Traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition as well as a preparation method and application thereof, and particularly belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-20 parts of radix et rhizoma rhei, 80-100 parts of mirabilite, 10-15 parts of borneol and 10-15 parts of cortex cinnamomi. The traditional Chinese medicine composition is mainly prepared from medicines capable of clearing away heat and toxic materials and promoting blood circulation and softening hard mass, has the effects of eliminating heat toxicity and promoting blood circulation of adipose tissues of incisions, can prevent and / or treat red and swollen incisions and fat liquefaction of the incisions during abdominal operation in the obstetrics and gynecology department, and also has good prevention and treatment effects on patients with cold bodies.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a preparation method thereof and an application thereof. Background Art

[0002] Fat liquefaction is a common complication after abdominal surgery in obstetrics and gynecology. The main manifestation is that yellowish oily liquid oozes from the incision 3 to 7 days after the operation, without signs of infection (no redness, pus). It is common in operations such as cesarean section and hysterectomy. Although there are currently some methods and drugs for the prevention and treatment of fat liquefaction of abdominal surgical incisions in obstetrics and gynecology, the existing drugs still have the problem of poor treatment effect. For example, the traditional Chinese medicine preparation composed of rhubarb and mirabilite reported currently has a good effect on the red and swollen incisions with a feeling of heat, but is often ineffective for patients with incisions of cold coagulation and blood stasis. At the same time, when applying traditional Chinese medicine externally, the patient feels too cold, which is likely to block the qi mechanism and accumulate phlegm-dampness in patients with cold body constitution, and instead cause fat liquefaction of cold-type incisions, affecting the medical treatment and quality of life of patients. Currently, there is a lack of a traditional Chinese medicine composition with better treatment effect on fat liquefaction of abdominal surgical incisions in obstetrics and gynecology. Summary of the Invention

[0003] The purpose of the present invention is to provide a traditional Chinese medicine composition, a preparation method thereof and an application thereof. The traditional Chinese medicine composition of the present invention is mainly composed of drugs for clearing heat and detoxifying, promoting blood circulation and softening hard masses, which can play the role of eliminating heat toxin and promoting blood circulation of adipose tissue at the incision, and can prevent and / or treat the redness and swelling of abdominal surgical incisions in obstetrics and gynecology and incision fat liquefaction, and also has good preventive and therapeutic effects on patients with cold body constitution.

[0004] The present invention provides a traditional Chinese medicine composition, including the following raw materials for preparation in parts by weight: 15 - 20 parts of rhubarb, 80 - 100 parts of mirabilite, 10 - 15 parts of borneol and 10 - 15 parts of cinnamon.

[0005] Preferably, it includes the following raw materials for preparation in parts by weight: 20 parts of rhubarb, 100 parts of mirabilite, 15 parts of borneol and 15 parts of cinnamon.

[0006] The present invention also provides a preparation method of the traditional Chinese medicine composition described in the above technical solution, including the following steps:

[0007] Crush and mix rhubarb, mirabilite, borneol and cinnamon to obtain the traditional Chinese medicine composition.

[0008] The present invention also provides an application of the traditional Chinese medicine composition described in the above technical solution in the preparation of a drug for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology.

[0009] The present invention also provides an application of the traditional Chinese medicine composition described in the above technical solution in the preparation of a drug for accelerating the healing of abdominal surgical incisions in obstetrics and gynecology.

[0010] The present invention also provides a traditional Chinese medicine preparation for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology, which comprises the traditional Chinese medicine composition described in the above technical solution and pharmaceutically acceptable excipients or carriers.

[0011] Preferably, the type of the traditional Chinese medicine preparation includes traditional Chinese medicine external preparations.

[0012] Preferably, the excipients include gauze.

[0013] The present invention also provides an external-use bag of traditional Chinese medicine powder for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology. The preparation method of the external-use bag of traditional Chinese medicine powder comprises: putting the traditional Chinese medicine composition described in the above technical solution into a gauze bag to obtain the external-use bag of traditional Chinese medicine powder.

