Sprayable lipid liquid crystal gel precursor as well as preparation method and application thereof

Abstract

The invention relates to a sprayable lipid liquid crystal gel precursor containing a periplaneta americana freeze-dried concentrate as well as a preparation method and application thereof, belongs to the technical field of pharmaceutical preparations, and solves the problems that an existing gel dosage form containing a periplaneta americana extract adopts a water-based gel matrix with high water content, a high-dose preservative needs to be added, and the cost is high. And the damaged skin is possibly stimulated. The lipid liquid crystal gel precursor comprises the following main active ingredients in percentage by mass: 1%-6% of periplaneta americana freeze-dried concentrate, 0.05%-1% of SOD (superoxide dismutase), 0.5%-3% of triethanolamine, 20%-30% of SPC (sodium phosphate), 50%-60% of GDO (glucose dissolved oxygen) and 5%-15% of absolute ethyl alcohol. The preparation method comprises the following steps: 1, preparing a liquid crystal matrix phase and an active component phase; and 2, uniformly mixing the liquid crystal matrix phase and the active component phase according to a mass ratio of (85-90): (10-15) to obtain the lipid liquid crystal gel precursor.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical formulation technology, specifically to a lipid liquid crystal spray gel formulation based on freeze-dried concentrate of American cockroach, and its application in the prevention and treatment of radiation-induced skin damage in cancer patients. Background Technology

[0002] Radiation-induced skin damage is a skin reaction caused by radiation exposure, commonly seen in radiotherapy patients, those exposed to nuclear leaks, and radiation workers. After exposure, the skin may exhibit pathological changes such as discoloration and structural damage; grade III-IV damage can lead to ulcers that are difficult to heal. Currently, there is a lack of universally effective treatment measures. The mechanisms of radiation-induced skin damage include DNA damage, inhibition of growth factor expression, and apoptosis. Under the GBZ106-2002 standard, grade III-IV damage manifests as moist desquamation and exposure of the dermis; severe cases can be life-threatening. 95% of radiotherapy patients experience skin toxicity, and 47% develop grade II or higher damage; high-dose irradiation is the main risk.

[0003] Existing gel formulations containing American cockroach extract use a water-based gel matrix with high water content, requiring the addition of high doses of preservatives, which may irritate damaged skin. Summary of the Invention

[0004] Based on the above analysis, the present invention aims to provide a sprayable lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, its preparation method and application, in order to solve the problem that existing gel formulations containing American cockroach extract use a water-based gel matrix with high water content, requiring the addition of high doses of preservatives, which may irritate damaged skin.

[0005] The objective of this invention is mainly achieved through the following technical solutions: In a first aspect, the present invention provides a sprayable lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, wherein the main active ingredients, by mass percentage, include 1%-6% freeze-dried concentrate of American cockroach, 0.05%-1% SOD and 0.5%-3% triethanolamine.

[0006] Optionally, the lipid liquid crystal gel precursor further comprises 20%-30% SPC, 50%-60% GDO, and 5%-15% anhydrous ethanol.

[0007] Optionally, the lipid liquid crystal gel precursor comprises 25%-30% SPC, 50%-56% GDO, 1%-5% American cockroach lyophilized concentrate, 0.05%-0.5% SOD, 0.5%-2.5% triethanolamine, and 7%-12% anhydrous ethanol.

[0008] Secondly, the present invention provides a method for preparing a lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, which includes the following steps: Step 1: Prepare the liquid crystal matrix phase and the active ingredient phase; Step 2: Mix the liquid crystal matrix phase and the active ingredient phase evenly at a mass ratio of (85-90):(10-15) to obtain the lipid liquid crystal gel precursor.

[0009] Optionally, in step 1, the preparation of the liquid crystal matrix phase includes: mixing soybean lecithin and room temperature liquefied diglyceride in a mass ratio of (32-38):(62-68) to obtain the liquid crystal matrix phase.

[0010] Optionally, in step 1, the preparation of the active ingredient phase includes the following steps: Step a: Prepare freeze-dried concentrate of American cockroaches; Step b: Mix the freeze-dried concentrate of American cockroaches, superoxide dismutase, triethanolamine and anhydrous ethanol to obtain the active ingredient phase.

