CN111012878A

CN111012878A - Prostate bacteriostatic gel and preparation method thereof

Info

Publication number: CN111012878A
Application number: CN201911425684.9A
Authority: CN
Inventors: 赵显梁
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-12-31
Filing date: 2019-12-31
Publication date: 2020-04-17

Abstract

The invention discloses a prostate bacteriostatic gel and a preparation method thereof, belonging to the field of medicines and comprising the following components in a mass ratio of 1-2: 4 and auxiliary materials, wherein the raw materials of the active component comprise: the prostate bacteriostatic gel has the beneficial effects of high-efficiency antibiosis and anti-inflammation, harmful bacteria killing, no drug resistance, mildness and no stimulation, local pain relieving, pain disappearance or alleviation after conditioning, adjustment and improvement of local immunity, and the effect of inhibiting humoral immunity.

Description

Prostate bacteriostatic gel and preparation method thereof

Technical Field

The invention relates to a gel and a preparation method thereof, in particular to a prostate bacteriostatic gel and a preparation method thereof, belonging to the field of medicines.

Background

The prostate (prostate) is a sexual gland organ peculiar to men, is composed of a glandular tissue and a muscular tissue, is a sexual secretory gland which is very few in human bodies and has a double secretory function of internal secretion and external secretion, is used as an external secretory gland, secretes about 2 ml of prostatic fluid every day, and is a main component for constituting semen; the hormone secreted by the prostate gland, which is an endocrine gland, is called "prostaglandin".

Prostatitis (prostatis) is a common disease of urology surgery, is a prostate disease mainly and clinically manifested by urethral irritation symptom and chronic pelvic pain due to various complex reasons, and is roughly divided into specific prostatitis and non-specific prostatitis, the specific prostatitis can be caused by gonococcus, tubercle bacillus, fungi, parasites (such as trichomonas), viruses, mycoplasma and chlamydia infection besides bacterial acute or chronic prostatitis caused by common bacteria, the etiology of the non-specific prostatitis is very complex, and is widely disputed, most students consider that the main etiology of the prostatitis can be urination dysfunction, psychologic factors, neuroendocrine factors, immune response abnormity, oxidative stress, lower urothelial dysfunction, sexual life overfrequency, excessive masturbation, sedentariness, riding, horse riding, alcoholism, excessive alcohol consumption, urinary tract dysfunction, chronic pelvic inflammation, chronic pelvic, Overeating spicy food and catching cold.

Prostatitis is mainly manifested by pain, abnormal urination, sexual dysfunction, etc. Pain is usually located in pubic, lumbosacral and perineal regions, and radiating pain can be manifested as pain in urethra, spermatic cord, testis, groin and intra-abdominal side, radiating to abdomen exactly resembles an acute abdomen, radiating along urinary tract exactly resembles renal colic, often leading to misdiagnosis. Abnormal urination is manifested by frequent micturition, urgent micturition, painful urination, unsmooth urination, bifurcations of urinary cords, dribbling after urination, increased frequency of nocturia, and milky white secretion flowing out of urethra after urination or during defecation. The sexual dysfunction is manifested by hyposexuality, premature ejaculation, ejaculation pain, erection weakening and impotence, so the effective prevention and treatment of prostate diseases has important significance for preventing the occurrence of prostate cancer and improving the health level of middle-aged and elderly people.

At present, the medicines for treating prostatitis are generally taken orally or injected, but a prostate-blood barrier formed by a lipid membrane exists between prostate acinus and microcirculation, so that the barrier prevents water-soluble antibiotics from passing through, and the effect is not ideal.