[0014] The present invention provides a traditional Chinese medicine composition. The traditional Chinese medicine composition of the present invention is mainly composed of drugs for clearing heat and detoxifying, activating blood circulation and softening hard masses, which can eliminate heat toxins and promote the blood circulation of the adipose tissue at the incision, and can prevent and / or treat the redness and swelling of abdominal surgical incisions in obstetrics and gynecology and fat liquefaction of the incision. It is combined with drugs for detumescence and pain relief, and preventing putrefaction and promoting granulation to prevent fat liquefaction caused by necrosis of adipose tissue at abdominal surgical incisions in obstetrics and gynecology and promote incision healing. It is further supplemented with drugs for dispersing cold and dredging meridians to reinforce yang with fire and antibacterial and anti-inflammatory, so as to promote the growth of fibroblasts and achieve the effect of promoting wound healing. Therefore, the traditional Chinese medicine composition of the present invention has the characteristics of treating both the symptoms and root causes, having no toxic and side effects and good effects for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology. Detailed Embodiments

[0015] The present invention provides a traditional Chinese medicine composition, which comprises the following raw materials for preparation in parts by weight: 15-20 parts of rhubarb, 80-100 parts of mirabilite, 10-15 parts of borneol and 10-15 parts of cinnamon.

[0016] The traditional Chinese medicine composition of the present invention comprises 80-100 parts of mirabilite, specifically 100 parts. Mirabilite: It tastes salty, bitter and cold, and belongs to the stomach and large intestine meridians. Its active ingredient is sodium sulfate. When taken orally, it can purge heat and promote defecation, and moisten the dry and hard feces. It is a key medicine for treating interior accumulation of excessive heat and hard-to-pass dry feces. When used externally, in addition to clearing heat, it can also eliminate hard masses. It is commonly used for treating sores and swelling, and swelling and pain of hemorrhoids. It has the effects of purging, softening hardness, activating blood circulation, dissipating stasis and relieving pain. It is the monarch drug in this formula. Modern medical research also proves that mirabilite has an obvious inhibitory effect on the reticuloendothelial system, enhancing its hyperplasia phenomenon and phagocytic function, playing an anti-inflammatory role, having a strong water absorption function, being able to reduce the permeability of capillaries, enabling the liquefied adipose tissue and exudate at the incision to be absorbed, dissipating subcutaneous stasis, keeping the local area dry, and being able to play the effects of promoting blood circulation to remove blood stasis and dissipating pain in the treatment of fat liquefaction of the incision.

[0017] The traditional Chinese medicine composition described in the present invention comprises 15 to 20 parts of rhubarb, specifically 20 parts. Rhubarb: It is bitter and cold in nature, enters the stomach, large intestine and liver meridians. Its active ingredients mainly include rhein glycoside, rhein aglycone, anthraquinone, tannin, etc.; it can purge and break knots, clean the stomach and intestines of excessive heat accumulation, soothe the five internal organs, supplement and astringe the healthy qi, has the effect of removing stasis and promoting the growth of new tissues, and also has the effects of diuresis and detumescence, clearing heat and detoxifying, promoting blood circulation to remove stasis, astringing pain and stopping bleeding. Rhubarb assists mirabilite in dispersing stasis and dissipating nodules, and is the ministerial drug in the prescription. Analyzed from modern pharmacology, rhubarb can play a good inhibitory role on bacteria, viruses and fungi, etc. In addition, it can also reduce the permeability of capillaries, significantly improve the local microcirculation, and play a certain inhibitory effect on the exudation of wound fluid.

[0018] The traditional Chinese medicine composition described in the present invention comprises 10 to 15 parts of borneol, specifically 15 parts. Borneol: It is pungent, bitter and slightly cold in nature, and belongs to the heart, spleen and lung meridians. Its main component is dextrorotatory borneol. It can open all the orifices, disperse stagnant fire, reduce swelling and relieve pain, activate blood circulation and promote granulation; it can treat pathogenic factors in the heart and abdomen, rheumatism and accumulation; the ancients said: "This medicine is pungent, fragrant and intense, good at dispersing and dredging, with extremely quick effects. All sudden qi obstruction, phlegm binding and coma diseases cannot be treated without this medicine." Borneol has the effects of preventing corrosion and promoting granulation, clearing heat and detoxifying, and can relieve the pain sensation during the healing process of surgical incisions. It is a commonly used drug for promoting granulation and astringing sores in traditional Chinese medicine for external application of traumatic injuries. It plays an adjuvant role in this prescription.