[0011] Optionally, in step a, the preparation of the freeze-dried concentrate of American cockroaches includes: mixing dried American cockroaches with ethanol to obtain a mixed liquid; centrifuging the mixed liquid, taking the supernatant, and freeze-drying it to obtain the freeze-dried concentrate of American cockroaches. Optionally, the freeze-drying process includes pre-freezing; the pre-freezing temperature is -50°C to -40°C, and the pre-freezing time is 2-6 hours.

[0012] Optionally, the freeze-drying process also includes drying.

[0013] Thirdly, the present invention provides the application of the above-mentioned lipid liquid crystal gel precursor in the preparation of drugs for preventing and treating radiation-induced skin damage.

[0014] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects: (1) The liquid crystal gel precursor of the present invention uses a lipid gel matrix. The lipid gel matrix is ​​water-free and does not easily breed microorganisms. Therefore, no preservatives need to be added to the lipid liquid crystal gel precursor of the present invention, which is gentle on the skin and non-irritating.

[0015] (2) The lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroaches of the present invention is a sprayable solution, not a gel formulation. That is, when using it, the lipid liquid crystal gel precursor of the present invention is directly sprayed onto the damaged skin, and a gel is rapidly formed upon contact with body fluids, achieving sustained drug release and ensuring gel stability and controlled drug release effect. It also has the following advantages: a. Non-contact and non-invasive application greatly improves patient compliance and safety; Advantages: For painful wounds such as radiation dermatitis, oral ulcers, and burns, traditional application methods can cause mechanical friction, resulting in severe pain and even secondary damage. The spray formulation of this invention achieves "zero-contact" drug delivery, completely avoiding the pain and trauma caused by application, making it particularly suitable for patients sensitive to pain and children. In contrast, traditional gel application requires the use of cotton swabs or fingers, which cannot avoid physical contact.

[0016] b. Precise and uniform dosage and coverage ensure consistent therapeutic efficacy; Advantages: The spray delivers medication as a fine mist to the wound, ensuring thorough, thin, and even application regardless of the wound's shape (e.g., the nostrils, behind the ears). Each press delivers a relatively fixed dose, facilitating quantified treatment and avoiding the uneven application, drug buildup, or incomplete coverage issues associated with traditional ointments. In contrast, the application method makes it difficult to control the thickness and uniformity of the medication, which can easily lead to the accumulation of medication at the edges of the wound while the central area is not adequately covered.

[0017] c. Instant phase change forms a protective film with stronger adhesion and breathability; Advantages: Upon contact with moisture on the wound surface, the liquid crystal precursor of this invention undergoes a phase transition within seconds, transforming from a liquid into a robust, transparent, and breathable lipid liquid crystal gel film. This film, like "artificial skin," adheres tightly to the moist wound surface and is not easily detached due to movement or friction from clothing, providing continuous protection and a suitable environment for drug delivery. In contrast, while traditional pre-formed gels are viscous, their adhesion to moist wounds is limited, and they are easily diluted or washed away by exudate, requiring more frequent administration.

[0018] d. Suitable for administration over large areas and at special sites, expanding the scope of clinical applications; Advantages: The spray formulation is particularly suitable for rapid drug delivery to large wounds (such as systemic radiation dermatitis), significantly improving treatment efficiency. Furthermore, for special anatomical sites that are difficult to apply medication to, such as areas with dense hair, joint folds, and the oral cavity and throat, the spray is the only effective and convenient dosage form. In comparison, traditional gels are inefficient when applied over large areas, and are difficult to apply to hair follicles and cavities, resulting in a poor user experience.

[0019] e. Reduce the risk of secondary microbial contamination; Advantages: The "zero-contact" spray administration method avoids secondary contamination of the wound by hands or cotton swabs during the application of medication, which is especially important for patients with weakened immune function or those at risk of infection. In contrast, the process of applying medication topically inevitably introduces exogenous microorganisms.

[0020] f. Improve patients' psychological experience and ease of use; Advantages: The spray formulation is convenient to use, can be operated with one hand, and requires no auxiliary tools such as a mirror, giving patients greater autonomy and privacy. The refreshing spray also avoids the stickiness of traditional ointments, greatly improving the patient's medication experience and psychological comfort; In contrast, traditional gels are often cumbersome to apply, and their sticky texture can cause discomfort.

