Bladder perfusion pharmaceutical composition for urodynamic examination and preparation method and application thereof

Abstract

The invention relates to the technical field of medicine, in particular to a bladder perfusion pharmaceutical composition for urodynamics examination and a preparation method and application thereof.The bladder perfusion pharmaceutical composition is prepared from, by weight, 14-16 parts of astragalus membranaceus, 11-13 parts of felwort, 11-13 parts of plantain herb, 5-7 parts of caulis clematidis armandii, 14-16 parts of angelica sinensis, 8-10 parts of pseudo-ginseng and 11-13 parts of Chinese yam. The preparation method comprises the following steps: crushing, distilling to obtain rectified liquid, performing water extraction, alcohol precipitation and centrifugation on decoction dregs to obtain supernate, mixing the rectified liquid and the supernate, and performing ultrafiltration, filling and sterilization. The bladder perfusion pharmaceutical composition has good effects of resisting bacteria and diminishing inflammation, inducing diuresis for treating stranguria, relieving pain and stopping bleeding, promoting blood circulation to remove blood stasis and expelling toxin and pus under the mutual influence and synergistic effect of all the raw materials, is completely non-irritant, is simple in preparation method and easy to control, reduces complications of patients during and after examination, and has a good clinical application prospect. The symptoms such as pain, frequent urination, urgent urination and hematuresis of patients are relieved, and the comfort and satisfaction of the patients are improved.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a bladder instillation medicine composition for urodynamic examination, a preparation method and application thereof. Background Art

[0002] Urodynamic examination is a commonly used examination in urology. It is needed to evaluate bladder function and obstruction in patients with dysuria, urinary incontinence, and frequent urination. Urodynamic examination requires insertion of an examination tube and infusion of fluid, which takes a long time. Invasive catheterization can lead to lower urinary tract infection and bleeding, increase patient pain, increase antibiotic use, and increase medical expenses. It is mainly caused by specific and non-specific bacterial infection, burning sensation during urination, frequent urination, and pain during urination. Patients with urethral stenosis and prostatic hyperplasia are prone to bleeding during catheterization, and in severe cases, there is macroscopic hematuria and blood clots.

[0003] Urodynamic bladder instillation fluid is injected into the bladder at a speed of 10mL to 100mL / s by pumping during the examination. Each examination requires about 500mL to 1000mL of liquid, which takes about 30 minutes to 120 minutes. After the examination, the instillation fluid has been completely discharged from the body at the same time. Its purpose is to observe the patient's bladder function during the storage and urination phases during the examination. The medium fluid used in the examination is indispensable. At present, the commonly used bladder instillation fluid for urodynamic examinations in clinical practice is 0.9% normal saline, which has no anti-inflammatory and hemostatic effects. Summary of the invention

[0004] In view of the deficiencies of the above-mentioned prior art, the purpose of the present invention is to provide a bladder instillation pharmaceutical composition for urodynamic examination and a preparation method and application thereof. The bladder instillation pharmaceutical composition provided by the present invention can be used as a medium liquid for urodynamic bladder instillation solution and can also remove foreign matter such as blood clots, mucus, bacteria, etc. in the bladder, and prevent infection, bleeding, frequent urination, painful urination, and dysuria.

[0005] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0006] A bladder instillation pharmaceutical composition for urodynamic examination, which is composed of the following raw materials in parts by weight: 14-16 parts of astragalus, 11-13 parts of gentian, 11-13 parts of plantain, 5-7 parts of chuanketong, 14-16 parts of angelica, 8-10 parts of panax notoginseng, and 11-13 parts of yam.

[0007] In a preferred embodiment of the present invention, the bladder instillation pharmaceutical composition comprises the following raw materials in parts by weight: 15 parts of Astragalus, 12 parts of Gentiana, 12 parts of Plantago, 6 parts of Caulis Atractylodes, 15 parts of Angelica, 9 parts of Panax notoginseng, and 12 parts of Dioscorea opposita.

[0008] In a preferred embodiment of the present invention, the drug composition for bladder perfusion is made into a bladder perfusion fluid for urodynamic examination.