Disclosure of Invention

In view of the above, the invention provides a prostate bacteriostatic gel and a preparation method thereof, and specifically adopts the following technical scheme:

the prostate bacteriostatic gel comprises the following components in percentage by mass of 1-2: 4 and auxiliary materials, wherein the active components and the auxiliary materials,

the raw materials for preparing the active components comprise the following components in parts by weight: 30-50 parts of phellodendron, 10-50 parts of glabrous greenbrier rhizome, 10-40 parts of Chinese angelica, 20-30 parts of purslane, 20-30 parts of hiraute shiny bugleweed herb, 10-20 parts of lightyellow sophora root, 10-20 parts of dandelion, 5-10 parts of baical skullcap root, 3-6 parts of safflower, 1-10 parts of coptis root, 1-10 parts of honeysuckle stem, 2-10 parts of plantain seed, 1-5 parts of gentian, 1-5 parts of wild chrysanthemum flower, 5-20 parts of biological peptide and 5-10 parts of vitamin E,

preferably 30 parts of phellodendron, 20 parts of glabrous greenbrier rhizome, 10 parts of Chinese angelica, 20 parts of purslane, 20 parts of hiraute shiny bugleweed herb, 10 parts of lightyellow sophora root, 10 parts of dandelion, 8 parts of baical skullcap root, 6 parts of safflower, 5 parts of coptis chinensis, 5 parts of honeysuckle stem, 4 parts of plantain seed, 3 parts of gentian, 3 parts of wild chrysanthemum flower, 10 parts of biological peptide and 8 parts of vitamin E.

The prostate bacteriostatic gel has the beneficial effects that:

1. high-efficiency antibacterial and anti-inflammatory effects, killing harmful flora, no drug resistance, mildness and no irritation;

2. local pain relief, pain disappearance or alleviation after conditioning;

3. regulating and improving local immunity, and inhibiting humoral immunity;

4. the special traditional Chinese medicine components can directly permeate into the envelope, are beneficial to the absorption of the medicine and directly reach the affected part;

5. enhancing the activity of local antibacterial factors of prostate, and improving chronic congestion;

6. inhibiting gland tissue hyperplasia, relieving obstruction of gland duct, and promoting gland fluid drainage.

The prostate bacteriostatic gel provided by the invention is prepared on the basis of the theory of clearing away heat and toxic materials, promoting diuresis, and promoting blood circulation to remove blood stasis, various raw material medicines are coordinated with each other to exert the drug effect to the maximum extent, the traditional Chinese medicine for clearing away heat and toxic materials and promoting diuresis has the broad-spectrum anti-pathogenic microorganism effects, the traditional Chinese medicine for promoting blood circulation to remove blood stasis has the effects of improving microcirculation, relieving inflammatory obstruction, smoothing prostate duct glands and promoting glandular epithelial cell repair, and meanwhile, the prostate bacteriostatic gel has the effects of inhibiting inflammatory medium release, resisting fibrosis and regulating immunity, and can effectively treat various common diseases of male and female urogenital systems. Such as: prostatitis, prostatic hyperplasia, orchitis, epididymitis, seminal vesiculitis, urethritis, cystitis, semen abnormality, etc., and has no drug resistance, multiple levels, multiple targets, integral regulation, high cure rate and difficult recurrence.

The pharmacological and medicinal properties of the adopted traditional Chinese medicine components are as follows:

phellodendron bark, cortex Phellodendri, with cold nature and bitter taste, enters kidney and bladder meridians, has the effects of clearing heat and drying dampness, purging fire and removing steam, detoxifying and treating sores, and is used for treating damp-heat dysentery, jaundice and dark urine, leukorrhagia pruritus vulvae, heat stranguria and pain, beriberi flaccidity cramped, bone steaming and fatigue heat, night sweat, spermatorrhea, pyocutaneous disease and pyogenic infections, eczema and eczema. Salted cortex phellodendri is used for nourishing yin and reducing internal heat. Can be used for treating hyperactivity of fire due to yin deficiency, night sweat and steaming bone.