[0021] (3) In the preparation method of the present invention, a freeze-drying process with specific parameters is used. On the one hand, interfering components (water) are removed and the crude extract is transformed into a form suitable for compatibility with lipids. On the other hand, the biological activity of these heat-sensitive active ingredients is protected to the maximum extent while removing the solvent. It is a “mild” process specifically designed for the active ingredients of American cockroach.

[0022] (4) The present invention innovatively designed an A / B biphase system, which achieves stable loading of active ingredients in lipid precursors through a precise phase ratio of (85-90): (10-15).

[0023] (5) In the lipid gel matrix of the present invention, by precisely controlling the ratio of SPC:GDO to a specific lipid ratio of (32-38):(62-68), it can both support the complex drug solution B phase and ensure good gelation performance and mechanical strength of the final gel.

[0024] (6) The lipid liquid crystal gel precursor of the present invention has efficient penetration, long-lasting retention and tissue regeneration functions when sprayed onto damaged skin, which can meet the urgent clinical demand for this type of drug.

[0025] In this invention, the above-described technical solutions can be combined with each other to achieve more preferred combinations. Other features and advantages of this invention will be set forth in the following description, and some advantages will become apparent from the description or may be learned by practicing the invention. Attached Figure Description

[0026] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Throughout the drawings, the same reference numerals denote the same parts. Figure 1 Images of hydrogels prepared for Example 2; Figure 2 The experimental results of each group in the animal experiment of Example 1 of the present invention are shown. Detailed Implementation

[0027] Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which constitute a part of the present invention and, together with the embodiments, serve to illustrate the principles of the invention, but are not intended to limit the scope of the invention. Unless otherwise specified, the methods described are conventional methods. Unless otherwise specified, the raw materials are all available from commercially available sources.

[0028] Existing technologies include the use of American cockroach extract in gel formulations. However, these gel formulations use a water-based gel matrix, which has a high water content and is prone to becoming a breeding ground for microorganisms. For the nutrient-rich American cockroach extract, a high dose of preservatives needs to be added, which may irritate damaged skin.

[0029] The reason for not using a lipid gel matrix is ​​that the crude extract of American cockroaches has poor compatibility with lipid gel matrices and cannot form a homogeneous precursor. In addition, the crude extract disrupts the liquid crystal structure, has poor gelling properties or is unstable, making it very difficult to achieve a "sprayable" formulation conversion.

[0030] In a first aspect, the present invention provides a sprayable lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, wherein the main active ingredients, by mass percentage, include 1%-6% freeze-dried concentrate of American cockroach, 0.05%-1% SOD and 0.5%-3% triethanolamine.

[0031] The aforementioned sprayable lipid liquid crystal gel precursor containing freeze-dried American cockroach concentrate also contains 20%-30% SPC, 50%-60% GDO, and 5%-15% anhydrous ethanol.

[0032] Preferably, the sprayable lipid liquid crystal gel precursor containing freeze-dried American cockroach concentrate, by weight percentage, comprises 25%-30% SPC, 50%-56% GDO, 1%-5% freeze-dried American cockroach concentrate, 0.05%-0.5% SOD, 0.5%-2.5% triethanolamine, and 7%-12% anhydrous ethanol.

[0033] Secondly, the present invention also provides a method for preparing a lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, for preparing the above-mentioned lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, comprising the following steps: Step 1: Prepare the liquid crystal matrix phase (phase A) and the active ingredient phase (phase B); Step 2: Mix the liquid crystal matrix phase (phase A) and the active ingredient phase (phase B) evenly at a mass ratio of (85-90):(10-15) to obtain the lipid liquid crystal gel precursor.

[0034] In step 1, the preparation of the liquid crystal matrix phase (phase A) includes: mixing soybean lecithin (SPC) and room temperature liquefied diglyceride (GDO) at a mass ratio of (32-38):(62-68) at room temperature to obtain the liquid crystal matrix phase (phase A).

