Nasal washing liquid and preparation method thereof

Abstract

The invention discloses nasal washing liquid and a preparation method thereof, and belongs to the field of pharmaceutical preparations. The medicine formed by the nasal washing liquid is obtained through repeated optimization of clinical research and fundamental research. Experimental research and human body tests show that the nasal cavity irrigator has the effect of irrigating the nasal cavity and also has the outstanding effects that (1) the nasal cavity irrigator has a lubricating effect, and secretions are easier to discharge in the irrigating process; (2) the moisturizing effect on nasal mucosa is achieved, a peptizing layer protective film is formed on the surface layer of the mucosa after rejection, and the function of protecting cilia activity is achieved; and (3) the traditional Chinese medicine composition has the anti-inflammatory effect by inhibiting inflammatory media, reducing vascular permeability and promoting mucous membrane repair.

Description

Technical Field

[0001] The invention relates to the field of pharmaceutical preparations, and in particular to a nasal wash solution and a preparation method thereof. Background Art

[0002] Nasal cleaning is part of the current treatment plan for nasal diseases such as acute and chronic rhinitis, allergic rhinitis, nasal polyps, sinusitis, etc. At present, the nasal wash used for nasal cleaning on the market is mainly made of sodium chloride (or seawater) and purified water. This nasal wash has no pharmacological effect. It mainly uses isotonic or hypertonic aqueous solutions that meet the physiological pH range to clean foreign matter in the nasal cavity, and only plays the role of nasal flushing.

[0003] The nasal irrigation solution of the prior art has a cleaning effect on rhinitis inflammatory secretions, allergens, fine dust, etc., but repeated irrigation will lead to nasal dryness, decreased nasal mucociliary function, thinning of the surface gel layer, and poor effect on chronic rhinitis and atrophic rhinitis. Summary of the invention

[0004] The object of the present invention is to provide a nasal wash solution and a preparation method thereof. The obtained nasal wash solution overcomes the defects of the nasal irrigation solution in the prior art and has good preventive and therapeutic effects on allergic rhinitis.

[0005] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical scheme.

[0006] Technical solution 1: A nasal wash solution, whose raw materials include, by weight: 0.5-20 parts of sodium hyaluronate, 6-9 parts of sea salt, 1-5 parts of potassium chloride, 1-5 parts of calcium chloride, 0.1-2 parts of glyceryl glucoside, and 0.1-2 parts of ectoine.

[0007] The preparation method of the nasal wash solution is as follows: Take 0.5-20 parts of sodium hyaluronate and add it to 100 parts of water, stir and dissolve, and wait until the sodium hyaluronate is completely dissolved and uniform to prepare a sodium hyaluronate aqueous solution for use; Take 6-9 parts of sea salt, 1-5 parts of potassium chloride, and 1-5 parts of calcium chloride, stir and dissolve evenly in 1000 ml of sodium hyaluronate aqueous solution; Take 0.1-2 parts of glyceryl glucoside and 0.1-2 parts of ectoine, add them to the solution of the above step, stir and dissolve, and obtain a nasal wash solution.

[0008] Technical Solution 2: A nasal wash solution, whose raw materials include, by weight: 0.5-20 parts of carbomer, 6-9 parts of sea salt, 1-5 parts of potassium chloride, 1-5 parts of calcium chloride, 0.1-2 parts of glyceryl glucoside, and 0.1-2 parts of ectoine.

[0009] The preparation method of the nasal wash solution is as follows: (1) Add 0.5-20 parts of carbomer to 100 parts of water, stir and dissolve, and wait until the carbomer is completely dissolved to prepare a carbomer aqueous solution for later use; (2) Take 6-9 parts of sea salt, 1-5 parts of potassium chloride, and 1-5 parts of calcium chloride in 1000 ml of carbomer aqueous solution and stir to dissolve evenly; (3) Take 0.1-2 parts of glyceryl glucoside and 0.1-2 parts of ectoine, add them to the solution of the above step, stir and dissolve, and obtain a nasal wash solution.

[0010] In technical solutions 1 and 2, the active ingredient content of glyceryl glucoside is 40-60%.