[0019] The traditional Chinese medicine composition described in the present invention comprises 10 to 15 parts of cinnamon, specifically 15 parts. Cinnamon: It is pungent and sweet in taste, hot in nature, and belongs to the kidney, spleen, heart and liver meridians. It has the effects of tonifying fire and assisting yang, dispersing cold and dredging meridians, promoting blood circulation to relieve pain. It is a guiding drug in this prescription and plays the role of envoy drug. Cinnamaldehyde has anti-excitation and analgesic effects. Cinnamon plays the role of antibacterial and anti-inflammatory, and promoting wound healing in the present invention. This product enters the blood aspect, can clear the stasis in the blood. Its nature is slow, and it can assist sweating and excretation. It can generate muscles, eliminate stasis, break up accumulations and masses, internally support carbuncles, abscesses, pox and sores, can lead blood to transform into sweat and suppurate, and has the effect of warming and transporting yang qi, inspiring the growth of qi and blood. When the meridians are blocked and the qi and blood circulation is not smooth, there must be stasis blockage after a long time of meridian blockage. The pungent and warm nature of cinnamon helps the qi and blood to circulate. Cinnamon, with its sweet, warm, pungent and hot nature, treats heat with heat, uses heat because of heat, leads back the floating fire, promotes the yang to attach to the yin, so that the yin and yang are in balance and the spirit is regulated. It is also used for the heat syndrome of true cold with false heat. "Compendium of Materia Medica Seeking Truth" states that: "It greatly tonifies the ministerial fire of the life gate, nourishes yang and treats yin... Those caused by cold and stagnation can be treated effectively with this medicine." The abdominal incision in gynecological abdominal surgery belongs to the lower abdomen in traditional Chinese medicine, which is the location of the original qi in traditional Chinese medicine. Cinnamon leads back the floating fire and is the guiding drug in this prescription, playing the role of envoy drug.

[0020] The present invention also provides a preparation method of the traditional Chinese medicine composition described in the above technical solution, comprising the following steps:

[0021] Crush and mix rhubarb, mirabilite, borneol and cinnamon to obtain the traditional Chinese medicine composition. In a specific embodiment, after crushing, it is sieved through a 80-mesh sieve.

[0022] The present invention also provides the use of the Chinese medicine composition described in the above technical solution in the preparation of a medicine for preventing and / or treating fat liquefaction in gynecological abdominal surgical incisions.

[0023] The present invention also provides the use of the traditional Chinese medicine composition described in the above technical solution in preparing a medicine for accelerating the healing of gynecological abdominal surgical incisions.

[0024] The present invention also provides a Chinese medicine preparation for preventing and / or treating fat liquefaction in gynecological abdominal surgery, comprising the Chinese medicine composition described in the above technical solution and a pharmaceutically acceptable excipient or carrier. In a specific embodiment, the type of the Chinese medicine preparation includes a Chinese medicine external preparation. In a specific embodiment, the excipient includes gauze.

[0025] The present invention also provides a Chinese medicine powder external bag for preventing and / or treating fat liquefaction of gynecological abdominal surgical incisions. The preparation method of the Chinese medicine powder external bag comprises: putting the Chinese medicine composition described in the above technical solution into a gauze bag to obtain the Chinese medicine powder external bag. In a specific embodiment, the gauze bag is a double-layer gauze bag for Chinese medicine medicine. In a specific embodiment, the double-layer gauze bag for Chinese medicine medicine medicine is customized according to the size of the incision, and the Chinese medicine powder external bag completely covers the incision and ensures that its edge exceeds the incision by at least 3 cm. If the incision is covered with gauze, the Chinese medicine bag is placed on the outer layer of gauze and fixed. In a specific embodiment, the amount of the Chinese medicine composition filled is preferably enough to fill the gauze bag. In the present invention, the use method of the Chinese medicine powder external bag comprises: applying the Chinese medicine powder external bag on sterile gauze and fixing it. In a specific embodiment, according to the patient's condition, the dressing is changed 1 to 2 times a day, and the external application is continued for 3 days after the incision is free of exudate and lumps.