[0035] It should be noted that the core of the process for preparing sprayable formulations is the "liquid precursor," which aims for storage stability and instantaneous phase change; while the core of the process for non-spray gels is the "semi-solid," which aims for immediate morphological stability and adhesion. Therefore, the process of non-spray gels is completely irrelevant for preparing sprayable formulations.

[0036] If the SPC ratio is too high, for example, >40:60, the resulting precursor solution will have too high viscosity, the liquid crystal phase will form too early or be too rigid, resulting in failure to spray smoothly or excessively thick film after spraying.

[0037] If the GDO ratio is too high, for example, <30:70, on the one hand, the hydrophobicity is too strong, which makes the precursor solution unstable and the effective components precipitate; on the other hand, the phase change rate with water is too fast, which may form a gel in the nozzle and cause blockage; in addition, the formed gel film is too soft and lacks strength, making it easy to break.

[0038] The preparation of the active ingredient phase (Phase B) includes the following steps: Step a: Prepare freeze-dried concentrate of American cockroaches; Step b: Mix the freeze-dried concentrate of American cockroaches, superoxide dismutase (SOD), triethanolamine and anhydrous ethanol in a mass ratio of (0.1-0.5):(0.01-0.02):(0.1-0.5):1 to obtain the active ingredient phase (phase B).

[0039] Step a, the preparation of the freeze-dried concentrate of American cockroaches includes the following steps: Step a-1: Crush dried American cockroaches (purchased from Beijing Tongrentang) and sieve through a 300-mesh sieve to obtain dried American cockroach powder; Step a-2: Mix the dried American cockroach powder with 70% ethanol evenly, heat in a water bath to 60-75℃, and stir to obtain a mixed liquid; Step a-3: Let the mixed liquid stand at room temperature, centrifuge, and take the supernatant for freeze-drying to obtain freeze-dried concentrate of American cockroach.

[0040] In step a-2, the mass ratio of dried American cockroach powder to 70% ethanol is 1:(5-15), for example, 1:5, 1:7, 1:9, 1:11, 1:13, 1:15. Preferably, it is 1:10. The stirring speed is 100-300 r / min, for example, 100 r / min, 200 r / min, 300 r / min. The stirring time is 24-96 h, for example, 24 h, 30 h, 40 h, 50 h, 70 h, 80 h, 90 h, 96 h.

[0041] In step a-3, the settling time is 20-30 hours, for example, 20 hours, 22 hours, 24 hours, 26 hours, 28 hours, or 30 hours.

[0042] The centrifugation speed is 6000-10000 r / min, for example, 6000 r / min, 8000 r / min, 10000 r / min. The centrifugation time is 10-20 min, for example, 10 min, 15 min, 20 min.

[0043] In step a-3, the freeze-drying process includes pre-freezing and drying. The pre-freezing temperature is -50℃ to -40℃, for example, -50℃, -45℃, -40℃. The pre-freezing time is 2-6 hours, for example, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours.

[0044] If the pre-freezing temperature is not low enough (e.g., >-30℃), the ice crystals will grow too large and puncture the cell structure, causing the active ingredients to degrade and become inactive during the drying process.

[0045] Drying is carried out under vacuum conditions, including primary drying and secondary drying. The temperature for primary drying is -20℃ to -15℃, for example, -20℃, -18℃, and -15℃. The drying time for primary drying is 20-24 hours, for example, 20 hours, 21 hours, 22 hours, 23 hours, and 24 hours. The vacuum pressure for primary drying is ≤0.2 mbar.

[0046] If the primary drying temperature is too high (e.g., >-10℃), the material will collapse while a large amount of ice is still present, forming a dense structure. This will affect the secondary drying and further removal of moisture, resulting in a final product with high residual moisture, easy deterioration, and poor resolubility, which will affect subsequent gelation.

[0047] The secondary drying temperature is 20℃~30℃, for example, 20℃, 25℃, 30℃. The secondary drying time is 12-28h, for example, 12h, 15h, 18h, 20h, 22h, 24h, 26h, 28h. The vacuum pressure for secondary drying is ≤0.1mbar.

[0048] The freeze-drying process of this invention can remove solvents while maximizing the protection of the bioactivity of these heat-sensitive active ingredients.

