CN103041262B - Traditional Chinese medicine enema for curing chronic prostatitis and preparing method thereof - Google Patents

Abstract

The invention provides a traditional Chinese medicine enema for treating chronic prostatitis. The parts by weight of the crude drug are: 10-20 parts of Liedang, 10-20 parts of Poria cocos, 10-20 parts of Wangbuliuxing, and 10-20 parts of Schisandra chinensis. 10-20 parts of Epimedium, 10-20 parts of Cuscuta, 10-20 parts of Yizhiren, 10-20 parts of Cornus officinalis, 10-20 parts of Hedyotis diffusa, 10-20 parts of Dandelion, 10-20 parts of Shouwu 20 parts, 10-20 parts of plantain seed, 10-20 parts of salvia miltiorrhiza, 10-20 parts of Cortex Phellodendri, 10-20 parts of Alisma, 10-20 parts of Prunella vulgaris, 10-20 parts of cnidium, 10-20 parts of Patrinia 10-20 parts of Radix Scutellariae, 10-20 parts of Radix Paeoniae Rubra, 10-20 parts of Smilax Smilax, 10-20 parts of Raspberry, 10-20 parts of Cortex Moutan, and 10-20 parts of Miltonia Spatholobus. The invention adopts the traditional Chinese medicine for promoting blood circulation and removing blood stasis, which can improve capillary permeability and reduce inflammation reaction.

Description

A traditional Chinese medicine enema for treating chronic prostatitis and its preparation method

technical field

The invention relates to a medical preparation containing components derived from plants, animals or minerals, in particular to a traditional Chinese medicine enema for treating chronic prostatitis and a preparation method thereof.

Background technique

Chronic prostatitis is a common disease of the male reproductive system. It is mostly related to excessive drinking, eating irritating food, sitting in a saddle chair for a long time, constipation and other factors. A few are caused by acute prostatitis that has not been completely cured. However, most patients have never had an acute inflammation stage, and the prostatic fluid of such patients often has pathogenic bacteria. Chronic prostatitis can cause infertility, posterior urethritis, cystitis, and bladder neck sclerosis, which seriously interfere with the quality of life of patients. It brings a great mental burden to the patients, and many patients are combined with mental weakness and lack confidence in the cure.

Chronic prostatitis belongs to the category of "jing turbidity" and "gonorrhea" in traditional Chinese medicine. Its main pathogenesis is caused by traumatic dampness and heat, drinking, excessive spicy, overworked essence, poor blood vessels, stagnation of qi and blood stasis, which make dampness and heat viscous. , qi and blood stasis, deficiency of kidney qi, intertwined with each other, separate or combined to cause disease, because most of them have no obvious pathogenic bacteria, the effect of western medicine is poor. The effect of oral Chinese medicine is slow.

Traditional Chinese medicine believes that the cause of the disease is firstly addicted to smoking, alcohol, spicy, fat, sweet and thick taste, which damages the spleen and stomach, produces damp heat, and flows into the lower burner; Influenced by environmental factors, media stimulation, etc., sexual desire cannot be ventilated normally, frequent masturbation, sexual intercourse, and ejaculation will not ejaculate, resulting in repeated congestion of the prostate, stasis of semen and obstruction of the sperm chamber, long-term accumulation of poison, and obstruction of the meridians; Or emotional will is not smooth, stagnant anger hurts the liver, liver qi loses in dredging, long-term blood circulation will not be smooth, resulting in stagnation of qi and blood, stagnation of qi and blood can aggravate the formation of damp-heat toxins, and the two are mutually causal. Symptoms of chronic prostatitis vary from person to person, and are mainly divided into the following two types: one is pain symptoms, including pain in the lower abdomen, lumbosacral region, around the anus, perineum, testicles, and penis; the other is discomfort during urination , such as incomplete urination, frequent urination, urgency, weak urination, white dribbling, etc. Systemic symptoms are mainly anxiety, inability to concentrate, and lack of energy, accompanied by abnormal sexual function, such as too fast ejaculation, weak penile erection, and low libido.

Prostatitis is divided into different types such as acute bacterial, chronic bacterial and non-bacterial. Its pathogenesis is bacterial infection; immune reaction of Staphylococcus epidermidis; arthritis, iritis, urethral instrument examination, catheter placement, upper respiratory tract, urinary tract infection, sexual function changes or improper diet, mood and anger from time to time cause internal dampness and heat , stagnant essence turbid rot, leading to gland inflammation, abscess. Typical symptoms in the acute phase are chills and fever, elevated body temperature, nausea and vomiting, frequent urination and urgency, dysuria and cloudy urination, constipation, distending pain in the perineum and lower back, and swelling and pain in the prostate gland. The clinical manifestations of the chronic phase are dizziness and dizziness, waist pain, frequent urination, urgency, incomplete urination, mucus discharge after urination, loss of libido, impotence and premature ejaculation, testicular swelling and pain. characteristics of recurrence. In traditional medicine, the method of clearing away dampness and heat, and treating stranguria with heat and poison can be effective.

Chronic prostatitis is a common disease in young and middle-aged men, and the prevalence of chronic prostatitis in men over 36 years old can be as high as 35%-37%. Clinically, it is characterized by slow onset, complex etiology and pathology, various symptoms, atypical signs, protracted and repeated attacks, and difficult to heal after a long period of time. At present, the main treatment methods for chronic prostatitis are drug therapy and physical therapy. The drug therapy includes various antibiotics, α receptor blockers, immunosuppressants, and zinc and vitamin supplements. The drug routes are oral administration, injection, rectal perfusion, Anal packing, glandular injection, etc. Physical therapy includes microwave, muscle electrical stimulation, hot water hip bath, prostate massage, double-capsule four-lumen catheter administration, direct injection (through rectum or perineum), and direct current introduction of drugs.

But adopt above-mentioned therapeutic method, patient is more painful, and treatment duration is longer, and effect is not ideal. The above methods either damage testicular spermatogenesis, or are only adjuvant treatment methods, and even some methods are complicated to operate, and there are many problems such as unsafe, cross-infection, etc. Other suppositories and ointments for anorectal administration have unreasonable dosage forms, The disadvantages of unscientific compatibility and poor treatment. However, traditional Chinese medicine has achieved good curative effect in the treatment of chronic prostatitis, especially in improving the symptoms of patients and improving the quality of life of patients with obvious advantages, and the cost is relatively low. Research has received more and more attention from researchers in this field.

Contents of the invention

The technical problem to be solved by the present invention is that in the existing treatment methods, the patients are more painful, the treatment duration is longer, and the effect is not ideal. Either it damages testicular spermatogenesis, or it is only for adjuvant treatment, and even some methods are complicated to operate, and there are many problems such as unsafety and cross infection. Other suppositories and ointments for anorectal administration have unreasonable dosage forms, unscientific compatibility, and treatment Poor disadvantages; Chinese medicine decoction is taken orally, though some curative effect is arranged, curative effect is not good enough, takes effect slowly, and medicine production cost is higher, and preparation cycle is longer, and medicine absorption rate is low.

In order to solve these technical problems, the present invention provides a traditional Chinese medicine enema for treating chronic prostatitis, the parts by weight of various raw materials in the traditional Chinese medicine enema can be: Liedang 10-20 parts, Poria cocos 10-20 parts 10-20 parts of Wangbuliuxing, 10-20 parts of Schisandra, 10-20 parts of Epimedium, 10-20 parts of Cuscuta, 10-20 parts of Yizhiren, 10-20 parts of Cornus officinalis, 10 parts of Hedyotis diffusa ～20 parts, 10～20 parts of Dandelion, 10～20 parts of Shouwu, 10～20 parts of Plantago, 10～20 parts of Salvia, 10～20 parts of Cortex Phellodendri, 10～20 parts of Alisma, 10～20 parts of Prunella vulgaris Cnidium 10-20, Patrinia 10-20, Scutellaria baicalensis 10-20, Radix Paeoniae Rubra 10-20, Smilax smilax 10-20, raspberry 10-20, Moutan bark 10-20 , 10-20 copies of Milletanus spathalis.

The traditional Chinese medicine enema for treating chronic prostatitis, the parts by weight of various raw materials in the traditional Chinese medicine enema can also be: 10-15 parts of Liedang, 10-15 parts of Poria cocos, 10-15 parts of Wang Buliuxing Schisandra 10-15 parts, Epimedium 10-15 parts, Cuscuta 10-15 parts, Yizhiren 10-15 parts, Cornus officinalis 10-15 parts, Hedyotis diffusa 10-15 parts, Dandelion 10-15 parts , making 10-15 parts of Shouwu, 10-15 parts of Plantago, 10-20 parts of Salvia Miltiorrhiza, 10-20 parts of Cortex Phellodendri, 10-20 parts of Alisma, 10-20 parts of Prunella vulgaris, 10-20 parts of Cnidium, Patrinia 10-20 parts, Scutellaria baicalensis 10-20 parts, Radix Paeoniae Rubra 10-20 parts, Smilax tuckahoe 10-20 parts, raspberry 10-20 parts, Moutan cortex 10-20 parts, Milletah 10-20 parts.

