitis and preparation method thereof
Technical Field
The invention relates to a cold compress gel for treating rhinitis and a preparation method thereof, belonging to the field of medicines.
Background
Rhinitis is an inflammatory disease of the mucous membrane of the nasal cavity caused by viruses, bacteria, allergens, various physicochemical factors and certain systemic diseases. Rhinitis, the primary cause of inflammatory nasal disease, is viral infection, or secondary bacterial infection on the basis of viral infection. Clinically, the traditional Chinese medicine composition is commonly used for treating acute and chronic rhinitis, allergic rhinitis and the like, mainly has symptoms of nasal obstruction, watery nasal discharge, dry nose, nasal odor, headache and the like, and causes great pain and discomfort to patients. These diseases are often associated with the stimulation of harmful dust, gases. In recent years, the incidence of these diseases has been on an increasing trend year by year with the development of industry and the increase of atmospheric pollution. At present, the medicines for clinically treating the diseases comprise ephedrine normal saline solution, oxymetazoline hydrochloride spray, oral traditional Chinese medicine orifice-freeing rhinitis tablets and the like. The medicines have relatively slow effect, are usually required to be treated for 5-7 days to take effect, have the side effects of nasal dryness and the like, and are easy to cause drug-induced rhinitis.
The pathology of the nasal obstruction is the congestion and swelling of nasal mucosa caused by various reasons, and the common rhinitis patch for treating rhinitis shrinks the blood vessels of the nasal mucosa through the physical cooling effect of the cold compress gel of the cold compress patch, thereby achieving the effect of relieving the nasal obstruction. It can be applied on nasal skin surface, and has no significant effect on symptoms such as dry itching caused by rhinitis, mucosa injury, sneeze and watery nasal discharge caused by bacterial and viral dust irritation. Traditional cold compress gel is sticky, and the mobility is poor, can not be used for atomizer can only paint for the clothing is easily polluted on the skin surface, and the special part in the nasal cavity is hardly paintd evenly, glues to paste ventilative, uses unusual inconvenient, and patient experience is extremely poor.
Chloramphenicol is a broad-spectrum antibiotic, is fat-soluble, diffuses into bacterial cells, and is combined with the 50S subunit of bacterial ribosome to inhibit the synthesis of bacterial protein to produce an antibacterial effect. Due to serious toxic and side effects, chloramphenicol is not generally used for mild infection, is mainly used for typhoid fever, paratyphoid fever and other salmonella infections, can be used for haemophilus influenzae meningitis together with ampicillin, has granulocytopenia, thrombocytopenia, aplastic anemia and the like as adverse reactions, and can cause optic neuritis, ataxia, superinfection and the like after long-term use. The externally applied chloramphenicol can effectively kill bacteria, viruses and other microorganisms in local environment, and is a bacteriostatic agent.
In the prior art, no product for treating rhinitis by taking chloramphenicol as an active ingredient exists.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides the cold compress gel for treating the rhinitis, and the preparation has the advantages of high safety, exact curative effect, quick response and convenient use.
As one aspect of the invention, the invention provides a cold compress gel for treating rhinitis, which comprises the following raw materials in percentage by weight: 0.01-80% of medicine component, 0.001-10% of hydrogel resin, 0.001-10% of collagen, 0.001-10% of hyaluronic acid and the balance of water; the medicinal component is selected from the medicaments which are disclosed at present or applied clinically and have the treatment effect on the rhinitis.
Preferably, the cold compress gel consists of the following raw materials in percentage by weight: 0.1 to 70 percent of medicine component, 0.002 to 5 percent of hydrogel resin, 0.01 to 8 percent of collagen, 0.01 to 8 percent of hyaluronic acid and the balance of water.
Further preferably, the cold compress gel is composed of the following raw materials by weight percentage: 5 to 65 percent of medicine component, 0.005 to 1 percent of hydrogel resin, 0.1 to 5 percent of collagen, 0.1 to 5 percent of hyaluronic acid and the balance of water.
Still more preferably, the cold compress gel is composed of the following raw materials by weight percentage: 10 to 60 percent of medicine component, 0.01 to 0.05 percent of hydrogel resin, 0.5 to 3 percent of collagen, 0.5 to 3 percent of hyaluronic acid and the balance of water.
Most preferably, the cold compress gel consists of the following raw materials in percentage by weight: 50% of medicine component, 0.05% of hydrogel resin, 1% of collagen, 1% of hyaluronic acid and the balance of water.
