TWI351970B - Long-acting chinese medicine formula reduce inflam - Google Patents

Description

VI. Description of the Invention: [Technical Field] The present invention is a novel Chinese medicine preparation using modern dosage form manufacturing technology, and such a liniment, a poor agent, an emulsion and a patch can clinically reduce itching, redness, etc. The probability of drug moles appearing. These blankets are traditionally used in the treatment of blood stasis, or in the gynecological delivery of menstrual pain, the Transkinetic Absorption (Trans_dermalabs i〇n) dosage form. [Prior Art] In the typical climate of Taiwan and the southeast coast of the mainland, there are winds, colds, heat, dampness, dryness, fire, etc., which are enough to cause dampness, heat and phlegm. Anyone in the world is often affected by the seven emotions of joy, anger, worry, thought, sorrow, fear, and shock, leading to blood stasis, liver and kidney deficiency and other diseases. However, whether it is due to exogenous wetness = cold or (four) 'long-term induced qi and blood in the human body, the muscles are not harmonious, ^ ^ 搔 pain, or lining pain 'qing pain, both with so-called muscle strain, injury, Inflammation, soreness, gout and other diseases. ί often look forward to the use of traditional Chinese medicine prescriptions to rule 2 is forced by modern people when riding time limit no money slow can not talk about whether the medicine is authentic. What's more, Chinese medicine prescriptions are used in medicine. J Youguang (4), or need to pay attention to. For example, Ruyi Golden Powder is an external agent used in traditional Chinese medicine for the appropriate amount of treatment, for the treatment of two, stop-like impurities. On prescription, such as m 3, there are Tiannanxing, Big Page, Cangshu, etc. The herbs need to be processed. Atractylodes sinensis 64 g powder 320 g, Baiding 160 g, rhubarb 160 g, turmeric (10) g, Astragalus licorice 64 g, Magnolia 64 g, tangerine peel 64 g , 生天^ ^柏药/^, in the clinically desirable golden scattered in the skin ulceration damage at the time of the risk of damage. When using this gauze to apply this powder, the loose ^ lead to the loss of the private powder scattering effect, and not fully dry The shortcomings of the medicinal herbs. Sword, in preparation, ρί-face, dog traditional Chinese medicine patch mostly used to travel glue lion to adhere to the injury caused by the injury = a considerable degree of danger to the body. In addition, in the process of making benzene solvent, it is often the cause of pollution in the drying process, and it is also the cause of the air around the factory of the media. In addition to the traditional Chinese medicine trauma, the use of powder, Ruyi Golden Powder, a change of two cited = pain to relieve pain and swelling. Because the skeletal joint system's orthopedics, rehabilitation, and pain department outpatient diseases, drugs, sprays: sticks, medicine ί for a kind of thin pain or relieve swelling and pain, often use creamy, also accept this The patient is based on the combination of the effect and the recipe of Xuxiang single-flavored medicine. However, it is not necessary to simply combine several herbs to form a proper prescription to distinguish syndromes. According to each therapy, the selection, the party _ reduction _ syndrome =, '3 ^; ^ ' = ^ 'medicine" and other parts of the diagnosis of the Chinese medicine theory dialectical = its agent. The current system & surgery ^ ^ ^ = according to the correct prescription of the prescription, first of all to apply some good agents for the use of ff agent in the use of the drug; even the prescription of the prescription to reduce the side effects of the patient's authentic medicinal herbs, according to Zhao disease is combined with syndrome differentiation and treatment, and the appropriate dosage form is selected. "When the test is appropriate, the single-flavored medicinal material of the prescription is suitable for the accumulation of the experience of the times, and the pills with the curative effect are f*dan, and modern is the service." Modern dosage forms such as concentrates, lozenges, granules, sacs, liniments, emulsions and patches. The diagnosis and treatment of the second shots relies on the transfer of bribes to alleviate the symptoms = the body achieves the goal of treating diseases, so take Decoction of decoction in order to achieve greater efficacy. However, the traditional decoction dosage form is not only difficult to carry and easy to carry, but also has long-term storage problems. Therefore, it is in the pill, scattered, cream, Dan, Wine, dew, ingots, gums, teas, sputums, and creams can make up for some of the missing forms. (4) The scent of granules, granules, capsules, sugars, liniments, emulsions, and drugs, using Western pharmaceutical technology Make it more convenient to carry, administer, and dose This study has such characteristics. The primary object of the present invention is to disclose the formulation technology of some modern dosage forms, and to use the powder for external use for a long time to prepare a modern preparation dosage form which is convenient to carry. The present invention particularly emphasizes the hydrophilic patch. The hydrophilic patch is less toxic to human skin. The hydrophilic patch is formulated with Ruyi Golden Paste and Acrylic Resin and Fiber g to form a slow-mixing __ type. Guanli Lion and _ acceptable The objects and advantages of the present invention will be apparent from the following description of the preferred embodiments illustrated in the accompanying drawings. This application is to change the Chinese ancient external powder into its rubbing agent (medicated lotion), ointment, and patch (see Examples 9, 10, 11, 12, 13). In the prescription, it still includes traditional Glue resin, rosin, zinc oxide, winter green oil', sesame oil. 2. This application also improves the Chinese ancient prescription powder for the purpose of the golden powder, improved into its rubbing agent (including drug lotion), hydrophilic cream And the patch (see Example U) The agent (medicated lotion) does not contain the resin. 3. The hydrophilic paste and patch of the present application prove to have the functions of relieving pain and swelling. 4. The hydrophilic paste and paste of the present application The agent has been proven to reduce the irritation of Shengnanxing. 5. The hydrophilic patch has been clinically proven to have a sustained analgesic effect, and its action can last for more than 12 hours. 6. The hydrophilic paste and patch of the present application have been proved and The drug-free sputum reaction, the local itching and redness, is different from the rubber-containing resin-based drug patch. 7. The storage of the hydrophilic paste and the patch of the present application proves that there is no moldy phenomenon, which is different from If the golden sugar is not stored properly, it should be placed in the refrigerator after adjustment. 8. The alcohol contained in the hydrophilic paste and patch of this application can be gradually volatilized in hot air drying and storage, but does not affect the efficacy. The Chinese medicine patch contains an acrylic resin and a cellulose derivative (see Examples 1 to 8), and is absolutely free of the solvent or the toluene of the solvent used for the rubber resin. 