The traditional Chinese medicine enema for treating chronic prostatitis, the parts by weight of various raw materials in the traditional Chinese medicine enema can also be: 10-20 parts of Liedang, 10-20 parts of Poria cocos, 10-20 parts of Wang Buliuxing 10-20 parts of schisandra, 10-20 parts of epimedium, 10-20 parts of dodder, 10-20 parts of Yizhi kernel, 10-20 parts of dogwood, 10-20 parts of Hedyotis diffusa, 10-20 parts of dandelion , making 10-20 parts of Shouwu, 10-20 parts of Plantago, 10-15 parts of Salvia Miltiorrhiza, 10-15 parts of Cortex Phellodendri, 10-15 parts of Alisma, 10-15 parts of Prunella vulgaris, 10-15 parts of Cnidium, 10-15 parts of Patrinia, 10-15 parts of Scutellaria baicalensis, 10-15 parts of Radix Paeoniae Rubra, 10-15 parts of Smilax smilax, 10-15 parts of raspberry, 10-15 parts of Cortex Moutan, and 10-15 parts of Miltonia Spatholobus.

In order to solve the above-mentioned technical problems, the present invention also provides a preparation method of a traditional Chinese medicine enema for the treatment of chronic prostatitis, the preparation steps comprising:

a. The crude drug is mixed, chopped, sieved and soaked.

b. adding ethanol to the soaked crude drug and heating to reflux for extraction twice;

c. take the above-mentioned medicinal residues after ethanol extraction, add water and heat and reflux to extract twice;

d. Combine the above two extracts, recover ethanol under reduced pressure and disinfect the preparation.

In the step a, the crude drug can be mixed first and then chopped, firstly into coarse powder, then further pulverized, passed through a 120 mesh sieve, so that the amount of fine powder that can pass through the 120 mesh sieve reaches 30%, and is collected through a 120 mesh sieve. The fine powder of the mesh sieve is fine powder for later use, and the unsieved coarse particles are soaked in ethanol for 8-12 hours.

In the step b, the soaked crude drug coarse particles can be heated and refluxed twice for 1-2 hours each time, and the two extracts are combined and allowed to stand.

In the step c, the medicinal dregs extracted with ethanol can be heated and refluxed twice for 1 to 2 hours each time, and the extracts from the two times can be combined and allowed to stand.

In the step d, the above two extracts can be combined, the filtrate with a relative density of 1.35 at 80°C can be concentrated under reduced pressure, ethanol can be recovered, and the specific gravity of the obtained filtrate can be adjusted to 1.06, and a pasty object can be obtained under reduced pressure, and then sterilized with ultraviolet rays Sterilization, into an enema.

In order to solve the above-mentioned technical problems, the present invention provides a preparation method of a traditional Chinese medicine enema for the treatment of chronic prostatitis, and the preparation method may further include:

a. Take the raw material drug and soak it in ethanol, heat extract twice, and form a paste, which is component 1;

b. The dregs are extracted twice with water, concentrated and filtered to form a paste, which is component 2;

c. Combine the above two pastes into an enema.

In the step a, the raw material drug can be added to 5-10 times the amount of ethanol and soaked for 1-2 hours, heated and extracted twice, each time for 1-2 hours, the supernatant is removed, and the extract is combined, 100-120 mesh Filtration, and then ultrafiltration through an ultrafiltration column with a cut-off molecular weight of 5000-10000, the ultrafiltrate is concentrated under reduced pressure to an extract with a relative density of 1.36 at 80°C, heated and concentrated to a paste, and left to stand for later use to become component 1; In the step b, put the dregs extracted by ethanol into 10 times the amount of water, heat and reflux to extract twice, each extraction time is 1 to 2 hours, filter through 100-120 mesh, and then pass through the cut-off molecular weight of 5000- 10,000 ultrafiltration column ultrafiltration, the ultrafiltrate decompressed and concentrated the extract with a relative density of 1.36 at 80°C, heated and concentrated to a paste, left standing for later use, and became component 2; in the step c, the above two The pasty concentrates of the two components are combined, and then sterilized by ultraviolet light to form an enema.

The using method of the enema of the present invention: select raw material drug, can prepare enema with the method for the embodiment provided by the present invention, also can decoct 150-120ml with clear water 500ml, take supernatant and cool to medicine temperature and be 30-40 At about ℃, instruct the patient to lie on the side after defecation, insert the anal canal about 20cm into the anus, use a 50ml syringe to inhale the drug solution slowly from the anal canal (or infuse with an infusion set) into the rectum for retention enema, and raise it slightly after the enema Buttocks supine for 30 minutes, enema once a day, treatment for 10 days as a course of treatment. When administered rectally, the drug can be absorbed in the rectum by 50% to 70%, and directly enter the three venous systems of the pelvic organs without passing through the liver, so that the prostate can recover quickly under the action of the effective concentration of the drug.

From an anatomical point of view, the anatomical position of the prostate and the rectum is adjacent, and there are abundant blood vessels in the local area, and the lymphatic network around the prostate is mainly behind the prostate, and part of the lymphatic network has abundant communication with the rectum. Therefore, traditional Chinese medicine retention enema can make the medicine absorbed through the rectal mucosa and reach the disease site directly. It can have a higher concentration in the diseased prostate, and the therapeutic effect is better. At the same time, it also avoids some adverse reactions of oral medicine and intravenous medicine.

The beneficial technical effects of the present invention are: adopting Chinese herbal medicine for promoting blood circulation and removing blood stasis can improve capillary permeability, reduce inflammatory response, promote the regression and absorption of inflammatory lesions, improve the metabolism of connective tissue, not only can promote the transformation and absorption of hyperplasia lesions, but also can Rejuvenates atrophied connective tissue. When administered rectally, the drug can be absorbed in the rectum and directly enter the three venous systems of the pelvic organs without passing through the liver, so that the prostate can recover quickly under the action of the effective concentration of the drug. The enema can make the drug absorbed through the rectal mucosa and directly reach the disease site. It can have a higher concentration in the diseased prostate, and the therapeutic effect is better. At the same time, it also avoids some adverse reactions of oral administration and intravenous administration. The invention has low price, simple and easy preparation method, and can create good social and economic benefits.

Detailed ways

Chronic prostatitis is one of the common diseases in urology. There is no name for this disease in traditional Chinese medicine, but according to its symptoms and signs, it belongs to the category of essence turbidity disease in traditional Chinese medicine, mostly caused by kidney deficiency and blood stasis. Oral and intravenous drugs cannot penetrate the prostate capsule very well, and the treatment effect is often unsatisfactory. Treating chronic prostatitis with traditional Chinese medicine for nourishing the kidney and promoting blood circulation through the rectum, not only can exert the medicinal effect through the absorption of the liquid in the intestinal wall, but also promote the effect of oral and intravenous administration, and strengthen the curative effect, so that patients with chronic prostatitis can recover as soon as possible .

Chronic prostatitis is called "white turbidity" and "essence turbidity" in traditional Chinese medicine. "Suwen Tiaojing Lun": Shaoyang is in the spring, the guest wins, and even white urine. "Yuji Zhenzang Lun": The lower abdomen is injustice and hot, and the disease is white. "Origin of Miscellaneous Diseases Rhinoceros Candle·Five Drenches and Two Turbidity Origins": White lewdness, heat depression disease, also known as Gu. The kidney vessel runs through the spine, belongs to the kidney, and connects to the bladder, so the lower abdomen is hot and painful, and white fluid is oozing out. According to this, the spleen is affected by wind evil and spreads to the kidneys. Shou, while the white things come out promiscuously. "Self-Treatment for Kidney Diseases, Self-Treatment for Draining Turbidity, Self-Treatment for the Beginning of White Turbidity": After urinating, the semen oozes out, like swill, which is neither painful nor itchy. Prostatitis was not uncommon in ancient times, and there has been a relatively complete discussion. Traditional Chinese medicine believes that its pathogenesis is mainly caused by damp heat descending, stagnant heat blocking the lower burner, resulting in unfavorable spermatozoa and disease. TCM syndromes are various. , but recent studies by relevant scholars have found that chronic prostatitis is mainly of damp-heat type and blood stasis type, and the two syndromes are often combined, reaching 78.59% of the total number of cases.

Modern medical research has found that chronic prostatitis often occurs in young adults, and excessive or frequent sexual impulses in the sexually mature stage lead to chronic congestion and edema of the prostate tissue. resulting in massive inflammatory cell infiltration.

Traditional medicine believes that the basic pathogenesis of chronic prostatitis with kidney deficiency is based on kidney deficiency, supplemented by blood stasis. Enema traditional Chinese medicine is aimed at the pathogenesis, with the treatment principle of nourishing the kidney and activating blood circulation. In chronic prostatitis, due to hypertrophy of the prostatitis, the posterior urethra is oppressed, causing poor urination, lack of drip, and inability to understand, which affects the penetration of antibiotics into the inflamed area to play a role.