[0049] In step 2, the mass ratio of the liquid crystal matrix phase (phase A) to the active component phase (phase B) can be, for example, 85:15, 86:14, 87:13, 88:12, 89:11, or 90:10.

[0050] If the proportion of phase B is too high (e.g., >20%), there will be too much solvent such as ethanol in the system, which will inhibit or destroy the formation of the liquid crystal structure, resulting in failure to form a gel or very poor gel strength.

[0051] The mass ratio of the liquid crystal matrix phase (phase A) to the active ingredient phase (phase B) determines the drug loading, stability, and phase transition behavior of the liquid crystal precursor during final use. By controlling the ratio of the two to be (85-90):(10-15), sufficient drug loading can be ensured while ensuring that ethanol and other substances do not affect the gelling ability of SPC / GDO.

[0052] When using this product, if there is bodily fluid on the damaged skin, the lipid liquid crystal gel precursor of this invention can be sprayed directly onto the damaged skin. Upon contact with the bodily fluid, a gel will quickly form, achieving sustained drug release and ensuring gel stability and controlled drug release. If there is no bodily fluid on the damaged skin, water can be sprayed onto the damaged skin first, followed by the lipid liquid crystal gel precursor of this invention. The mass ratio of water to lipid liquid crystal gel precursor is 1:1. Alternatively, the lipid liquid crystal gel precursor of this invention can be mixed with water at a 1:1 mass ratio before use to obtain a gel, which can then be applied to the damaged skin.

[0053] Compared with the prior art, the beneficial effects of the present invention are: 1. Dual treatment mechanism: Through the bioactive components of the freeze-dried concentrate of Kangfuxin Liquid (such as American cockroach extract), it can both prevent the occurrence of radiation dermatitis (keeping the skin dry and absorbing secretions) and promote the repair of wounds that have already developed dermatitis (inducing the regeneration of granulation tissue and removing necrotic tissue).

[0054] 2. Intelligent drug delivery: Based on the SPC / GDO (35:65) lipid liquid crystal system, it has lyotropic liquid crystal properties and can quickly form a gel after contact with body fluids to achieve sustained drug release, ensuring gel stability and drug controlled release effect.

[0055] 3. Synergistic effect of the formulation: Combining SOD (antioxidant) with triethanolamine (pH adjuster) enhances the formulation's inhibitory effect on inflammatory responses. Anhydrous ethanol, as a co-solvent, promotes the mixing of liquid crystal precursors and also provides local disinfection.

[0056] This invention combines bioactive ingredients with an advanced delivery system, offering both preventative (skin barrier protection) and therapeutic (repair promotion + anti-inflammation) benefits, demonstrating better clinical applicability in the management of radiation dermatitis.

[0057] Thirdly, the present invention also provides the application of the above-mentioned lipid liquid crystal gel precursor in the prevention and treatment of radiation-induced skin damage.

[0058] The present invention will now be described in detail with reference to specific embodiments.

[0059] Examples 1-3 of the present invention provide a sprayable lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach and its preparation method.

[0060] Example 1 500g of crushed and sieved (300 mesh) dried American cockroach powder was uniformly mixed with 5 L of 70% ethanol and heated in a water bath at 60℃ with a stirring speed of 300 r / min for 96 h. The mixture was then allowed to stand at room temperature for 24 h. The supernatant was centrifuged at 8000 r / min for 15 min, and then freeze-dried. The freeze-drying process was as follows: Pre-freezing: -40℃, 6 h; First drying: -15℃, 20 h; vacuum pressure ≤0.2 mbar; Second drying: 20℃, 28 h; vacuum pressure ≤0.1 mbar. This yielded a freeze-dried concentrate of American cockroaches.

[0061] SPC and room temperature liquefied GDO were mixed in a ratio of 32:68 and denoted as A. American cockroach lyophilized concentrate, SOD, triethanolamine and anhydrous ethanol were mixed (in a mass ratio of 0.1:0.02:0.1:1) and denoted as B. 88 wt% of A and 12 wt% of B were mixed and vortexed until uniformly mixed to obtain a sprayable lipid liquid crystal gel precursor containing American cockroach lyophilized concentrate.