10. The hydrophilic Chinese medicine patch contains an acrylic resin and a cellulose derivative (see Examples 1 to 8), and the solvent used for the rubber resin is never used in the production process. Description of the invention The traditional Chinese medicine is used to relieve the symptoms, regulate or rehabilitate the body. Because of the six cockroaches, the 3 疋 moxibustion cans can reduce the swelling and relieve pain. Section, or ΐίϊΙ, Γ赫 and other illnesses, may be caused by exogenous heat and cold, induced by the body == no pain = soreness, _, convincing abdominal pain, menstrual pain, to remove the patient for each pain or relief Accept this type of medication disposal. Because of the material, Lang has a curative effect of the prescription, choose Chinese medicine or transport ‘good 2==遽, concentrated, make a high content of ointment, drug patch. The method of rubber patch preparation is made of hydrophilic and safe. The powder used outside the traumatology department, Ruyi Golden Powder is a traditional Chinese medicine containing Tianhua powder, which is analgesic and swelling. And the medical sects of the golden collection of the peach red four things Ding Ganren family pass Zhenfang pain. Medicine and incense are used for symptomatic delay, menstrual pain and other symptoms. Salvia miltiorrhiza var. var. var. var. var. var. var. var. var. var. var. var. var. medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal medicinal Swelling and pain. This kind of prescriptions = indeed, the compatibility of the towels with the flavors of the early flavors, it is inevitable that some of the effects are not completely clear 1 Chinese Physician's point of view, the party is a cool prescription, so the birth of π (four) chicks = enough ancient, this study 463 one hundred feet still join as ίί yellow Ϊ (People's Republic of China Pharmacopoeia, _ edition, a contained gold version ^ ^ ^ ^ Department of North China Cuba traumatology powders for 'gold Kam Kee (Qing Dynasty' author: Wu Qian), Vol. Upper, surgical sputum application g records are recorded in the following 1G kinds of traditional Chinese medicine village smashed into fine powder, evenly paid. The powder is some yellow to golden yellow powder, gas slightly fragrant, smallpox powder 320g, white full 160g, rhubarb 160g, turmeric 16〇g, cork l6〇g, licorice 64g, magnolia 64g, dried tangerine peel 64g, raw Tiannanxing 64g, 苍jjt 64g. The modern preparation dosage form of traditional Chinese medicine prepared by the invention will be selected by using traditional Chinese medicine deionized water. The method of extraction is carried out, and the extract is reduced by a fine amount to reduce the water content, and the appropriate amount of the tree is added (including rubber resin and pressed 1351970, tree, cellulose, zinc oxide as excipients) or additional rosin , winter green oil (including 11 ^ 1 called 8 汕 (^13 Menthol (5%) is a cooling agent. If necessary, add an appropriate amount of Benadryl (Diphenhydmmine) itch agent. The so-called traditional Chinese medicine preparation of the present invention refers to the use of modern dosage forms, and the surgery will contain Trichosanthin Chinese medicine prescription, made into a liniment, ointment, patch, medicated lotion and emulsion. These dosage forms are prepared by applying the auxiliary agent, the adhesive and the excipient after the uniform preparation according to the conventional preparation method. Machine and dryer, the ointment is smeared on the cellophane and pressed with non-woven fabric or release paper to make a hydrophilic Chinese medicine ointment, a liniment (medicine lotion) and a patch. Adding auxiliaries, bonding The ingredients and excipients are all available in the traditional ingredients. The ratio of the 10 kinds of traditional Chinese medicine ingredients is fixed. It is not fixed by additives, binders and Φ excipients. However, it can be seen that the ship-based system calls the role of the lesser-born Tiannanxing. The so-called vegetable oil ester refers to the saturated or unsaturated medicinal vegetable oils with carbon number below 20, such as soybean oil and sesame oil. Cellulose, may include hydroxyethyl fibers (hydroxy ethylcellul〇se), hydroxy propyl cellulose, ethyl edlul ()Se, carboxyl methyl eellulose sodium. The above s stomach acrylic resin It may include acrylic resin, and polyacrynamide and its esterified product containing methyl, ethyl, propyl, isopropyl and butyl. The invention firstly uses acrylic resin and fiber. It is made into a long-acting analgesic = sexual Chinese medicine patch, that is, a wishful golden patch. The hydrophilic patch is a sustained-release transdermal absorption type formulated by using Ruyijin plaster, that is, acrylic resin and cellulose. This long-acting analgesic effect has been clinically proven. The hydrophilic Chinese medicine patch is obtained by extracting the Chinese medicine component with water. The method and the method are different from the conventional method of mixing the powder with the rubber powder. The conventional method is not extracted, and when the Chinese medicinal material powder is mixed with the rubber resin or the Chinese medicinal material powder is directly coated, it is 'effectively released' and thus cannot fully produce the medicinal effect. Generally, the patch made of rubber does not meet water. But the patch made of acrylic acid resin in this study is hydrophilic, and it can be removed from the coffee using 9 1351970 points, which is harmless and Fang = according to the disappearable j = two moving stars: the actual test two = the system is suitable for long-term hydrophilic Chinese medicine patch technology difficulty is the method of plant extraction 'refers to the general extraction of herbs or Hi, supercritical : carbon oxide extraction method, volatile solution or stone column separation method (charcoal column separation ΪΓ \. Because ί in the extraction process, it is selected from water, or a small amount of ethanol (Ethanol) for the mixed solvent system And ^ = type (S. running) extraction device, or extraction equipment == catching hot air, and decompression to remove ethanol. ... f invention patch 'in the manufacturing process must roll J 〇 ^ ii said skin red On the side, it is required to be harmless, and even requires hydrophilicity. It is technically located. 2 and 4 of the present invention are related to water, in the fineness of traditional Chinese medicine: the rubbing agent or the ir agent day 2: amount = other symptoms In order to promote the circulation of blood and slow down the soreness of the disease. Ruyi golden; will: = such as; S and the emergence of drug lotion, so It is a new product, with the preparation of its tincture and medicated lotion. It will take 2 ft rides, and it will be placed on the second floor of the crane plus coins. It will be filtered after j hours of drawing, concentrated under reduced pressure, and cooled. Add appropriate amount of alcohol, > 専荷脑's and sheep are all after the sentence transition, and add wintergreen oil (including coffee (4) 10 1351970 sf^ylate) 'If necessary, add vegetable oil to the total of 2 peaks. Bone agent and Preparation and coating of patches