Modern pharmacological studies have confirmed that blood-activating and stasis-removing drugs can improve the permeability of capillaries, reduce inflammation, promote the regression and absorption of inflammatory lesions, and improve the metabolism of connective tissue. Organizational recovery. When administered rectally, the drug can be absorbed 50%-70% in the rectum, and directly enter the three venous systems of the pelvic organs without passing through the liver, so that the prostate can recover quickly under the action of the effective concentration of the drug. From an anatomical point of view, the anatomical position of the prostate and the rectum is adjacent, and there are abundant blood vessels in the local area, and the lymphatic network around the prostate is mainly behind the prostate, and part of the lymphatic network has abundant communication with the rectum. Therefore, the traditional Chinese medicine enema can make the medicine absorbed through the rectal mucosa and directly reach the disease site. It can have a higher concentration in the diseased prostate, and the therapeutic effect is better. At the same time, it also avoids some adverse reactions of oral medicine and intravenous medicine.

In the prescription, it is listed as replenishing qi and astringing yin, which can help nourish qi and generate yin; Angelica nourishes yin and moistens dryness, clears away heat and troubles; Ascending, making the medicinal power go upwards, enabling qi and blood, making all the medicines nourish but not greasy, nourishing without leaving blood stasis; Blood, the merit of promoting qi, promoting blood circulation and relieving pain. Fructus Cnidii is sterilizing and anti-inflammatory, Scutellaria baicalensis cools blood and detoxifies, drains pus, sores and promotes granulation; Liedang and Plantaginaceae are anti-inflammatory and sterilizing, promote blood circulation and nourish skin, clear away heat and detoxify, promote muscle growth, and make Shouwu and Epimedium tonify the kidney Essence, treating impotence and premature ejaculation, yin deficiency and blood exhaustion; good medicine for weak qi and yin deficiency; Poria cocos, salvia miltiorrhiza to promote blood circulation and remove blood stasis, red peony root to clear away heat; the combination of various medicines has the effects of invigorating the spleen and expelling dampness, clearing away heat and detoxification, drying dampness and suppressing sores, promoting muscle growth and muscle growth It can improve the permeability of capillaries, reduce inflammation, promote the regression and absorption of inflammatory lesions, improve the metabolism of connective tissue, not only promote the transformation and absorption of hyperplastic lesions, but also restore the atrophic connective tissue.

Prunella vulgaris is slightly bitter, clears the liver, dissipates stagnation, and diuresis; treats plague, mastitis, eye pain, jaundice, gonorrhea, high blood pressure and other diseases; treats lymphatic tuberculosis, goiter, scrofula, goiter, mastitis, breast cancer, Eye pain at night, shameful tears, dizziness, crooked mouth and eyes, muscle and bone pain, tuberculosis, acute jaundice infectious hepatitis, blood metrorrhagia, leukorrhea. Prunella vulgaris is an important medicine for clearing liver-fire and dispelling stagnation, and it mainly treats diseases of the liver meridian. This product is combined with chrysanthemum and cassia seed, which can clear the liver and improve eyesight, and treat red eyes, swelling and pain; it is combined with stone cassia and uncaria, which can calm down the liver yang, cure headache and dizziness; Product, can soften hard mass and resolve stagnation, and control scrofula and tuberculosis. "Southern Yunnan Materia Medica": Dispelling liver wind, running meridians, and treating crooked mouth and eyes. Promoting liver qi, dispelling stagnation of the liver, relieving pain in muscles and bones, pain in eyes and pearls, dispersing scrofula, and tuberculosis all over the body.

Hedyotis diffusa is also called Hedyotis diffusa, Erye, Bamboo leaf vegetable, and Hedyotis diffusa. Taste slightly bitter, sweet, cold. Enter the stomach, large intestine, and small intestine meridian, bitter cold clears heat and detoxifies, sweet cold clears damp heat, and has strong detoxifying and eliminating carbuncle effects on carbuncles, sore throat, snake bites, etc. It is generally used to treat sores, sore throat, intestinal abscess and abdominal pain, snake bites, and it is also used for hot stranguria pain and dysuria. It is a good medicine for expelling toxins and dampness.

Scutellaria baicalensis has heat-clearing and damp-drying, cooling blood and anti-abortion, detoxification effects. Indications for febrile disease, upper respiratory tract infection, lung-heat cough, damp-heat jaundice, pneumonia, dysentery, hemoptysis, red eyes, restless fetus, high blood pressure, carbuncle, swollen boils and other diseases. The clinical application of Scutellaria baicalensis is better than that of Coptis chinensis, and it does not produce drug resistance. With the help of the characteristics of strong broad-spectrum antibacterial effect, we use it in the fungal culture of miscellaneous bacterial infections, and the effect of using the extract of Scutellaria baicalensis is very good. "Ben Cao Jing Shu": Scutellaria baicalensis, its nature is clear and purifying, so it eliminates evils: it tastes bitter so it dries dampness; yin and cold so it overcomes heat, so it controls all heat. For those with all kinds of heat, pathogenic heat and pervasive heat, jaundice, intestinal withdrawal, and diarrhea are all diseases caused by damp heat. If you analyze the root, all diseases will heal by themselves. Bitter cold can remove dampness and heat, so the small intestine is sharp and the water is self-dispelling, and the source is clear and the flow is clean. For those with closed blood, the excess heat is in the blood system, that is, it heats up the blood chambers, causing amenorrhea. For malignant sores and ulcers, the blood heat will stay and become carbuncles, swollen and rotten; for fire sores, fire qi will damage the blood, and cooling the blood to remove heat will heal itself. Scutellaria baicalensis has anti-allergic and anti-inflammatory effects: baicalin and baicalein contained in scutellaria baicalensis can significantly inhibit the allergic contraction reaction of the isolated small intestine and isolated trachea of sensitized guinea pigs to antigens, and it is effective for passive systemic reactions in guinea pigs and mice. Allergic reactions and passive skin allergies in guinea pigs, baicalin and baicalein also have inhibitory effects. Scutellaria baicalensis has antipyretic effect, and most experiments have proved that the active ingredient baicalin in Scutellaria baicalensis has antipyretic effect. Scutellaria baicalensis has detoxification effect, and baicalin has obvious detoxification effect, which may be due to the fact that under the action of β-glucuronidase, baicalin decomposes glucuronic acid and combines with various poisons. 10 mg of baicalin can increase the LD 50 of strychnine by 2.5 times, and increase the liver glycogen content of carbon tetrachloride poisoned mice.

The traditional Chinese medicine Polygonum Polygoni Multiflori can be divided into raw Shouwu and Zhishouwu. It is directly sliced and used as raw Shouwu, and it is mixed with black bean juice and steamed, then dried and used as Zhishouwu. The functions of the two are different: raw Shouwu has the functions of detoxification, eliminating carbuncles, and laxatives. For beard and hair, strong bones and muscles, used for blood deficiency and chlorosis, dizziness and tinnitus, premature graying of beard and hair, soreness of waist and knees, numbness of limbs, metrorrhagia and vaginal discharge, chronic malaria and physical weakness. The Shouwu used in the present invention is a good product for invigorating and tonifying the kidney.

Danshen bitter, slightly cold. GUIXIN, Liver Channel. Dispelling blood stasis and relieving pain, promoting blood circulation to stimulate menstrual flow, clearing away heart-fire and relieving restlessness. For irregular menstruation, amenorrhea dysmenorrhea, accumulation of lumps in the abdomen, tingling pain in the chest and abdomen, heat arthralgia pain, sore swelling and pain, vexation and insomnia. It is used for sternocostal and hypochondriac pain, rheumatic arthralgia, lumps in the abdomen, swelling and pain of sores, pain from falls, irregular menstruation, amenorrhea dysmenorrhea, postpartum stasis and pain, etc. It is effective in treating sternocostal pain, lumps in the abdomen, irregular menstruation and amenorrhea. . "Compendium" contains: Danshen, according to "Furenming Theory", Siwu Decoction can be used to treat women's diseases, regardless of prenatal and postpartum, and the amount of menstrual fluid, but only Danshen powder, the same indications. Salvia miltiorrhiza can break old blood, replenish new blood, give birth to a fetus, stop stillbirth, stop stagnation in metrorrhagia, and regulate meridians.

Semen Cuscutae Gan Xinping enters the Liver and Kidney Channels. Tonifying the kidney and replenishing essence, nourishing the liver and improving eyesight, preventing miscarriage. For liver and kidney deficiency, waist and knee pain, impotence and nocturnal emission, frequent urination and enuresis, dim eyesight, restless fetal movement and other diseases. Function nourishes the liver and kidney, solidifies essence and reduces urination, prevents miscarriage, improves eyesight, and relieves diarrhea. For impotence and nocturnal emission, residual urination, enuresis, frequent urination, soreness of the waist and knees, dizziness and tinnitus, fetal leakage due to kidney deficiency, restless fetal movement, diarrhea due to spleen and kidney deficiency.

Epimedium pungent, sweet, warm, returns liver, kidney meridian. It can invigorate the kidney and support yang, strengthen muscles and bones, dispel wind and dampness, and be good at treating deficiency of kidney yang, impotence and spermatorrhea, enuresis and frequent urination; rheumatic arthralgia, bone impotence and paralysis. "Book of Materia Medica" says "Yin Yang Huo, "The Classic" medicine mainly impotence and injury, "Rihuazi" also first said that it cures men to eliminate yang and women to eliminate yin, it is said that the one who enters the gate of life and supplements the true yang is Also. Covering the gate of life is the true yang in the kidney, that is, the vitality of the human body. The so-called absolute yang and yin, the vitality that is not the original, why should it be in the already dry. The so-called benefit energy, strengthen the will, and cure cold and fatigue, Syndrome such as convulsions and urgency of muscles and bones are all due to the aid of vitality. The elderly are fainted, the middle-aged are forgetful, and all of them are those whose Yuan Yang has weakened and cannot rise. It must be known that this smell is ascending from descending, and its ascending is due to descending."

