A traditional Chinese medicine composition for treating chronic prostatitis and a preparation method thereof

Abstract

The application relates to the field of traditional Chinese medicine compositions, and particularly discloses a traditional Chinese medicine composition for treating chronic prostatitis and a preparation method thereof; the traditional Chinese medicine composition comprises the following steps: S1: preparing a matrix material by taking amphoteric starch, L-arginine hydrochloride, hydroxypropyl cellulose, water and glutaraldehyde; S2: preparing traditional Chinese medicine extracts by taking sophora flavescens, psoralea corylifolia, patrinia, cuscuta chinensis, herba epimedii, red peony root, verbena, Chinese chive seed, Chinese yam, prepared rehmannia, cornus officinalis, radix paeoniae rubra, alisma orientale, poria cocos, cassia, prepared aconite, and yam of china; S3: preparing a traditional Chinese medicine gel by taking the traditional Chinese medicine extracts, water and the matrix material; S4: preparing a warming agent by taking an emulsifier, water, n-docosane and hydroxypropyl cellulose; and S5: uniformly mixing the traditional Chinese medicine gel, borneol, the warming agent, poloxamer, carboxymethyl cellulose, hydroxypropyl-BETA-cyclodextrin and ethanol, controlling the pH value to be 7.3-7.5, and obtaining the traditional Chinese medicine composition.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, and specifically discloses a traditional Chinese medicine composition for treating chronic prostatitis and its preparation method. Background Technology

[0002] Prostatitis can cause symptoms such as premature ejaculation, difficulty urinating, incomplete urination, lower back pain, weakness in the limbs, and nocturnal emission. It may even lead to diseases such as posterior urethritis, epididymo-orchitis, etc.

[0003] Traditional Chinese medicine (TCM) ingredients are safe and inexpensive, offering advantages in improving prostatitis. However, the difficulty in delivering the drugs to the affected tissue increases the complexity of treatment. Rectal administration offers the advantage of targeted drug delivery to the prostate, characterized by rapid delivery and high drug concentration. However, current TCM enemas generally suffer from poor retention and leakage, reducing their efficacy. Therefore, researching an effective TCM composition for treating prostatitis and its preparation method is of great significance. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for treating chronic prostatitis and its preparation method, so as to solve the problems mentioned in the background art.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a traditional Chinese medicine composition for treating chronic prostatitis, characterized in that it comprises the following raw materials, in parts by mass: 80-120 parts of traditional Chinese medicine gel, 0.2-0.5 parts of borneol, 10-20 parts of warming agent, 2-5 parts of poloxamer, 0.2-0.5 parts of carboxymethyl cellulose, 2-5 parts of hydroxypropyl-BETA-cyclodextrin, and 1-3 parts of ethanol.

[0006] Preferably, the preparation of the traditional Chinese medicine gel includes the following steps: S1: Take amphoteric starch, L-arginine hydrochloride, hydroxypropyl cellulose, and water, stir evenly, add glutaraldehyde, stir at 35-45℃ for 5-10 hours, remove water, and freeze dry to obtain matrix material;

[0007] S2: Take the Chinese herbal extract, water, and matrix material, stir until transparent, and then stir for 3-4 hours to obtain the Chinese herbal gel.

[0008] Preferably, the matrix material comprises the following raw materials in parts by weight: 1-2 parts amphoteric starch, 10-20 parts hydroxypropyl cellulose, 1-2 parts L-arginine hydrochloride, 150-250 parts water, and 0.5-2 parts glutaraldehyde; the traditional Chinese medicine gel comprises the following raw materials in parts by weight: 15-25 parts traditional Chinese medicine extract, 80-120 parts water, and 5-8 parts matrix material.

[0009] Preferably, the preparation of the warming agent includes the following steps: taking emulsifier and water, heating to 85-95°C, stirring until clear, adjusting pH to 8-9, cooling to 55-65°C, adding heated and melted n-dodecane, stirring at 1000-1500 r / min for 8-15 min, and then shearing at 10000-12000 r / min for 3-8 min; adding hydroxypropyl cellulose, stirring for 3-6 h, and drying to obtain the warming agent.

[0010] Preferably, the warming agent comprises the following raw materials, in parts by weight: 0.5 to 1.5 parts emulsifier, 60 to 80 parts water, 5 to 15 parts n-docosahexanes, and 5 to 15 parts hydroxypropyl cellulose.

[0011] Preferably, the emulsifier comprises a polystyrene-maleic anhydride copolymer.

[0012] Preferably, the preparation of the traditional Chinese medicine extract includes the following steps: taking the medicinal materials, decocting them twice with water, the first extraction adding water at a volume of 10-15 times the weight of the medicinal materials, soaking for 0.5-1 hour, and then heating and refluxing for 3-4 hours; the second extraction adding water at a volume of 8-10 times the weight of the medicinal materials, heating and refluxing for 3-4 hours, adding ethanol to make the ethanol content 30-40%, filtering, concentrating, and drying to a moisture content of 2-5%, to obtain the traditional Chinese medicine extract; the medicinal materials include one or more of the following: Sophora flavescens, Psoralea corylifolia, Patrinia scabiosaefolia, Cuscuta chinensis, Epimedium brevicornu, Paeonia lactiflora, Verbena officinalis, Allium tuberosum seed, Dioscorea opposita, Rehmannia glutinosa, Cornus officinalis, Paeonia suffruticosa, Alisma plantago-aquatica, Poria cocos, Cinnamomum cassia, Aconitum carmichaelii (processed), and Coix lacryma-jobi.