[0062] Example 2 500g of crushed and sieved (300 mesh) dried American cockroach powder was mixed evenly with 5 L of 70% ethanol and heated in a water bath at 70℃ with stirring at 300 r / min for 96 h. The mixture was then allowed to stand at room temperature for 24 h. The supernatant was centrifuged at 8000 r / min for 15 min, and then freeze-dried. The freeze-drying process was as follows: Pre-freezing: -50℃, 4 h; First drying: -15℃, 24 h; vacuum pressure ≤0.2 mbar; Second drying: 25℃, 24 h; vacuum pressure ≤0.1 mbar. This yielded a freeze-dried concentrate of American cockroaches.

[0063] SPC and room temperature liquefied GDO were mixed in a ratio of 35:65 and denoted as A. American cockroach freeze-dried concentrate, SOD, triethanolamine and anhydrous ethanol were mixed (in a mass ratio of 0.2:0.01:0.1:1) and denoted as B. 85 wt% of A and 15 wt% of B were mixed and vortexed until uniformly mixed to obtain a sprayable lipid liquid crystal gel precursor containing American cockroach freeze-dried concentrate.

[0064] The prepared sprayable lipid liquid crystal gel precursor was mixed with water at a mass ratio of 1:1 to obtain a gel.

[0065] Example 3 500g of crushed and sieved (300 mesh) dried American cockroach powder was uniformly mixed with 5 L of 70% ethanol and heated in a water bath at 75℃ with stirring at 300 r / min for 96 h. The mixture was then allowed to stand at room temperature for 24 h. The supernatant was centrifuged at 8000 r / min for 15 min, and then freeze-dried. The freeze-drying process was as follows: Pre-freezing: -45℃, 5 h; First drying: -18℃, 22 h; vacuum pressure ≤0.2 mbar; Second drying: 30℃, 12 h; vacuum pressure ≤0.1 mbar. This yielded a freeze-dried concentrate of American cockroaches.

[0066] SPC and room temperature liquefied GDO were mixed in a ratio of 38:62, denoted as A. The freeze-dried concentrate of American cockroaches, SOD, triethanolamine and anhydrous ethanol were mixed (in a mass ratio of 0.5:0.015:0.3:1), denoted as B. 90 wt% of A and 10 wt% of B were mixed and vortexed until uniformly mixed to obtain a sprayable lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroaches.

[0067] Comparative Example 1 The comparative example is basically the same as Example 1, except that the ratio of SPC to room temperature liquefied GDO is 45:55. The prepared precursor solution has too high a viscosity and cannot be sprayed out smoothly.

[0068] Comparative Example 2 The comparative example is basically the same as Example 1, except that the ratio of SPC to room temperature liquefied GDO is 25:75. The gel film formed after the prepared precursor solution was sprayed out was too soft, lacked strength, and was easily damaged.

[0069] Comparative Example 3 The comparative example is basically the same as Example 2, except that the pre-freezing temperature is -30°C.

[0070] Comparative Example 4 This comparative example is essentially the same as Example 1, except that the initial drying temperature is -10°C. The prepared precursor solution cannot form a gel mold after being sprayed out.

[0071] Application Example 1 Animal experiments: 19-21g male BALB / c mice were selected and divided into 4 groups: blank control group, X-ray group, X-ray + gel group, and X-ray + Kangfuxin liquid (commercially available Good Doctor Kangfuxin liquid) group.

[0072] Experimental method: All animals were anesthetized by intraperitoneal injection of 3% sodium pentobarbital. The long hair on the back of the mice was removed with an electric shaver, covering an area of ​​about 4cm × 4cm. Then, the hair on the back was completely removed with depilatory cream.

[0073] X-ray irradiation: Irradiate with an X-ray tube (50 kV, 75 µA) for 90 seconds without administering any medication.

[0074] Blank control group: No irradiation, no drug administration; X-ray group: only X-ray irradiation (50 kV, 75 µA irradiation for 90 seconds), no drug administration; X-ray + gel group: 0.1g of the gel prepared in Example 2 was applied and X-ray irradiation was performed 2 hours later; X-ray + Kangfuxin solution group: Apply 0.1g of commercially available Kangfuxin solution, and then undergo X-ray irradiation 2 hours later.