H warm will be prescribed Chinese herbal medicines, one by one, and placed in a stainless steel two-layer pot for 2 hours, filtered under reduced pressure and concentrated under reduced pressure. After the concentrated solution is cooled, add alcohol, menthol, cellulose, acrylic Resin, add vegetable oil to M g, stir evenly, place it in the coating facility of Kaowang Enterprise Co., Ltd. (Kaohsiung), transfer to the coater by roller, and then evenly spread the ointment on cellophane. In the dryer, the aqueous alcohol is removed by high-speed hot air, dried and concentrated, and then covered with a non-woven fabric, and the roller is pressed to make a medicinal paste containing the medicinal paste, or a burn patch, and the thickness is 〇2 coffee. Finally, cut it into different areas, such as the Golden Patch, finished or burned patch. [Embodiment] The present invention is a liniment and ointment containing traditional Chinese medicine of trichosanthin, considering the ancient classics = containing: t- possessing toxicity or taking care of the medicinal materials, it is necessary to avoid the processing and fun, and must pay attention to whether the symptoms of the patient are yin deficiency, Loss of filial piety and so on. Therefore, the treatment will be bloated, erysipelas, love hurt, fall and fall damage, and have some facial, detoxification, and pain relief, including some traditional Chinese medicines. For example, (4) People’s Republic,

In the 2000 edition, one (463 pages, Chemical Industry Press, Beijing) will be the medical medicinal gold, the volume, the surgical swelling of the prescriptions such as Ruyi Golden Powder, and the use of modern pillings to indicate the content of 10 Chinese herbal medicines. The prescription contains herbs such as Araceae, which need to be processed. f Trichosanthin 320 g, Baiding 160 g, Rhubarb 16〇 g, turmeric 16〇 g, Phellodendron 16〇g, licorice 64g, Magnolia 64g, dried tangerine peel 64g, Shengtiannanxing 64g, Atractylodes 64g. In the total amount of 1280g of medicinal materials, the amount of araceae is 64 § 5%, due to the birth of the celestial celestial star Tiannan Xinglong Tiannanxing (Arisaema &

Sc_ and dry tubers of the same relatives. The most common poison of fresh products, including the stimulation of the skin and _, can cause swelling and pain in the chest, and even cause swelling of the throat, difficulty breathing or stimulating the gastrointestinal mucosa causing nausea, vomiting, abdominal pain, severe poisoning. Death due to suffocation. Therefore, Shengna Nanxing must be removed from the stimulating substance of paralysis by 11 1351970 to become the Tiannan star. The medicinal golden powder recorded in the medical medicinal Jinjian is used in the powder of the wounded department, but it is directly formulated with Shengtian Nanxing Ruyi Golden Rubbing and medicated lotion. 150 g of white powder, 75 g of white peony, 75 g of rhubarb, 75 g of turmeric , Cork 75 g, Licorice 25 g, Magnolia 25 g, dried tangerine peel 25 g, Shengtiannanxing 25 g, ^ 25 g and water 790 g were placed in a stainless steel two-layer pot and heated for 2 hours, extracted, filtered, and concentrated under reduced pressure. After cooling, add 23 〇g of alcohol and 1 〇〇g of menthol. After stirring, filter and then add 'winter green oil (including methyl salicyIaie). 2 〇 & must = add vegetable oil to a total amount of 2 kg. ─ Preparation and coating of Ruyi Golden Paste and Patch

150 g of Tianhua powder, 75 g of white peony, 75 g of rhubarb, 75 g of turmeric, 75 g of turmeric, 25 g of licorice, 25 g of licorice, 25 g of magnolia, 25 g of dried tangerine peel, 25 g of raw celestial granules, 25 g of water and 575 g of water are placed in the second layer of non-recorded steel. After 2 hours of Fo Teng, the shoulders were filtered and concentrated under reduced pressure. After the concentrate was cooled, add 25 酒精$, 3 〇〇g, 1250 g of cellulose, 2750 g of acrylic resin, and add vegetable oil to 6k. After being evenly placed in the coating facility of the assisting Wang Enterprise # Co., Ltd. (Kaohsiung), the woven machine will be evenly coated on the cellophane, and the high temperature hot air will be used to remove the aqueous alcohol. Dry and concentrated, then cover with no knot f, add •, make a medicinal f of the Xin Li Ruyi stickers (Sinlix (four)