[0013] Preferably, the herbal extract comprises the following raw materials in parts by weight: 20-30 parts Sophora flavescens, 10-20 parts Psoralea corylifolia, 20-40 parts Patrinia scabiosaefolia, 10-20 parts Cuscuta chinensis, 10-20 parts Epimedium brevicornu, 15-21 parts Paeonia lactiflora, 10-14 parts Verbena officinalis, 15-21 parts Allium tuberosum, 20-40 parts Dioscorea opposita, 20-40 parts Rehmannia glutinosa, 10-20 parts Cornus officinalis, 10-20 parts Paeonia suffruticosa, 10-20 parts Alisma plantago-aquatica, 20-40 parts Poria cocos, 10-20 parts Cinnamomum cassia, 10-15 parts Aconitum carmichaelii (processed), and 20-40 parts Coix lacryma-jobi.

[0014] Preferably, the preparation of the amphoteric starch includes the following steps: taking 3-dimethyl(chloropropyl)ammonium propanesulfonate and water, stirring evenly to obtain a 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; taking starch and water, stirring and mixing, adding NaOH solution, stirring at 35-45℃ for 1-2 hours, adding the 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stirring, reacting at 65-75℃ for 6-8 hours, adjusting the pH to neutral, precipitating with methanol, stirring, centrifuging, washing the filter cake with methanol, and vacuum drying for 20-25 hours to obtain amphoteric starch.

[0015] Preferably, the amphoteric starch comprises the following raw materials, by mass fraction: 2-4 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate, 5-20 parts of water, 1-2 parts of starch, 0.5-1 parts of NaOH solution, and 100-150 parts of methanol.

[0016] Preferably, the preparation of 3-dimethyl(chloropropyl)ammonium propanesulfonate includes the following steps: taking 10-20 parts of N,N-dimethylaminochloropropane hydrochloride and 10-20 parts of water, stirring evenly to obtain an N,N-dimethylaminochloropropane hydrochloride solution; adding 5-15 parts of NaOH solution dropwise to the N,N-dimethylaminochloropropane hydrochloride solution, separating by a separatory funnel, and taking the upper layer to obtain N,N-dimethylaminochloropropane; taking 15-25 parts of propanesulfonyl lactone and 80-150 parts of 1,2-dichloroethane, stirring evenly, adding N,N-dimethylaminochloropropane, stirring, reacting at 75-80℃ for 5-8 hours, filtering, washing the filter cake with 1,2-dichloroethane, and vacuum drying for 20-25 hours to obtain 3-dimethyl(chloropropyl)ammonium propanesulfonate.

[0017] Preferably, the preparation of 3-dimethyl(chloropropyl)ammonium propanesulfonate includes the following steps: taking 15 parts of N,N-dimethylaminochloropropane hydrochloride and 15 parts of water, stirring evenly to obtain an N,N-dimethylaminochloropropane hydrochloride solution; adding 12 parts of NaOH solution dropwise to the N,N-dimethylaminochloropropane hydrochloride solution, separating by a separatory funnel, and taking the upper layer to obtain N,N-dimethylaminochloropropane; taking 20 parts of propanesulfonyl lactone and 120 parts of 1,2-dichloroethane, stirring evenly, adding N,N-dimethylaminochloropropane, stirring, reacting at 75°C for 7 hours, filtering, washing the filter cake with 1,2-dichloroethane, and vacuum drying for 24 hours to obtain 3-dimethyl(chloropropyl)ammonium propanesulfonate.

[0018] Preferably, the NaOH solution is a 40% (w / v) NaOH solution.

[0019] Preferably, the traditional Chinese medicine composition is administered rectally.

[0020] Preferably, a method for preparing a traditional Chinese medicine composition for treating chronic prostatitis includes the following steps: taking a traditional Chinese medicine gel, borneol, a warming agent, poloxamer, carboxymethyl cellulose, hydroxypropyl-BETA-cyclodextrin, and ethanol, mixing them evenly, and controlling the pH to 7.3-7.5 to obtain the traditional Chinese medicine composition.

[0021] Compared with the prior art, the beneficial effects achieved by the present invention are: (1) The Chinese medicine composition is administered rectally and absorbed directly into the macrocirculation through the intestinal mucosa, avoiding the first-pass effect of the liver and avoiding the destruction of the drug by digestive juices, and has the characteristics of fast drug delivery and high drug utilization.