Fructus Cnidii nature is pungent, bitter, warm; There is little poison. Return the kidney channel. Cure mainly warming kidney and strengthening yang, drying damp, expelling wind, killing parasites. It is used for impotence, cold uterus, cold-damp leukorrhagia, lumbago due to dampness; external treatment of vulvar eczema, pruritus vulvae; trichomonas vaginitis, is a good medicine for external use in gynecology. "Compendium of Materia Medica" contains: Cnidium, bitter and flat; Therefore, housewives have swelling and pain in the vagina, men's impotence, dampness and itching, remove numbness, sharpen joints, and malignant sores. "Bie Lu" warms the middle and lowers the qi, making women take heat, and men's yin is strong, making them fertile. Covering the tongue can remove dampness, warm can dispel cold, pungent can moisten the kidney, sweet can benefit the spleen, so it can eliminate all diseases caused by deficiency, cold and damp in women and men. When the cold and dampness are eliminated, the disease will be gone, and the function will benefit yang, so the disease can be cured, and there will be benefits.

Schisandra is warm; sour and sweet; returns to the lung, heart, and kidney meridians; astringent and astringent, nourishing qi and promoting body fluid, nourishing the kidney and calming the heart. For chronic cough and shortness of breath, nocturnal spermatorrhea, enuresis, frequent urination, chronic diarrhea, spontaneous sweating, night sweats, thirsty body fluid wounds, shortness of breath and arteries, internal heat and quenching thirst, palpitations and insomnia. "Compendium of Materia Medica" contains: Schisandra governs Qi, the lungs govern all Qi, acid can be absorbed, and it is entering the lungs to nourish the lungs, so it also replenishes Qi. It mainly focuses on those who cough against the upper qi, and if the qi is deficient, the upper qi will be obstructed and not return to the original source. If the acid is absorbed, the qi will be absorbed and returned to the original source, and the cough and upper qi will be eliminated by itself. Lose weight due to overwork, replenish deficiencies, strengthen yin, and benefit men's essence. "Bie Lu" nourishes the five viscera, removes heat, and grows the middle muscles of the yin. When the dross is turned into fine particles, the essence will be self-generated, and when the essence is born, the yin will grow, so it is the same as the above-mentioned diseases.

Patrinia is bitter and flat in nature and taste, and has the effects of clearing away heat and detoxifying, draining pus and breaking blood stasis. It can treat intestinal abscess, diarrhea, red and white vaginal discharge, postpartum stasis and abdominal pain, red eyes, swelling and pain. Go into stomach, large intestine, Liver Channel. Cure mainly heat-clearing and toxic substances removing, eliminating carbuncle and discharging pus, promoting blood circulation and promoting blood stasis. For intestinal abscess, pulmonary abscess, sore carbuncle and swollen toxin, chest and abdomen pain caused by excess heat stasis, postpartum stasis abdominal pain and other diseases.

Liedang invigorates the kidney and yang, strengthens the bones and muscles. For sexual neurasthenia, sore waist and legs; for external use to treat diarrhea, enteritis, and dysentery in children. "Kaibao Materia Medica": Mainly for men with five labors and seven injuries, nourishes the waist and kidneys, makes people have children, and removes wind and blood. However, the column can reduce the percentage of ANAE+ lymphocytes at high or low concentrations. It can be seen that the kidney-tonifying medicine Liedang can promote the formation of rosettes of Ea at a certain concentration, and the rosette test of Ea is a common method for measuring the number of human T cells, which can reflect the cellular immune function of the body to a certain extent.

Poria cocos is sweet, light, and flat in nature. When used as medicine, it has the functions of diuresis and dampness, spleen and stomach, and calming the mind. Modern medical research: Poria cocos can enhance the immune function of the body, and Poria cocos polysaccharide has obvious anti-tumor and liver-protecting effects. For dysuria, edema and other diseases. Poria cocos function diuresis and exuding dampness, and the property of medicine is mild, diuresis without hurting righteousness, is the key medicine for diuresis and expelling dampness. All the symptoms of dysuria and water-dampness stagnation, whether they are cold-damp, damp-heat, or spleen-deficiency and damp-accumulated, can be used together. If it is more cold and damp, it can be compatible with Guizhi and Atractylodes macrocephala; if it is more damp and hot, it can be compatible with Polyporus, Alisma, etc.; Those who can also be used with aconite, Atractylodes atractylodes, etc.

Cornus officinalis, mainly cures cold and heat in the heart, warms the middle, expels cold and warm arthralgia, removes three insects, and has the effects of strengthening yin and nourishing essence, calming the five internal organs, clearing the nine orifices, and stopping urination; long-term use can improve eyesight and strengthen the body long years. Cornus officinalis, also known as yam meat, medicinal jujube, real jujube, jujube skin, meat jujube, etc., is a commonly used and precious Chinese medicinal material in my country with a long history of application. It has been favored by ancient medicine for its special effects such as strengthening and calming, strengthening yang but not helping fire, nourishing yin but not greasy, astringent but not staying evil. Zhang Zhongjing created "Jin Kui Shen Qi Wan" with Cornus officinalis as the king. According to chemical analysis, Cornus officinalis contains active ingredients such as cornel, tartaric acid, gallic acid, malic acid, resin, tannins and multivitamins with strong physiological activities, which have pharmacological effects such as enhancing immunity, anti-inflammatory, and antibacterial. A common medicine in Chinese medicine.

Wangbuliu is the dried seed of Vaccariasegetalis (neck) Garcker, a plant of Caryophyllaceae family, which has the functions of promoting blood circulation, promoting menstruation, reducing swelling and relieving pain, and promoting milk production. Indications for irregular menstruation, lack of milk, dystocia, carbuncle and furunculosis embolism, is an important medicine commonly used in clinical practice. "Herbal Classic": main golden sore, hemostasis and pain relief, thorns, and eliminating wind and internal cold. 2. "Bie Lu": stop vexation and epistaxis, carbuncle and malignant sore, flaccid breast, woman's dystocia.

Yizhiren: Latin formal name, Fructus Alpinae Oxyphyllae. Warming and nourishing the body, warming the spleen and stopping diarrhea, taking saliva, warming the kidney, strengthening essence and reducing urination, mainly treating spleen and kidney deficiency and cold, abdominal pain and diarrhea; or kidney qi deficiency and cold frequent urination, enuresis, spermatorrhea, white turbidity; or chronic diarrhea caused by spleen and stomach deficiency and cold Diarrhea and saliva flow out of the mouth and cannot be controlled. Yizhiren contains volatile oil, Yizhiren ketone, vitamin B1, vitamin B2, vitamin C, vitamin E and various amino acids and fatty acids. Yizhiren decoction has the functions of invigorating the stomach, anti-diuresis and reducing saliva secretion. Its water extract can inhibit ascites sarcoma S180. role in cell growth. Its water extract and ethanol extract have the effect of inhibiting ileum contraction. In addition, its methanol extract has the effects of enhancing the contractility of the left atrium, inhibiting the aortic contraction caused by potassium chloride, and inhibiting the activity of prostaglandin synthase.

Dandelion Dandelion plant contains dandelion alcohol, dandelion, choline, organic acid, inulin and other healthy nutrients, which have diuretic, laxative, jaundice-reducing and choleretic effects. Dandelion also contains protein, fat, carbohydrates, trace elements and vitamins, etc., and has rich nutritional value. It can be eaten raw, fried, and made into soup. It is a plant that can be used as both medicine and food. Dandelion is a perennial herb belonging to the family Asteraceae. It is a plant with both medicine and food. According to the "Compendium of Materia Medica", it is flat in nature, sweet and slightly bitter, has the functions of clearing away heat and detoxifying, reducing swelling and promoting lactation, and is very effective in treating mastitis. Whether it is decocted orally or mashed and applied externally, it is all effective. In addition, dandelion has diuretic, laxative, anti-jaundice, choleretic and other effects, and is widely used in clinical practice. "Compendium of Materia Medica" has a saying: "Dandelion tender seedlings are edible, and raw food is especially good for treating infectious diseases." "Shen Nong's Materia Medica", "Tang Materia Medica", "Dictionary of Chinese Medicine" and other medical monographs of all dynasties have given high praise.

Fructus Plantaginis returns Lung Channel; Liver Channel; Kidney Channel; Bladder Channel. Function: heat-clearing and diuretic; expelling dampness and stopping diarrhea; improving eyesight; eliminating phlegm. Indications: Difficulty in urination; stranguria with diarrhea; edema and fullness; heat-damp diarrhea; red eyes and cloudy eyes; phlegm-heat cough and asthma. Diuretic effect, normal people take 10g of plantago decoction orally, it has diuretic effect, but the total volume of the decoction and the daily water intake are not recorded, and there is a lack of strict control. Normal people and rabbits have no obvious diuretic effect after taking plantain seed decoction. Plantain seeds also have no diuretic effect. "Rihuazi Materia Medica": relieves urination and drenchs astringent, aphrodisiac. Treatment of spermatorrhea, upset. Lower your breath.

