Suppository excipient fused with saxifraga stolonifera extract

Abstract

The suppository excipient comprises 100% of the saxifraga stolonifera extract and a suppository matrix fused with the saxifraga stolonifera extract, and the saxifraga stolonifera extract is prepared according to the following method: (1) processing medicinal materials: taking dried whole saxifraga stolonifera as a raw medicinal material, cleaning the raw medicinal material, and crushing the cleaned raw medicinal material until the particle size is 40-80 meshes; (2) extraction: crushing the processed medicinal materials to obtain medicinal material powder; and adding water or an organic solvent into the medicinal material powder according to a solid-liquid ratio of 1: 10, and extracting to obtain the medicinal material extract. When the medicine disclosed by the invention is cooperatively used, the medicine shows a certain obvious inhibiting effect on prostate growth caused by testosterone; the medicine has a good curative effect on internal hemorrhoid bleeding and anal papillitis; due to special anatomical positions and tissue structures of prostate and unique disease positions of internal hemorrhoids, clinical application of suppository anus administration treatment has obvious advantages; the irritation on the rectum is small; the formula is simple, the production process is simple and scientific, and the preparation is stable.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a suppository excipient fused with a saxifrage extract. Background Art

[0002] Saxifraga stolonifera (L) Meerb. was first recorded in 1220 in the Lu Cang Yan Materia Medica written by Wang Jie, a medical scientist in the Southern Song Dynasty. More than 500 years later, in 1753, Linnaeus formally established the genus Saxifrage L. in his famous book Slantarum ed.l. Its medicinal use was first recorded in the Compendium of Materia Medica, which records that it tastes pungent and bitter, is cold in nature, has a slight toxicity, has the functions of clearing heat, detoxifying, and reducing swelling, and is used to treat rubella, eczema, otitis media, erysipelas, coughing and vomiting blood, itching and other diseases.

[0003] Modern research shows that saxifrage has cardiotonic, diuretic, anti-tumor, hepatoprotective, apoptosis-inducing, antioxidant, antibacterial, anti-inflammatory, hypoglycemic, antitussive, anti-estrogens, anti-prostatic hyperplasia, and protective effects on acute lung injury in mice. Saxifrage suppositories are administered by rectal route and are mainly used to treat prostate diseases including prostatitis, prostatic hyperplasia and prostate cancer, and anorectal diseases including internal hemorrhoid bleeding and anal papillitis.

[0004] The rectal drug delivery system has a long history. It was recorded in Egypt as early as 1500 BC. The earliest Chinese medicine rectal drug delivery appeared in the Treatise on Febrile Diseases written by Zhang Zhongjing in the Han Dynasty. Modern medical research has confirmed that the blood circulation of the rectal mucosa is vigorous and has a strong absorption capacity. The drug is mixed in the rectal secretion fluid. After being absorbed through the mucosa, it first passes through the middle rectal vein, the inferior rectal vein and the anal canal vein, bypassing the liver and directly entering the general circulation; second, it passes through the inferior rectal vein, enters the liver through the portal vein for metabolism, and then enters the human body circulation to the whole body; third, it absorbs a small amount of drug into the general circulation through the rectal lymphatic system. Compared with oral drugs, anorectal drug delivery has obvious advantages. The bioavailability of drugs is high. The active ingredients enter the inferior vena cava directly from the venous plexus without passing through the liver, avoiding the first-pass effect of the liver, preventing or reducing the destruction of drugs in the liver, and because the drugs do not pass through the stomach and small intestine, the pH and enzymes of the digestive fluid can be avoided. The effect and destructive effect of the drugs can be avoided, thereby increasing the absorption of drugs, improving bioavailability, making full use of drugs, and enhancing the efficacy. Moreover, the active ingredients are absorbed quickly and the effects are rapid, which is comparable to that of intravenous injection.

[0005] Shafit's study found that there are 2-6 small hemorrhoidal genital veins communicating between the venous plexus of the lower rectum and the urogenital venous plexus. These communicating branches transport the venous blood returning from the rectum to the urogenital venous plexus around the prostate in a one-way manner, making it easy for the drug to form a high concentration in the local prostate.