[0022] (2) The traditional Chinese medicine extract prepared in this invention is loaded with a matrix material to obtain a traditional Chinese medicine gel. The gel can form a bioadhesion with the rectal mucosa, increasing the contact time and contact density between the drug and the mucosa, thereby improving the absorption rate of the drug in the rectum. The matrix material includes a certain proportion of amphoteric starch, L-arginine hydrochloride, and hydroxypropyl cellulose. Hydroxypropyl methylcellulose has good water solubility and gel-forming properties, which can regulate the release rate of the drug. The gel can stay in the rectum for a longer time, further improving the absorption rate of the drug. Amphoteric starch has good anti-protein adsorption capacity. When the drug is administered, biomolecules in the rectum will attach to the surface of the drug and form a protein crown, affecting the drug release capacity. Amphoteric starch contains amphoteric ions, which can form a strong repulsive hydration layer, playing an anti-protein adsorption role and ensuring that the drug can be absorbed efficiently. L-arginine hydrochloride has a certain buffering and protective effect, which helps to reduce the stimulation of the drug to the rectum. Arginine has a positive effect on maintaining the normal metabolism and repair of intestinal epithelial cells. At the same time, L-arginine hydrochloride has a certain lubricating effect, which can improve the safety and comfort of medication.

[0023] (3) Add a warming agent, n-dodecane coated with hydroxypropyl cellulose. When the warm liquid is used for enema, it can promote local blood circulation, accelerate metabolism, relieve inflammatory edema and pain, and promote drug penetration and absorption. The coating material and the matrix material of the traditional Chinese medicine gel also contain hydroxypropyl cellulose, and the final traditional Chinese medicine composition has good stability. Detailed Implementation

[0024] The following are preferred embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. For those skilled in the art, all other embodiments obtained by those skilled in the art without creative effort without departing from the principles of the embodiments of the present invention are within the scope of protection of the present invention.

[0025] Example 1: S1: Take 3 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate and 3 parts of water, stir evenly to obtain 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; take 2 parts of starch and 12 parts of water, stir and mix, add 0.6 parts of NaOH solution, stir at 40°C for 1 h, add 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stir, react at 70°C for 7 h, adjust pH to neutral, precipitate with 120 parts of methanol, stir, centrifuge, wash filter cake with methanol, vacuum dry for 24 h to obtain amphoteric starch;

[0026] S2: Take 2 parts amphoteric starch, 1 part L-arginine hydrochloride, 18 parts hydroxypropyl cellulose, and 200 parts water, stir evenly, add 1 part glutaraldehyde, stir at 42℃ for 8 hours, remove water, and freeze dry to obtain matrix material.

[0027] S3: Take 25 parts Sophora flavescens, 15 parts Psoralea corylifolia, 25 parts Patrinia scabiosaefolia, 10 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 15 parts Paeonia lactiflora, 10 parts Verbena officinalis, 16 parts Allium tuberosum, 20 parts Dioscorea opposita, 20 parts Rehmannia glutinosa, 10 parts Cornus officinalis, 10 parts Paeonia suffruticosa, 10 parts Alisma plantago-aquatica, 20 parts Poria cocos, 10 parts Cinnamomum cassia, 15 parts Aconitum carmichaelii (processed), and 20 parts Coix lacryma-jobi. Decoction the herbs twice with water. For the first extraction, add 12 times the weight of the herbs, soak for 0.5 hours, and reflux for 4 hours. For the second extraction, add 10 times the weight of the herbs, reflux for 3 hours, add ethanol to make the ethanol content 35%, filter, concentrate, and vacuum dry at 45℃ until the moisture content is 4%, to obtain the herbal extract.

[0028] S4: Take 20 parts of Chinese herbal extract, 100 parts of water, and 6 parts of matrix material, stir until transparent, and then stir for 4 hours to obtain Chinese herbal gel.

[0029] S5: Take 1 part emulsifier and 70 parts water, heat to 90℃, stir until clear, adjust pH=9, and wait for cooling to 60℃. Add 12 parts of n-dodecane that has been melted by heating at 60℃, stir at 1200r / min for 10min, and then shear at 10000r / min for 6min; add 12 parts hydroxypropyl cellulose, stir for 5h, and dry to obtain the warming agent;

[0030] S6: Take 100 parts of traditional Chinese medicine gel, 0.3 parts of borneol, 15 parts of warming agent, 4 parts of poloxamer, 0.4 parts of carboxymethyl cellulose, 3 parts of hydroxypropyl-BETA-cyclodextrin, and 2 parts of ethanol, mix them evenly, and control the pH to 7.4 to obtain the traditional Chinese medicine composition.

[0031] Example 2: S1: Take 3 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate and 3 parts of water, stir evenly to obtain a 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; take 2 parts of starch and 12 parts of water, stir and mix, add 0.6 parts of NaOH solution, stir at 40°C for 1 h, add 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stir, react at 70°C for 7 h, adjust pH to neutral, precipitate with 120 parts of methanol, stir, centrifuge, wash filter cake with methanol, vacuum dry for 24 h to obtain amphoteric starch;

[0032] S2: Take 1 part amphoteric starch, 2 parts L-arginine hydrochloride, 20 parts hydroxypropyl cellulose, and 150 parts water, stir evenly, add 0.5 parts glutaraldehyde, stir at 35℃ for 10 hours, remove water, and freeze dry to obtain matrix material.