[0009] Another object of the present invention is to provide a method for preparing the above-mentioned bladder perfusion fluid for urodynamic examination. The rectified liquid is obtained by crushing and distillation, and the supernatant is obtained by water extraction, alcohol precipitation and centrifugation of the medicinal residues. The two are mixed, ultrafiltered, filled and sterilized to obtain the bladder perfusion fluid, which specifically includes the following steps:

[0010] (1) Weigh the following raw materials in parts by weight: 14-16 parts of Astragalus membranaceus, 11-13 parts of Gentiana scabra, 11-13 parts of Plantago asiatica, 5-7 parts of Clematis armandii, 14-16 parts of Angelica sinensis, 8-10 parts of Panax notoginseng, 11-13 parts of Dioscorea opposita, and wash and crush the raw materials into powder;

[0011] (2) Add 8-10 times the weight of water based on the weight of the raw medicinal materials, collect the distillate by steam distillation method, and re-distill the distillate to obtain the rectified liquid for standby;

[0012] (3) Add 8-10 times the weight of water based on the weight of the medicinal materials after distillation to the medicinal residues, boil and decoct at least twice, each time for 1-2 hours, filter, combine the two filtrates, and concentrate the filtrate;

[0013] (4) Slowly add ethanol to the filtrate with stirring until the alcohol content reaches more than 60%, let it stand for precipitation and filtration, recover the ethanol from the filtrate, and concentrate it. Then add ethanol until the alcohol content reaches more than 80%, let it stand for precipitation and filtration, recover the ethanol from the filtrate until it is exhausted, adjust the pH to 6.0-8.0, refrigerate at 0-10°C, and let it stand for filtration to obtain the filtrate;

[0014] (5) Add povidone iodine and Tween 80 to the filtrate after refrigeration and standing filtration, mix evenly, adjust the pH to 6.0-7.0, centrifuge after refrigeration, take the supernatant, add the above-mentioned rectified liquid, mix evenly, and ultrafilter after adding injection water;

[0015] (6) Ultrafiltrate is filled and sealed under dust-free and sterile conditions, sterilized by flowing steam at 100°C for 30 minutes, and packaged.

[0016] In addition, between steps (4) and (5), add 0.5% of activated carbon based on the weight of the filtrate obtained in step (4), stir and heat to boiling, and filter to remove carbon until it is clear.

[0017] As described therein:

[0018] (1) The sovereign drug, Astragalus membranaceus, is a common traditional Chinese medicine, which has the effects of invigorating qi and consolidating the exterior, promoting diuresis and strengthening the heart, and anti-fatigue. From a nutritional perspective, Astragalus membranaceus contains rich nutrients such as flavonoids, polysaccharides, and saponins, which have a certain auxiliary effect on improving human immunity, antioxidant, and anti-fatigue. In traditional Chinese medicine theory, Astragalus membranaceus is slightly warm in nature, sweet in taste, and enters the spleen and lung meridians, with the effects of invigorating qi and lifting yang, benefiting the defensive qi and consolidating the exterior, expelling toxins and promoting granulation, and promoting diuresis and reducing swelling. Specifically, Astragalus membranaceus can be used to treat symptoms such as qi deficiency and fatigue, middle qi sinking, lung deficiency cough, chronic diarrhea and rectal prolapse, exterior deficiency spontaneous sweating, etc., and can also be used for insomnia and palpitations caused by qi and blood deficiency. At the same time, Astragalus membranaceus also has certain effects of promoting diuresis and reducing swelling, strengthening the heart and lowering blood pressure.

[0019] (2) The sovereign drug, Gentiana scabra, is a traditional Chinese medicine, also known as gallbladder herb and gentian violet. It is the dried root and rhizome of Gentiana manshurica, Gentiana scabra, Gentiana triflora, or Gentiana rigescens of the Gentianaceae family. It is cold in nature and bitter in taste, with the effects of clearing heat and drying dampness, purging liver and gallbladder fire, and can relieve symptoms such as damp-heat jaundice, genital swelling and itching, and leukorrhea. Gentiana scabra also has the effect of purging liver and gallbladder fire, and can treat discomfort symptoms caused by excessive liver and gallbladder fire, such as bitter taste in the mouth, dizziness, pain in both flanks, dizziness and red eyes, etc.;

[0020] (3) The sovereign drug, Plantago asiatica, is a common herbaceous plant and also a herb widely used in traditional Chinese medicine. It has the effects of clearing heat and detoxifying, promoting diuresis and relieving stranguria, and clearing the liver and improving eyesight, and can be used to treat heat syndrome problems such as sore throat, oral ulcers, and difficult urination;

[0021] (4) The sovereign drug, Clematis armandii, is a plant belonging to evergreen lianas. The medicinal part of Clematis armandii is mainly its dried vine stem, with a bitter and cold taste, and it belongs to the heart, small intestine, and bladder meridians. In traditional Chinese medicine, it has the effects of promoting diuresis and relieving stranguria, clearing the heart and relieving vexation, and promoting menstruation and lactation. It is mainly used to treat symptoms such as stranguria, edema, vexed and reddish urination, oral ulcers, amenorrhea and less lactation, and damp-heat arthralgia pain;