[0006] Cheng Junping reported that there is only a small amount of fat tissue and venous plexus between the prostate and the anterior wall of the rectum. The prostate is close to the anterior wall of the rectum. The distance from the posterior wall of the prostate to the anterior wall of the rectum is (5.1-6.5) mm, with an average of about 5.8 mm. The molecular weight of traditional Chinese medicine is between 270-388, which is smaller than that of commonly used Western medicines. It is easy to pass through the prostate capsule to reach the prostate tissue. The prostate tissue is adjacent to the rectum. After local medication, the small molecular substances of the effective ingredients of traditional Chinese medicine can be passively transported, passing through the mucosa, tissue, and prostate capsule to diffuse into the prostate, allowing the drug to reach the diseased area directly to exert its therapeutic effect.

[0007] However, the current Saxifraga preparations have technical defects such as complex formula, complicated production process, and unstable preparation. Summary of the invention

[0008] The technical problem to be solved by the present invention is to overcome the defects of the above-mentioned technology and provide a suppository excipient which is fused with the saxifrage extract.

[0009] In order to solve the above technical problems, the technical solution provided by the present invention is a suppository excipient melted with the saxifrage extract: comprising 100% saxifrage extract and a suppository base melted with the saxifrage extract.

[0010] Furthermore, the saxifrage extract is prepared according to the following method:

[0011] (1) Processing medicinal materials: Take the dried whole herb of Saxifraga as the raw medicinal material, first clean the raw medicinal material, and grind it into a particle size of 40-80 mesh;

[0012] (2) Extraction: crushing the processed medicinal materials to obtain medicinal powder; adding water or an organic solvent to the medicinal powder at a solid-liquid ratio of 1:10 to perform extraction to obtain a medicinal extract.

[0013] Furthermore, when water is added to the medicinal material powder, it is first soaked in water for 60 minutes, boiled for 60 minutes, and the medicinal liquid is taken for the first time; water is then added to make the material-liquid ratio 1:10, boiled for 60 minutes, and the medicinal liquid is taken for the second time, the two medicinal liquids are combined, heated and concentrated, 95% alcohol is added, adjusted to an alcohol concentration of 85%, allowed to stand for 24 hours, and the supernatant is taken for use; the supernatant is distilled to recover the alcohol, and heated and concentrated to the required viscosity to obtain an extract.

[0014] Furthermore, when adding an organic solvent to the medicinal material powder, soak it for 48 hours, during which it is turned over and stirred every 4-6 hours; take the medicinal solution for the first time after 48 hours; then add the organic solvent to make the material-liquid ratio 1:10, soak it for 24 hours, take the medicinal solution for the second time, combine the two medicinal solutions, let it stand and take the supernatant for use; take the supernatant to distill and recover the organic solvent, heat and concentrate it to the required viscosity to obtain an extract;

[0015] The organic solvent is ethanol or ethyl acetate.

[0016] Furthermore, water is added to the medicinal material powder, firstly soaked in water for 60 minutes, boiled for 60 minutes, and the medicinal liquid is taken for the first time; water is then added to make the solid-liquid ratio 1:10, boiled for 60 minutes, and the medicinal liquid is taken for the second time, the two medicinal liquids are combined, heated and concentrated, 95% alcohol is added, adjusted to an alcohol concentration of 85%, allowed to stand for 24 hours, and the supernatant is taken for use; the supernatant is taken for distillation to recover alcohol, and heated and concentrated to a specific gravity of 1.3-1.45 to obtain an extract.

[0017] Furthermore, 55%-60% ethanol is added to the medicinal material powder, and the mixture is first soaked for 48 hours, during which the mixture is turned over and stirred every 4-6 hours; the medicinal solution is taken for the first time after 48 hours; 55%-60% ethanol is then added to make the solid-liquid ratio 1:10, and after soaking for 24 hours, the medicinal solution is taken for the second time, the two medicinal solutions are combined, and the mixture is allowed to stand for use, and the supernatant is taken for use; the supernatant is distilled to recover ethanol, and the mixture is concentrated by heating to a specific gravity of 1.3-1.45 to obtain an extract.