[0033] S3: Take 25 parts of Sophora flavescens, 15 parts of Psoralea corylifolia, 25 parts of Patrinia scabiosaefolia, 10 parts of Cuscuta chinensis, 15 parts of Epimedium brevicornu, 15 parts of Paeonia lactiflora, 10 parts of Verbena officinalis, 16 parts of Allium tuberosum, 20 parts of Dioscorea opposita, 20 parts of Rehmannia glutinosa, 10 parts of Cornus officinalis, 10 parts of Paeonia suffruticosa, 10 parts of Alisma plantago-aquatica, 20 parts of Poria cocos, 10 parts of Cinnamomum cassia, 15 parts of Aconitum carmichaelii (processed), and 20 parts of Coix lacryma-jobi. Decoction the herbs twice with water. For the first extraction, add 15 times the weight of the herbs, soak for 1 hour, and reflux for 3 hours. For the second extraction, add 10 times the weight of the herbs, reflux for 3 hours, add ethanol to make the ethanol content 40%, filter, concentrate, and vacuum dry at 55℃ until the moisture content is 4%, to obtain the herbal extract.

[0034] S4: Take 15 parts of Chinese herbal extract, 80 parts of water, and 5 parts of matrix material, stir until transparent, and then stir for 4 hours to obtain Chinese herbal gel.

[0035] S5: Take 0.5 parts of emulsifier and 70 parts of water, heat to 90℃, stir until clear, adjust pH=9, and wait for cooling to 60℃. Add 5 parts of n-dodecane that has been melted by heating at 60℃, stir at 1200r / min for 10min, and then shear at 10000r / min for 6min; add 5 parts of hydroxypropyl cellulose, stir for 5h, and dry to obtain the warming agent;

[0036] S6: Take 80 parts of traditional Chinese medicine gel, 0.2 parts of borneol, 10 parts of warming agent, 2 parts of poloxamer, 0.2 parts of carboxymethyl cellulose, 2 parts of hydroxypropyl-BETA-cyclodextrin, and 1 part of ethanol, mix them evenly, and control the pH to 7.4 to obtain the traditional Chinese medicine composition.

[0037] Example 3: S1: Take 3 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate and 3 parts of water, stir evenly to obtain 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; take 2 parts of starch and 12 parts of water, stir and mix, add 0.6 parts of NaOH solution, stir at 40°C for 1 h, add 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stir, react at 70°C for 7 h, adjust pH to neutral, precipitate with 120 parts of methanol, stir, centrifuge, wash filter cake with methanol, vacuum dry for 24 h to obtain amphoteric starch;

[0038] S2: Take 2 parts amphoteric starch, 2 parts L-arginine hydrochloride, 20 parts hydroxypropyl cellulose, and 250 parts water, stir evenly, add 2 parts glutaraldehyde, stir at 45℃ for 5 hours, remove water, and freeze dry to obtain matrix material.

[0039] S3: Take 25 parts Sophora flavescens, 15 parts Psoralea corylifolia, 25 parts Patrinia scabiosaefolia, 10 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 15 parts Paeonia lactiflora, 10 parts Verbena officinalis, 16 parts Allium tuberosum, 20 parts Dioscorea opposita, 20 parts Rehmannia glutinosa, 10 parts Cornus officinalis, 10 parts Paeonia suffruticosa, 10 parts Alisma plantago-aquatica, 20 parts Poria cocos, 10 parts Cinnamomum cassia, 15 parts Aconitum carmichaelii (processed), and 20 parts Coix lacryma-jobi. Decoction the herbs twice with water. For the first extraction, add 15 times the weight of the herbs, soak for 0.5 hours, and reflux for 3 hours. For the second extraction, add 10 times the weight of the herbs, reflux for 4 hours, add ethanol to make the ethanol content 30%, filter, concentrate, and vacuum dry at 55℃ until the moisture content is 4%, to obtain the herbal extract.

[0040] S4: Take 25 parts of Chinese herbal extract, 120 parts of water, and 8 parts of matrix material, stir until transparent, and then stir for 4 hours to obtain Chinese herbal gel.

[0041] S5: Take 1.5 parts of emulsifier and 70 parts of water, heat to 90℃, stir until clear, adjust pH=9, and wait for cooling to 60℃. Add 15 parts of n-dodecane that has been melted by heating at 60℃, stir at 1200r / min for 10min, and then shear at 10000r / min for 6min; add 15 parts of hydroxypropyl cellulose, stir for 5h, and dry to obtain the warming agent;

[0042] S6: Take 120 parts of traditional Chinese medicine gel, 0.5 parts of borneol, 20 parts of warming agent, 5 parts of poloxamer, 0.5 parts of carboxymethyl cellulose, 5 parts of hydroxypropyl-BETA-cyclodextrin, and 3 parts of ethanol, mix them evenly, and control the pH to 7.4 to obtain the traditional Chinese medicine composition.