In specific embodiments, the pharmaceutical ingredient is selected from chloramphenicol, levofloxacin, roxithromycin, dexamethasone, mometasone furoate, loratadine, diclofenac sodium, oxymetazoline, triclosan, and various extracts of traditional Chinese medicines for treating rhinitis, such as herba Achilleae extract, Scutellariae radix extract, fructus Xanthii extract, flos Caryophylli extract, herba Menthae extract, etc. The traditional Chinese medicine extract is obtained by extracting traditional Chinese medicines by a conventional extraction solvent according to a conventional method. The conventional extraction solvent comprises water or ethanol, and the conventional extraction method comprises soaking, decocting, refluxing, steam distilling, microwave, ultrasound, etc.
In a specific embodiment, the cold compress gel can also be added with a flavoring plant essential oil, wherein the flavoring plant essential oil is selected from any one or more of lavender oil, rosemary oil, lemon oil, clove oil, peppermint oil, cinnamon oil, eucalyptus oil, rose essential oil and thyme oil.
In a specific embodiment, the hydrogel resin is selected from any one or more of carbomer, polyacrylic acid, gelatin, hydroxypropyl methylcellulose, microcrystalline cellulose and modified starch. Polyacrylic acid is preferred.
In a specific embodiment, the collagen has a molecular weight of less than 2000 Da.
As another aspect of the invention, the invention provides chloramphenicol-containing cold compress gel, which is composed of the following raw materials in percentage by weight: 0.01-80% of chloramphenicol, 0.001-10% of hydrogel resin, 0.001-10% of collagen, 0.001-10% of hyaluronic acid and the balance of water.
Preferably, the cold compress gel consists of the following raw materials in percentage by weight: 0.1 to 70 percent of chloramphenicol, 0.002 to 5 percent of hydrogel resin, 0.01 to 8 percent of collagen, 0.01 to 8 percent of hyaluronic acid and the balance of water.
Further preferably, the cold compress gel is composed of the following raw materials by weight percentage: 5 to 65 percent of chloramphenicol, 0.005 to 1 percent of hydrogel resin, 0.1 to 5 percent of collagen, 0.1 to 5 percent of hyaluronic acid and the balance of water.
Still more preferably, the cold compress gel is composed of the following raw materials by weight percentage: 10 to 60 percent of chloramphenicol, 0.01 to 0.05 percent of hydrogel resin, 0.5 to 3 percent of collagen, 0.5 to 3 percent of hyaluronic acid and the balance of water.
Most preferably, the cold compress gel consists of the following raw materials in percentage by weight: 50% of chloramphenicol, 0.05% of hydrogel resin, 1% of collagen, 1% of hyaluronic acid and the balance of water.
In a specific embodiment, 0.001% -10% of flavoring plant essential oil selected from any one or more of lavender oil, rosemary oil, lemon oil, clove oil, peppermint oil, cinnamon oil, eucalyptus oil, rose essential oil and thyme oil can be added into the cold compress gel.
In a specific embodiment, the hydrogel resin is selected from any one or more of carbomer, polyacrylic acid, gelatin, hydroxypropyl methylcellulose, microcrystalline cellulose and modified starch. Polyacrylic acid is preferred.
In a specific embodiment, the collagen has a molecular weight of less than 2000 Da.
In a specific embodiment, the chloramphenicol is a commercially available chloramphenicol eye drop with a concentration of 2.5mg/ml
As another aspect of the invention, the invention provides a preparation method of the chloramphenicol-containing cold compress gel, which comprises the following steps:
step a, adding hydrogel resin, collagen and hyaluronic acid into partial water for dissolving;
and step b, uniformly mixing the chloramphenicol and the hydrogel resin solution obtained in the step a, and adding the balance of water to obtain the chloramphenicol hydrogel resin.
The invention has the beneficial effects that:
1. the safety is high. The toxic and side effect of chloramphenicol on blood system is toxic bone marrow suppression, and anemia is clinically manifested or accompanied by leukopenia and thrombocytopenia. The product combines the chloramphenicol and the reticular flocculation structure of the hydrogel into a stable molecular complex, locks the chloramphenicol molecules in the gel structure, and effectively avoids serious toxic and side effects caused by the chloramphenicol entering the blood system of a human body.
2. Has definite curative effect. The total clinical effective rate of the product for treating rhinitis reaches 100%, the obvious effective rate reaches 96.6%, and the product has obvious relieving effect on various symptoms caused by rhinitis, such as dry itch, sneeze, nasal obstruction, headache and watery nasal discharge.
3. Has quick action. The product of the invention is added with collagen, so that the onset time of the cold compress gel reaches the second level, the cold compress gel takes effect rapidly after nasal spray administration, and forms a moisturizing film on the skin or the mucosa surface to isolate further stimulation of dust and the like to the nasal mucosa, thereby effectively relieving symptoms of sneezing, watery nasal discharge and the like caused by nasal cavity dry and itching, mucosa damage, and stimulation of bacteria and virus dust.
4. Is convenient to use. General cold compress gel is sticky, and the mobility is poor, can not be used for atomizer only to paint for the easy contaminated clothing in skin surface, and the special part in the nasal cavity is hardly paintd evenly, glues to paste ventilative, uses very inconvenient, and patient experience is extremely poor. The product of the invention is added with hyaluronic acid to prepare a spray which can be used by a spraying device, and the spray can be directly sprayed in nasal cavities, and is convenient and comfortable to use.