[0018] Furthermore, the suppository base is one or more of glycerin gelatin, polyoxyethylene (40) monostearate, poloxamer, polysorbate 61, water-soluble chitosan, cocoa butter, semi-synthetic fatty acid glyceride, and synthetic fatty acid ester.

[0019] Furthermore, a preservative is added to the suppository excipient.

[0020] Compared with the prior art, the advantages of the present invention are as follows: the saxifrage extract of the present invention contains bergenin, succinic acid, protocatechuic acid and gallic acid, and an ingenious preparation method is used during extraction, so that the pharmaceutical composition, when used in combination, shows a certain obvious inhibitory effect on prostate growth caused by testosterone; has a good therapeutic effect on internal hemorrhoid bleeding and anal papillitis; because of the special anatomical position and tissue structure of the prostate and the unique location of internal hemorrhoids, the clinical use of suppositories for anal administration has obvious advantages; a suppository excipient that is fused with the saxifrage extract and has no irritation to the rectum is adopted, and suppository excipients that are irritating to the rectum, such as polyethylene glycol 4000 and polyethylene glycol 6000, are excluded, and the irritation to the rectum is small; the formula is simple, the production process is simple and scientific, and the preparation is stable. DETAILED DESCRIPTION

[0021] The present invention is described in detail below in conjunction with various embodiments, but it should be noted that these embodiments are not limitations of the present invention, and any equivalent transformations or substitutions in functions, methods, or structures made by ordinary technicians in the field based on these embodiments are all within the scope of protection of the present invention.

[0022] The suppository excipient melted with the saxifrage extract comprises 100% saxifrage extract and a suppository base melted with the saxifrage extract.

[0023] The saxifrage extract is prepared as follows:

[0024] (1) Processing medicinal materials: Take the dried whole herb of Saxifraga as the raw medicinal material, first clean the raw medicinal material, and grind it into a particle size of 40-80 mesh;

[0025] (2) Extraction: crushing the processed medicinal materials to obtain medicinal powder; adding water or an organic solvent to the medicinal powder at a solid-liquid ratio of 1:10 to perform extraction to obtain a medicinal extract.

[0026] When the water extraction method is used for drug extraction, water is added to the medicinal material powder, first soaked in water for 60 minutes, boiled for 60 minutes, and the medicinal liquid is taken for the first time; water is added again to make the material-liquid ratio 1:10, boiled for 60 minutes, and the medicinal liquid is taken for the second time, the two medicinal liquids are combined, heated and concentrated, 95% alcohol is added, adjusted to an alcohol concentration of 85%, and left to stand for 24 hours, and the supernatant is taken for standby; the supernatant is taken for distillation to recover the alcohol, heated and concentrated to a specific gravity of 1.3-1.45, and a type-attached agent is added to make tablets, suppositories or gels. The supernatant medicinal liquid can also be taken and subjected to ethyl acetate reflux extraction 2-3 times using the conventional method for making Chinese medicine injections; and then antioxidant and acid-base balance treatment is performed: the above-mentioned recovered liquid is subjected to antioxidant treatment with sodium bisulfite using the conventional method for making Chinese medicine injections, and acid-base balance is performed, the pH value is adjusted to between 3.1-3.4, and then filtered with a microporous membrane, bottled and sterilized.

[0027] Alternatively, an organic solvent may be added to the medicinal material powder for extraction. After adding the organic solvent, the medicinal material powder is first soaked for 48 hours, during which the powder is turned over and stirred every 4-6 hours; the medicinal liquid is taken for the first time after 48 hours; the organic solvent is added again to make the material-liquid ratio 1:10, and after soaking for 24 hours, the medicinal liquid is taken for the second time, the two medicinal liquids are combined, and the supernatant is taken for standby use; the supernatant is taken for distillation to recover the organic solvent, and the extract is obtained by heating and concentrating to a suitable viscosity. The organic solvent is ethanol or ethyl acetate.

[0028] Taking ethanol as an organic solvent as an example: add 55%-60% ethanol to the medicinal material powder, soak for 48 hours, turn over and stir every 4-6 hours; take the medicinal solution for the first time after 48 hours; then add 55%-60% ethanol to make the solid-liquid ratio 1:10, soak for 24 hours, take the medicinal solution for the second time, combine the two medicinal solutions, let stand and take the supernatant for use; take the supernatant to distill and recover ethanol, heat and concentrate to a specific gravity of 1.3-1.45, and obtain an extract.