[0022] (5) The ministerial drug, Panax notoginseng, is a perennial herb of the genus Panax in the Araliaceae family. It is named because it is dug and harvested three to seven years after sowing, and each plant has three petioles, and each petiole has seven leaves. It is native to China, mainly distributed in Yunnan, Guangxi and other places, and is mainly cultivated. Panax notoginseng is a shade-loving plant, which likes warm and slightly shady and humid environments. It is sweet and slightly bitter in taste, warm in nature, and belongs to the liver and stomach meridians. Panax notoginseng has the effects of enriching blood and stopping bleeding, promoting blood circulation and removing blood stasis, can antiplatelet aggregation, promote blood coagulation, and play a role in enriching blood and stopping bleeding. At the same time, Panax notoginseng is also rich in antioxidant components, which can scavenge excessive free radicals in the human body, play a role in anti-aging and anti-fatigue. In addition, Panax notoginseng also has an immune regulatory function, which can restore the too high or too low immune response to normal.

[0023] (6) The ministerial drug Angelica sinensis. Angelica sinensis is a traditional Chinese medicine and is the dried root of the umbelliferous plant Angelica sinensis. It is mainly produced in the southeastern part of Gansu Province, with Min County having a large output and good quality. It is also cultivated in provinces such as Yunnan, Sichuan, Shaanxi, and Hubei. It is widely used in traditional Chinese medicine and has various effects such as enriching blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting defecation. Angelica sinensis tastes sweet and pungent, is warm in nature, and belongs to the liver, heart, and spleen meridians. It is commonly used in the treatment of symptoms such as sallow complexion due to blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, cold pain in the abdomen, rheumatic arthralgia, traumatic injury, carbuncles and ulcers, and intestinal dryness and constipation. Angelica sinensis can both activate blood circulation and enrich blood, and for women, it is an important medicine for regulating menstruation in gynecology. At the same time, modern research shows that Angelica sinensis is also used to treat coronary heart disease angina pectoris, thromboangiitis obliterans, etc., and certain curative effects have been achieved;

[0024] (7) The adjuvant drug Dioscorea opposita. Dioscorea opposita is a food homologous to medicine. It is both a nutritious food ingredient and a traditional Chinese medicine with various effects. First of all, from a nutritional perspective, Dioscorea opposita is rich in various nutrients and is a healthy food with high nutritional value. Its diosgenin is called the natural "mother of hormones", which can promote the synthesis of endocrine hormones, enhance the metabolism of epidermal cells of the skin and the function of skin moisturization, and contribute to improving the physique. In terms of medicine, Dioscorea opposita is neutral in nature, sweet in taste, and belongs to the spleen, lung, and kidney meridians, and has the effects of invigorating the spleen and nourishing the stomach, promoting the production of body fluid and benefiting the lungs, and tonifying the kidney and arresting seminal emission. Specifically, Dioscorea opposita can effectively promote blood circulation, improve myocardial contractility, and lower blood pressure. At the same time, it can also reduce inflammation and relieve pain, and has obvious therapeutic effects on various swellings and pains of the human body. In addition, Dioscorea opposita also contains a variety of natural active enzymes, which can delay the aging of the human body, promote blood circulation, and improve the functions of various organs of the human body, and also play a positive role in preventing various inflammations and cancers. From the perspective of traditional Chinese medicine, Dioscorea opposita also has the effects of strengthening the spleen and benefiting the stomach, and nourishing the kidney and essence. It is beneficial to enhancing the digestive and absorptive functions of the spleen and stomach, and can be used to treat symptoms such as weakness of the spleen and stomach, loss of appetite and general fatigue, and diarrhea. At the same time, Dioscorea opposita can also strengthen the body and nourish the kidney and essence, and has good therapeutic effects on symptoms such as spermatorrhea due to kidney deficiency, profuse leukorrhea in women, and frequent urination.

[0025] Principle of formula: For the pain, bleeding, and infection caused by urethral catheterization during urodynamic examination in patients, the treatment of bladder and urethral infections, bleeding, frequent urination, and pain with these traditional Chinese medicines is mainly due to their different pharmacological effects. Astragalus membranaceus is a traditional Chinese medicine for replenishing qi, with the effects of replenishing qi and strengthening the surface, promoting diuresis and reducing swelling, strengthening the heart and lowering blood pressure, etc. It can improve symptoms such as frequent urination and urgency caused by cystitis, and at the same time can enhance the patient's immunity and promote the body's self-repair. Gentiana scabra has the effects of clearing heat and detoxifying, and promoting diuresis and draining dampness, which helps to eliminate the inflammation and dampness of cystitis and relieve symptoms such as frequent urination and pain during urination. Plantago asiatica has the effects of promoting diuresis, clearing heat and detoxifying, and anti-inflammatory, which helps to relieve symptoms such as frequent urination, urgency, and pain during urination caused by cystitis. Panax notoginseng has the effects of stopping bleeding, reducing swelling, and relieving pain, which can promote the body's self-repair and help relieve the pain and bleeding symptoms caused by cystitis. Clematis armandii has the effects of promoting diuresis and clearing heat, which can improve the abnormal urination caused by cystitis. Angelica sinensis and Chinese yam have the effects of replenishing qi and nourishing blood, tonifying the kidney and strengthening the spleen, which helps to enhance the body's immunity and promote the recovery of cystitis. In summary, the formula of these traditional Chinese medicines has a certain therapeutic effect on bladder and urethral infection, bleeding, frequent urination, and pain, mainly due to their respective pharmacological effects and synergistic effects.