Clinical results experiment
When 60 cases (including 30 cases of a control group) of rhinitis are treated by using the chloramphenicol-containing cold compress gel prepared by the invention, the curative effect and the side effect are considered, and the observed results are summarized as follows:
1. general clinical data:
the group of 60 cases, 30 cases in each of the treatment group and the control group, 35 cases in male (18 cases in the treatment group and 17 cases in the control group), 25 cases in female (12 cases in the treatment group and 13 cases in the control group), age 20-45 years, mean age 27 years, and course of disease varying from 6 months to 10 years. Classifying according to disease conditions: 24 cases of chronic rhinitis (12 cases of the control group of the treatment group) and 36 cases of allergic rhinitis (18 cases of the control group of the treatment group).
It is mainly manifested as nasal obstruction, pain and itching, watery nasal discharge, sneezing, and headache and vertigo in some patients. No other treatment was done before treatment.
2. Selecting an observation object:
(1) disease diagnosis standard conditions: the chronic rhinitis and the allergic rhinitis occur, and the clinical manifestations of nasal obstruction, sneezing, nasal discharge and the like are shown.
(2) Disease diagnosis symptom grading: see table 1.
TABLE 1 disease diagnostic symptom grading
Figure BDA0002317484980000051
3. The treatment scheme comprises the following steps:
(1) number and grouping of observation cases: 30 cases of the treatment group and 30 cases of the control group, 60 cases in total.
(2) Grouping: the total number of cases is divided into two groups, which are numbered according to the treatment order and are divided into 1: 1 draw and group, and require the age, sex, symptoms and disease length as consistent as possible.
(3) Experimental drugs: prescription: polyacrylic acid 0.05 parts, peppermint essential oil 0.005 parts, collagen 1 part, hyaluronic acid 1 part, chloromycetin eyedrops 50 parts with the concentration of 2.5mg/ml, and the balance of purified water added to 100 ml.
The preparation method comprises the following steps: taking the raw materials according to the proportion, adding 20 parts of purified water into polyacrylic acid, collagen, hyaluronic acid and mint essential oil according to the total weight of 100%, uniformly stirring, mixing with 50 parts of chloramphenicol eye drops, mixing uniformly, adding the balance of purified water, and uniformly mixing to obtain the chloramphenicol-containing cold compress gel.
Control drugs: it can be used for treating nasal drop.
(4) The medication method comprises the following steps:
the treatment group uses the product of the invention, and the nasal cavity is sprayed and washed once every 2 to 4 hours, and 4 to 8 times per day. The control group used naseberry.
(5) The course of treatment is as follows: the treatment group and the control group are both 7-20 days.
(6) The source of the cases is: the treatment group and the control group are all treated in an outpatient way, but variable factors are required to be controlled, and the patients are ensured to only use the product and the control drug.
4. The evaluation standard of curative effect is as follows:
(1) and (3) clinical control:
A. stage I: the disease is cured within 5 days;
B. and II, stage: curing the disease in 10-15 days;
C. grade III: the disease can be cured within 16-20 days without any symptom;
D. the disease symptoms disappear more than 90%.
(2) The effect is shown: the subjective symptoms basically disappear, and no nasal obstruction, sneeze, watery nasal discharge and other clinical manifestations exist, and no author appears after more than 2 months after the treatment is finished.
(3) The method has the following advantages: the subjective symptoms are relieved, and the patients with nasal obstruction, sneezing, watery nasal discharge and other clinical manifestations occasionally occur, and the onset of the disease occurs 2 months after the treatment is finished.
(4) And (4) invalidation: the symptoms and the onset of disease are not changed before treatment.
5. Observation indexes are as follows:
(1) and (3) observation of curative effect:
A. nasal mucosal symptom changes: lightening, disappearing, aggravating, etc.;
B. swelling change of nasal mucosa: lightening, disappearing, aggravating, etc.;
C. nasal mucosa healing conditions: complete healing, partial healing, non-healing.
6. The treatment results are as follows:
(1) the two groups of clinical effects are compared: see table 2.
TABLE 2 results of two groups of clinical effects
Grouping Number of cases Clinical control Show effect Is effective Invalidation Total effective rate (%)
Treatment group 30 29 0 1 0 100
Control group 30 9 7 6 8 73.3
The total effective rate of the treatment group is 100 percent, and the obvious effective rate is 96.6 percent. The total effective rate of the control group is 73.3 percent, the obvious effective rate is 53.3 percent, and the curative effect of the treatment group is obviously better than that of the control group (P is less than 0.01) through analysis.