[0029] The saxifrage extract and the suppository base are fully melted to prepare a suppository; the suppository base is one or more of glycerin gelatin, polyoxyethylene (40) monostearate, poloxamer, polysorbate 61, water-soluble chitosan, cocoa butter, semi-synthetic fatty acid glyceride, and synthetic fatty acid ester.

[0030] The suppository excipients are added with preservatives, such as various sulfites, cysteine, potassium sorbate, etc. 0.5-1 g of preservatives are added to every 800 g of dried whole saxifrage grassland material to prepare 100 suppositories.

[0031] Example 1: Polyoxyethylene (40) monostearate matrix suppository process

[0032] Preparation: 160g of polyoxyethylene (40) monostearate of pharmaceutical standard; 50g of Saxifraga extract, and 0.4g of sodium bisulfite.

[0033] Mixing process: Place the above materials in a suitable container (such as a stainless steel pot) and heat with a water bath or electric heating jacket at 50-60°C. During the heating process, use gentle stirring methods such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm) for 15-30 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0034] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0035] Example 2: Poloxamer 188 Matrix Suppository Process

[0036] Preparation: Take 160g of pharmaceutical standard Poloxamer 188, 50g of Saxifrage extract, and 0.4g of sodium bisulfite.

[0037] Mixing process: Place the above materials in a suitable container (such as a stainless steel pot) and heat with a water bath or electric heating jacket at 50-60°C. During the heating process, use gentle stirring methods such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm) for 15-30 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0038] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0039] Example 3: Glycerin-gelatin matrix suppository process

[0040] Preparation: 16g of pharmaceutical standard glycerin, 32g of gelatin, 112g of water, 50g of saxifrage extract, and 0.4g of sodium bisulfite.

[0041] Preparation of the matrix: Put gelatin into an appropriate amount of water and allow it to fully absorb water and swell. This process usually takes a while, soaking for about 30-60 minutes to ensure that the gelatin can fully absorb water and facilitate subsequent dissolution. Put the expanded gelatin and water mixture into a constant temperature water bath, heat and stir, and control the temperature at 60-80℃. When the gelatin is completely dissolved, add glycerin and continue to stir and mix evenly to form about 160g of glycerin gelatin matrix.

[0042] Mixing process: Put the above glycerin gelatin matrix and 50g of Saxifraga extract into a suitable container (such as a stainless steel pot), heat it with a water bath or an electric heating jacket, and control the temperature at 50-60°C. During the heating process, use gentle stirring methods, such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm), for 15-30 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0043] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0044] Example 4: Polysorbate 61 Suppository Process

[0045] Preparation: Take 160g of pharmaceutical standard polysorbate 61, 50g of saxifrage extract, and 0.4g of sodium bisulfite.

[0046] Mixing process: Place the above materials in a suitable container (such as a stainless steel pot) and heat them in a water bath or electric heating jacket at a temperature of 50-60°C. During the heating process, use gentle stirring methods such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm), generally for 15-30 minutes, until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0047] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0048] Embodiment 5: cocoa butter suppository process

[0049] Preparation: 160g of cocoa butter of medicinal standards, 50g of saxifrage extract, and 0.4g of sodium bisulfite.

[0050] Mixing process: Place the above materials in a suitable container (such as a stainless steel pot) and heat with a water bath or electric heating jacket at 35-40°C. During the heating process, use gentle stirring methods such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm) for 15-30 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0051] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0052] Example 6: Water-soluble chitosan suppository

[0053] Preparation: 20g of water-soluble chitosan of pharmaceutical standard, 50g of Saxifrage extract, 0.4g of sodium bisulfite, 2g of glycerol, and 2g of ethylparaben.

[0054] Matrix preparation: Place 20g of water-soluble chitosan in a container and add purified water. The weight ratio of water-soluble chitosan to purified water is 1:5-1:10. Place the container in a constant temperature water bath, set the temperature to 40-60°C, turn on the magnetic stirrer to fully dissolve the water-soluble chitosan to form a uniform solution. Add glycerol and stir evenly.