The thickness is α2 mm. Finally, cut it into different areas, women's golden patches, finished products or burn patches. Other Extensible Examples Pharmacological Experiments f: Males with a weight of about 120 to 130 grams in 4-6 weeks. Male rats were further divided into 4 groups and kept in an air-conditioned room at room temperature maintained at 22 ± 3. Hey, let it/free drink and feed with chicken feed. In addition, the weight of about 2 〇 ~ 25 gram of it is not divided, let it freely drink water, also feed with chicken feed. First, the use of music and herbs: 1. 1 / 〇 w / v carrageenan (carrageenan) also known as carrageenan 12 1351970 (Sigma Chemical Co. USA) powder 100 mg plus physiological saline 1 , prepared before the experiment. In the experiment, the rats were injected subcutaneously for 5 days under the left hind leg of the rats, so as not to cause injury. 2. Ruyi Golden Rubbing (medicine lotion) · Main: For. Tianhuan, Baiyou, Rhubarb, Turmeric, Phellodendron, Licorice, Magnolia, Chenpi, Shengtiannanxing, Atractylodes, Menthol, Alcohol, Vegetable Oils and fatty acid. 3. Ruyi Golden Ointment The main ingredients are. Trichosanthin, Angelica, Rhubarb, Turmeric, Phellodendron, Licorice, Magnolia, Chenpi, Shengtiannanxing, Atractylodes, Menthol, Alcohol, Cellulose, Resin, Vegetable Oils and Fatty Acids. φ 4. If the wishful golden powder is processed and the raw Tiannanxing is not processed, the Ruyi Golden Powder will be divided into two groups: the non-alcoholic, menthol and resin paste solution (100mg/kg), via the mouse. Intraperitoneal injection, or made into an aqueous solution of an ointment (5%), dripped into the eyes of mice. Tiannan, the non-command group refers to Ruyi Golden Powder, Shengtian Nanxing is first extracted with alcohol, then dried at room temperature under reduced pressure, and then added to other ingredients that have been processed to form a golden color. 5. Preparation of patch: 150 g of trichosanthin, 75 g of white peony, 75 g of rhubarb, 75 g of turmeric, 75 g of phellodendron, 25 g of licorice, 25 g of licorice, 25 g of dried magnolia, 25 g of dried tangerine peel, 25 g of raw celestial star, 25 g of celestial genus And water 575 g was placed in a stainless steel two-layer pot and heated to boil for 2 hours, filtered under reduced pressure and concentrated under reduced pressure. After the concentrated liquid was cooled, 250 g of alcohol, 3 〇〇g of menthol, 1250 g of cellulose, acrylic resin were added. 2750g, add vegetable oil to 6k and pass the county evenly. g 6·SinlixRuyiPatch coating ^ Will Ruyi Golden Cream, using the coating of the company (Kaohsiung), the roller is transferred to the coater, and then the cream is evenly coated On the cellophane', the aqueous alcohol is removed by high-speed hot air on the dryer and dried and concentrated. Then, it is covered with a non-woven fabric, and the roller is pressed to make a medicinal paste. (Sin丨ixRuyi 13

Patch) or burn patch, thickness 〇 2 mm. Finally, cut it into a golden patch of different sizes. 3. Experimental Instruments: 1. The swell tester (7150, Plethysmometer, UGO, Basile, Italy) was used to measure the swelling coefficient of the left hind limb after normal rats and after carrageenan injection. 2. The pain valve was measured using a white mouse tail tester (736〇, Tail Hk^k, UGO, Basile, Italy) to determine the use of infrared rays in rats under normal conditions and after injection of carrageenan. A pain valve that causes heat pain in the left hind leg and causes a contraction in the hind leg. IV. Experimental methods and grouping: Lu entrusted Kaohsiung Medical University and affiliated hospitals to conduct animal tests and clinical trials for swelling, pain relief, abdominal pain and eyelids. The acute inflammatory reaction of the hind limbs of the white rats used in the animal experiment is carried out according to the method of carragenan induced by Winter CA. et al. in 1962 (plus c, 111, 544-547, 1962.) One group of male rats was injected with carrageenan on the left hind paw to induce an acute inflammatory reaction. The papers of this study will be published separately in academic journals. 1. Swelling control group: Before the carrageenan injection, and 4 hours after the injection, the swelling coefficient before the injection (CSB, Swelling bef〇re coffee (4) and / after the main shot of the swelling coefficient (CSA) , Swelling by control group after injection), the difference between the two is the swelling rate cSR = [ (CSACSB) / CSB] xl 〇〇〇 / 〇〇 2. Pain control group: y carrageen (carrageen fat) before injection, The pain valve (cp.) before injection was measured 1 hour after injection and 4 hours after injection, respectively. After the injection, the width of the hour (CP1) and the pain of 4 hours after the injection (cp4) were reduced. CPi was the valve difference ( CPD) 'CPd if negative value indicates increased pain sensation, positive value 14 1351970 3. Ruyi golden rubbing swelling group: carrageenan pre-injection test swelling coefficient (lsb. Swelling by Liniment before injection), injection i Apply an gram after an hour. Rub the agent on the left hind leg of the foot, and then measure the swelling system (lsa, Swelling by Liniment after injection), and then find the swelling rate LSR = [ (LSA-LSB) / LSB]xl00°/〇. 4. Ruyi Golden Rubbing Analgesic Group: Antlers Glucose (carrageenan) before the injection of pain detection np), sputum shot 0 hours and then measure the pain side (LPl), followed by ^ ((lg;) holding = left hind limb foot, 4 hours after injection Retest - pain valve (Lp). Milk reduction! ^ can get pain valve difference (LPd). ^ · 5. Ruyi golden cream swelling group: Carrageenan (carrageenan) before injection test swelling coefficient (PSB, Swelling By plaster (ointment) before injection), one gram of ointment 1 gram after injection (lg) on the sole of the left hind limb, and then measured the swelling coefficient (PSA, Swelling by plaster•...intment;) after injection ), and then find the swelling rate PSR = [ (PSA_psB) / pSB] xl (nine)%]. 6. Ruyi Golden Cream Analgesic Group: Determination of pain valve (pp) before carrageenan injection, i-hour after injection - pain valve (4), then wipe (() g): · shot carrageenan ( Carrageenan) The foot of the foot, and then the pain valve (PP4) 〇PP4 minus PP] is the pain valve difference (PPd) 4 hours after the injection. 7. Ruyi Golden Cream's Abdominal Pain Experiment divides Ruyi Golden Powder into two groups, which are processed and made into a non-alcoholic, menthol and resin paste solution (8), dissolved in 0.3 ml of water, via a mouse. Intraperitoneal injection, the number of abdominal pain (writhing syndrome) was recorded and observed for 6 minutes. 8. Ruyi Golden Cream's Blinking Experiment divides Ruyi Golden Cream into two groups, which are processed and produced by Tiannanxing. Each of them is made into an aqueous solution (5%) containing no alcohol, menthol and resin, and drops into the eyes of mice. 1351970 Record the number of blinks in both hands and observe for 60 minutes. 9. Clinical trial of SinlixRuyiPatch. In the Affiliated Hospital of Shangxiong Medical University, 4 clinical patients with painful appeals were collected. From June 1st to July 30th, according to the painful part of the patient, Xinli was attached. (SinlixRuyiPatch), but not given other analgesics. In order to observe the long-term analgesic effect of the patch, the patient applied 12 to 24 hours before bathing. The removal of the patch and the residue on the skin is done with the help of bath water. Pharmacological effect of swelling test results The swelling coefficient of the control group before injection of carrageenan (CSB) was 1.1〇±〇.〇4, and the swelling coefficient (CSA) after carrageenan injection was 1.53±0.06 (Figure) 1A), its swelling rate (CSr) is about 6% of soil (Figure 1B). The swelling coefficient (LSB) of the rubbing agent before carrageenan injection was 1.02 soil 0.08 'swelling coefficient after rubbing was eight) 1.31±〇.〇9 (Fig. 1A) 'The swelling rate (LSR) was about It is 0.11% for 30 士 (Fig. iB). The swelling coefficient (PSB) of the ointment before injection of carrageenan was 1.〇2±〇.〇9, and the swelling coefficient (PSA) after application was 1.19±〇·12 (Fig. 1A), and its swelling rate (psr) It is about 17±0.14% (Fig. 1Β). The swelling effect of the application is remarkable, LSR < CSR (tw〇 way ANOVA test; Ρ < 〇. 〇 1). The swelling effect of the rubbing drug is remarkable, LSR <CSR φ (two_wayANOVAtest; Ρ<〇·〇ΐ). The swelling effect of the ointment is better than that of the liniment, PSR < LSR (two-way ANOVAtest; P<G.〇l). Analgesic test results The pain control valve (Cp〇) of the control group before carrageenan injection was 1.63±0.16 seconds. The pain valve (CPi) 1 hour after injection was 1 21 ± 〇 u seconds, 4 hours after injection. The pain valve (CI > 4 ) was 丨〇 5 ± 〇 12 seconds ^ the pain difference (CPD ) was -〇.16 ± 〇.1 〇 seconds (Fig. 2A). The pain agent before the carrageenan injection (SP〇) was 156±〇14 seconds, 1 hour (SP) after rubbing was 1.23±0.14 seconds, and the pain valve was wiped 4 hours after the rubbing (SP4) is 1.39 ± 0.10 seconds (Fig. 2A) 'The pain difference (LPD) is 〇m 〇〇 6 seconds (Fig. 16 1351970 2B). The pain valve (pp 〇) before the injection of carrageenan was 1.66=0.25 seconds, and the pain valve 1 hour after administration) was 丨36 soil for 16 seconds. The pain valve (ΡΡ4) was 4 hours after administration. 1.57 ± 0.11 seconds (Fig. 2Α), the pain difference (PPD) is 〇.2〇±〇·〇9 seconds (Fig. 2Β). The analgesic effect of the ointment is remarkable, PPD > CPD (two-way ANOVA test; Ρ < 〇. 〇 5). The liniment also has an analgesic effect ‘ LPD > CPD (two-way ANOVA test; Ρ < 〇. 〇 5); but ppD fish LPd is equal ‘no intentional difference. Experimental results of abdominal pain