(2) The ratio of the main symptoms before and after treatment and the disappearance of nasal mucosa swelling is compared: see table 3.
TABLE 3 comparison of the symptoms before and after treatment and the disappearance of swelling of nasal mucosa
Figure BDA0002317484980000071
The two groups have significant difference except that the nasal obstruction is not significant difference, which shows that the treatment group is obviously superior to the control group.
The results show that: the product of the invention has obviously better curative effect on simple rhinitis and allergic rhinitis than the control group of nose drops, mainly shows in the aspect of improving various symptoms of rhinitis, has definite curative effect and no toxic or side effect, and is completely suitable for various patients.
Detailed Description
Example 1
Prescription: polyacrylic acid 0.01g, collagen 1g, hyaluronic acid 0.5g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method comprises the following steps: taking the raw materials according to the proportion, adding polyacrylic acid, collagen and hyaluronic acid into 20g of purified water by taking the total weight as 100%, uniformly stirring, mixing with 50g of chloramphenicol eye drops, uniformly mixing, adding the balance of purified water, and uniformly mixing to obtain the chloramphenicol-containing cold compress gel.
Investigation of onset time:
the cold compress gel without collagen prepared according to example 1, and 40 rhinitis patients (including 20 control group) were treated with the cold compress gel of example 1, respectively, and the effect time was examined, and the observed results are summarized as follows:
1. general clinical data:
40 cases in this group, 20 cases in the treatment group and the control group, 21 males (10 cases in the treatment group and 11 cases in the control group), 19 females (10 cases in the treatment group and 9 cases in the control group), age 17-40 years, mean age 24 years, and course of disease varied from 3 months to 8 years.
It is mainly manifested as nasal obstruction, pain and itching, watery nasal discharge, sneezing, and headache and vertigo in some patients. No other treatment was done before treatment.
2. Selecting an observation object:
subjective feeling of the patient, pain and itch, nasal obstruction, sneezing, comfortable feeling of the nasal cavity and the like.
3. The treatment scheme comprises the following steps:
(1) number and grouping of observation cases: the treatment group comprises 20 cases, and the control group comprises 20 cases, and the total number of the cases is 40.
(2) Grouping: the total number of cases is divided into two groups, which are numbered according to the treatment order and are divided into 1: 1 draw and group, and require the age, sex, symptoms and disease length as consistent as possible.
(3) The medication method comprises the following steps:
the treatment group uses the product of the invention, and the nasal cavity is sprayed and washed once every 2 to 4 hours, and 4 to 8 times per day. The control group used a cold-compress gel without collagen to irrigate the nasal cavity.
(4) The course of treatment is as follows: the treatment group and the control group are both 7-20 days.
4. Onset evaluation criteria:
the nasal cavity is moist, the pain and itch feel disappears, the nasal obstruction is relieved, and sneezing is avoided.
5. The treatment results are as follows:
the onset times of both groups are shown in Table 4.
TABLE 4 comparison of symptom disappearance times before and after treatment
Figure BDA0002317484980000081
The results show that: the addition of collagen is significantly different from the absence of collagen in onset time. The product of the invention is added with collagen, so that the onset time reaches the second level, the nasal spray can take effect quickly after administration, and a moisturizing film is formed on the surface of skin or mucosa to isolate further stimulation of dust and the like to the nasal mucosa, thereby effectively relieving symptoms of sneezing, watery nasal discharge and the like caused by nasal cavity dryness and itch, mucosa damage, and bacterial and viral dust stimulation.
Example 2
Prescription: polyacrylic acid 0.01g, collagen 1g, hyaluronic acid 1g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method is the same as example 1.
Example 3
Prescription: polyacrylic acid 0.01g, collagen 1g, hyaluronic acid 2g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method is the same as example 1.
Example 4
Prescription: polyacrylic acid 0.05g, collagen 1g, hyaluronic acid 0.5g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method is the same as example 1.
Example 5
Prescription: polyacrylic acid 0.05g, collagen 1g, hyaluronic acid 1g, chloramphenicol eye drops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
Example 6
Prescription: polyacrylic acid 0.05g, collagen 1g, hyaluronic acid 2g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method is the same as example 1.
Example 7
Prescription: polyacrylic acid 0.1g, collagen 1g, hyaluronic acid 0.5g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method is the same as example 1.
Example 8
Prescription: polyacrylic acid 0.1g, collagen 1g, hyaluronic acid 1g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method is the same as example 1.
Example 9