[0026] The bladder perfusion fluid for urodynamic examination prepared by the above preparation process and method has the effects of good antibacterial and anti-inflammatory, promoting diuresis and relieving stranguria, relieving pain and stopping bleeding, promoting diuresis and reducing swelling, promoting blood circulation to remove stasis, and expelling pus by draining toxins. It is completely non-irritating, the preparation method is simple, easy to control, and convenient to use, reducing the complications of patients during and after the examination, alleviating the symptoms of pain, frequent urination, urgency, and hematuria of patients, greatly reducing the usage amount of antibiotics, reducing the medical expenses of patients, and improving the comfort and satisfaction of patients.

[0027] Compared with the prior art, the beneficial effects of the present invention are:

[0028] 1. The basic pathogenesis of traditional Chinese medicine for bladder and urethral infections is that dampness and heat accumulate in the bladder, affecting the operation of qi and blood and the metabolism of body fluids, and then affecting the functions of zang-fu organs, showing a series of damp-heat symptoms. The focus of traditional Chinese medicine treatment is on clearing heat and promoting diuresis, promoting qi flow and relieving pain. If there is deficiency and stasis due to long-term illness, herbs for tonifying qi and blood and dissipating stasis are added. The present invention makes use of the characteristics of the bitter taste and cold nature of Gentiana scabra, Plantago asiatica, and Clematis armandii, and has significant effects of clearing heat and promoting diuresis, and promoting diuresis and relieving stranguria. Astragalus membranaceus is used heavily to replenish qi and raise yang, and promote diuresis and reduce swelling. The four herbs of Astragalus membranaceus, Gentiana scabra, Plantago asiatica, and Clematis armandii are used as the sovereign herbs, complementing each other. With the effect of Astragalus membranaceus in replenishing qi and raising yang, the qi transformation of the bladder can be regulated, strengthening the effects of the other three herbs in clearing heat and promoting diuresis, promoting diuresis and relieving stranguria, and also promoting diuresis and reducing swelling, so that the accumulated dampness and heat can be quickly excreted through urine.

[0029] 2. The astragalus membranaceus used in the intravesical perfusion pharmaceutical composition of the present invention has the effects of invigorating qi and ascending yang, securing the exterior and stopping sweating, promoting diuresis and alleviating edema, promoting the production of body fluid and nourishing blood, activating qi and dredging collaterals, expelling pus by supporting healthy qi; gentiana scabra has the effects of antibacterial, anti-inflammatory, analgesic, and improving immune regulation; plantago asiatica has the effects of clearing heat and promoting diuresis, cooling blood, and detoxifying; akebia quinata has the effects of clearing the heart and relieving restlessness, and promoting diuresis and relieving stranguria; notoginseng has the effects of promoting blood circulation to remove stasis, reducing swelling and alleviating pain, and stopping bleeding; angelica sinensis has the effects of enriching and nourishing blood, promoting blood circulation to remove stasis and relieve pain, moistening the intestines and relaxing bowel movements, and warming the channels and dispelling cold; Dioscorea opposita has the effects of treating symptoms such as frequent urination and leukorrhea. Under the mutual influence and synergistic effect of each raw material of the intravesical perfusion pharmaceutical composition of the present invention, it can achieve good antibacterial and anti-inflammatory effects, promote diuresis and relieve stranguria, relieve pain and stop bleeding, promote diuresis and alleviate edema, promote blood circulation to remove stasis, and expel pus by supporting healthy qi. It is completely non-irritating, the preparation method is simple, easy to control, and convenient to use, reducing the complications of patients during and after the examination, alleviating the symptoms of pain, frequent urination, urgency, hematuria, etc. of patients, reducing the medical expenses of patients, and improving the comfort and satisfaction of patients.

[0030] 3. The present invention provides a urokinetic examination bladder perfusion fluid for preventing infection, stopping bleeding, relieving pain, being non-irritating, safe and without side effects during urokinetic invasive examinations. Clinical experiments have proved that the present invention has the effects of hemostasis, antibacterial, analgesic, and anti-bladder spasm, is non-toxic, non-irritating, and non-allergic to the human body, reduces the use of antibiotics, and reduces the discomfort of patients during the examination. Detailed implementation manners

[0031] The following combines the embodiments of the present invention, and uses preferred embodiments and data to cooperate with a detailed description to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the protection scope of the present invention.