[0043] Comparative Example 1 (the amounts of amphoteric starch, L-arginine hydrochloride, and hydroxypropyl cellulose were changed, while the remaining steps were the same as in Example 1): S1: Take 3 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate and 3 parts of water, stir evenly to obtain a 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; take 2 parts of starch and 12 parts of water, stir and mix, add 0.6 parts of NaOH solution, stir at 40°C for 1 h, add 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stir, react at 70°C for 7 h, adjust the pH to neutral, precipitate with 120 parts of methanol, stir, centrifuge, wash the filter cake with methanol, and vacuum dry for 24 h to obtain amphoteric starch;

[0044] S2: Take 5 parts amphoteric starch, 0.5 parts L-arginine hydrochloride, 15 parts hydroxypropyl cellulose, and 200 parts water, stir evenly, add 1 part glutaraldehyde, stir at 42℃ for 8 hours, remove water, and freeze dry to obtain matrix material.

[0045] S3: Take 25 parts Sophora flavescens, 15 parts Psoralea corylifolia, 25 parts Patrinia scabiosaefolia, 10 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 15 parts Paeonia lactiflora, 10 parts Verbena officinalis, 16 parts Allium tuberosum, 20 parts Dioscorea opposita, 20 parts Rehmannia glutinosa, 10 parts Cornus officinalis, 10 parts Paeonia suffruticosa, 10 parts Alisma plantago-aquatica, 20 parts Poria cocos, 10 parts Cinnamomum cassia, 15 parts Aconitum carmichaelii (processed), and 20 parts Coix lacryma-jobi. Decoction the herbs twice with water. For the first extraction, add 12 times the weight of the herbs, soak for 0.5 hours, and reflux for 4 hours. For the second extraction, add 10 times the weight of the herbs, reflux for 3 hours, add ethanol to make the ethanol content 35%, filter, concentrate, and vacuum dry at 45℃ until the moisture content is 4%, to obtain the herbal extract.

[0046] S4: Take 20 parts of Chinese herbal extract, 100 parts of water, and 6 parts of matrix material, stir until transparent, and then stir for 4 hours to obtain Chinese herbal gel.

[0047] S5: Take 1 part emulsifier and 70 parts water, heat to 90℃, stir until clear, adjust pH=9, and wait for cooling to 60℃. Add 12 parts of n-dodecane that has been melted by heating at 60℃, stir at 1200r / min for 10min, and then shear at 10000r / min for 6min; add 12 parts hydroxypropyl cellulose, stir for 5h, and dry to obtain the warming agent;

[0048] S6: Take 100 parts of traditional Chinese medicine gel, 0.3 parts of borneol, 15 parts of warming agent, 4 parts of poloxamer, 0.4 parts of carboxymethyl cellulose, 3 parts of hydroxypropyl-BETA-cyclodextrin, and 2 parts of ethanol, mix them evenly, and control the pH to 7.4 to obtain the traditional Chinese medicine composition.

[0049] Comparative Example 2 (the amounts of warming agent and traditional Chinese medicine gelling agent were changed, and the remaining methods and steps were the same as in Example 1): S1: Take 3 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate and 3 parts of water, stir evenly to obtain 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; take 2 parts of starch and 12 parts of water, stir and mix, add 0.6 parts of NaOH solution, stir at 40°C for 1 h, add 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stir, react at 70°C for 7 h, adjust pH to neutral, precipitate with 120 parts of methanol, stir, centrifuge, wash filter cake with methanol, vacuum dry for 24 h to obtain amphoteric starch;

[0050] S2: Take 2 parts amphoteric starch, 1 part L-arginine hydrochloride, 18 parts hydroxypropyl cellulose, and 200 parts water, stir evenly, add 1 part glutaraldehyde, stir at 42℃ for 8 hours, remove water, and freeze dry to obtain matrix material.

[0051] S3: Take 25 parts Sophora flavescens, 15 parts Psoralea corylifolia, 25 parts Patrinia scabiosaefolia, 10 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 15 parts Paeonia lactiflora, 10 parts Verbena officinalis, 16 parts Allium tuberosum, 20 parts Dioscorea opposita, 20 parts Rehmannia glutinosa, 10 parts Cornus officinalis, 10 parts Paeonia suffruticosa, 10 parts Alisma plantago-aquatica, 20 parts Poria cocos, 10 parts Cinnamomum cassia, 15 parts Aconitum carmichaelii (processed), and 20 parts Coix lacryma-jobi. Decoction the herbs twice with water. For the first extraction, add 12 times the weight of the herbs, soak for 0.5 hours, and reflux for 4 hours. For the second extraction, add 10 times the weight of the herbs, reflux for 3 hours, add ethanol to make the ethanol content 35%, filter, concentrate, and vacuum dry at 45℃ until the moisture content is 4%, to obtain the herbal extract.

[0052] S4: Take 20 parts of Chinese herbal extract, 100 parts of water, and 6 parts of matrix material, stir until transparent, and then stir for 4 hours to obtain Chinese herbal gel.