[0011] In technical solution 1 and technical solution 2, the pH value of the prepared nasal wash solution is between 7 and 8. Beneficial Effects

[0012] Among the various drugs used in the present invention, the solution prepared by sodium chloride, potassium chloride and calcium chloride is an electrolyte solution, which can achieve electrolyte balance. Sodium hyaluronate and carbomer can lubricate the nasal cavity and accelerate the excretion of foreign matter and inflammatory secretions in the nasal wash. Ectoin is a mucosal protective agent, which has the effect of controlling inflammatory factors and anti-inflammatory effects. Glycerol glucoside moisturizer strengthens the effects of Ectoin and sodium hyaluronate, forms a moist gelatinous film on the surface of the mucosa, and protects and promotes the function of cilia.

[0013] The nasal wash liquid prepared by the present invention has been experimentally studied and tested on human bodies. In addition to having the effect of flushing the nasal cavity, the present invention has the following outstanding effects: (1) it has a lubricating effect, making it easier to discharge secretions during the flushing process; (2) it has a moisturizing effect on the nasal mucosa, and after rejection, a gelatin layer protective film is formed on the surface of the mucosa to protect the ciliary activity function; (3) it has an anti-inflammatory effect by inhibiting inflammatory mediators, reducing vascular permeability, and promoting mucosal repair. DETAILED DESCRIPTION

[0014] The following examples are provided to further understand the present invention, but are not intended to limit the best mode of implementation and do not limit the content and protection scope of the present invention.

[0015] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in this field can be used. If no manufacturer is specified for the reagents or instruments used, they are all conventional reagent products that can be obtained commercially. All medicinal materials or pharmaceutical excipients have passed the inspection and meet the standards of the Pharmacopoeia of the People's Republic of China.

[0016] Embodiment 1: A nasal wash solution, whose raw materials include, by weight: 0.5-20 parts of sodium hyaluronate, 6-9 parts of sea salt, 1-5 parts of potassium chloride, 1-5 parts of calcium chloride, 0.1-2 parts of glyceryl glucoside, and 0.1-2 parts of ectoine.

[0017] The preparation method of the nasal wash solution is as follows: Take 0.5-20 parts of sodium hyaluronate and add it to 100 parts of water, stir and dissolve, and wait until the sodium hyaluronate is completely dissolved and uniform to prepare a sodium hyaluronate aqueous solution for use; Take 6-9 parts of sea salt, 1-5 parts of potassium chloride, and 1-5 parts of calcium chloride, stir and dissolve evenly in 1000 ml of sodium hyaluronate aqueous solution; Take 0.1-2 parts of glyceryl glucoside and 0.1-2 parts of ectoine, add them to the solution of the above step, stir and dissolve, and obtain a nasal wash solution.

[0018] Embodiment 2: A nasal wash solution, whose raw materials include, by weight: 0.5-20 parts of carbomer, 6-9 parts of sea salt, 1-5 parts of potassium chloride, 1-5 parts of calcium chloride, 0.1-2 parts of glyceryl glucoside, and 0.1-2 parts of ectoine.

[0019] The preparation method of the nasal wash solution is as follows: (1) Add 0.5-20 parts of carbomer to 100 parts of water, stir and dissolve, and wait until the carbomer is completely dissolved to prepare a carbomer aqueous solution for later use; (2) Take 6-9 parts of sea salt, 1-5 parts of potassium chloride, and 1-5 parts of calcium chloride in 1000 ml of carbomer aqueous solution and stir to dissolve evenly; (3) Take 0.1-2 parts of glyceryl glucoside and 0.1-2 parts of ectoine, add them to the solution of the above step, stir and dissolve, and obtain a nasal wash solution.

[0020] In Example 1 and Example 2, the effective ingredient content of the glyceryl glucoside is 40-60%.

[0021] In Example 1 and Example 2, the pH value of the prepared nasal wash solution is between 7 and 8.

[0022] Experimental Example 1: Evaluation of the effect of nasal wash on promoting nasal cilia function Test system and demonstration: Guinea pig nasal mucosal fibroblasts were selected and placed in a culture bottle containing MEM. The guinea pig nasal mucosal fibroblasts were propagated in an environment of 37°C and 5% carbon dioxide. The cells were cultured in MEM medium until the end of the logarithmic growth phase. Then, the cells were suspended in MEM medium and the cell concentration was adjusted to 1×10 511 culture dishes were prepared and numbered. The culture dishes were gently rotated to make the guinea pig nasal mucosal fibroblasts evenly distributed on the bottom of each culture dish. The dishes were then placed in a saturated water vapor chamber at (37 ± 1) °C containing 5% (volume fraction) CO. 2 After 24 hours of incubation, the confluence and morphology of the cultured cells were examined under a microscope before testing. 2.0 mL of different test solutions (see Table 1 for specific test solutions) were added to the culture dishes, and then placed at 37°C and 5% CO 2 , incubate in an environment with relative humidity >90% for 48 hours, and then observe the cell activity frequency CBF under a microscope.