The number of abdominal pain (writhing syndrome) caused by intraperitoneal injection of 10 white mice (100 mg/kg) occurred 4±1 times in 60 minutes. The non-combustion group (100mg/kg) of the sinensis was found to have 24±3 times, and there was a significant difference between the two (Fig. 3A). The results of the blinking experiment are as follows: 1% aqueous solution of the golden cream, and dripped into the eyes of 10 white mice, the number of blinks produced is 13±2 times in 60 minutes, and 32 people in the non-combustion group 4 times, there is a significant difference between the two (Figure 3B). Clinical trial results of SinlixRuyiPatch

Forty clinical patients with painful claims, the gender distribution is 〖: 5 (16: 24, male and female). The average age is 49.5 soil and 13.8 years old. Most of the patient's pain occurs in the upper body. Shoulder pain (9/40, 22.5%), upper arm (7/40, 17.5%), back = upper (7/40: 17.5%), neck (5/4 (^.5%) Stick with Xin Liru, Sinlix Ruyi Patch's Pain Relief Index (VAS Pain Sc〇re) and δ ' at 1, 4, 8, 12 and 16 hours after patching, each of which is 7 3 ± 21, 71 ± 18, 5·3±2·4, 3.5±1.4, 4.3±1.5 and 5.8±2.4 (Table 2). After 16.6±7.9 mm, there is temperature perception and maintain i57±7.2 min (Tables 3 and 4). During the dispensing process, 5/40 (12.5%) patients with pain had a burning sensation and maintained 27 3 ± 12 6 minutes, but recovered after removal of the patch (Table 5). A few patients with squamous epithelial desquamation, cause The patch is too sticky, and it is taught to use the bath to rinse with water, so that the patch can be detached, and the epithelial desquamation can be avoided. In terms of comfort, 36/4 〇 (9 〇%) has a comfortable feeling after affixing, only 4/40 (10%) has no comfort (Table 6). 17 1351970 In terms of long-term analgesic effect, patients are posted with singularity (Sinlix)

After 12 to 16 hours of Ruyi Patch, the VAS (visual analog scale) was 4.3±1.5~5·8±2.4, and the analgesic response was statistically significant. The strongest analgesic effect was achieved at 8 hours, which was 3.5 ± 1.4 (Table 2). The invention utilizes the traditional Chinese medicine compound external traumatic preparation such as Ruyi Golden Powder as a material, and uses modern scientific methods to make a medicinal agent and a paste (sticking agent) to examine the effect of treating acute soft tissue inflammation by using an animal experiment method, including swelling, analgesic and anti-inflammatory. And so on. In addition, clinical trials have shown that Sinlix RUyi patch can alleviate clinical pain in humans. The acute inflammatory response of the hind paws of the white rats used in this study

The method of Winter CA was induced using carragenan (Proc & cExpMec/. · 111, 544-547, 1962.). Carrageenan is a non-irritating and inflammatory substance. According to Newbould BB. c/Ptovwaa?/. 35, 487_497. 1969.) 'Flower R. (Nature New Bio, 238, 104-106, 1972.)'