Rhizoma Smilacis Glabrae, sweet and light in nature, flat in taste, entering liver and stomach channels, removing toxic substance, eliminating dampness, and easing joint movement, and can be used for treating limb spasm and bone and muscle pain caused by syphilis and mercury poisoning; stranguria with turbid damp-heat, leukorrhagia, abscess, scrofula, scabies and tinea.

Chinese angelica is warm in nature, sweet and pungent in taste, enters liver, heart and spleen channels, enriches blood and activates blood, regulates menstruation and relieves pain, and has the functions of relaxing bowel, and is used for treating blood deficiency and chlorosis, dizziness and palpitation, irregular menstruation, amenorrhea and dysmenorrheal, deficiency cold and abdominal pain, rheumatic arthralgia, traumatic injury, carbuncle, ulcer, intestinal dryness and constipation. The wine angelica sinensis can activate blood and promote menstruation. Can be used for treating amenorrhea, dysmenorrhea, rheumatalgia, and traumatic injury.

Purslane, cold in nature and sour in taste, enters liver and large intestine channels, has the effects of clearing heat and removing toxicity, cooling blood and stopping bleeding, and can be used for treating heat-toxin bloody dysentery, carbuncle, furuncle, eczema, erysipelas, snake and insect bite, hematochezia, hemorrhoidal bleeding, metrorrhagia and metrostaxis.

Herba Lycopi, warm in nature, bitter and pungent in taste, enters liver and spleen channels, promotes blood circulation, regulates menstruation, removes blood stasis, eliminates carbuncle, induces diuresis, and reduces edema, and can be used for treating menoxenia, amenorrhea, dysmenorrhea, puerperal blood stasis and abdominal pain, skin ulcer, carbuncle, toxic swelling, edema and ascites.

Lightyellow sophora root, cold in nature, bitter in taste, entering heart, liver, stomach, large intestine and bladder channels, clearing heat and drying dampness, killing parasites and inducing diuresis, is used for treating dysentery with fever, hematochezia, jaundice anuresis, leucorrhea with reddish discharge, vulva swelling and pruritus vulvae, eczema, skin pruritus, mange leprosy and externally treating trichomonas vaginitis.

Herba Taraxaci, being cold in nature, bitter and sweet in taste, entering liver and stomach channels, clearing heat and detoxicating, reducing swelling and resolving hard mass, inducing diuresis for treating stranguria, and can be used for treating furuncle and toxic swelling, acute mastitis, scrofula, conjunctival congestion, pharyngalgia, pulmonary abscess, intestinal abscess, damp-heat jaundice, and stranguria with astringency and pain.

Baikal skullcap root, with cold nature and bitter taste, enters lung, gallbladder, spleen, large intestine and small intestine channels, clears heat and dries dampness, purges fire and detoxifies, stops bleeding and prevents abortion, and is used for treating damp warmth, summer dampness, chest distress and nausea, damp heat and fullness, diarrhea, jaundice, lung heat cough, high fever polydipsia, blood heat hematemesis and epistaxis, carbuncle swelling and sore toxicity and threatened abortion.

Safflower, with warm nature and pungent taste, enters heart and liver meridians, activates blood and passes through meridians, removes stasis and relieves pain, and is used for amenorrhea, dysmenorrhea, lochiorrhea, abdominal mass, thoracic obstruction, cardialgia, abdominal pain due to stasis, stabbing pain in chest and hypochondrium, traumatic injury, sore and ulcer with swelling and pain.

Coptis chinensis, cold in nature, bitter in taste, entering heart, spleen, stomach, liver, gallbladder and large intestine channels, clearing heat and drying dampness, purging fire and removing toxicity, is used for treating damp-heat fullness, vomiting and acid regurgitation, dysentery, jaundice, high fever and coma, hyperactivity of heart fire, vexation and insomnia, palpitation and restlessness, blood heat and hematemesis and epistaxis, conjunctival congestion, toothache, thirst quenching, carbuncle and swelling and sore; it is used externally to treat eczema, eczema and purulent ear canal.