Alisma (rhizome) is one of the traditional Chinese medicines. The theory of traditional Chinese medicine believes that it is cold in nature and has the effect of diuresis and dampness. According to modern medical research, Alisma can reduce serum total cholesterol and triacylglycerol content, and slow down the formation of atherosclerosis; Alisma and its preparations are also used in the treatment of inner ear vertigo, dyslipidemia, spermatorrhea, fatty liver and diabetes. The fat-soluble part of Alisma has obvious cholesterol-lowering and anti-atherosclerotic effects on rabbits with experimental hypercholesterolemia. The alisol A, B and alisol A, B, C isolated from it Acetate esters, except alisitol B, have significant cholesterol-lowering effects. Adding 0.1% content to the diet of experimental hyperlipidemic rats can reduce blood cholesterol by more than 50%, among which alisitol A-24-acetate has the strongest effect. Alisma ethanol extract, ethyl acetate extract of ethanol extract, etc. have hypolipidemic effects on experimental hypercholesterolemia rabbits and rats. The ethyl acetate extract and its residue insoluble in acetic acid-water had the strongest effect. Oral administration of ethyl acetate extract at 1g/kg per day also has a significant cholesterol-lowering effect on normal rats fed with ordinary feed. The isotope labeling method proved that alisol A has the ability to inhibit the esterification of cholesterol in the small intestine of mice, and can reduce the absorption rate of cholesterol in the small intestine of rats by 34%, but it does not affect the absorption of linoleic acid.

Radix Paeoniae Rubra, promoting blood stasis, relieving pain, cooling blood, detumescence. Indications: Treatment of stagnant amenorrhea, accumulation of hernia, abdominal pain, hypochondriac pain, epistaxis, bloody dysentery, intestinal wind bleeding, red eyes, carbuncle, and injury from falls. Radix Paeoniae Rubra can clear blood and divide excess heat, dispel blood stasis and stagnant blood. The function of this product is similar to that of Moutan bark, so it is often used in conjunction with Moutan bark. However, Moutan Cortex has a better effect of clearing away heat and cooling blood. It can not only clear away excess heat from blood, but also treat fever due to yin deficiency; while red peony root can only be used for excess heat in blood, and is good at promoting blood circulation and dispelling stasis. "Herbal Classic": the main pathogenic abdominal pain, except blood numbness, broken hard accumulation, cold and heat hernia, pain relief, diuresis, benefit qi.

Smilax smilax nature and flavor: sweet and light, flat. Channels returned: Liver Channel; Stomach Channel; Spleen Channel. Function: detoxification, dehumidification, sharp joints. Indications: Treatment of syphilis, turbid stranguria, muscle and bone pain, beriberi, furunculosis, carbuncle, scrofula, limb spasm, muscle and bone pain caused by syphilis and mercury poisoning. Myrica rubra sore, erysipelas. "Compendium": invigorate the spleen and stomach, strengthen the bones and muscles, remove rheumatism, sharpen the joints, and stop diarrhea. Control spasm bone pain; malignant sore carbuncle. Detoxification mercury powder, vermilion poison.

Raspberry is warm in nature; sweet and sour; returns to kidney and bladder channels. Indications: Tonifying the kidney, strengthening essence, reducing urination. For kidney deficiency enuresis, frequent urination, impotence and premature ejaculation, nocturnal emission and spermatorrhea. "Compendium of Materia Medica": "Raspberry, its main benefit is Qi, and it is also said to benefit essence. Kidney stores essence, kidney receives Qi, and if essence is sufficient, the body will be light and the hair will not be white. Su Gong advocates tonic and continuation Absolutely, strengthens yin and builds yang, brightens the skin, harmonizes viscera. Zhen Quan masters men with kidney deficiency and impotence, and women eat and have children. Great Ming masters the five internal organs, improves color, nourishes essence, grows hair, and strengthens will All take its beneficial kidney to add essence, and the artificial ear of sweet and sour convergence." "On the Nature of Medicine" contains it: "The main man's kidney essence is exhausted, and the woman eats to have children. Main impotence."

Peony bark. "Compendium of Materia Medica" contains it: "Nourishing yin and reducing fire, detoxifying spots, benefiting throat, clearing blood stagnation in urine. Later generations use yellow tiller to treat phase fire, but they don't know that Moutan bark is more effective. Red flowers benefit, white flowers People are also seldom comprehended, so it is advisable to distinguish them." Modern research shows that the contained paeonol and other glycoside components have anti-inflammatory effects; the methanol extract of Moutan cortex has the effect of inhibiting platelets; paeonol has sedative, Cooling, antipyretic, analgesic, antispasmodic and other central inhibitory effects and anti-atherosclerosis, diuretic, anti-ulcer effects.

Spatholobus Spatholobus is bitter, sweet and warm in nature. Return liver, kidney meridian, enrich blood, invigorate blood circulation, dredging collaterals. For irregular menstruation, blood deficiency and chlorosis, numbness and paralysis, rheumatic arthralgia, promoting blood circulation and relaxing tendons; nourishing blood and regulating menstruation, "Compendium of Materia Medica Supplements" contains that it can treat numbness of hands and feet; limb paralysis; rheumatic arthralgia; women have irregular menstruation; dysmenorrhea .

Cortex Phellodendri clears heat and dries dampness, relieves fire and removes steam, detoxifies and treats sores. For damp-heat diarrhea, jaundice, leukorrhagia, pyrexia, beriberi, flaccidity, bone steaming and labor-heat, night sweats, nocturnal emission, sore swelling, eczema and itching. Salt Phellodendron nourishes yin and reduces fire. For hyperactivity of fire due to yin deficiency, night sweat and bone steam. "Chinese Pharmacopoeia" records Phellodendron Phellodendri's ability to clear away heat and dampness, which is similar to that of Scutellaria baicalensis and Coptis chinensis, but it is better for removing dampness and heat in the lower burnt body.

Embodiment 1: the production process of the enema of the present invention is: 1000g of Liedang, 1000g of Poria cocos, 1000g of Wangbuliuxing, 1000g of Schisandra chinensis, 1000g of Epimedium, 1000g of Cuscuta, 1000g of Yizhiren, 1000g of Cornus officinalis, and Hedyotis diffusa 1000g, Dandelion 1000g, Shouwu 1000g, Plantago 1000g, Salvia 1000g, Phellodendron 1000g, Alisma 1000g, Prunella vulgaris 1000g, Cnidium 1000g, Patrinia 1000g, Scutellaria baicalensis 1000g, Radix Paeoniae Rubra 1000g, Smilax tuckahoe 1000g, Pot 1000g, Moutan bark 1000g, Mildew Spatholobus 1000g. Firstly, the crude drug is pulverized into a coarse powder, further pulverized, and passed through a 120-mesh sieve, so that the amount of fine powder passing through the 120-mesh sieve reaches 30%, and the fine powder a is collected through the 120-mesh sieve to obtain fine powder a; Coarse powder that cannot pass through a 120 mesh sieve is put into a multi-functional extraction tank for extraction twice. For the first time, add 8-10 times the amount of ethanol to decoct for 1-2 hours, and for the second time add 4-8 times the amount of water to decoct for 1-2 hours. , combined two decoctions, and filtered to obtain the filtrate; heated and concentrated to a paste, sterilized by ultraviolet rays to form an enema.

Embodiment 2: the production process of the enema of the present invention can also be: Liedang 1500g, Poria cocos 1500g, blancia 1500g, schisandra 1500g, epimedium 1500g, dodder 1500g, Yizhiren 1500g, dogwood 1500g, white snake Tongue 1500g, Dandelion 1500g, Radix Polygoni Multiflori 1500g, Plantago 1500g, Salvia miltiorrhiza 1000g, Phellodendron 1000g, Alisma 1000g, Prunella vulgaris 1000g, Cnidium 1000g, Patrinia 1000g, Scutellaria baicalensis 1000g, Radix Paeoniae Rubra 1000g, Smilax tuckahoe 1000g , Raspberry 1000g, Moutan Bark 1000g, Milletah 1000g. Blend, chop, soak. The soaked crude drug is heated and refluxed twice for 1 to 2 hours each time, and the two extracts are combined and left to stand. Then add 5-8 times the amount of 60-70% ethanol to the above-mentioned medicinal dregs extracted by water, heat and reflux to extract twice, each time for 1-2 hours, and combine the two extracts to stand still. Combine the above two extracts, concentrate the filtrate with a relative density of 1.35 (80°C) under reduced pressure, recover ethanol, adjust the specific gravity of the obtained filtrate to 1.06, and obtain an extract under reduced pressure, which can be used directly after being sterilized by ultraviolet rays.