Prescription: polyacrylic acid 0.1g, collagen 1g, hyaluronic acid 2g, chloromycetin eyedrops with concentration of 2.5mg/ml 50g, and purified water in balance to 100 g.
The preparation method is the same as example 1.
The cold-compressed gels prepared in examples 1 to 9 were collected and subjected to property examination, and the results are shown in Table 5.
TABLE 5 measurement results of each prescription
Figure BDA0002317484980000101
The results of examination showed that examples 7 to 9 had high viscosity and poor spraying effect. Examples 1 to 6 all met the requirements. Example 5 is an optimal prescription, combining clinical practice and cost considerations.
Example 10
The formulation was substantially the same as in example 5, with carbomer replacing the polyacrylic acid.
Example 11
The formulation was substantially the same as in example 5, with gelatin replacing polyacrylic acid.
Example 12
The formulation was substantially the same as in example 5, except that hydroxypropyl methylcellulose was used in place of polyacrylic acid.
Example 13
The formulation was substantially the same as in example 5, with microcrystalline cellulose replacing the polyacrylic acid.
Example 14
The formulation was substantially the same as in example 5, with polyacrylic acid being replaced by modified starch.
The cold-compress gels prepared in example 5 and examples 10 to 11 were taken and examined for the cumulative permeation of chloramphenicol at different times.
The experimental method comprises the following steps: the nasal cavity of a newly slaughtered sheep within 10min is cut, the nasal mucosa is carefully stripped along the nasal septum cartilage by a blade, blood stains are cleaned by normal saline, and the sheep is placed in the normal saline for later use. The selected device is a vertical Franz diffusion cell, the upper part is a dosing cell, and the lower part is a receiving cell. The receiving pool is filled with physiological saline, the pretreated nasal mucosa is fixed at the interface of the horizontal diffusion pool, the cilia of the mucosa face the supply chamber, the dermis faces the receiving chamber, and the receiving chamber is clamped. And starting the automatic stirring and constant-temperature water bath device. After the balance of the circulating water bath at 37 +/-1 ℃ for 0.5 hour, 100 mul of prepared liquid medicine is dripped on the surface of the mucosa by using a micro-syringe, then a medicine chamber is closed, 1.5ml of the prepared liquid medicine is sampled from a receiving chamber in 20, 40, 60, 120 and 180 minutes, and the physiological saline with the equal volume of 37 ℃ is supplemented to keep the state of a leakage groove. The concentration of chloramphenicol in the sample was measured and the percent of chloramphenicol cumulative permeation per unit area was calculated by calibration. The results are shown in Table 6.
TABLE 6 mean cumulative percent penetration of chloramphenicol through the nasal mucosa of sheep under the action of different hydrogel resins (n-3)
Figure BDA0002317484980000111
The key point of the invention is that proper hydrogel resin is selected, so that the transdermal absorption of chloramphenicol can be reduced, and local adverse reaction is not generated. But also maintains the effective concentration of local chloramphenicol and keeps the bacteriostatic effect continuously. From the experimental results in table 6, it can be seen that the above hydrogel resins all have significant differences in reducing the transdermal absorption of chloramphenicol from the blank group without hydrogel resin, when the other ingredients in the formulation are fixed. This means of reducing chloramphenicol absorption by addition of hydrogel resin was shown to be highly effective. Polyacrylic acid has the least absorption and is significantly different from other hydrogel resins. Polyacrylic acid is preferred for the hydrogel resin of the formulation of the present invention.
Example 15
Example 1-14 any of the formulations was supplemented with 0.005g of peppermint essential oil.
Example 16
Example 1-14 any of the formulas was supplemented with 0.005g of lavender essential oil.
Example 17
In any of the formulations of examples 1-14, 0.005g of clove essential oil was added.
Example 18
Example 1-14 any of the formulations was supplemented with 0.005g rose essential oil.
Example 19
Example 1-14 any of the formulas was supplemented with 0.005g rosemary oil.
Example 20
Prescription: polyacrylic acid 0.05g, mint essential oil 0.005g, collagen 1g, hyaluronic acid 1g, roxithromycin 10g and the balance of purified water to 100 g.
Example 21
Prescription: polyacrylic acid 0.02g, peppermint essential oil 0.005g, collagen 1g, hyaluronic acid 1g, mometasone furoate 30g, and the balance of purified water to 100 g.
Example 22
Prescription: polyacrylic acid 0.05g, peppermint essential oil 0.005g, collagen 1g, hyaluronic acid 1g, loratadine 20g, and the balance of purified water to 100 g.
Example 23
Prescription: polyacrylic acid 0.02g, clove extract 5g, collagen 1g, hyaluronic acid 1g, and the balance of purified water to 100 g.
Example 24
Prescription: polyacrylic acid 0.05g, peppermint essential oil 0.005g, collagen 1g, hyaluronic acid 1g, levofloxacin eye drops 50g, and the balance of purified water to 100 g.
Example 25
Prescription: polyacrylic acid 0.05g, mint essential oil 0.005g, collagen 1g, hyaluronic acid 1g, dexamethasone 50g, and the balance of purified water to 100 g.