[0055] Mixing process: Place the above materials in a suitable container (such as a stainless steel pot) and heat with a water bath or electric heating jacket at a temperature of 40-60°C. During the heating process, use gentle stirring methods such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100 rpm) for 10-20 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0056] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0057] Embodiment 7: Semi-synthetic fatty acid glyceride suppository process

[0058] Preparation: 160g semi-synthetic fatty acid glyceride of pharmaceutical standard, 50g saxifrage extract, and 0.4g sodium bisulfite.

[0059] Mixing process: Place the above materials in a suitable container (such as a stainless steel pot) and heat with a water bath or electric heating jacket at a temperature of 50-70°C. During the heating process, use gentle stirring methods such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm) for 15-30 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0060] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0061] Example 8: Process for synthesizing fatty acid ester suppositories

[0062] Here we take propylene glycol stearate as an example:

[0063] Preparation: 160g of propylene glycol stearate of pharmaceutical standard, 50g of saxifrage extract, and 0.4g of sodium bisulfite.

[0064] Mixing process: Place the above materials in a suitable container (such as a stainless steel pot) and heat with a water bath or electric heating jacket at 60-80°C. During the heating process, use gentle stirring methods such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm) for 15-30 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0065] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. The weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0066] Example 9: Mixed matrix suppository process

[0067] Commonly used fat-soluble suppository bases include cocoa butter, semi-synthetic fatty acid glycerides (coconut oil or palm kernel oil, etc.), synthetic fatty acid esters (such as propylene glycol stearate) and water-soluble suppository bases include glycerin gelatin, polyoxyethylene (40) monostearate, poloxamer, polysorbate 61, polyethylene glycol 4000 and polyethylene glycol 6000. One or more of the mixed bases composed of a certain proportion in the mixed base are fully melted; the saxifrage extract and the fat-soluble suppository base are not melted; the saxifrage extract and the water-soluble suppository base are first mixed and melted, and then melted with the fat-soluble suppository base.

[0068] Polyethylene glycol 4000 and polyethylene glycol 6000 have irritating effects on the rectum. About 5-10% of patients will experience mild rectal discomfort, including hyperborax, a feeling of heaviness, mild pain, and diarrhea in severe cases. These symptoms will generally gradually ease after stopping use, affecting medication compliance. For example:

[0069] Preparation: 100 g of synthetic fatty acid ester of pharmaceutical standard (propylene glycol stearate); 30 g each of polyethylene glycol 4000 and polyethylene glycol 6000; 50 g of saxifrage extract; 0.4 g of sodium bisulfite.

[0070] Mixing process: Put polyethylene glycol 4000, polyethylene glycol, and saxifrage extract into a suitable container (such as a stainless steel pot), heat with a water bath or an electric heating jacket, and control the temperature at 60-80°C. After melting, add propylene glycol stearate and sodium bisulfite to melt. During the heating process, use gentle stirring methods, such as magnetic stirring or mechanical stirring (speed controlled at a low speed, such as 50-100rpm), for 15-30 minutes until the drug and excipients are fully mixed with the matrix to form a uniform mixture.

[0071] Suppository molding: Select a 2g, torpedo-shaped mold, apply a thin layer of lubricant (such as silicone oil) inside the mold, pour the mixed material into the mold while it is hot (the temperature is kept above the melting point of the matrix), and pay attention to avoid bubbles during pouring. Generally, the weight error of each suppository should be controlled within ±7%. After pouring, let the suppository cool naturally in the mold. When the suppository is completely solidified, demold it.

[0072] The medicinal suppository for treating prostate diseases and anorectal diseases of the present invention has the effects of enhancing astringency, hemostasis and anti-inflammatory; can reduce inflammatory edema, improve glandular microcirculation, reduce the volume of hyperplastic prostate, facilitate drainage, and promote diuresis, thereby achieving the purpose of effectively treating prostate diseases. The suppository is suitable for treating symptoms such as frequent urination, painful urination, etc. caused by prostatitis and prostate hyperplasia, and symptoms such as bleeding, perianal moisture, itching, etc. caused by anorectal diseases.