Kubota T. {Arch Int. Pharmacodyn. 237, 169-176, 1979.) ' ^ Vinegar R· ( /Wer corpse wc. 46 (1), 118-126, 1987.) and other scholars' research found that carrageenan (carrageenan) induced the pulsation of the paw of the rat to show biphasic. The first phase edema immediately after the injection and reached its peak after 30 minutes. The reason for this period of edema is mainly that mast cells absorb carrageenan particles and then damage cytoplasmic enzymes and serotonin (ser〇t〇nin), causing swelling and hyperalgesia. The edema of the first phase is called a non-phagocytic inflammatory response. The second phase occurs 1 to 4 hours after the injection of carrageenan, which causes the edema to reach its maximum extent and then gradually subsides. The reaction of this phase is related to the release of bradykinin, protease, prostaglandin, slow releasing substance-A (SRS-A) and lysosomalenzyme. Carrageenan passes through the endothelium and then invades the tissue to release interleukin-1, which changes the surface structure of the injured cortex and causes the neutrophils to accumulate due to chemotaxis. (carrageenan) destroys the neutrophil 18 1351970 cells to release more lysozyme (lyS0S0ma! enzyme), activates the production of prostaglandins, causing phagocytic aggregation, producing symptoms of inflammation and hyperalgesia. Therefore, the second phase can be referred to as a phagocytic inflammatory response. The inflammatory response induced by carrageenan is similar to the acute inflammatory response seen clinically' including the increase of 4 adenine and leuk〇trienes, releasing histamine and serotonin (ser〇t) 〇nin) and bradykinin (bradykmm), resulting in increased vascular permeability and nucleus of the nucleus and mononuclear spheres. Therefore, the anti-acute inflammatory effect of the drug is evaluated by carrageenan-induced inflammatory response, which is a reasonable and commonly used animal experimental mode. ,

The present invention utilizes Tail Flick, which is produced by Ugo (Italy), to illuminate the sole of the rat with infrared rays, so that the contraction reaction of local pain can be obtained due to heat and pain. If the reaction is blocked due to the use of the drug, then the drug has an analgesic effect. The hair of the hair ((^ where _) riding the acute inflammatory reaction, through the use of Ruyi Jin 1 and such as the Golden Cream Ship's have varying degrees of _, pain relief and anti-inflammatory effect. Use the Ruyi golden wipe group swelling The rate (LSR) was 194% = the CSR of the group was 43.1%, and there was significant difference (4) Sichuan stage 1B). ^ Aspect, the pain of the wishful golden liniment is poor LPd : 〇 17±〇 〇