Embodiment 3: The preparation method of the enema of the present invention can also be: Jiang Liedang 1000g, Poria cocos 1000g, Wangbuliuxing 1000g, Schisandra 1000g, Epimedium 1000g, Cuscuta 1000g, Yizhiren 1000g, Cornus officinalis 1000g, white snake Tongue 1000g, Dandelion 1000g, Shouwu 1000g, Plantago 1000g, Salvia 1500g, Phellodendron 1500g, Alisma 1500g, Prunella vulgaris 1500g, Cnidium 1500g, Patrinia 1500g, Scutellaria baicalensis 1500g, Radix Paeoniae Rubra 1500g, Smilax tuckahoe 1500g , 1500g of raspberry, 1500g of Moutan cortex, and 1500g of Millet Spatholobus, add 5-10 times the amount of water to soak for 1-2 hours, extract twice; heat and extract for 1-2 hours, concentrate to extract, and become component 1 Add 60-90% ethanol to the remaining dregs and soak for 0.5-1.5 hours, extract twice, each time for 1-2 hours, combine the extracts, filter, concentrate, filter at 80-160 mesh, and centrifuge at 6000-10000 rpm The final supernatant is ultrafiltered through an ultrafiltration column with a cut-off molecular weight of 5000-10000, and the ultrafiltrate is concentrated under reduced pressure to a extract with a relative density of 1.35 (80°C), heated and refluxed twice, each time for 30 minutes to 45 Minutes, extract the active ingredient, combine the two extracts and let it stand to form an extract, which is used as component 2. Combined with ultraviolet light, disinfection.

The traditional Chinese medicine enema can make the medicine absorb through the rectal mucosa and reach the disease directly. It can have a higher concentration in the diseased prostate, and the therapeutic effect is better. At the same time, it also avoids some adverse reactions of oral medicine and intravenous medicine.

Pharmacological toxicity test

1. Antibacterial experiment

In vivo antibacterial test results show that the enema of the present invention has obvious protective effect on the animals of Escherichia coli and Proteus, can reduce the development of the disease, and reduce the mortality of animals; Bacteria have different degrees of antibacterial and bactericidal effects; the experimental results of the effect on experimental rat prostatitis show that the present invention can inhibit the weight gain of the prostate gland after bacterial infection, slow down the development of the disease, and inhibit the pathological changes of the prostate tissue ; 2-5 hours after administration, the urine output of animals can be significantly increased; 5 hours after administration, the temperature rise of rabbits caused by fresh yeast is significantly lowered; p-xylene can cause animal ear swelling and cotton balls Granuloma tissue has obvious inhibitory effect, and inhibits the increase of capillary permeability; it has a certain inhibitory effect on the pain caused by chemical substances stimulating the animal peritoneum or temperature stimulating the animal body surface.

2. Animal acute toxicity test research:

When the present invention adopts rectal administration route, it is recorded that the maximum administration dose of mice is 62.7g/kg (in terms of powder), which is about 1567.5 times of the proposed clinical human dosage (in terms of 60kg), and that of rats The maximum dosage per day is 62.7g/kg (calculated as powder), which is about 1567.5 times the intended clinical human dosage. The experimental animals were observed continuously for one week, and no obvious abnormalities were found in their appearance, signs, mental state, diet, drinking water, and feces. At the end of the experiment, the animals were all healthy and alive with weight gain.

3. Animal long-term toxicity test research:

This test establishes high, middle and low dose groups of the present invention's medicine and matrix control group, blank control group, adopts rectal administration route to give rats, and dosage is respectively 3.2, 2.4 and 1.6g/kg (calculated as medicine powder), It is equivalent to 80, 60 and 40 times of the dosage [0.04g (powder)/kg] of the intended clinical patient, and it is administered continuously for 2 months. Compared with the blank control group, appearance signs, behavioral activities, mental state, coat color, and feces properties, there was no significant difference (P>0.05), and the animal weight growth value and main organ coefficient were not significantly different from the blank control group (P>0.05 ), hematology and blood biochemical indexes test results were significantly different from those of the blank control group (P<0.05), but after the recovery period, the hematology and blood biochemical indexes with differences had returned to normal, and other indexes were compared with those of the blank control group. Compared with the blank control group, the difference was not significant (P>0.05). There was no significant difference in the main organs of the animals in the high-dose group and the blank control group in the histological examination during the administration period and the recovery period, and no delayed toxicity was observed.

4. Animal local irritation test:

Guinea pig skin allergy test and rat rectal administration irritation test of the enema of the present invention.

The results show that: in the skin allergy test, 0.8g (medicine powder)/kg in the high-dose group and 0.1g (medicine powder)/kg in the low-dose group are respectively equivalent to 20 times and 2.5 times the proposed clinical human dosage [0.04g (medicine powder)/kg]. times, through the skin administration, no animals were seen to produce allergic reactions; the high dose group of rectal administration irritation test was 5.0g (medicine powder)/kg, and the low dose group was 3.2g (medicine powder)/kg, which were respectively equivalent to 5.0g (medicine powder)/kg of the proposed clinical human dosage. 125, 80 times, the rectal mucosa was observed within the specified time without congestion, edema, etc., and there was no significant difference in histopathological examination compared with the blank control group, and no obvious irritating reaction was seen. General condition, body weight, breathing, circulation, central nervous system and limb activities, etc., showed no obvious abnormal reaction.

Pharmacological experiment description:

One: Chinese medicine enema of the present invention carries out the experimental research of anti-prostatic hyperplasia

(1) After 7 days of castration, SD rats were subcutaneously injected with 4 mg/kg of testosterone, and at the same time, 0.0938, 0.1875, 0.375/kg of traditional Chinese medicine enema of the present invention (prepared by the method of Example 2 of the present invention) (equivalent to the proposed clinical dosage) 2.5, 5, and 10 times of 2.5, 5, and 10 times), once a day, 7 days a week, and executed for 5 consecutive weeks. The test showed that the prostate index, prostate dry weight and dorsal lobe weight of the large and medium dose groups were significantly different from those of the model group, and the prostate volume of the high dose group was significantly different from that of the model group; the glandular volume of the large and medium dose groups Compared with the model group, there were significant differences in epithelial height and lumen diameter, and there were significant differences in acid phosphatase and DNA content in the large and medium dose groups compared with the model group. The test suggests that the traditional Chinese medicine enema of the present invention has a more significant inhibitory effect on benign prostatic hyperplasia under the test conditions.

(2) subcutaneously inject testosterone 4mg/kg after SD rat castration 7 days, give 0.0938,0.1875,0.375/kg enema suspension enema of the present invention simultaneously (equivalent to 2.5,5,10 times of clinical intended dosage) , once a day, 7 days a week, for 5 consecutive weeks after death detection. Compared with the model group, the prostate index, prostate dry weight, and dorsal lobe weight of the large and medium dose groups were significantly different, and the prostate volume of the high dose group was significantly different from that of the model group; the glandular epithelial height, Compared with the model group, there was a significant difference in the diameter of the lumen of the gland, and there were significant differences in the acid phosphatase in the high-dose group, and the DNA content in the high-dose and medium-dose groups compared with the model group. The test suggests that the enema of the present invention has a more significant inhibitory effect on benign prostatic hyperplasia under the test conditions.

(3) Kunming mice are given 0.0938, 0.1875, 0.375g/kg of enema suspension canned intestines of the present invention (equivalent to 2.5, 5, and 10 times of the proposed clinical dosage) after Kunming mice are implanted in the reproductive antrum of fetal mice, once a day, 7 days a week, for 5 consecutive weeks post-sacrifice detection. The prostate index of the large dose group, the weight of the dorsal lobe of the large and medium dose groups, and the volume of the medium dose group were significantly different from those of the model group; There was a significant difference in the model group, and the acid phosphatase in the large and small dose groups was significantly different from that in the model group. The test suggests that the present invention has a significant inhibitory effect on benign prostatic hyperplasia under the test conditions.

Two, the inhibitory effect of rat cotton ball granuloma hyperplasia of the present invention is to the inhibitory effect of pain in Kunming mice

1. Purpose of the test: to observe the continuous administration of the test substance for one week, the inhibitory effect on the hyperplasia of cotton ball granuloma in rats and the inhibitory effect on the pain of Kunming mice.

2. Test substance

Traditional Chinese medicine enema of the present invention (made by the method of Example 3 of the present invention); SD rat provided by the Experimental Animal Center of Shandong University as an animal, 4 months old, body weight: test body weight 362 ± 22 (-X ± SD) g . Gender: male; number of animals in each group: 10 each; feeding conditions: clean animal room, temperature 22±2°C, humidity 45±10%, ventilation rate 12 times/min, feeding conventional sterilized rat feed, drinking and sterilizing Water, group breeding, 5 per cage.

Dose setting and reason: Refer to the pharmacology guidelines of new drugs, the proposed clinical dose provided by the hospital is 2.25g/d for adults, calculated on the basis of 60kg body weight, 2.25g/d÷60kg body weight: 0.0375g/kg/d. The dosage of animals is divided into 2.5 times, 5 times and 10 times of the planned clinical dosage, and three dosage groups are set up as small, medium and large. (1) Low-dose group, 0.0375g/kgx2.5 times = 0.09375g/kg/d; (2) Medium-dose group, 0.0375g/kgx5 times = 0.1875g/kg/d, (3) High-dose group 0.0375g /kgx10 times=0.375g/kg/d.