Honeysuckle stem, cold in nature and sweet in taste, enters lung and stomach meridians, clears away heat and toxic materials, dispels wind and unblocks collaterals, and is used for epidemic febrile disease and fever, heat-toxin and bloody dysentery, carbuncle swelling, sore and ulcer, rheumatism and heat arthralgia, and joint inflammation and pain.

Semen plantaginis, cold in nature and sweet in taste, enters liver, kidney, lung and small intestine channels, clears heat, induces diuresis, treats stranguria, excretes dampness, stops diarrhea, improves eyesight and eliminates phlegm, and is used for treating heat stranguria, astringing pain, edema and fullness, summer-heat dampness diarrhea, conjunctival congestion and swelling pain, phlegm-heat cough.

Gentian, being cold in nature and bitter in taste, enters lung and liver meridians, and is used for clearing heat, drying dampness and purging liver and gallbladder fire. Can be used for treating jaundice due to damp-heat pathogen, pudendal swelling, pudendal pruritus, leukorrhagia, eczema, pruritus, liver fire with conjunctival congestion, tinnitus, deafness, hypochondriac pain, bitter taste in mouth, middle-jiao strengthening, and convulsion.

Wild chrysanthemum flower, slightly cold in nature, bitter and pungent in taste, entering liver and heart meridians, clearing heat and removing toxicity, purging fire and calming liver, is used for treating furuncle, carbuncle, conjunctival congestion, swelling and pain, headache and vertigo.

Further, the auxiliary materials comprise gel matrix, purified water, glycerol and propylene glycol, preferably, the auxiliary materials also comprise other pharmaceutically acceptable gel preparation auxiliary materials, such as stabilizing agent, humectant, tackifier and the like, and preferably, the gel matrix is carbomer and/or cellulose.

The gel has the advantages that the gel is prepared by using the safe and effective pharmaceutical auxiliary materials with low cost, the cost for preparing the gel is saved, the effect of the gel is not influenced, carbomer and/or cellulose is/are selected as the gel substrate, and the prepared prostate bacteriostatic gel is easy to disperse due to good water solubility of the cellulose, and the cellulose solution has good viscosity, so that the prepared gel is not layered and is easy to coat.

The invention also provides a preparation method of the prostate bacteriostatic gel, which comprises the following steps:

1) weighing the raw materials in parts by weight;

2) mixing cortex Phellodendri, rhizoma Smilacis Glabrae, radix Angelicae sinensis, herba Portulacae, herba Lycopi, radix Sophorae Flavescentis, herba Taraxaci, Scutellariae radix, Carthami flos, Coptidis rhizoma, caulis Lonicerae, semen plantaginis, radix Gentianae and flos Chrysanthemi Indici, crushing, grinding, and sieving with 20-40 mesh sieve to obtain mixed powder;

3) adding 90-95% ethanol 3-5 times the weight of the mixed powder into the mixed powder, heating and refluxing, concentrating under reduced pressure to 0.2 times the original volume, vacuum drying, crushing, sieving with 60-80 mesh sieve, adding biological peptide and vitamin E, and mixing to obtain active component;

4) mixing the active component with adjuvants, and stirring.

The preparation method has simple and reasonable process, easy production and good stability of mass production products.

Further, the operation of uniformly mixing and stirring in the step 4) comprises the following steps: mixing gel matrix, glycerol and propylene glycol, wetting, dispersing and stirring into paste, adding purified water, stirring, adding active component, and stirring.

The gel matrix and the purified water are mixed in advance, are wetted and dispersed and are stirred into paste, so that the gel matrix and the purified water can be effectively prevented from being agglomerated after being directly mixed and are not easy to dissolve, and the quality of a final product is influenced.

Further, the heating reflux temperature in the step 3) is 60-80 ℃, and the time is 4-6 h;

the pressure for decompression concentration is 20-35 kPa, and the temperature is 40-60 ℃.