[0032] It should be noted that all the professional terms used in the present invention are only for the purpose of describing specific embodiments, and are not intended to limit the protection scope of the present invention. Unless otherwise specifically stated, various raw materials, reagents, instruments, and equipment used in the following embodiments of the present invention can be obtained through market purchase or prepared by existing methods.

[0033] Example 1

[0034] A preparation method of a urokinetic examination bladder perfusion fluid includes the following steps:

[0035] (1) Wash 15 g of astragalus membranaceus, 12 g of gentiana scabra, 12 g of plantago asiatica, 6 g of akebia quinata, 15 g of angelica sinensis, 9 g of notoginseng, and 12 g of Dioscorea opposita, and pulverize them into coarse powder of 60 meshes;

[0036] (2) Add water with a weight 9 times that of the raw medicinal materials, collect the distillate by steam distillation method, and subject the distillate to double distillation to obtain the rectified distillate for standby;

[0037] (3) Add water with a weight 9 times that of the medicinal residues after distillation to the medicinal residues, boil and decoct for 2 times, each time for 1.5 hours, filter, combine the filtrates of the two times, and concentrate the filtrate;

[0038] (4) Slowly add ethanol to the filtrate under stirring until the ethanol content reaches more than 60%, let it stand for precipitation and filtration, recover the ethanol from the filtrate, and concentrate. Then add ethanol again until the ethanol content reaches more than 80%, let it stand for precipitation and filtration, recover the ethanol from the filtrate until it is exhausted, adjust the pH to 7.0, refrigerate at 0°C, and let it stand for filtration;

[0039] (5) Add 2 g of povidone iodine and 2 g of tween 80 to the filtrate, mix evenly, adjust the pH to 7.0, refrigerate for 24 hours, centrifuge with a centrifuge, take the supernatant, add the above-mentioned rectified distillate, mix evenly, add injection water and then ultrafilter;

[0040] (6) Fill and seal under dust-free and aseptic conditions, sterilize with flowing steam at 100°C for 30 minutes, and package.

[0041] Example 2

[0042] A preparation method of a bladder perfusion fluid for urodynamic examination, comprising the following steps:

[0043] (1) Clean 14 g of raw astragalus membranaceus, 11 g of gentiana scabra, 11 g of plantago asiatica, 5 g of aristolochia manshuriensis, 14 g of angelica sinensis, 8 g of panax notoginseng, and 11 g of Chinese yam, and pulverize them into coarse powder of 60 meshes;

[0044] (2) Add water with a weight 9 times that of the raw medicinal materials, collect the distillate by steam distillation method, and subject the distillate to double distillation to obtain the rectified distillate for standby;

[0045] (3) Add water with a weight 9 times that of the medicinal residues after distillation to the medicinal residues, boil and decoct for 2 times, each time for 1.5 hours, filter, combine the filtrates of the two times, and concentrate the filtrate;

[0046] (4) Slowly add ethanol to the filtrate under stirring until the ethanol content reaches more than 60%, let it stand for precipitation and filtration, recover the ethanol from the filtrate, and concentrate. Then add ethanol again until the ethanol content reaches more than 80%, let it stand for precipitation and filtration, recover the ethanol from the filtrate until it is exhausted, adjust the pH to 7.0, refrigerate at 0°C, and let it stand for filtration;

[0047] (5) Add 2 g of povidone iodine and 2 g of tween 80 to the filtrate, mix evenly, adjust the pH to 7.0, refrigerate for 24 hours, centrifuge with a centrifuge, take the supernatant, add the above-mentioned rectified distillate, mix evenly, add injection water and then ultrafilter;

[0048] (6) Fill and seal under dust-free and aseptic conditions, sterilize with flowing steam at 100 °C for 30 minutes, and then package.

[0049] Example 3

[0050] A method for preparing a bladder perfusion fluid for urodynamic examination, comprising the following steps:

[0051] (1) Wash 16 g of raw Astragalus membranaceus, 13 g of Gentiana scabra, 13 g of Plantago asiatica, 7 g of Clematis armandii, 16 g of Angelica sinensis, 10 g of Panax notoginseng, and 13 g of Dioscorea opposita, and pulverize them into coarse powder of 60 mesh.

[0052] (2) Add water with a weight 9 times that of the raw medicinal materials, collect the distillate by steam distillation method, and subject the distillate to double distillation to obtain a rectified distillate for standby.

[0053] (3) Add water with a weight 9 times that of the medicinal residues after distillation to the medicinal residues, boil and decoct twice, each time for 1.5 hours, filter, combine the two filtrates, and concentrate the filtrate.