Pain difference (0>D) ·· _αΐ6±0.10 seconds, prolonged, with g ism ϋ)〇^2Β). In addition, the swelling rate of the group using the Ruyi Golden Ointment was significantly lower than that of the control group (CSR): 43.1%, and f difference (ρ<〇·〇1) (Fig. 1B); The pain of sputum is poor (called ^^ has less effect of prolonging pain, with significant difference (4) frequency diagram 2B). As the experimental mode, it can be seen that the acute inflammation of soft tissues has an analgesic effect by the powder containing the powder of the day powder, the instant agent and the agent. Clinically, the inflammation of Qiansi _ such as sprains and sputum can enhance the effect of relieving pain and relaxing muscles. 19 1351970 Sexually, the present invention reduces the amount of bacteria contained in the method by heating and concentrating, and can be proved by the abdominal pain and the blinking reaction of the mouse, which is different from the stimulating golden jelly which is not produced by the sinus. In addition, Sinlix Ruyi Patch, which is made with the human test golden paste, can inhibit clinical body surface pain. Example 1 Each gram of Ruyi Golden Cream contains: Trichosanthin 30 mg Pelican 15 mg Rhubarb 15 mg Turmeric 15 mg Cork 15 mg Licorice 5 mg Magnolia 5 mg Chenpi 5 mg Shengna Nanxing 5 mg Atractylodes 5 mg Cellulose 160 mg Water 100 Mg Alcohol 50 mg Menthol 50 mg Acrylic acid tree 350 mg Fat plus vegetable oil to 1 g Example 2 Per gram of Ruyi Golden Cream contains: Trichosanthin 30 mg White Soap 15 mg Rhubarb 15 mg Turmeric 15 mg Cork 15 Mg licorice 5 mg magnolia 5 mg orange peel 5 mg raw celestial star 5 mg atractylodes 5 mg menthol 50 mg 100 mg wine slightly 40 mg nandy 5 mg morphine 350 mg cellulose 160 mg fat plus vegetable oil to 1 gram Example 3 Each gram of Ruyi Golden Cream contains: Trichosanthin 30 mg Radix 15 mg Rhubarb 15 mg Turmeric 15 mg Cork 15 mg Licorice 5 mg 5 mg Magnolia 5 mg Chen Pisheng Tiannan Star 5 mg Atractylodes 5 mg Menthol 50 mg Alcohol 50 mg Water 100 mg Acrylic Resin 350 mg Add vegetable oil to 1 g Example 4 Per gram of Ruyi Golden Cream contains: Trichosanthin 30 mg Radix 15 mg Rhubarb 15 mg Turmeric 15 mg Yellow 15 mg licorice 5 mg Magnolia 5 mg Chenpi 5 mg Phytosan 5 mg Atractylodes 5 mg Mint 50 mg Water 100 mg Alcohol 40 mg Beinedi 5 mg Acrylic acid tree 350 mg Fat plus vegetable oil to 1 gram Example 5 Each gram of Ruyi Golden Cream contains: Trichosanthin 40 mg White stem 20 mg Rhubarb 20 mg Turmeric 20 mg 21 Cork 20 mg Raw Tiannan 10 mg Licorice 10 mg Atractylodes 10 mg Magnolia 10 mg Chenpi 10 mg Cellulose 160 mg Water 100 Mg Alcohol 50 mg Thin brain 50 mg Acrylic acid tree 350 mg Fat 1351970 Add vegetable oil to 1 gram Example 6 Per gram of Ruyi Golden Cream contains: Trichosanthin 40 mg Angelica 20 mg Turmeric 20 mg Rhubarb 20 mg Raw Araceae 10 mg Cork 20 mg Atractylodes 10 mg Licorice 10 mg Magnolia 10 mg Chenpi 10 mg Menthol 50 mg Cellulose 160 mg Water 100 mg Alcohol 50 mg Beinedi 5mg Acrylic resin 400 mg Add vegetable oil to 1 gram Example 7 Each gram of Ruyi Golden Cream contains: Trichosanthin 40 mg Pelican 20 mg Rhubarb 20 mg Turmeric 20 mg Cork 20 mg Raw Tiannan Star 10 mg Licorice 10 mg Atractylodes 10 mg Magnolia 10 mg Mint Brain 56 mg Orange peel 10 mg Alcohol 50 mg 22 1351970 Water 150 mg Acrylic resin 350 mg Add vegetable oil to 1 gram Example 8 Each gram of Ruyi Golden Cream contains: Trichosanthin 40 mg White peony 20 mg Rhubarb 20 mg Turmeric 20 Mg Cork 20 mg Biostar 10 mg Licorice 10 mg Cang 10 mg Magnolia 10 mg Penindi 5 mg Menthol 50 mg Chenpi 10 mg Alcohol 50 mg Water 150 mg Acrylic acid tree 350mg Fat plus vegetable oil to 1 Gram Example 9 Each gram of Ruyi Golden Cream contains: Trichosanthin 30 mg Radix 15 mg Rhubarb 15 mg Turmeric 15 mg Cork 15 mg Licorice 5 mg Magnolia 5 mg Chenpi 5 mg Raw Tiannan 5 mg Atractylodes 5 mg Wintergreen oil 20 mg Rosin 20 mg Zinc Oxide 60 mg Sesame oil 585 mg Menthol 50 mg / Rubber waste resin, 200 mg Add vegetable oil to 1 g Example 10 Per gram of Ruyi Golden Cream contains: 23 1351970 Trichosanthin 30 mg Radix 15 mg Rhubarb 15 mg Turmeric 15 mg Cork 15 mg Licorice 5 mg Magnolia 5 mg Chenpi 5 mg Shengna Nanxing 5 mg Atractylodes 5 mg Thin He Brain 50 mg Rosin 20 mg Beinandi 5 mg Zinc Oxide 60 mg Winter Green Oil 2 0 mg sesame oil 485 mg rubber resin 200 mg plus vegetable oil to 1 gram

Example 11 Each gram of Ruyi Golden Cream contains: Trichosanthin 40 mg Angelica 20 mg Rhubarb 20 mg Turmeric 20 mg Cork 20 mg Biostar 10 mg Licorice 10 mg Atractylodes 10 mg Magnolia 10 mg Chenpi 10 mg Menthol 50 mg Rosin 20 Mg Winter Green Oil 20 mg Zinc Oxide 60 mg Sesame Oil 480 mg Rubber·Resin 200 mg Add vegetable oil to 1 g

Example 12 Each gram of Ruyi Golden Cream contains: Trichosanthin 40 mg Angelica 20 mg Rhubarb 20 mg Turmeric 20 mg Cork 20 mg Raw Tiannan Star 10 mg Licorice 10 mg Cang 10 mg 24 Magnolia 10 mg Chenpi 10 mg Menthol 50 mg Rosin 20 mg Beinedi 5 mg Oxidation 60 mg Wintergreen oil 20 mg Sesame oil 430 mg Rubber resin 200 mg Add vegetable oil to 1 g Example 13 Per 5.5 g Ruyi Golden Cream contains: Trichosanthin 137.5 mg Angelica 68.8 mg Large Yellow 68.8 mg turmeric 68.8 mg Cork 68.8 mg orange peel 22.9 mg licorice 22.9 mg atractylodes 22.9 mg magnolia 22.9 mg menthol 275 mg cellulose 1145.9 mg acrylic resin 2520.9 mg plus vegetable oil to 5.5 g 1351970 Example 14 per 30 g Taohong Siwutang extract contains: peach kernel 5. 〇g angelica 5. 〇g 芍 5_〇g radix rehmanniae 5.0g safflower 2.5 g Chuanxiong 2.5g alcohol 5.0g menthol 1.5g cellulose 12g water ig acrylic Acid tree l〇g fat plus vegetable oil to 30 g Example 15 per 70 grams of Taohong Siwu Tang addition and subtraction (Source: Medical Zongjinjian) extract contains 25 1351970 peach kernel 9.0g when 9.0g red 芍 9.0g rehmannia glutinosa 5. 〇g safflower 2.5 g Chuanxiong 6.0g fragrant 9.0g yuan Hu 9-〇g achyranthes 9.0g cellulose 24g menthol 3.5g alcohol l〇.〇g water 20g acrylic Resin 40 g plus vegetable oil to 70 g Example 16