Claims (10)

1. The cold compress gel for treating rhinitis is characterized by comprising the following raw materials in percentage by weight: 0.01-80% of medicine component, 0.001-10% of hydrogel resin, 0.001-10% of collagen, 0.001-10% of hyaluronic acid and the balance of water; wherein the medicinal components are selected from one or more of chloramphenicol, levofloxacin, roxithromycin, dexamethasone, mometasone furoate, loratadine, diclofenac sodium, oxymetazoline, triclosan, herba Achilleae extract, Scutellariae radix extract, fructus Xanthii extract, flos Caryophylli extract, and herba Menthae extract.
2. A cold compress gel according to claim 1, wherein the cold compress gel is comprised of the following raw materials in weight percent: 0.1-70% of medicine component, 0.002-5% of hydrogel resin, 0.01-8% of collagen, 0.01-8% of hyaluronic acid and the balance of water;
or 5 to 65 percent of medicine component, 0.005 to 1 percent of hydrogel resin, 0.1 to 5 percent of collagen, 0.1 to 5 percent of hyaluronic acid and the balance of water;
or the cold compress gel is composed of the following raw materials in percentage by weight: 10 to 60 percent of medicine component, 0.01 to 0.05 percent of hydrogel resin, 0.5 to 3 percent of collagen, 0.5 to 3 percent of hyaluronic acid and the balance of water.
3. A cold compress gel according to claim 2, wherein the cold compress gel is comprised of the following raw materials in weight percent: 50% of medicine component, 0.05% of hydrogel resin, 1% of collagen, 1% of hyaluronic acid and the balance of water.
4. A cold compress gel according to any one of claims 1 to 3, wherein a flavouring agent plant essential oil is added to the cold compress gel, the flavouring agent plant essential oil being selected from any one or more of lavender oil, rosemary oil, lemon oil, clove oil, peppermint oil, cinnamon oil, eucalyptus oil, rose essential oil, thyme oil.
5. A cold pack gel according to any one of claims 1 to 3, wherein said hydrogel resin is selected from any one or more of carbomer, polyacrylic acid, gelatin, hydroxypropylmethyl cellulose, microcrystalline cellulose, modified starch.
6. A cold pack gel according to claim 5, wherein said hydrogel resin is polyacrylic acid.
7. The chloramphenicol-containing cold compress gel is characterized by being prepared from the following raw materials in percentage by weight: 0.01-80% of chloramphenicol, 0.001-10% of hydrogel resin, 0.001-10% of collagen, 0.001-10% of hyaluronic acid and the balance of water; the hydrogel resin is polyacrylic acid; the chloramphenicol is chloramphenicol eye drops with the concentration of 2.5 mg/ml.
8. A cold compress gel according to claim 7, wherein said cold compress gel is comprised of the following raw materials in weight percent: 0.1-70% of chloramphenicol, 0.002-5% of hydrogel resin, 0.01-8% of collagen, 0.01-8% of hyaluronic acid and the balance of water;
or, 5 to 65 percent of chloramphenicol, 0.005 to 1 percent of hydrogel resin, 0.1 to 5 percent of collagen, 0.1 to 5 percent of hyaluronic acid and the balance of water;
or the cold compress gel is composed of the following raw materials in percentage by weight: 10 to 60 percent of chloramphenicol, 0.01 to 0.05 percent of hydrogel resin, 0.5 to 3 percent of collagen, 0.5 to 3 percent of hyaluronic acid and the balance of water.
9. A cold compress gel according to claim 8, wherein the cold compress gel comprises the following raw materials in weight percent: 50% of chloramphenicol, 0.05% of hydrogel resin, 1% of collagen, 1% of hyaluronic acid and the balance of water.
10. A process for the preparation of a chloramphenicol-containing cold compress gel as claimed in any one of claims 7 to 9, which process comprises:
step a, adding hydrogel resin, collagen and hyaluronic acid into partial water for dissolving;
and step b, uniformly mixing the chloramphenicol and the hydrogel resin solution obtained in the step a, and adding the balance of water to obtain the chloramphenicol hydrogel resin.
CN201911283886.4A 2019-12-13 2019-12-13 Cold compress gel for treating rhinitis and preparation method thereof Active CN112006987B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201911283886.4A CN112006987B (en) 2019-12-13 2019-12-13 Cold compress gel for treating rhinitis and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201911283886.4A CN112006987B (en) 2019-12-13 2019-12-13 Cold compress gel for treating rhinitis and preparation method thereof