[0054] (4) Slowly add ethanol to the filtrate while stirring until the ethanol content reaches more than 60%, let it stand for precipitation and filtration, recover the ethanol from the filtrate, and concentrate it. Then add ethanol again until the ethanol content reaches more than 80%, let it stand for precipitation and filtration, recover the ethanol from the filtrate until it is exhausted, adjust the pH to 7.0, refrigerate at 0 °C, and let it stand for filtration.

[0055] (5) Add 2 g of povidone iodine and 2 g of Tween 80 to the filtrate, mix evenly, adjust the pH to 7.0, refrigerate for 24 hours, centrifuge with a centrifuge, take the supernatant, add the above-mentioned rectified distillate, mix evenly, add injection water and then ultrafilter.

[0056] (6) Fill and seal under dust-free and aseptic conditions, sterilize with flowing steam at 100 °C for 30 minutes, and then package.

[0057] Example 4

[0058] A method for preparing a bladder perfusion fluid for urodynamic examination, comprising the following steps:

[0059] (1) Wash 15 g of raw Astragalus membranaceus,, 12 g of Gentiana scabra, 12 g of Plantago asiatica, 6 g of Clematis armandii, 15 g of Angelica sinensis, 9 g of Panax notoginseng, and 12 g of Dioscorea opposita, and pulverize them into coarse powder of 55 mesh.

[0060] (2) Add water with a weight 8 times that of the raw medicinal materials, collect the distillate by steam distillation method, and subject the distillate to double distillation to obtain a rectified distillate for standby.

[0061] (3) Add water with a weight 8 times that of the medicinal residues after distillation to the medicinal residues, boil and decoct three times, each time for 1 hour, filter, combine the three filtrates, and concentrate the filtrate.

[0062] (4) Slowly add ethanol to the filtrate with stirring until the ethanol content reaches over 60%, let it stand for precipitation and then filter. Recover the ethanol from the filtrate and concentrate it. Then add ethanol again until the ethanol content reaches over 80%, let it stand for precipitation and filter. Recover the ethanol from the filtrate completely, adjust the pH to 6.0, refrigerate at 10°C, and let it stand for filtration;

[0063] (5) Add 3 g of povidone iodine and 3 g of Tween 80 to the filtrate, mix evenly, adjust the pH to 6.0, refrigerate for 24 hours, centrifuge with a centrifuge, take the supernatant, add the above-mentioned rectified liquid, mix evenly, add injection water and then ultrafilter;

[0064] (6) Fill and seal under dust-free and sterile conditions, sterilize in flowing steam at 100°C for 30 minutes, and then package.

[0065] Example 5

[0066] A preparation method of a bladder perfusion solution for urodynamic examination, comprising the following steps:

[0067] (1) Wash 15 g of raw Astragalus membranaceus, 12 g of Gentiana scabra, 12 g of Plantago asiatica, 6 g of Akebia quinata, 15 g of Angelica sinensis, 9 g of Panax notoginseng, and 12 g of Chinese yam, and crush them into coarse powder of 70 meshes;

[0068] (2) Add water with a weight 10 times that of the raw medicinal materials, collect the distillate by steam distillation method, and perform double distillation on the distillate to obtain a rectified liquid for standby;

[0069] (3) Add water with a weight 10 times that of the medicinal residues after distillation to the medicinal residues, boil and decoct for at least 2 times, each time for 2 hours, filter, combine the two filtrates, and concentrate the filtrate;

[0070] (4) Slowly add ethanol to the filtrate with stirring until the ethanol content reaches over 60%, let it stand for precipitation and then filter. Recover the ethanol from the filtrate and concentrate it. Then add ethanol again until the ethanol content reaches over 80%, let it stand for precipitation and filter. Recover the ethanol from the filtrate completely, adjust the pH to 8.0, refrigerate at 5°C, and let it stand for filtration;

[0071] (5) Add 2 g of povidone iodine and 2 g of Tween 80 to the filtrate, mix evenly, adjust the pH to 6.5, refrigerate for 24 hours, centrifuge with a centrifuge, take the supernatant, add the above-mentioned rectified liquid, mix evenly, add injection water and then ultrafilter;

[0072] (6) Fill and seal under dust-free and sterile conditions, sterilize in flowing steam at 100°C for 30 minutes, and then package.

[0073] The physical and chemical indexes of the obtained product meet the requirements of the Pharmacopoeia of the People's Republic of China for irrigation solutions. In the above preparation process, the water replenishment amount in the "ultrafiltration after adding injection water" in step 5 is preferably 3 - 5 g of crude drug content per mL of the final product, but it can also be a concentrated irrigation solution, which is used in combination with injection water or physiological saline before use.

[0074] The beneficial effects of the present invention are fully proven by clinical data as follows. The research drug uses the weight ratio of raw materials and the preparation method in Example 1, and the crude drug content per mL of the final product is 3 - 5 g.