The invention also provides a using method of the prostate bacteriostatic gel, which comprises the following steps:

when in use, the prostate bacteriostatic gel is pushed in from the anus by adopting the push tube, and meanwhile, the prostate close to the front wall of the rectum can be matched with the prone posture to fully contact the prostate bacteriostatic gel, and the prostate tissue can quickly absorb the medicament with higher concentration through the quick penetration and absorption of the rich capillary vessels of the rectal mucosa, thereby exerting good treatment effect.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

The preparation method of the bacteriostatic gel for prostate comprises the following steps:

1) weighing 30g of phellodendron, 20g of glabrous greenbrier rhizome, 10g of Chinese angelica, 20g of purslane, 20g of hiraute shiny bugleweed herb, 10g of lightyellow sophora root, 10g of dandelion, 8g of baical skullcap root, 6g of safflower, 5g of coptis root, 5g of honeysuckle stem, 4g of plantain seed, 3g of gentian, 3g of wild chrysanthemum flower, 10g of biological peptide and vitamin E8g for later use, and taking cellulose, purified water, glycerol and propylene glycol as auxiliary materials for later use;

2) mixing cortex Phellodendri, rhizoma Smilacis Glabrae, radix Angelicae sinensis, herba Portulacae, herba Lycopi, radix Sophorae Flavescentis, herba Taraxaci, Scutellariae radix, Carthami flos, Coptidis rhizoma, caulis Lonicerae, semen plantaginis, radix Gentianae and flos Chrysanthemi Indici, crushing, grinding, and sieving with 40 mesh sieve to obtain mixed powder;

3) adding 90% ethanol 5 times the mass of the mixed powder into the mixed powder, heating and refluxing at 80 deg.C for 5h, concentrating at 25kPa and 60 deg.C under reduced pressure to 0.2 times the original volume, vacuum drying, crushing, sieving with 80 mesh sieve, adding biological peptide and vitamin E, and mixing to obtain active component;

4) mixing cellulose, glycerol and propylene glycol, wetting, dispersing and stirring into paste, adding purified water, stirring uniformly, and then adding the following active components: the auxiliary materials are 1: 2, mixing the active components and the auxiliary materials according to the mass ratio, and uniformly stirring to obtain the prostatic bacteriostatic gel.

Example 2

1) weighing 30g of phellodendron, 10g of glabrous greenbrier rhizome, 10g of Chinese angelica, 20g of purslane, 20g of hiraute shiny bugleweed herb, 10g of lightyellow sophora root, 10g of dandelion, 5g of baical skullcap root, 3g of safflower, 1g of coptis root, 1g of honeysuckle stem, 2g of plantain seed, 1g of gentian, 1g of wild chrysanthemum flower, 5g of biological peptide and 5g of vitamin E for later use, and taking carbomer, purified water, glycerol and propylene glycol as auxiliary materials for later use;

2) mixing cortex Phellodendri, rhizoma Smilacis Glabrae, radix Angelicae sinensis, herba Portulacae, herba Lycopi, radix Sophorae Flavescentis, herba Taraxaci, Scutellariae radix, Carthami flos, Coptidis rhizoma, caulis Lonicerae, semen plantaginis, radix Gentianae and flos Chrysanthemi Indici, crushing, grinding, and sieving with 20 mesh sieve to obtain mixed powder;

3) adding 90% ethanol 3 times the mass of the mixed powder into the mixed powder, heating and refluxing for 4h at 60 ℃, concentrating under reduced pressure at 20kPa and 40 ℃ to 0.2 time of the original volume, drying under vacuum, crushing, sieving with a 60-mesh sieve, adding the biological peptide and the vitamin E, and mixing uniformly to obtain an active component;

4) mixing carbomer, glycerol and propylene glycol, wetting, dispersing and stirring into paste, adding purified water, stirring uniformly, and adding the following active components: the auxiliary materials are 1: 4, mixing the active components and the auxiliary materials according to the mass ratio, and uniformly stirring to obtain the prostatic bacteriostatic gel.