[0075] Application Example 2 This application example is basically the same as application example 1, except that the X-ray + gel group uses the gel prepared in comparative example 3.

[0076] Figure 2 The experimental results of each group in the animal experiment of Example 1 of this invention are presented. Figure 2 As can be seen, the fur of the mice in the X-ray group began to turn yellow on day 5 of the experiment, the skin of the mice was already damaged on day 10, and the skin damage of the mice was very serious on day 15. As the experiment progressed, the skin deteriorated very rapidly.

[0077] The results of the X-ray + Kangfuxin liquid group were similar to those of the X-ray group, proving that applying Kangfuxin liquid is not effective in preventing radiation-induced skin damage.

[0078] The X-ray + gel group, in which the gel prepared in Example 2 of this invention was applied, showed significantly better results than the X-ray group and the X-ray + Kangfuxin liquid group. On day 5 of the experiment, the mice's fur began to turn yellow, and no skin damage occurred until the end of the experiment; only the degree of yellowing of the fur intensified. This demonstrates that the gel prepared using the sprayable lipid liquid crystal gel precursor of this invention can effectively prevent radiation-induced skin damage.

[0079] The experimental results of applying the gel prepared in Comparative Example 3 of the present invention (Application Example 2) were similar to those of the X-ray group (not shown in the figure), and it could not effectively prevent radiation-induced skin damage. This proves that the pre-freezing temperature was too high, and the active ingredients were degraded and deactivated during the drying process, thus failing to achieve the desired effect. Therefore, it could not effectively prevent radiation-induced skin damage.

[0080] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A sprayable lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, characterized in that, Based on mass percentage, the main active ingredients include 1%-6% freeze-dried concentrate of American cockroach, 0.05%-1% SOD and 0.5%-3% triethanolamine.

2. The lipid liquid crystal gel precursor according to claim 1, characterized in that, It also contains 20%-30% SPC, 50%-60% GDO and 5%-15% anhydrous ethanol.

3. The lipid liquid crystal gel precursor according to claim 2, characterized in that, The lipid liquid crystal gel precursor contains 25%-30% SPC, 50%-56% GDO, 1%-5% American cockroach lyophilized concentrate, 0.05%-0.5% SOD, 0.5%-2.5% triethanolamine, and 7%-12% anhydrous ethanol.

4. A method for preparing a lipid liquid crystal gel precursor containing freeze-dried concentrate of American cockroach, characterized in that, The preparation of the lipid liquid crystal gel precursor according to any one of claims 1-3 comprises the following steps: Step 1: Prepare the liquid crystal matrix phase and the active ingredient phase; Step 2: Mix the liquid crystal matrix phase and the active ingredient phase evenly at a mass ratio of (85-90):(10-15) to obtain the lipid liquid crystal gel precursor.

5. The preparation method according to claim 4, characterized in that, In step 1, the preparation of the liquid crystal matrix phase includes: mixing soybean lecithin and room temperature liquefied diglyceride in a mass ratio of (32-38):(62-68) to obtain the liquid crystal matrix phase.

6. The preparation method according to claim 4, characterized in that, Step 1, the preparation of the active ingredient phase includes the following steps: Step a: Prepare freeze-dried concentrate of American cockroaches; Step b: Mix the freeze-dried concentrate of American cockroaches, superoxide dismutase, triethanolamine and anhydrous ethanol to obtain the active ingredient phase.

7. The preparation method according to claim 6, characterized in that, In step a, the preparation of freeze-dried American cockroach concentrate includes: mixing dried American cockroaches with ethanol to obtain a mixed liquid; centrifuging the mixed liquid, taking the supernatant and freeze-drying it to obtain freeze-dried American cockroach concentrate.

8. The preparation method according to claim 7, characterized in that, Freeze-drying includes pre-freezing; the pre-freezing temperature is -50℃ to -40℃, and the pre-freezing time is 2-6 hours.

9. The preparation method according to claim 8, characterized in that, Freeze-drying also includes drying.

10. The use of the lipid liquid crystal gel precursor according to any one of claims 1-3 in the preparation of a drug for preventing and treating radiation-induced skin damage.

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