[0023] The test results show that the test solutions of Example 1 and Example 2 of the present invention are superior to those of hypertonic saline, sea saline, saline and the blank control group in the activity of guinea pig nasal mucosal fibroblasts. See Table 1 for details.

[0024] Table 1. Activity frequency (CBF) of guinea pig nasal mucosal fibroblasts under different test solutions Group Test fluid CBF (times / second) Blank control group Purified water 9.10±2.1 Normal saline group Purified water containing 9% sodium chloride 10.15±2.0 Normal sea salt water group Sea salt water containing 9% sodium chloride 8.0±1.9 3.0% hypertonic saline Purified water containing 3% sodium chloride 5.8±1.9 7.0% hypertonic saline Purified water containing 9% sodium chloride 1.0±0.5 Sample group (1) of Example 1 of the present invention The solution described in Example 1 13±1.9 Sample group (2) of Example 1 of the present invention The solution described in Example 1 13±2.3 Sample group (3) of Example 1 of the present invention The solution described in Example 1 13± Sample group (1) of Example 2 of the present invention The solution described in Example 2 13±1.0 Sample group (2) of Example 2 of the present invention The solution described in Example 2 13±1.0 Sample group (3) of Example 2 of the present invention The solution described in Example 2 13± The test results show that the test solutions of Example 1 and Example 2 of the present invention are superior to those of the hypertonic saline, sea saline, normal saline and blank control group in the activity of guinea pig nasal mucosal fibroblasts.

Claims

1. A nasal wash solution, characterized in that: Calculated by weight, the raw materials of the nasal wash solution include 0.5-20 parts of sodium hyaluronate, 6-9 parts of sea salt, 1-5 parts of potassium chloride, 1-5 parts of calcium chloride, 0.1-2 parts of glyceryl glucoside, and 0.1-2 parts of ectoine.

2. The method for preparing the nasal wash solution according to claim 1, characterized in that: Take 0.5-20 parts of sodium hyaluronate and add it to 100 parts of water, stir and dissolve, and wait until the sodium hyaluronate is completely dissolved and uniform to prepare a sodium hyaluronate aqueous solution for use; Take 6-9 parts of sea salt, 1-5 parts of potassium chloride, and 1-5 parts of calcium chloride, stir and dissolve evenly in 1000 ml of sodium hyaluronate aqueous solution; Take 0.1-2 parts of glyceryl glucoside and 0.1-2 parts of ectoine, add them to the solution of the above step, stir and dissolve, and obtain a nasal wash solution.

3. A nasal wash solution, characterized in that: Calculated by weight, the raw materials of the nasal wash solution include 0.5-20 parts of carbomer, 6-9 parts of sea salt, 1-5 parts of potassium chloride, 1-5 parts of calcium chloride, 0.1-2 parts of glyceryl glucoside, and 0.1-2 parts of ectoine.

4. The method for preparing the nasal wash solution according to claim 3, characterized in that: (1) Add 0.5-20 parts of carbomer to 100 parts of water, stir and dissolve, and wait until the carbomer is completely dissolved to prepare a carbomer aqueous solution for later use; (2) Take 6-9 parts of sea salt, 1-5 parts of potassium chloride, and 1-5 parts of calcium chloride in 1000 ml of carbomer aqueous solution and stir to dissolve evenly; (3) Take 0.1-2 parts of glyceryl glucoside and 0.1-2 parts of ectoine, add them to the solution of the above step, stir and dissolve, and obtain a nasal wash solution.

5. A nasal wash solution according to claim 1 or 3, characterized in that: The effective component content of the glyceryl glucoside is 40-60%.

6. A nasal wash solution according to claim 1 or 3, or a method for preparing the nasal wash solution according to claim 2 or 4, characterized in that: The pH value of the prepared nasal wash solution is between 7 and 8.