3. Control group

a. Blank control group: given the same volume of sterilized drinking water; b. Qianliekang group: equivalent to 5 times the clinical oral dose. Adult 5g/d, calculated on the basis of 60kg, that is, 5g÷60kgx5 times=0.417g/kg/d; the dosage volume of each rat is 10ml/kg, and the concentration is different according to the same amount. The clinical route of administration is the same. Qianliekang, manufactured by Kangenbei Group Pharmaceutical Co., Ltd., commercially available, specification 0.5g x 60 tablets/bottle, clinical dosage, 3-4 tablets at a time, 3 times a day, orally. Absorbent cotton balls, made of weight 10±1g, similar in size, about 7mm in diameter, used after autoclaving.

4. Test method

4.1 Drug preparation: take the present invention and configure it into high-dose group, middle-dose group, and low-dose group, take Qianliekang 4.17g, dissolve it in 100ml drinking water, and configure it into a concentration of 4.17%.

4.2 Animal model: Rats were anesthetized with pentobarbital, cut a small hole in each of the left and right fossa, expanded the subcutaneous tissue with vascular forceps, implanted sterilized cotton balls into the subcutaneous tissue of the rat’s two sides of the fossa, and then sutured. On the next day, start administration according to the above dose, weigh on the 8th day, anesthetize the rat 2 hours after administration, peel off and take out the cotton ball granulation tissue, remove all the surrounding fat tissue, dry it at 60°C for 12 hours, and weigh it. Heavy.

4.3 Observation index Net weight of granuloma, the weight of dried granuloma minus the weight of raw cotton ball is the net weight of granuloma.

4.4 Statistical method Office software was used to calculate the weight of cotton balls per 100g of body weight (the index of granuloma in each group), calculate the mean value and standard deviation (X±SD), and then perform a significant t test.

5. Results and evaluation, the results are shown in the following table.

Influence of the tablet of the present invention on rat cotton ball granuloma hyperplasia

The results show that: the Qianliekang group of the present invention has the effect of inhibiting the hyperplasia of chronic granuloma, and the effect of the enema of the present invention is relatively ideal.

clinical information

1.1 Diagnosis and inclusion criteria

1 clinical data

1.1 General information

The 40 cases in this group all meet the following diagnostic criteria: a) The clinical symptoms are mainly distended discomfort and pain in the perineum, lumbosacral region and suprapubic region, or testicular anus and waist soreness, discomfort and pain, and sometimes the painful part moves around Unfixed, accompanied by frequent urination, urgency, urethral burning itching, white urine, etc.; b) routine test results of prostatic fluid showed: lecithin bodies decreased; c) bacterial culture of prostatic fluid mostly showed no bacteria; d) Before and after urination and defecation, the urethra overflows with white sticky secretions, hematuria or white blood cells under the microscope; e) The prostate gland feels full, soft or uneven, cystic, slightly tender, and the prostate becomes smaller, Tough. The age of onset ranged from 25 to 69 years, with an average of 45 years; the course of the disease ranged from 2 months to 20 years, with an average of 10 years.

1.2 Treatment methods

Traditional Chinese medicine enema is based on the treatment principle of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, relieving spasm and analgesia, reducing swelling and opening knots, and it can be added or subtracted according to the severity of symptoms. Prescription: Liedang 15g, Poria 10g, Wangbuliuxing 10g, Schisandra 10g, Epimedium 10g, Cuscuta 12g, Yizhiren 13g, Cornus officinalis 14g, Hedyotis diffusa 11g, Dandelion 12g, Zhishouwu 12g, Qianzi 11g, Salvia miltiorrhiza 12g, Phellodendron 11g, Alisma 12g, Prunella vulgaris 11g, Cnidium 12g, Patrinia 13g, Scutellaria baicalensis 11g, Radix Paeoniae Rubra 12g, Smilax smilax 11g, raspberry 11g, Moutan bark 12g, Miltonia 11g Equal addition and subtraction, one dose per day, decoct in water for retention enema, the decoction juice is about 100mL-150mL, and the temperature is 33°C-40°C. Every night before going to bed, clean the bowels and defecate, take the left side lying position, apply a little liquid paraffin oil on the enema and anus, drain the air in the enema pipe, and then slowly and gently insert the enema 4cm~8cm from the anus , Open the enema, slowly infuse the liquid medicine into the rectum, the operation time is 2 minutes to 5 minutes, and the total amount of infusion is 100mL to 150mL, and close the enema after the operation. Press the anus with the paper in your left hand, and slowly pull out the enema device with your right hand. The patient takes the right decubitus position, supine position, prone position, left decumbent position, sitting position, and semi-recumbent position in turn, and adjusts the position according to the specific condition. Keep it overnight, and the course of treatment is 2 to 4 weeks.

2 results

2.1 Criteria for judging curative effect

Cure: the clinical symptoms disappear completely, and the prostatic fluid is normal. Markedly effective: the main clinical symptoms disappear, and the prostatic fluid is normal. Effective: the clinical symptoms are alleviated or disappeared, and the routine test of prostatic fluid is improved. Ineffective: the clinical symptoms were basically not improved before and after treatment, and the routine test of prostatic fluid had no obvious improvement.

2.2 Treatment Outcomes

Among the 40 patients, 27 cases were cured, accounting for 67.5%; 6 cases were markedly effective, accounting for 15%; 5 cases were effective, accounting for 12.5%; 2 cases were ineffective, accounting for 5%.

3 Discussion

Chronic prostatitis is a common disease of the male reproductive system. It is mostly related to excessive drinking, eating irritating food, sitting in a saddle chair for a long time, constipation and other factors. A few are caused by acute prostatitis that has not been completely cured. However, most patients have never had an acute inflammation stage, and the prostatic fluid of such patients often has pathogenic bacteria. Chronic prostatitis can cause infertility, posterior urethritis, cystitis, and bladder neck sclerosis, which seriously interfere with the quality of life of patients. It brings a great mental burden to the patients, and many patients are combined with mental weakness and lack confidence in the cure.

Chronic prostatitis belongs to the category of "jing turbidity" and "gonorrhea" in traditional Chinese medicine. Its main pathogenesis is caused by traumatic dampness and heat, drinking, excessive spicy, overworked essence, poor blood vessels, stagnation of qi and blood stasis, which make dampness and heat viscous. , qi and blood stasis, deficiency of kidney qi, intertwined with each other, separate or combined to cause disease, because most of them have no obvious pathogenic bacteria, the effect of western medicine is poor. The effect of oral Chinese medicine is slow. According to the theory of traditional Chinese medicine, the present invention treats based on dialectical signs and symptoms, enemas with traditional Chinese medicines, so that the medicines can directly reach the sick place, mainly for promoting qi and blood circulation, clearing away heat and detoxification, relieving spasm and pain, reducing swelling and unblocking knots, and supplementing qi and tonifying kidney and other symptomatic treatments. Obtain very good curative effect.

Detailed ways:

Specific embodiment 1: Lee, male, 43 years old, first visit on October 10, 2009. The patient complained that in recent years, he often felt dull pain in the perineum and lower abdomen. After digital rectal examination and prostatic fluid test, he was diagnosed as chronic prostatitis. The state of an illness increases the weight of over the past six months, and companion sexual dysfunction. Acute diagnosis: dull pain and discomfort in the perineum and lower abdomen, white discharge often flows out from the urethral opening after urination and defecation, sexual dysfunction, dizziness, dizziness, fatigue, fatigue, red tongue, less coating, yellow greasy roots, Thin and stringy pulse. Prostatic fluid test: red blood cells (+), white blood cells (++), a small amount of pus cells. Digital rectal examination: prostatic hypertrophy, pain. Medicinal: Liedang 12g, Poria 10g, Wangbuliuxing 10g, Schisandra 10g, Epimedium 10g, Cuscuta 12g, Yizhiren 11g, Cornus officinalis 12g, Hedyotis diffusa 13g, Dandelion 12g, Shouwu 12g, Qianzi 11g, Salvia miltiorrhiza 12g, Phellodendron 11g, Alisma 12g, Prunella vulgaris 11g, Cnidium 12g, Patrinia 13g, Scutellaria baicalensis 11g, Radix Paeoniae Rubra 11g, Smilax smilax 12g, raspberry 12g, Moutan bark 12g, Miltonia 13g . Every night before going to bed, clean the bowels and defecate, take the left side lying position, apply a little liquid paraffin oil on the enema and anus, drain the air in the enema pipe, and then slowly and gently insert the enema 4cm ~ 8cm from the anus , Open the enema, slowly infuse the liquid medicine into the rectum, the operation time is 2 minutes to 5 minutes, and the total amount of infusion is 100mL to 150mL, and close the enema after the operation. Press the anus with the paper in your left hand, and slowly pull out the enema device with your right hand. The patient takes the right decubitus position, supine position, prone position, left decumbent position, sitting position, and semi-recumbent position in turn, and adjusts the position according to the specific condition. Keep it overnight, 10 days is a course of treatment, and the interval between courses of treatment is 3 days. After the 3 courses of treatment, the above symptoms are relieved, and the prostatic fluid is reexamined.