Every 700 grams of female treasures are contained in the pill extract

All Angelica 96g 乌药6〇g Salvia 240g Fragrant 96g White peony 45g Small flax 9〇g Wide skin 36g Chuanxiong 24 g Motherwort 120g Menthol 35g Alcohol l〇〇g Water 2〇g Cellulose 240g Acrylic resin 280 g Add vegetable oil to 700 g Example 17 Every 30 grams of Taohong Siwutang extract contains: peach kernel 5.0g angelica 5.〇g chalk 5.0g rehmannia root 5.0g safflower 2.5 g Chuanxiong 2.5g zinc oxide 60 mg mint Brain l-5g sesame oil 585 mg winter green oil 20 mg rosin 20 mg plus vegetable oil to 30 g 26 1351970 Example 18 Per 70 grams of Taohong Siwu Decoction (Source: Medical Zongjinjian) extract contains peach kernel 9.0 g Angelica 9.0g Red 芍 9.0g Rehmannia glutinosa 5. 〇g safflower 2.5 g Chuanxiong 6.0g fragrant 9.0g Yuan Hu 9.0g Achyranthes 9.0g Winter green oil 20 mg Menthol 3.5g Zinc oxide 60 mg Sesame oil 485 mg Rubber resin 200 mg plus vegetable oil to 70 g Example 19 Every 700 grams of female Bao Tiao Pill extract contains all Angelica 96g Wuwu 60g Salvia 240g Xiang Fu 96 g White Peony 45g Small Flax 9〇g Guangpi 36g Chuanxiong 24 g Motherwort 120g menthol 35g winter green oil 20 mg Rosin 20 mg Sesame oil 485 mg Zinc oxide 60 mg Add vegetable oil to 700 g The above prescriptions, the proportion of Chinese medicine members are based on the ratio of the original. 27 1351970 Table 1: Number of patients in the distribution of cases/total number of people (ratio) Gender distribution (male: female) 16/24 (1: 1.5) Age distribution 49. 5±13.8 y/o Painful upper limb 16/40 (40 %) Back 12/40 (30%) Lower limbs 7/40 (17.5 %) Head and neck 6/40 (15 %) Pain area: One part/two parts/three parts 25/12/3 Table 2: Patch Analgesic effect (0, 0.5, 1, 4, 8, 12, 16-hour pain index VAS after post-sticking) Post-sticking time (hours) VAS pain score 0 7.3 ±2.1 0.5 7.1 ±1.8 1 5.3 ±2.4 4 3.5 ± 1.4* 8 3.8 ± 1.7* 12 4·3± 1.5* 16 5.8 ±2.4 Differences in data presentation (P<〇.〇5) 28 Table 3: Temperature perception after application (Evaluation of the Warming effect of the Patch) Onset time that felt warm after patching 16,6 ± 7.9 min Duration of warming effects lasted for 157.4 ±7.2 min 1351970 Table 4: Degree of warming effects Degree of people / total number of people is strong (Severe) 4/40 10% Moderate (M Oderate) 13/40 30.3 % Weak (Mild) 18/40 45% None (None) 5/40 12.5 % Table 5: Side effects after dispensing (Parameters) Number of people / Total number (ratio) Burning sensation 5/40 (12.5 %) Skin Itching (Pniritis) 2/40 (5 %) Desquamation 2/40 (5 %) Skin rash 0/40 Skin bruising 0/40 Systemic symptoms (ΝίΥ, dizziness, general itching, etc) 0/40 29 Table 6: Satisfaction satisfaction number / total number (rate) Most satisfied 12/36 (33.3 %) Moderate Satisfied 15/36 (38.7 %) Moderately satisfied 9/36 (29.0 %) 1351970 [Simplified illustration] Figure 1A: Swelling coefficient of various preparations before and after administration 1. Swelling coefficient of control group before administration (CSB) 2. Control group Swelling coefficient after administration (CSA) · 3. Swelling coefficient before lapping (LSB) 4. Swelling coefficient after liniment administration (LSA) 5. Swelling coefficient before ointment (PSB) 6. After administration of ointment ( Swelling coefficient of PSA) Figure 1B Swelling rate of Luo preparations (Swelling%) 1. Swelling rate of control group (CSR) 2. Rubbing agent (LSR) Swelling coefficient 3. Swelling coefficient of ointment (PSR) Figure 2A: Pain valve changes of various preparations before and after administration · 1. Pain valve before administration (CP0) in the control group 2. Pain 1 hour after administration (CP 1) in the control group Valve 3. The pain in the control group 4 hours after administration (CP 4 ) is wide 4. The pain valve before the administration of the rubbing agent (LP0) 5. The pain valve 1 hour after the administration of the rubbing agent (LP 1 ) 6. After the rubbing agent is administered 4 Pain valve for hours (LP 4 ) 7. Pain valve before administration of the ointment (PP 0 ) 8. Pain valve 1 hour after the administration of the ointment (PP 1 ) 9. Pain valve 4 hours after the administration of the ointment (PP4) Figure 2B: Changes in control pain deviation (CPD) of various preparations 30 1351970 1. Poor pain in the control group (CPD) 2. Poor pain in the liniment (LPD) 3. Poor pain in the ointment (PPD) Figure 3A: Abdominal pain of the ointment Experiment 1. Processing group 2. Raw Tiannanxing non-manufacturing group Figure 3B: Blinking experiment of paste 1. Processing group 2. Shengtiannanxing non-manufacturing group [Main component symbol description] 31

Claims (1)

VII. Patent application scope: L A hydrophilic Ruyi golden cream Chinese medicine patch comprising: cellophane; resin; and a drug layer disposed between the cellophane and the resin, wherein the drug layer: flower bud, white peony, rhubarb, turmeric , Phellodendron, Shengtiannan i,: Drought, Cangshu, Magnolia, Chenpi Chinese medicine composition and excipients. Its preparation method is to take the cap, water to ίΐίϊί rubber resin and acrylic resin, fiber The oxidative η [; medium" is selected from the group consisting of menthol, ί: ίτ soap, and the method of extracting 'extracting the extract under reduced pressure, -, one ~ this / u / v is 曰, fiber difficult f Zinc is an excipient, or add rosin, winter green oil (including methyl for customs clearance, or add i amount of sedum, rosin, zinc oxide, winter green oil 32