Example 3

1) weighing 50g of phellodendron, 50g of glabrous greenbrier rhizome, 40g of Chinese angelica, 30g of purslane, 30g of hiraute shiny bugleweed herb, 20g of lightyellow sophora root, 20g of dandelion, 10g of baical skullcap root, 6g of safflower, 10g of coptis root, 10g of honeysuckle stem, 10g of plantain seed, 5g of gentian, 5g of wild chrysanthemum flower, 20g of biological peptide and 10g of vitamin E for later use, and taking carbomer, cellulose, purified water, glycerol and propylene glycol as auxiliary materials for later use;

3) adding 95% ethanol 5 times the mass of the mixed powder into the mixed powder, heating and refluxing at 80 deg.C for 6h, concentrating at 35kPa and 60 deg.C under reduced pressure to 0.2 times the original volume, vacuum drying, crushing, sieving with 80 mesh sieve, adding biological peptide and vitamin E, and mixing to obtain active component;

4) mixing carbomer, cellulose, glycerol and propylene glycol, wetting, dispersing and stirring into paste, adding purified water, stirring uniformly, and adding the following active components: the auxiliary materials are 1: 2, mixing the active components and the auxiliary materials according to the mass ratio, and uniformly stirring to obtain the prostatic bacteriostatic gel.

Example 4

1) weighing 50g of phellodendron, 30g of glabrous greenbrier rhizome, 20g of Chinese angelica, 25g of purslane, 30g of hiraute shiny bugleweed herb, 10g of lightyellow sophora root, 15g of dandelion, 8g of baical skullcap root, 6g of safflower, 5g of coptis root, 10g of honeysuckle stem, 2g of plantain seed, 4g of gentian, 3g of wild chrysanthemum flower, 15g of biological peptide and vitamin E12g for later use, and taking cellulose, purified water, glycerol and propylene glycol as auxiliary materials for later use;

3) adding 95% ethanol 3 times the mass of the mixed powder into the mixed powder, heating and refluxing for 6h at 70 ℃, concentrating under reduced pressure at 30kPa and 60 ℃ to 0.2 time of the original volume, drying under vacuum, crushing, sieving with a 70-mesh sieve, adding the biological peptide and the vitamin E, and uniformly mixing to obtain an active component;

4) mixing cellulose, glycerol and propylene glycol, wetting, dispersing and stirring into paste, adding purified water, stirring uniformly, and then adding the following active components: the auxiliary materials are 1: 4, mixing the active components and the auxiliary materials according to the mass ratio, and uniformly stirring to obtain the prostatic bacteriostatic gel.

Example 5

1) weighing 40g of phellodendron, 20g of glabrous greenbrier rhizome, 30g of Chinese angelica, 20g of purslane, 20g of hiraute shiny bugleweed herb, 10g of lightyellow sophora root, 20g of dandelion, 10g of baical skullcap root, 5g of safflower, 4g of coptis root, 5g of honeysuckle stem, 5g of plantain seed, 3g of gentian, 5g of wild chrysanthemum flower, 10g of biological peptide and vitamin E8g for later use, and taking carbomer, cellulose, purified water, glycerol and propylene glycol as auxiliary materials for later use;

2) mixing cortex Phellodendri, rhizoma Smilacis Glabrae, radix Angelicae sinensis, herba Portulacae, herba Lycopi, radix Sophorae Flavescentis, herba Taraxaci, Scutellariae radix, Carthami flos, Coptidis rhizoma, caulis Lonicerae, semen plantaginis, radix Gentianae and flos Chrysanthemi Indici, crushing, grinding, and sieving with 30 mesh sieve to obtain mixed powder;