[0026] In order to further illustrate the present invention, a Chinese medicine composition provided by the present invention and its preparation method and application are described in detail below in conjunction with examples, but they should not be construed as limiting the scope of protection of the present invention.

[0027] Example 1

[0028] A traditional Chinese medicine composition for preventing and / or treating fat liquefaction in gynecological abdominal surgery is prepared by weighing the following traditional Chinese medicine raw materials: 200g of rhubarb, 1000g of sodium sulfate, 150g of borneol and 150g of cinnamon bark.

[0029] Preparation method: Grind the above four herbs into powder, pass through an 80-mesh sieve and mix thoroughly to obtain a Chinese medicine composition, and put the Chinese medicine composition into a double-layer medical gauze bag of Chinese medicine prepared in advance (the amount of medicine is based on filling the double-layer medical gauze bag of Chinese medicine), to obtain a Chinese medicine powder bag for external use.

[0030] Customize a double-layer medical gauze bag of traditional Chinese medicine according to the size of the incision, completely cover the incision with the external-use bag of traditional Chinese medicine powder, and ensure that its edge extends at least 3 cm beyond the periphery of the incision. If the incision is already covered with gauze, place the traditional Chinese medicine bag on the outer layer of the gauze for fixation.

[0031] Example 2

[0032] A traditional Chinese medicine composition for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology is prepared by weighing the following traditional Chinese medicine raw materials: 200 g of rhubarb, 800 g of mirabilite, 100 g of borneol, and 100 g of cinnamon. The preparation method is the same as that in Example 1.

[0033] Example 3

[0034] A traditional Chinese medicine composition for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology is prepared by weighing the following traditional Chinese medicine raw materials: 200 g of rhubarb, 1000 g of mirabilite, 100 g of borneol, and 100 g of cinnamon. The preparation method is the same as that in Example 1.

[0035] Example 4

[0036] The external-use bag of traditional Chinese medicine powder prepared in Example 1 was used for a clinical preventive treatment trial, and the treatment effect was compared with that of a traditional Chinese medicine prescription (200 g of rhubarb, 1000 g of mirabilite):

[0037] There were 180 cases in the treatment group, 100 cases in the control group, and 89 cases in the blank control group.

[0038] Treatment group: The external-use bag of traditional Chinese medicine powder prepared in Example 1 was used. The patients were aged 20 - 48 years, with an average age of (36.78 ± 8.46) years, and their body weight was 53 - 74 kg, with an average of (62.38 ± 8.64) kg;

[0039] Control group: A traditional Chinese medicine composition composed of rhubarb and mirabilite (the mass ratio of rhubarb to mirabilite is 1:5) was prepared into an external-use bag of traditional Chinese medicine powder according to the preparation method in Example 1. The patients were aged 19 - 46 years, with an average age of (35.67 ± 7.38) years, and their body weight was 51 - 82 kg, with an average of (63.15 ± 7.58) kg.

[0040] The using method of the external-use bag of traditional Chinese medicine powder in the treatment group and the control group: Apply it on the sterile gauze of the patient's incision and fix it. According to the actual situation of the patient, change the dressing 1 - 2 times a day. After applying externally until there is no exudate and no induration in the incision, continue to apply for 3 days.

[0041] Blank control group: Routine aseptic operation in medical surgery. Change the sterile gauze of the incision every day. Try to squeeze out as much fat liquefaction exudate as possible. After disinfecting with iodine tincture and 75% ethanol cotton balls, cover the incision with a sterile dressing and fix it with adhesive tape. Change the dressing again after 12 h.