[0075] Clinical tests

[0076] The bladder perfusion solution prepared in Example 1 was applied to patients during the examination, and the application data are as follows:

[0077] Example 1

[0078] Female patient, 54 years old, with frequent urination and urgency for more than half a year. Diagnosis: OAB and urge incontinence. The bladder was perfused with the perfusion solution during urodynamic examination. During the examination, it was perfused into the bladder at a speed of 30 mL / s by the pumping method. Approximately 500 mL of liquid was used for the examination, and it took about 36 minutes. During the examination, the patient had no symptoms such as pain or bleeding. During the 3-day follow-up after the examination, the patient urinated smoothly and had no discomfort symptoms such as dysuria, urethralgia, or hematuria.

[0079] Example 2

[0080] Male patient, 61 years old, with prostate hyperplasia. The bladder was perfused with the perfusion solution during urodynamic examination. The patient had pain and a small amount of bleeding during intubation. During the examination, it was perfused into the bladder at a speed of 20 mL / s by the pumping method. Approximately 660 mL of liquid was used for the examination, and it took about 51 minutes. Twenty minutes after the perfusion solution entered the bladder, the patient reported that the pain was relieved and the bleeding was observed to decrease. Five hours after the examination, the patient reported that the pain had improved and there was no gross hematuria. During the 4-day follow-up after the examination, the urine routine examination showed no infection or hematuria.

[0081] Example 3

[0082] Female patient, 48 years old, with stress urinary incontinence. The bladder was perfused with the perfusion solution during urodynamic examination. The patient had pain and discomfort during intubation and no bleeding. During the examination, it was perfused into the bladder at a speed of 50 mL / s by the pumping method. Approximately 700 mL of liquid was used for the examination, and it took about 59 minutes. Ten minutes after the perfusion solution entered the bladder, the patient reported that the pain had improved and there was no gross hematuria. During the 2-day follow-up after the examination, the urine routine examination showed normal results, no infection, no hematuria, and the patient reported no frequent urination, urgency, or urethralgia and urinated smoothly.

[0083] Example 4

[0084] Male patient, 45 years old, with neurogenic bladder, underwent urodynamic examination with bladder perfusion fluid. During intubation, the patient experienced pain and a small amount of bleeding. During the examination, the fluid was pumped into the bladder at a speed of 30 mL / s. Approximately 330 mL of fluid was used for the examination, and it took about 35 minutes. Twenty minutes after the perfusion fluid entered the bladder, the patient reported that the pain had decreased, and no bleeding was observed. Five hours after the examination, the patient reported that the pain had improved, and no gross hematuria was observed. During the 4-day follow-up after the examination, there was no frequency, urgency, pain during urination, and the urine routine examination showed no infection or hematuria.

[0085] Case 5

[0086] Male patient, 45 years old, with lower urinary tract obstruction, underwent urodynamic examination with bladder perfusion fluid. During intubation, the patient experienced pain but no bleeding. During the examination, the fluid was pumped into the bladder at a speed of 40 mL / s. Approximately 430 mL of fluid was used for the examination, and it took about 45 minutes. Fifteen minutes after the perfusion fluid entered the bladder, the patient reported that the pain had decreased, and no bleeding was observed. Three hours after the examination, the patient reported that the pain had improved, and no gross hematuria was observed. During the 5-day follow-up after the examination, there was no frequency, urgency, pain during urination, and the urine routine examination showed no infection or hematuria.

[0087] In summary, the perfusion fluid provided by the present invention can be used as a medium for urodynamic bladder perfusion fluid and can simultaneously eliminate foreign substances such as blood clots, mucus, and bacteria in the bladder, preventing infection, bleeding, frequency, pain during urination, and dysuria. Astragalus membranaceus used in the bladder perfusion pharmaceutical composition of the present invention has the effects of invigorating qi and ascending yang, consolidating the exterior and stopping sweating, promoting diuresis and alleviating edema, promoting fluid production and nourishing blood, promoting qi circulation and dredging collaterals, and expelling pus by supporting healthy qi; Gentiana scabra has the effects of antibacterial, anti-inflammatory, analgesic, and improving immune regulation; Plantago asiatica has the effects of clearing heat and promoting diuresis, cooling blood, and detoxifying; Caulis Lignan has the effects of clearing the heart and relieving restlessness, and promoting diuresis and relieving stranguria; Angelica sinensis has the effects of enriching blood and nourishing, promoting blood circulation and removing blood stasis to relieve pain, moistening the intestines and promoting defecation, and warming the meridians and dispelling cold; Panax notoginseng has the effects of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, and stopping bleeding; Dioscorea opposita has the effects of treating symptoms such as frequency of urination and leukorrhea. Under the mutual influence and synergistic effect of each raw material in the bladder perfusion pharmaceutical composition of the present invention, it can achieve good antibacterial and anti-inflammatory, diuretic and stranguria-relieving, pain-relieving and bleeding-stopping, diuretic and edema-relieving, blood-activating and stasis-removing, and pus-expelling and toxin-removing effects, is completely non-irritating, has a simple preparation method, is easy to control, and is also convenient to use, reducing the complications of patients during and after the examination, alleviating the symptoms of pain, frequency, urgency, and hematuria of patients, reducing the medical expenses of patients, and improving the comfort and satisfaction of patients.