[0073] The drug suppository for treating prostate diseases and anorectal diseases of the present invention solves the problem that systemic medication such as oral, intramuscular, and intravenous administration cannot form an effective drug concentration in the prostate, and overcomes the influence of the "blood-prostate barrier" on the conservative treatment of prostate diseases.

[0074] The present invention and its implementation methods are described above. Such description is not restrictive. If a person skilled in the art is inspired by it and creatively designs implementation methods and embodiments similar to the technical solution without departing from the purpose of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A suppository excipient melted with a saxifrage extract, characterized in that: The invention comprises 100% saxifrage extract and a suppository base melted with the saxifrage extract.

2. The suppository excipient melted with the Saxifraga extract according to claim 1, characterized in that: The saxifrage extract is prepared as follows: (1) Processing medicinal materials: Take the dried whole herb of Saxifraga as the raw medicinal material, first clean the raw medicinal material, and grind it into a particle size of 40-80 mesh; (2) Extraction: crushing the processed medicinal materials to obtain medicinal powder; adding water or an organic solvent to the medicinal powder at a solid-liquid ratio of 1:10 to perform extraction to obtain a medicinal extract.

3. The suppository excipient melted with the Saxifraga extract according to claim 2, characterized in that: When water is added to the medicinal material powder, first soak it in water for 60 minutes, boil it for 60 minutes, and take the medicinal solution for the first time; then add water to make the material-liquid ratio 1:10, boil it for 60 minutes, take the medicinal solution for the second time, combine the two medicinal solutions, heat and concentrate, add 95% alcohol, adjust the alcohol concentration to 85%, let it stand for 24 hours, take the supernatant for use; take the supernatant to distill and recover the alcohol, heat and concentrate it to the required viscosity, and obtain an extract.

4. The suppository excipient melted with the Saxifraga extract according to claim 2, characterized in that: When adding an organic solvent to the medicinal material powder, soak it for 48 hours, during which time it is turned over and stirred every 4-6 hours; take the medicinal solution for the first time after 48 hours; then add the organic solvent to make the material-liquid ratio 1:10, soak it for 24 hours, take the medicinal solution for the second time, combine the two medicinal solutions, let it stand and take the supernatant for use; take the supernatant and distill it to recover the organic solvent, heat and concentrate it to the required viscosity to obtain an extract; The organic solvent is ethanol or ethyl acetate.

5. The suppository excipient melted with the Saxifraga extract according to claim 3, characterized in that: Add water to the medicinal material powder, soak it in water for 60 minutes, boil it for 60 minutes, and take the medicinal solution for the first time; then add water to make the material-liquid ratio 1:10, boil it for 60 minutes, take the medicinal solution for the second time, combine the two medicinal solutions, heat and concentrate, add 95% alcohol, adjust the alcohol concentration to 85%, let it stand for 24 hours, take the supernatant for use; take the supernatant to distill and recover the alcohol, heat and concentrate it to a specific gravity of 1.3-1.45, and obtain an extract.

6. The suppository excipient melted with the Saxifraga extract according to claim 4, characterized in that: 55%-60% ethanol is added to the medicinal material powder, and the powder is first soaked for 48 hours, during which the powder is turned over and stirred every 4-6 hours; the medicinal solution is taken for the first time after 48 hours; 55%-60% ethanol is added again to make the material-liquid ratio 1:10, and after soaking for 24 hours, the medicinal solution is taken for the second time, the two medicinal solutions are combined, and the supernatant is taken for standby use; the supernatant is taken for distillation to recover ethanol, and the supernatant is concentrated by heating to a specific gravity of 1.3-1.45 to obtain an extract.

7. The suppository excipient melted with the Saxifraga extract according to any one of claims 1 to 6, characterized in that: The saxifrage extract and the suppository base are fully melted to prepare a suppository; The suppository base is one or more of glycerin gelatin, polyoxyethylene (40) monostearate, poloxamer, polysorbate 61, water-soluble chitosan, cocoa butter, semi-synthetic fatty acid glyceride, and synthetic fatty acid ester.

8. The suppository excipient melted with the Saxifraga extract according to any one of claims 1 to 6, characterized in that: A preservative is added to the suppository excipients.