Specific example 2: Yang, man, 32 years old, likes tobacco and alcohol, lives irregularly, self-report suffers from chronic prostatitis, prostatic hypertrophy, symptoms are thin urine line, dysuria, urethral opening burning pain, and low libido, impotence Symptoms seriously affect sleep. The effect of various diagnosis and treatment is not good. After checking the prostatic fluid, there were 16 white blood cells/HP (high power field under microscope) red blood cells (-). Medicinal: Liedang 13g, Poria cocos 10g, Wangbuliuxing 10g, Schisandra 10g, Epimedium 10g, Cuscuta 12g, Yizhiren 11g, Cornus officinalis 13g, Hedyotis diffusa 13g, Dandelion 12g, Shouwu 12g, Qianzi 11g, Salvia miltiorrhiza 12g, Phellodendron 11g, Alisma 12g, Prunella vulgaris 11g, Cnidium 12g, Patrinia 13g, Scutellaria baicalensis 11g, Radix Paeoniae Rubra 11g, Smilax cocos 13g, Raspberry 12g, Moutan bark 12g, Miltonia 14g . Make an enema. Every night before going to bed, clean the bowels and defecate, take the left side lying position, apply a little liquid paraffin oil on the enema and anus, drain the air in the enema pipe, and then slowly and gently insert the enema 4cm ~ 8cm from the anus , Open the enema, slowly infuse the liquid medicine into the rectum, the operation time is 2 minutes to 5 minutes, and the total amount of infusion is 100mL to 150mL, and close the enema after the operation. Press the anus with the paper in your left hand, and slowly pull out the enema device with your right hand. The patient takes the right decubitus position, supine position, prone position, left decumbent position, sitting position, and semi-recumbent position in turn, and adjusts the position according to the specific condition. Keep it overnight, 10 days is a course of treatment. After 15 days, the symptoms are relieved and relieved. After 3 more courses of treatment, the genitals have a cool feeling, the lower abdomen is not distended, the wet phenomenon disappears, and the body returns to normal. There has been no recurrence so far.

Claims (10)

1. treat the Chinese medicinal enema of chronic prostatitis for one kind, it is characterized in that, in described Chinese medicinal enema, the parts by weight of various crude drug are: 10～20 parts of Herba Orobanchess, 10～20 parts, Poria, 10～20 parts of Semen Vaccariae, 10～20 parts of Fructus Schisandrae Chinensis, 10～20 parts of Herba Epimedii, 10～20 parts of Semen Cuscutae, 10～20 parts of Fructus Alpiniae Oxyphyllae, 10～20 parts of Fructus Corni, 10～20 parts of Herba Hedyotidis Diffusaes, 10～20 parts of Herba Taraxacis, 10～20 parts of Radix Polygoni Multiflori Preparata, 10～20 parts of Semen Plantaginiss, 10～20 parts of Radix Salviae Miltiorrhizaes, 10～20 parts of Cortex Phellodendris, 10～20 parts of Rhizoma Alismatis, 10～20 parts of Spica Prunellaes, 10～20 parts of Fructus Cnidiis, 10～20 parts of Herba Patriniae, 10～20 parts of Radix Scutellariaes, 10～20 parts of Radix Paeoniae Rubra, 10～20 parts of Rhizoma Smilacis Glabraes, 10～20 parts of Fructus Rubies, 10～20 parts of Cortex Moutans, 10～20 parts of Caulis Spatholobis.

2. treat according to claim 1 the Chinese medicinal enema of chronic prostatitis, it is characterized in that, in described Chinese medicinal enema, the parts by weight of various crude drug are: 10～15 parts of Herba Orobanchess, 10～15 parts, Poria, 10～15 parts of Semen Vaccariae, 10～15 parts of Fructus Schisandrae Chinensis, 10～15 parts of Herba Epimedii, 10～15 parts of Semen Cuscutae, 10～15 parts of Fructus Alpiniae Oxyphyllae, 10～15 parts of Fructus Corni, 10～15 parts of Herba Hedyotidis Diffusaes, 10～15 parts of Herba Taraxacis, 10～15 parts of Radix Polygoni Multiflori Preparata, 10～15 parts of Semen Plantaginiss, 10～20 parts of Radix Salviae Miltiorrhizaes, 10～20 parts of Cortex Phellodendris, 10～20 parts of Rhizoma Alismatis, 10～20 parts of Spica Prunellaes, 10～20 parts of Fructus Cnidiis, 10～20 parts of Herba Patriniae, 10～20 parts of Radix Scutellariaes, 10～20 parts of Radix Paeoniae Rubra, 10～20 parts of Rhizoma Smilacis Glabraes, 10～20 parts of Fructus Rubies, 10～20 parts of Cortex Moutans, 10～20 parts of Caulis Spatholobis.

3. treat according to claim 1 the Chinese medicinal enema of chronic prostatitis, it is characterized in that, in described Chinese medicinal enema, the parts by weight of various crude drug are: 10～20 parts of Herba Orobanchess, 10～20 parts, Poria, 10～20 parts of Semen Vaccariae, 10～20 parts of Fructus Schisandrae Chinensis, 10～20 parts of Herba Epimedii, 10～20 parts of Semen Cuscutae, 10～20 parts of Fructus Alpiniae Oxyphyllae, 10～20 parts of Fructus Corni, 10～20 parts of Herba Hedyotidis Diffusaes, 10～20 parts of Herba Taraxacis, 10～20 parts of Radix Polygoni Multiflori Preparata, 10～20 parts of Semen Plantaginiss, 10～15 parts of Radix Salviae Miltiorrhizaes, 10～15 parts of Cortex Phellodendris, 10～15 parts of Rhizoma Alismatis, 10～15 parts of Spica Prunellaes, 10～15 parts of Fructus Cnidiis, 10～15 parts of Herba Patriniae, 10～15 parts of Radix Scutellariaes, 10～15 parts of Radix Paeoniae Rubra, 10～15 parts of Rhizoma Smilacis Glabraes, 10～15 parts of Fructus Rubies, 10～15 parts of Cortex Moutans, 10～15 parts of Caulis Spatholobis.

4. a preparation method for the treatment of the Chinese medicinal enema of chronic prostatitis as described in any one in claim 1～3, is characterized in that, the preparation process of described enema comprises:

A. described crude drug is mixed, chopping, sieves, and soaks;

B. the crude drug of immersion being added to alcohol heating reflux extracts 2 times;

C. get again the medicinal residues after above-mentioned ethanol extraction, the heating and refluxing extraction that adds water 2 times;

D. above-mentioned two kinds of extracting solution are merged to decompression recycling ethanol disinfectant preparation.

5. treat according to claim 4 the preparation method of the Chinese medicinal enema of chronic prostatitis, it is characterized in that, in described step a, chopping after first described crude drug being mixed, XianCheng's coarse powder, more further pulverize, cross 120 mesh sieves, the fine powder amount that enable pass is crossed 120 mesh sieves is reaching 30%, collects that to obtain fine powder by the fine powder of 120 mesh sieves for subsequent use, and unsifted coarse granule is placed on and in ethanol, soaks 8-12 hour.

6. the preparation method for the treatment of according to claim 4 the Chinese medicinal enema of chronic prostatitis, is characterized in that, in described step b, by soaked crude drug coarse granule heating and refluxing extraction 2 times, each 1～2 hour, 2 extracting solution is merged and is left standstill.

7. the preparation method for the treatment of according to claim 4 the Chinese medicinal enema of chronic prostatitis, is characterized in that, in described step c, by add water heating and refluxing extraction 2 times of the medicinal residues after above-mentioned ethanol extraction, each 1～2 hour, 2 extracting solution is merged and is left standstill.

8. treat according to claim 4 the preparation method of the Chinese medicinal enema of chronic prostatitis, it is characterized in that, in described steps d, above-mentioned two kinds of extracting solution are merged, 1.35 filtrate when concentrating under reduced pressure relative density is 80 DEG C, reclaim ethanol, gained filtrate is adjusted to proportion to 1.06, paste materials reduces pressure to obtain, with ultraviolet-ray sterilizing, become enema.

9. a preparation method for the treatment of the Chinese medicinal enema of chronic prostatitis as described in any one in claim 1～3, is characterized in that, its preparation process comprises:

A, get crude drug and put into ethanol and soak, heat is extracted 2 times, becomes paste, is component 1;

B, medicinal residues extracting in water 2 times, thickening filtration is paste, is component 2;

C, above-mentioned two kinds of pastes are merged into enema.

10. the preparation method for the treatment of according to claim 9 the Chinese medicinal enema of chronic prostatitis, is characterized in that, in described step a, get in the ethanol that raw material adds 5-10 doubly to measure and soak 1-2 hour, heating extraction 2 times, each 1-2 hour, get supernatant, merge extractive liquid,, 100-120 order filters, then is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, 1.36 extractum when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C, heating is concentrated into paste, and stand for standby use, becomes component 1; In described step b, the medicinal residues that ethanol extraction is crossed are put into 10 times of water gagings, heating and refluxing extraction 2 times, each extraction time is 1～2 hour, and 100-120 order filters, then is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, 1.36 extractum when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C, heating is concentrated into paste, and stand for standby use, becomes component 2; In described step c, above-mentioned two kinds of component paste concentrated solutions are merged, then use ultraviolet, disinfection, becomes enema.