[0042] Comparison of the incision healing conditions among three groups of patients

[0043] Regarding the observation of the incision healing conditions of the three groups, the excellent healing rate of the treatment group was higher than that of the control group, and the overall incision healing condition was better than that of the control group (P<0.05). See Table 1. There was no occurrence of incision fat liquefaction in the treatment group, and the fat liquefaction rate was significantly lower than that of the control group and the blank control group. There were statistically significant differences when compared with the two groups respectively. See Table 1.

[0044] Table 1 Comparison of the incision healing conditions of three groups of parturients (n cases, %)

[0045]

[0046] Comparison of the time when the incisions of three groups of patients stopped oozing and the healing time

[0047] The three groups of patients were followed up for 14 days. The average time when the incisions of the treatment group patients stopped oozing and the healing time were both shorter than those of the control group and the blank control group. There were statistically significant differences when compared with the two groups respectively (P<0.05). See Table 2.

[0048] Table 2 Comparison of the time when the incisions of three groups of patients stopped oozing and the healing time (X±s)

[0049] Group Number of cases Time when incision stops oozing Wound healing time / d Treatment group 180 2.12±0.06 6.23±1.132 Control group 100 4.34±1.12 9.72±3.32 Blank control group 89 5.83±2.43 11.42±3.29

[0050] Comparison of the VAS scores of three groups of patients

[0051] When comparing the VAS scores of the three groups of patients on the 1st day after surgery, there was no statistically significant difference (P>0.05); while when comparing the VAS scores of the patients on the 5th and 10th days after surgery, those of the treatment group were lower than those of the control group and the blank control group (P<0.05). See Table 3.

[0052] Table 3 Comparison of the VAS scores of three groups of patients

[0053] Group Number of cases 1 day after surgery 5 days after surgery 10 days after surgery Treatment group 180 5.36±2.17 3.35±1.12 0.26±1.34 Control group 100 5.45±1.89 5.26±2.24 3.32±1.73 Blank control group 89 7.24±3.73 6.43±4.12 5.82±2.58

[0054] The control group had an obvious effect on preventing the occurrence of fat liquefaction of the incisions after gynecological and obstetric abdominal surgeries. However, it was found in the present invention that the control group had a good effect on the red and swollen incisions with a feeling of heat, but was ineffective for the patients with incisions of cold coagulation and blood stasis. At the same time, when the traditional Chinese medicine powder external application bag of the control group was applied externally, the patients felt too cold, which was likely to block the qi movement and accumulate phlegm-dampness in the patients with cold body constitution, resulting in cold-type incision fat liquefaction and affecting the medical treatment and quality of life of the patients.

[0055] Example 5

[0056] Considering to improve the cold feeling of the patients, based on the control group of Example 4 (200 g of rhubarb, 1000 g of mirabilite), the hot-natured traditional Chinese medicine prepared aconite root was added to obtain a warm traditional Chinese medicine formula (200 g of rhubarb, 1000 g of mirabilite, 100 g of prepared aconite root).

[0057] The external-use bag of traditional Chinese medicine powder prepared in Example 1 was used for a clinical preventive treatment effect verification test, with a warm traditional Chinese medicine prescription as the control.

[0058] The specific clinical exploration results are as follows:

[0059] There were 180 cases in the treatment group and 30 cases in the warm traditional Chinese medicine prescription group.

[0060] Treatment group: The external-use bag of traditional Chinese medicine powder in Example 1 was used, and the usage method was the same as that in Example 4. The patients' ages were from 20 to 48 years old, with an average of (36.78 ± 8.46) years old, and their body weights were from 53 to 74 kg, with an average of (62.38 ± 8.64) kg;

[0061] Warm traditional Chinese medicine prescription group: The warm traditional Chinese medicine prescription was used, and the usage method was the same as that in Example 4. The ages were from 20 to 51 years old, with an average of (36.15 ± 7.98) years old, and their body weights were from 52 to 81 kg, with an average of (64.52 ± 6.83) kg.

[0062] The blank control group was the same as Example 4.