3) adding 90% ethanol 5 times the mass of the mixed powder into the mixed powder, heating and refluxing at 80 deg.C for 5h, concentrating at 30kPa and 50 deg.C under reduced pressure to 0.2 times the original volume, vacuum drying, crushing, sieving with 70 mesh sieve, adding biological peptide and vitamin E, and mixing to obtain active component;

4) mixing carbomer, cellulose, glycerol and propylene glycol, wetting, dispersing and stirring into paste, adding purified water, stirring uniformly, and adding the following active components: the auxiliary materials are 1: 4, mixing the active components and the auxiliary materials according to the mass ratio, and uniformly stirring to obtain the prostatic bacteriostatic gel.

Example 6

Bacteriostasis test

The prostate bacteriostatic gel prepared in examples 1-5 was subjected to in vitro bacteriostatic tests according to the specifications of the test methods for the bactericidal performance, bacteriostatic performance and stability of the product in annex C of the hygienic standard of GB/T15979-2002 disposable hygienic products, and the test results are recorded as shown in Table 1 below.

Table 1 examples 1-5 results of bacteriostatic tests

Bacteriostasis rate of%	Example 1	Example 2	Example 3	Example 4	Example 5
						Staphylococcus aureus	72	60	68	69	65
Escherichia coli	92	85	88	89	86
						Pseudomonas aeruginosa	69	64	67	66	62
Candida albicans	81	76	80	78	79

As can be seen from Table 1, the product of the prostate bacteriostatic gel has strong bacteriostatic action.

Example 7

Skin irritation index (PII) determination test

The prostate bacteriostatic gels prepared in examples 1-5 were subjected to a skin irritation index determination test according to the method specified in GB/T16886.10-2005, which requires that the index is not greater than 0.5 after 24 hours of acute contact, and the determination results are shown in Table 2 below.

Skin sensitization test

The bacteriostatic prostaglandins prepared in examples 1 to 5 were subjected to a skin sensitization test according to the closed sensitization test method specified in GB/T16886.10-2005, and the results are shown in Table 2 below.

TABLE 2 measurement of skin irritation index (PII) and skin sensitization test results

Item	Example 1	Example 2	Example 3	Example 4	Example 5
						Index of skin irritation	0	0	0	0	0
Skin sensitization	Is free of	Is free of	Is free of	Is free of	Is free of

As shown in the table 2, the product of the prostate bacteriostatic gel has no stimulation to skin and does not cause skin sensitization.

Example 8

Clinical trial

20 prostatitis patients are selected to be diagnosed by the traditional Chinese medicine disease diagnosis curative effect standard, and the diagnosis standard is as follows:

a. clinical symptoms: abnormal urination: frequent micturition, urgent micturition, unsmooth urination or dribbling after urination, white urine drop; the pain symptoms are: perineal lower abdomen lumbosacral pain, penile testicular pain; sexual dysfunction: impotence, premature ejaculation, and hyposexuality.

b. Rectal palpation: the volume of the prostate is larger or smaller than normal, the rigidity and toughness of the prostate is increased, and the prostate can touch the small hard segment with obvious tenderness.

c. Microscopic examination of prostatic fluid (EPS): WBC > 10/HP. The lecithin bodies are reduced or disappeared.

After the consent of the patients, the prostate bacteriostatic gel prepared in the embodiment 1 of the invention is packaged into a gel product with the specification of 5 mL/piece, each patient uses 1 piece of the gel product every day, before sleeping, before anus cleaning, the gel is completely pushed into the rectum, the prone posture is 30min for 30 days, the treatment period is forbidden, no wine is given, no desire is given, and the use of other medicines or treatment means with the same effect (including antibiotics) is interrupted,

after 30 days of use, the prostate fluid of 20 patients was examined normally, 2 patients had no prostatitis symptoms, the prostate fluid examination was significantly improved, 12 patients had symptoms and signs significantly improved, 4 patients had symptoms and signs improved, 2 patients had discontinued clinical tests due to personal reasons, and none of the above patients had prostate fluid examination.