[0088] It should be noted that when the present invention involves numerical ranges, it should be understood that both endpoints of each numerical range and any value between the two endpoints can be selected. Since the steps and methods adopted are the same as those in the embodiments, in order to prevent redundancy, the present invention describes preferred embodiments. Although the preferred embodiments of the present invention have been described, those skilled in the art can make additional changes and modifications to these embodiments once they know the basic creative concept. Therefore, the appended claims are intended to be construed as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.

[0089] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention is also intended to include these modifications and variations.

Claims

1. A pharmaceutical composition for bladder instillation for urodynamic examination, characterized in that: The bladder instillation pharmaceutical composition comprises the following raw materials in parts by weight: 14-16 parts of astragalus, 11-13 parts of gentian, 11-13 parts of plantain, 5-7 parts of chuanxiong, 14-16 parts of angelica, 8-10 parts of panax notoginseng and 11-13 parts of yam.

2. The pharmaceutical composition for bladder instillation for urodynamic examination according to claim 1, characterized in that: The bladder instillation pharmaceutical composition comprises the following raw materials in parts by weight: 15 parts of astragalus, 12 parts of gentian, 12 parts of plantain, 6 parts of chuanxiong, 15 parts of angelica, 9 parts of panax notoginseng and 12 parts of yam.

3. The pharmaceutical composition for bladder instillation for urodynamic examination according to claim 1 or 2, characterized in that: The composition is prepared as a bladder irrigation solution for urodynamic examination.

4. A method for preparing the pharmaceutical composition for bladder instillation for urodynamic examination according to claim 3, characterized in that: The method for preparing bladder instillation solution for urodynamic examination comprises the following steps: Weigh the following raw materials in parts by weight: 14-16 parts of astragalus, 11-13 parts of gentian, 11-13 parts of plantain, 5-7 parts of chuanketong, 14-16 parts of angelica, 8-10 parts of panax notoginseng and 11-13 parts of yam, wash and crush the raw materials into powder; Add 8 to 10 times the weight of water to the powdered raw material, collect the distillate by steam distillation, and redistillate the distillate to obtain a rectified liquid for use; Add 8 to 10 times the amount of water to the raw drug residue after redistillation, boil twice or more, filter, combine the filtrate, and then concentrate the filtrate; Add ethanol to the concentrated filtrate until the alcohol content reaches more than 60%, let it stand for precipitation and filter, recover ethanol from the filtrate, and concentrate, then add ethanol to the filtrate until the alcohol content reaches more than 80%, let it stand for precipitation and filter, recover ethanol from the filtrate until all the ethanol is exhausted, adjust the pH, refrigerate and let it stand for filtration; Add povidone iodine and Tween 80 to the filtrate after refrigeration and static filtration, mix evenly, adjust the pH to 6.0-7.0, centrifuge after refrigeration, take the supernatant, add the distilled liquid, mix evenly, and ultrafilter; The ultrafiltrate is sterilized to obtain the bladder instillation fluid for urodynamic examination.

5. The method for preparing the pharmaceutical composition for bladder instillation for urodynamic examination according to claim 4, characterized in that: The mesh size of the powder is 55 to 70 mesh.

6. The method for preparing the pharmaceutical composition for bladder instillation for urodynamic examination according to claim 4, characterized in that: Each boiling time is 1 to 2 hours.

7. The method for preparing the pharmaceutical composition for bladder instillation for urodynamic examination according to claim 4, characterized in that: The pH is adjusted to 6.0-8.0 and the refrigerated temperature is 0-10°C.

8. The method for preparing the pharmaceutical composition for bladder instillation for urodynamic examination according to claim 4, characterized in that: The sterilization method is 100°C circulating steam sterilization, and the sterilization time is 30 minutes.

9. The method for preparing the pharmaceutical composition for bladder instillation for urodynamic examination according to claim 4, characterized in that: Before adding povidone iodine and Tween 80 to the filtrate, add activated carbon with a mass fraction of 0.5% of the filtrate, stir and heat until boiling, and filter to remove the activated carbon until it is clear.

10. Use of the bladder instillation pharmaceutical composition according to claim 1 or 2 in preparing bladder instillation solution for urodynamic examination.