[0063] 1 Comparison of the incision healing conditions of the three groups of patients

[0064] For the observation of the incision healing conditions of the three groups, the first-class healing rate of the treatment group was higher than that of the warm traditional Chinese medicine prescription group, and the overall incision healing condition was better than that of the warm traditional Chinese medicine prescription group (P < 0.05). See Table 4. There was no statistically significant difference in several indicators between the warm traditional Chinese medicine prescription group and the blank control group (P > 0.05), see Table 4.

[0065] Table 4 Comparison of the incision healing conditions of the three groups of parturients (n cases, %)

[0066]

[0067]

[0068] 2 Comparison of the time when the incisions of the three groups of patients stopped oozing and the healing time

[0069] The three groups of patients were followed up for 14 days. The average time when the incisions of the treatment group patients stopped oozing and the healing time were both shorter than those of the warm traditional Chinese medicine prescription group and the blank control group. Compared with the two groups respectively, the differences were statistically significant (P < 0.05). There was no statistically significant difference between the warm traditional Chinese medicine prescription group and the blank control group (P > 0.05), see Table 5.

[0070] Table 5 Comparison of the time when the incisions of the three groups of patients stopped oozing and the healing time (X ± s)

[0071] Group Number of cases Time when incision stops oozing Wound healing time / d Treatment group 180 2.12±0.06 6.23±1.132 Warm traditional Chinese medicine prescription group 30 5.98±2.62 12.11±4.14 Blank control group 89 5.83±2.43 11.42±3.29

[0072] The warm traditional Chinese medicine prescription is an exploratory study before obtaining the traditional Chinese medicine composition of the present invention. Its clinical results prove that the traditional Chinese medicine composition of the present invention has better preventive and therapeutic effects.

[0073] The rationality of the traditional Chinese medicine combination of the present invention lies in the use of the hot traditional Chinese medicine cinnamon to reinforce yang and disperse cold, relieve pain, and warm the meridians. Compared with aconite, which is also hot in nature and mainly functions to restore yang and rescue from collapse and is more suitable for aversion to cold and cold limbs, cinnamon focuses more on improving local blood circulation. For the incision with cold congealing and blood stasis, manifested as purplish dark skin color around the incision, it can warm the meridians and promote blood circulation, remove blood stasis and relieve pain, which is beneficial to promoting the qi and blood circulation of the incision and accelerating the incision healing.

[0074] Although the above embodiments have made a detailed description of the present invention, they are only a part of the embodiments of the present invention, not all of them. People can also obtain other embodiments based on these embodiments without creative efforts, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The preparation raw materials include the following parts by weight: 15-20 parts of Rheum officinale, 80-100 parts of mirabilite, 10-15 parts of borneol and 10-15 parts of cinnamon.

2. The traditional Chinese medicine composition according to claim 1, wherein The preparation raw materials include the following parts by weight: 20 parts of Rheum officinale, 100 parts of mirabilite, 15 parts of borneol and 15 parts of cinnamon.

3. The preparation method of the traditional Chinese medicine composition according to claim 1 or 2, comprising the following steps: Crush and mix Rheum officinale, mirabilite, borneol and cinnamon to obtain the traditional Chinese medicine composition.

4. The application of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for preventing and / or treating fat liquefaction of the abdominal surgical incision in obstetrics and gynecology.

5. The application of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for accelerating the healing of the abdominal surgical incision in obstetrics and gynecology.

6. A traditional Chinese medicine preparation for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology, characterized in that, It includes the traditional Chinese medicine composition according to claim 1 or 2 and a pharmaceutically acceptable excipient or carrier.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The type of the traditional Chinese medicine preparation includes traditional Chinese medicine external preparations.

8. The traditional Chinese medicine preparation according to claim 6, characterized in that, The excipient includes gauze.

9. A traditional Chinese medicine powder external application bag for preventing and / or treating fat liquefaction of abdominal surgical incisions in obstetrics and gynecology, characterized in that, The preparation method of the external-use bag of traditional Chinese medicine powder includes: putting the traditional Chinese medicine composition according to claim 1 or 2 into a gauze bag to obtain the external-use bag of traditional Chinese medicine powder.

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