As known from clinical tests, the prostate bacteriostatic gel has a remarkable effect on treating prostatitis.

Claims

1. The prostate bacteriostatic gel is characterized by comprising the following components in percentage by mass of 1-2: 4, active components and auxiliary materials;

the raw materials for preparing the active component comprise the following components in parts by weight: 30-50 parts of phellodendron, 10-50 parts of glabrous greenbrier rhizome, 10-40 parts of Chinese angelica, 20-30 parts of purslane, 20-30 parts of hiraute shiny bugleweed herb, 10-20 parts of lightyellow sophora root, 10-20 parts of dandelion, 5-10 parts of baical skullcap root, 3-6 parts of safflower, 1-10 parts of coptis chinensis, 1-10 parts of honeysuckle stem, 2-10 parts of plantain seed, 1-5 parts of gentian, 1-5 parts of wild chrysanthemum flower, 5-20 parts of biological peptide and 5-10 parts of vitamin E.

2. The bacteriostatic gel for prostate according to claim 1, characterized in that the raw materials for preparing the active components comprise the following components in parts by weight: 30 parts of phellodendron, 20 parts of glabrous greenbrier rhizome, 10 parts of Chinese angelica, 20 parts of purslane, 20 parts of hiraute shiny bugleweed herb, 10 parts of lightyellow sophora root, 10 parts of dandelion, 8 parts of baical skullcap root, 6 parts of safflower, 5 parts of coptis chinensis, 5 parts of honeysuckle stem, 4 parts of plantain seed, 3 parts of gentian, 3 parts of wild chrysanthemum flower, 10 parts of biological peptide and 8 parts of vitamin E.

3. The bacteriostatic gel for prostate according to claim 1 or 2, wherein said adjuvant comprises gel matrix, purified water, glycerin, propylene glycol.

4. The bacteriostatic gel for prostate according to claim 3, wherein said gel matrix is carbomer and/or cellulose.

5. A preparation method of a prostate bacteriostatic gel is characterized by comprising the following steps:

1) weighing the raw materials according to the parts by weight of any one of claims 1 to 4;

2) mixing cortex Phellodendri, rhizoma Smilacis Glabrae, radix Angelicae sinensis, herba Portulacae, herba Lycopi, radix Sophorae Flavescentis, herba Taraxaci, Scutellariae radix, Carthami flos, Coptidis rhizoma, caulis Lonicerae, semen plantaginis, radix Gentianae and flos Chrysanthemi Indici, crushing, grinding, and sieving to obtain mixed powder;

3) adding ethanol 3-5 times the weight of the mixed powder into the mixed powder, heating and refluxing, concentrating under reduced pressure to 0.2 time the original volume, vacuum drying, crushing, sieving, adding biological peptide and vitamin E, and mixing to obtain active component;

4) and mixing and stirring the active components and the auxiliary materials uniformly to obtain the prostatic bacteriostatic gel.

6. The method for preparing a prostatic bacteriostatic gel according to claim 5, wherein the mixing and stirring operation in step 4) is as follows: mixing gel matrix, glycerol and propylene glycol, wetting, dispersing and stirring into paste, adding purified water, stirring, adding active component, and stirring.

7. The method for preparing a prostate bacteriostatic gel according to claim 5, wherein the sieving in step 2) is 20-40 mesh sieving;

and in the step 3), the crushing and sieving are 60-80 mesh sieves.

8. The method for preparing a prostate bacteriostatic gel according to claim 5, wherein the temperature of the heating reflux in step 3) is 60-80 ℃ for 4-6 h;

the pressure of the reduced pressure concentration is 20-35 kPa, and the temperature is 40-60 ℃.

9. The method for preparing a prostatic bacteriostatic gel according to claim 5, wherein the ethanol in step 3) is 90-95% ethanol.