Publications (2)

Publication Number Publication Date
CN112006987A true CN112006987A (en) 2020-12-01
CN112006987B CN112006987B (en) 2023-04-28

Family

ID=73506462

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201911283886.4A Active CN112006987B (en) 2019-12-13 2019-12-13 Cold compress gel for treating rhinitis and preparation method thereof

Country Status (1)

Country Link
CN (1) CN112006987B (en)

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003063957A (en) * 2001-08-23 2003-03-05 Tokyo Bikagaku Kenkyusho:Kk Nasal drop
WO2006066500A1 (en) * 2004-12-20 2006-06-29 Peixue Ling The preparation process of quinazoline derivatives and application for the manufacture for the treatment of tumor disease
US20070148219A1 (en) * 2005-12-28 2007-06-28 Sphere Tech Co., Ltd. Liposomal Nanowater-Containing Patch-Type Nanodermal Gel for Transdermal Delivery and Method for Preparing the Same
US20070202051A1 (en) * 2006-02-10 2007-08-30 Pari Gmbh Aerosols for sinunasal drug delivery
CN101352408A (en) * 2007-07-27 2009-01-28 肖正连 Alficetin in situ forming eye gel
CN101468205A (en) * 2007-12-27 2009-07-01 凌沛学 Aqueous medicinal composition
US20110189106A1 (en) * 2008-07-15 2011-08-04 Schering Corporation Intranasal compositions, dosage forms and methods of treatment
US20140044667A1 (en) * 2011-04-06 2014-02-13 Biopass S.A. Healing composition for topical application
CN103735496A (en) * 2014-02-14 2014-04-23 孙迎东 Compound nasal gel for treating allergic rhinitis and preparing method thereof
CN106540314A (en) * 2016-11-25 2017-03-29 陕西巨子生物技术有限公司 A kind of Human-like Collagen nasal membrane repairs gel
CN109568333A (en) * 2018-12-26 2019-04-05 江西润泽药业有限公司 A kind of nasal drops and preparation method thereof for treating rhinitis