[0053] S5: Take 1 part emulsifier and 70 parts water, heat to 90℃, stir until clear, adjust pH=9, and wait for cooling to 60℃. Add 12 parts of n-dodecane that has been melted by heating at 60℃, stir at 1200r / min for 10min, and then shear at 10000r / min for 6min; add 12 parts hydroxypropyl cellulose, stir for 5h, and dry to obtain the warming agent;

[0054] S6: Take 110 parts of traditional Chinese medicine gel, 0.3 parts of borneol, 5 parts of warming agent, 4 parts of poloxamer, 0.4 parts of carboxymethyl cellulose, 3 parts of hydroxypropyl-BETA-cyclodextrin, and 2 parts of ethanol, mix them evenly, and control the pH to 7.4 to obtain the traditional Chinese medicine composition.

[0055] Comparative Example 3 (with different medicinal materials, but the rest of the methods and steps are the same as in Example 1): S1: Take 3 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate and 3 parts of water, stir evenly to obtain a 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; take 2 parts of starch and 12 parts of water, stir and mix, add 0.6 parts of NaOH solution, stir at 40°C for 1 h, add 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stir, react at 70°C for 7 h, adjust the pH to neutral, precipitate with 120 parts of methanol, stir, centrifuge, wash the filter cake with methanol, and vacuum dry for 24 h to obtain amphoteric starch;

[0056] S2: Take 2 parts amphoteric starch, 1 part L-arginine hydrochloride, 18 parts hydroxypropyl cellulose, and 200 parts water, stir evenly, add 1 part glutaraldehyde, stir at 42℃ for 8 hours, remove water, and freeze dry to obtain matrix material.

[0057] S3: Take 5 parts Lygodium japonicum, 25 parts Sophora flavescens, 2 parts Schisandra chinensis, 2 parts Cnidium monnieri, 2 parts Glycyrrhiza uralensis, 40 parts Astragalus membranaceus, 20 parts Plantago asiatica, 20 parts Taraxacum mongolicum, 1 part Tetrapanax papyriferus, 10 parts Aconitum carmichaelii (processed), 15 parts Gentiana scabra, 20 parts Gardenia jasminoides, 20 parts Lonicera japonica, and 20 parts Inula japonica. Decoction the herbs twice with water. For the first extraction, add 12 times the amount of water as the weight of the herbs, soak for 0.5 hours, and reflux for 4 hours. For the second extraction, add 10 times the amount of water as the weight of the herbs, reflux for 3 hours, add ethanol to make the ethanol content 35%, filter, concentrate, and vacuum dry at 45℃ until the moisture content is 4% to obtain the Chinese herbal extract.

[0058] S4: Take 20 parts of Chinese herbal extract, 100 parts of water, and 6 parts of matrix material, stir until transparent, and then stir for 4 hours to obtain Chinese herbal gel.

[0059] S5: Take 1 part emulsifier and 70 parts water, heat to 90℃, stir until clear, adjust pH=9, and wait for cooling to 60℃. Add 12 parts of n-dodecane that has been melted by heating at 60℃, stir at 1200r / min for 10min, and then shear at 10000r / min for 6min; add 12 parts hydroxypropyl cellulose, stir for 5h, and dry to obtain the warming agent;

[0060] S6: Take 100 parts of traditional Chinese medicine gel, 0.3 parts of borneol, 15 parts of warming agent, 4 parts of poloxamer, 0.4 parts of carboxymethyl cellulose, 3 parts of hydroxypropyl-BETA-cyclodextrin, and 2 parts of ethanol, mix them evenly, and control the pH to 7.4 to obtain the traditional Chinese medicine composition.

[0061] Comparative Example 4 (the amount of Chinese herbal extract and matrix material added was changed, and the rest of the method and steps were the same as in Example 1): S1: Take 3 parts of 3-dimethyl(chloropropyl)ammonium propanesulfonate and 3 parts of water, stir evenly to obtain 3-dimethyl(chloropropyl)ammonium propanesulfonate solution; take 2 parts of starch and 12 parts of water, stir and mix, add 0.6 parts of NaOH solution, stir at 40°C for 1 h, add 3-dimethyl(chloropropyl)ammonium propanesulfonate solution, stir, react at 70°C for 7 h, adjust pH to neutral, precipitate with 120 parts of methanol, stir, centrifuge, wash filter cake with methanol, vacuum dry for 24 h to obtain amphoteric starch;

[0062] S2: Take 2 parts amphoteric starch, 1 part L-arginine hydrochloride, 18 parts hydroxypropyl cellulose, and 200 parts water, stir evenly, add 1 part glutaraldehyde, stir at 42℃ for 8 hours, remove water, and freeze dry to obtain matrix material.

[0063] S3: Take 25 parts Sophora flavescens, 15 parts Psoralea corylifolia, 25 parts Patrinia scabiosaefolia, 10 parts Cuscuta chinensis, 15 parts Epimedium brevicornu, 15 parts Paeonia lactiflora, 10 parts Verbena officinalis, 16 parts Allium tuberosum, 20 parts Dioscorea opposita, 20 parts Rehmannia glutinosa, 10 parts Cornus officinalis, 10 parts Paeonia suffruticosa, 10 parts Alisma plantago-aquatica, 20 parts Poria cocos, 10 parts Cinnamomum cassia, 15 parts Aconitum carmichaelii (processed), and 20 parts Coix lacryma-jobi. Decoction the herbs twice with water. For the first extraction, add 12 times the weight of the herbs, soak for 0.5 hours, and reflux for 4 hours. For the second extraction, add 10 times the weight of the herbs, reflux for 3 hours, add ethanol to make the ethanol content 35%, filter, concentrate, and vacuum dry at 45℃ until the moisture content is 4%, to obtain the herbal extract.

[0064] S4: Take 30 parts of Chinese herbal extract, 100 parts of water, and 3 parts of matrix material, stir until transparent, and then stir for 4 hours to obtain Chinese herbal gel.

[0065] S5: Take 1 part emulsifier and 70 parts water, heat to 90℃, stir until clear, adjust pH=9, and wait for cooling to 60℃. Add 12 parts of n-dodecane that has been melted by heating at 60℃, stir at 1200r / min for 10min, and then shear at 10000r / min for 6min; add 12 parts hydroxypropyl cellulose, stir for 5h, and dry to obtain the warming agent;

[0066] S6: Take 100 parts of traditional Chinese medicine gel, 0.3 parts of borneol, 15 parts of warming agent, 4 parts of poloxamer, 0.4 parts of carboxymethyl cellulose, 3 parts of hydroxypropyl-BETA-cyclodextrin, and 2 parts of ethanol, mix them evenly, and control the pH to 7.4 to obtain the traditional Chinese medicine composition.

[0067] Unless otherwise specified, the experimental methods used in the above embodiments are conventional methods; unless otherwise specified, the raw materials used are all commercially available, and the sources of the raw materials are as follows: N,N-dimethylaminochloropropane hydrochloride (S66271, Shanghai Yuanye); propane sulpholone (CAS: 1120-71-4); 1,2-dichloroethane (CAS: 107-06-2); starch (S11004, Shanghai Yuanye); methanol (CAS: 67-56-1); L-arginine hydrochloride (S20011, Shanghai Yuanye); hydroxypropyl cellulose (S14170) , Shanghai Yuanye); glutaraldehyde (CAS: 111-30-8); emulsifier (polystyrene maleic anhydride copolymer, Y47209, Shanghai Yuanye); n-Docosane (CAS: 629-97-0); borneol (CAS: 507-70-0); poloxamer (P407, Wuhan Xindadi Environmental Protection Materials Co., Ltd.); carboxymethyl cellulose (S14019, Shanghai Yuanye); hydroxypropyl-BETA-cyclodextrin (CAS: 128446-35-5, Hubei Huizepu Pharmaceutical Technology Co., Ltd.); ethanol (CAS: 64-17-5).

[0068] Experiment: Take the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4; (1) Take 70 male SD rats weighing 200-250g, divide them into 7 groups, feed them for one week to adapt to the environment, put the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4 into the rectal administration device, seal it with a sealing film, heat it in a constant temperature water bath at 50℃ for 10min, and then administer the drug 5-6cm away from the anus; 0.7% methylene blue dye was added to all 7 groups. The rats were fasted for 24 hours before administration but allowed to drink water, and were massaged to stimulate them to expel excess feces; after administration, they were placed in a clean box and the color of the rat excrement was observed to determine whether there was any feces in the rectum. (2) Take 70 male SD rats weighing 200-250g, divide them into 7 groups, dissect their rectums and cut them in half, rinse them with physiological saline, and test the content of matrine in the receiving pool at 2 and 6 hours by the Franz diffusion pool method (using the rectum as a diaphragm to divide the Franz diffusion pool and the receiving pool) and the intelligent transdermal diffusion instrument, and calculate the release percentage; see the table below for specific data; the matrine content determination refers to the content determination method under the Sophora flavescens item in Part I of the Chinese Pharmacopoeia 2020 edition, and the specific steps refer to: Preparation and evaluation of compound Sophora flavescens rectal in situ heating gel_Wang Fangqing, Section 2.3;

[0069]

[0070]

[0071] Conclusion: The traditional Chinese medicine composition prepared by this invention has good rectal retention properties; in Comparative Example 1, changing the amount of amphoteric starch, L-arginine hydrochloride, and hydroxypropyl cellulose significantly reduced the retention time; in Comparative Example 2, changing the amount of warming agent and traditional Chinese medicine gelling agent significantly reduced the release rate; in Comparative Example 3, changing the amount of medicinal materials reduced the performance, indicating that the selection and amount of medicinal materials are also important; in Comparative Example 4, changing the amount of traditional Chinese medicine extract and matrix material reduced the retention time, thus demonstrating the importance of matrix material; in summary, the traditional Chinese medicine composition prepared by this invention can effectively treat chronic prostatitis.

[0072] Finally, it should be noted that the above description is merely a preferred embodiment of the present invention, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the spirit and principles of the present invention and within the technical scope disclosed in this application should be included within the scope of protection of this application. Where there is no conflict, the embodiments and features described in the embodiments of this application can be combined with each other. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine composition for treating chronic prostatitis, characterized in that: The product comprises the following ingredients, by weight: 80-120 parts of traditional Chinese medicine gel, 0.2-0.5 parts of borneol, 10-20 parts of warming agent, 2-5 parts of poloxamer, 0.2-0.5 parts of carboxymethyl cellulose, and 2-5 parts of hydroxypropyl. BETA Cyclodextrin, 1-3 parts ethanol; Preparation of the Traditional Chinese Medicine Gel Includes the following steps: S1: Take amphoteric starch, L Arginine hydrochloride, hydroxypropyl cellulose, and water were mixed evenly, glutaraldehyde was added, and the mixture was stirred at 35-45°C for 5-10 hours. After removing the water, the matrix material was obtained by freeze-drying. S2: Take the Chinese herbal extract, water, and matrix material, stir until transparent, and then stir for 3-4 hours to obtain the Chinese herbal gel. The matrix material comprises the following raw materials, in parts by weight: 1-2 parts amphoteric starch, 10-20 parts hydroxypropyl cellulose, 1-2 parts L... Arginine hydrochloride, 150-250 parts water, 0.5-2 parts glutaraldehyde; the traditional Chinese medicine gel comprises the following raw materials, by mass: 15-25 parts traditional Chinese medicine extract, 80-120 parts water, 5-8 parts matrix material; The herbal extract comprises the following raw materials, in parts by weight: 20-30 parts Sophora flavescens, 10-20 parts Psoralea corylifolia, 20-40 parts Patrinia scabiosaefolia, 10-20 parts Cuscuta chinensis, 10-20 parts Epimedium brevicornu, 15-21 parts Paeonia lactiflora, 10-14 parts Verbena officinalis, 15-21 parts Allium tuberosum, 20-40 parts Dioscorea opposita, 20-40 parts Rehmannia glutinosa, 10-20 parts Cornus officinalis, 10-20 parts Paeonia suffruticosa, 10-20 parts Alisma plantago-aquatica, 20-40 parts Poria cocos, 10-20 parts Cinnamomum cassia, 10-15 parts Aconitum carmichaelii (processed), and 20-40 parts Coix lacryma-jobi. The heating agent comprises the following raw materials, by mass parts: 0.5-1.5 parts emulsifier, 60-80 parts water, 5-15 parts n-docosahexanes, and 5-15 parts hydroxypropyl cellulose; The amphoteric starch comprises the following raw materials, by mass fraction: 2-4 parts 3 Dimethylchloropropylammonium propanesulfonate, 5-20 parts water, 1-2 parts starch, 0.5-1 parts NaOH solution, 100-150 parts methanol.

2. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, characterized in that: The preparation of the warming agent includes the following steps: take emulsifier and water, heat to 85~95℃, stir until clear, adjust pH=8~9, wait for cooling to 55~65℃, add heated and melted n-dodecane, stir at 1000~1500r / min for 8~15min, then shear at 10000~12000r / min for 3~8min; add hydroxypropyl cellulose, stir for 3~6h, dry to obtain the warming agent.

3. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, characterized in that: The preparation of the herbal extract includes the following steps: taking the medicinal materials, decocting them twice with water, the first extraction with 10-15 times the amount of water as the weight of the medicinal materials, soaking for 0.5-1 hour, and then refluxing for 3-4 hours; the second extraction with 8-10 times the amount of water as the weight of the medicinal materials, refluxing for 3-4 hours, adding ethanol to make the ethanol content 30-40%, filtering, concentrating, and drying to a moisture content of 2-5%, to obtain the herbal extract; the medicinal materials are a combination of Sophora flavescens, Psoralea corylifolia, Patrinia scabiosaefolia, Cuscuta chinensis, Epimedium brevicornu, Paeonia lactiflora, Verbena officinalis, Allium tuberosum, Dioscorea opposita, Rehmannia glutinosa, Cornus officinalis, Paeonia suffruticosa, Alisma plantago-aquatica, Poria cocos, Cinnamomum cassia, Aconitum carmichaelii (processed), and Coix lacryma-jobi.

4. The traditional Chinese medicine composition for treating chronic prostatitis according to claim 1, characterized in that: Preparation of the amphoteric starch Includes the following steps: Take 3 Dimethylchloropropylammonium propanesulfonate and water were mixed thoroughly to obtain 3 Dimethylchloropropylammonium propanesulfonate solution; take starch and water, stir and mix, add NaOH solution, stir at 35~45℃ for 1~2 hours, add 3 Dimethylchloropropylammonium propanesulfonate solution was stirred and reacted at 65-75℃ for 6-8 hours. The pH was adjusted to neutral, and the mixture was precipitated with methanol. After stirring and centrifugation, the filter cake was washed with methanol and dried under vacuum for 20-25 hours to obtain amphoteric starch.

5. A method for preparing a traditional Chinese medicine composition for treating chronic prostatitis according to any one of claims 1 to 4, characterized in that, Includes the following steps: Take the following ingredients: Chinese herbal gel, borneol, warming agent, poloxamer, carboxymethyl cellulose, and hydroxypropyl. BETA Cyclodextrin and ethanol are mixed evenly, and the pH is controlled at 7.3-7.5 to obtain a traditional Chinese medicine composition.

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