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003063957A (en) * 2001-08-23 2003-03-05 Tokyo Bikagaku Kenkyusho:Kk Nasal drop
WO2006066500A1 (en) * 2004-12-20 2006-06-29 Peixue Ling The preparation process of quinazoline derivatives and application for the manufacture for the treatment of tumor disease
US20070148219A1 (en) * 2005-12-28 2007-06-28 Sphere Tech Co., Ltd. Liposomal Nanowater-Containing Patch-Type Nanodermal Gel for Transdermal Delivery and Method for Preparing the Same
US20070202051A1 (en) * 2006-02-10 2007-08-30 Pari Gmbh Aerosols for sinunasal drug delivery
CN101352408A (en) * 2007-07-27 2009-01-28 肖正连 Alficetin in situ forming eye gel
CN101468205A (en) * 2007-12-27 2009-07-01 凌沛学 Aqueous medicinal composition
US20110189106A1 (en) * 2008-07-15 2011-08-04 Schering Corporation Intranasal compositions, dosage forms and methods of treatment
US20140044667A1 (en) * 2011-04-06 2014-02-13 Biopass S.A. Healing composition for topical application
CN103735496A (en) * 2014-02-14 2014-04-23 孙迎东 Compound nasal gel for treating allergic rhinitis and preparing method thereof
CN106540314A (en) * 2016-11-25 2017-03-29 陕西巨子生物技术有限公司 A kind of Human-like Collagen nasal membrane repairs gel
CN109568333A (en) * 2018-12-26 2019-04-05 江西润泽药业有限公司 A kind of nasal drops and preparation method thereof for treating rhinitis

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
GRAT¸IELA TEODORA TIHAN等: "Chloramphenicol collagen sponges for local drug delivery in dentistry", 《COMPTES RENDUS CHIMIE》 *
徐志勇等: "复方氯霉素滴鼻液治疗青少年变应性鼻炎67例", 《中国药业》 *

Also Published As

Publication number Publication date
CN112006987B (en) 2023-04-28

Similar Documents

Publication Publication Date Title
WO2006076844A1 (en) Traditional chinese medicament for treating injuries from falls, rheumatism and ostealgia and method for manufacture thereof
CN106138190B (en) External gel preparation, preparation method and application thereof
CN108366991B (en) Synergistic compound of pyrrolidone carboxylic acid and/or salts thereof and hyaluronic acid and/or salts thereof for the treatment and/or prevention of dryness and irritation of mucous membranes, and related pharmaceutical formulations
CN105943666B (en) Composition for nursing sensitive skin of infant and preparation method thereof
JP2000512270A (en) Compositions and methods for the treatment of herpes simplex
CN104524247B (en) One treats migrainous medical composition and its use
CN113599498B (en) Composite antibacterial peptide and preparation method thereof, and bee venom conditioning cream capable of quickly relieving pain and preparation method thereof
CN112006987A (en) Cold compress gel for treating rhinitis and preparation method thereof
CN102552734B (en) Gargle for treating dental ulcer
CN106237029B (en) A kind of aloe antibiotic gel and preparation method thereof
CN103920010B (en) There is pharmaceutical composition of hemostasis and pain-relieving and antiinflammatory action and its production and use
CN105168629A (en) Traditional Chinese medicine gel for treating qi-stagnation and blood stasis type decubitus
CN109432185A (en) A kind of external medicine composition and its preparation method and application for treating myofascitis
CN111000902B (en) Traditional Chinese medicine tincture for treating acute soft tissue injury and preparation method thereof
CN109470788A (en) A kind of method of quality control of FUKE QIANJIN PIAN
CN110876770B (en) Traditional Chinese medicine spray for treating plaster allergy and preparation method
CN115518111B (en) Chinese herbal compound preparation for treating rhinitis and preparation method thereof
CN113713000B (en) Main medicine component composition for treating sore carbuncle, burn, scald and acne, sustained and controlled release pharmaceutical preparation, and preparation method and application thereof
CN111643606B (en) Gel plaster for treating insomnia and preparation method thereof
CN108853246B (en) Anti-inflammatory analgesic traditional Chinese medicine composition and preparation method and application thereof
CN105560532A (en) Medicine for treating onychomycosis and application thereof
RU2600795C1 (en) Vegetable composition in the form of a micellar solution
CN114984084A (en) Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating anorectal diseases such as hemorrhoids, preparation method and application
CN104435491A (en) Effective part composition of traditional Chinese medicine for treating parkinson disease and preparation method of effective part composition
CN113663028A (en) Traditional Chinese medicine gel for treating tuberculous ulcer and preparation method thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant