Traditional Chinese medicine composition for hemorrhoid postoperative repair, traditional Chinese medicine spray film-forming preparation and application

Abstract

The invention relates to a traditional Chinese medicine composition for hemorrhoid postoperative repair, a traditional Chinese medicine spray film-forming preparation and application. The traditional Chinese medicine composition comprises the following components in parts by weight: 20-33 parts of garden balsam stem, 18-20 parts of rheum officinale, 15-25 parts of schizonepeta, 16-18 parts of golden cypress, 16-19 parts of purslane, 10-15 parts of radix sophorae flavescentis, 12-15 parts of sophora fruit, 14-16 parts of sanguisorba officinalis and 8-12 parts of borneol. According to the traditional Chinese medicine composition provided by the invention, through compatibility of all the components, the traditional Chinese medicine composition is suitable for repairing a wound surface after a hemorrhoid operation, the problems of errhysis, pain, infection and slow healing in the hemorrhoid operation repairing are systematically solved, and the traditional Chinese medicine composition has a rapid repairing effect on the wound surface after the hemorrhoid operation.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine, specifically to a traditional Chinese medicine composition, a traditional Chinese medicine spray film-forming preparation and their uses for post-hemorrhoid operation repair. Background Art

[0002] Hemorrhoid surgery usually requires resection of the hemorrhoid nucleus and suture of the mucosa. The postoperative wound surface is mostly an open wound with a long healing period. Moreover, due to the special location of the hemorrhoids, daily activities such as defecation and sitting cause the wound surface to be continuously affected by sphincter contraction, fecal friction and humid environment, making it prone to secondary injury. And after the operation, qi and blood are deficient, and the intestines lack moisture nourishment. Patients often have dry stools, and the mechanical stimulation during defecation further aggravates the wound bleeding. Coupled with the complex microbial environment in this area and the high colonization rate of intestinal flora (such as Escherichia coli and anaerobic bacteria), the risk of postoperative open wound infection increases significantly.

[0003] Therefore, the postoperative care of hemorrhoids becomes extremely difficult, and there is an urgent need for a drug that can quickly repair the wound surface after hemorrhoid surgery. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition, a traditional Chinese medicine spray film-forming preparation and their uses, which are particularly suitable for repairing the wound surface after hemorrhoid surgery, and systematically solve the problems of bleeding, pain, infection and slow healing in post-hemorrhoid surgery repair.

[0005] The present invention adopts the following technical solutions:

[0006] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition for post-hemorrhoid operation repair, comprising the following components in parts by weight:

[0007] 20-33 parts of Speranskia tuberculata, 18-20 parts of Rheum palmatum, 15-25 parts of Schizonepeta tenuifolia, 16-18 parts of Phellodendron amurense, 16-19 parts of Portulaca oleracea, 10-15 parts of Sophora flavescens, 12-15 parts of Sophora japonica, 14-16 parts of Sanguisorba officinalis, 8-12 parts of Borneol.

[0008] Traditional Chinese medicine believes that hemorrhoid surgery, as a traumatic treatment method, can be classified into the scope of "golden injury" in traditional Chinese medicine. The golden blade injures the sphincter and muscle veins, the qi of the meridians and collaterals is blocked, the qi movement is unobstructed, the qi stagnation leads to blood stasis, and the qi and blood are blocked, so it is painful due to obstruction; the pulse is the channel of blood, and when the pulse is damaged, blood overflows, so it is easy to see bleeding on the wound surface; there is also the fumigation of damp-heat toxin here, when the heat is strong, the blood moves, and the blood moves without following the meridian, and the blood overflows outside the pulse, so bleeding or blood in the stool can be seen. After the operation, the qi and blood of the patient are more deficient than before the operation, and the ability to nourish the intestines is weakened compared with before, so it is easy to show symptoms such as dry, difficult and hard stools and difficult defecation during treatment.

[0009] Speranskia tuberculata is pungent in taste and warm in nature, enters the liver and kidney meridians, and has the effects of dispelling wind and dampness, relaxing tendons and activating blood circulation, dissipating stasis and swelling, and detoxifying and relieving pain.

[0010] Rhubarb has the effects of clearing away heat and purging fire, cooling blood and detoxifying. Schizonepeta is pungent in taste and cool in nature, and has the effects of dispersing wind and heat, activating blood circulation and stopping bleeding.

[0011] Huangbai is bitter in taste and cold in nature. It enters the kidney and bladder meridians. It has the effects of clearing away heat and dampness, purging fire and removing steaming, detoxifying and treating sores.

[0012] Purslane is sour in taste and cold in nature. It enters the large intestine and liver meridians. It has the effects of cooling blood and detoxifying, removing dampness and relieving stranguria, and stopping dysentery. Sophora japonica contains a large amount of flavonoids, which have antioxidant, antibacterial and anti-inflammatory effects, as well as cooling blood and removing blood stasis, clearing heat and dampness, and stopping bleeding.

[0013] Sophora flavescens has the effects of clearing away heat and dampness, anti-bacterial and anti-inflammatory, and strengthening the stomach and expelling parasites.

[0014] Sanguisorba officinalis tastes bitter, sour, astringent and slightly cold. It has the effects of cooling blood, stopping bleeding, detoxifying and healing sores.

[0015] Borneol tastes pungent, bitter and slightly cold. It has the effects of invigorating the mind, clearing away heat and dispersing toxins.

[0016] In the Chinese medicine composition of the present invention, Radix Angelicae Pubescentis is used as the main drug, which has the effect of promoting blood circulation and relieving pain; Radix Et Rhizoma and Radix Vitex are used as the assistant drugs, which have the effects of purging and attacking accumulation, clearing away heat and purging fire, cooling blood and detoxifying, and clearing rash and eliminating sores; Cortex Phellodendri, Herba Portulacae, Radix Sophorae Flavescentis, Fructus Sophorae and Radix Sanguisorbae are used as the adjuvant drugs, which have the effects of clearing away heat and detoxifying, cooling blood and stopping bleeding, and stopping dampness and stopping itching; Borneol is used as the envoy, which has the effect of clearing heat and stopping pain, and can reconcile various drugs, and lead the drug power to the diseased area. All the drugs are used together, which has the effects of removing blood stasis and unblocking channels, reducing swelling and relieving pain, removing rot and promoting muscle growth, and promoting blood circulation and stopping bleeding, and has obvious curative effect on a series of complications after hemorrhoid surgery, such as perianal incision pain, edema, bleeding, anal swelling, etc.

[0017] The Chinese medicine composition of the present invention, under the compatibility of the above-mentioned monarch, minister, assistant and guiding medicine, further realizes the "blood circulation-hemostasis" dynamic balance through the combination of Radix Sophorae Flavescentis, Radix Sanguisorbae, and Borneol, takes Radix Sophorae Flavescentis as the guide to promote local microcirculation by promoting blood circulation and unblocking collaterals, Radix Sanguisorbae cooling blood and stopping bleeding to prevent blood heat from running wildly, and Borneol guides the drug effect to reach the diseased area directly, forming a dynamic balance of "unblocking but not breaking, stopping but not stagnating", avoiding the contradiction between postoperative wound stasis and secondary bleeding. Further, through the combination of Radix Rhei, Cortex Phellodendri, and Herba Portulacae, the "antibacterial-anti-inflammatory-healing" trinity is realized, and the three synergistically cover infection control, inflammation relief and tissue repair. Further, through the combination of Radix Sophorae Flavescentis, Fructus Sophorae, and Herba Schizonepetae, the "drying dampness-moistening intestines" contradiction is reconciled, both dampness and heat are eliminated, and intestinal dryness is relieved by improving local microcirculation.

[0018] Preferably, the Chinese medicine composition comprises the following components in parts by weight:

[0019] Herba Polygoni Multiflori 30, Radix Rhei 20, Herba Schizonepetae 20, Cortex Phellodendri 15, Herba Portulacae 15, Herba Sophorae Flavescentis 15, Fructus Sophorae Fructus 15, Herba Sanguisorbae 15, and Borneol 10.

[0020] The second aspect of the present invention provides a traditional Chinese medicine spray film-forming preparation for post-hemorrhoid operation repair, comprising the following components:

[0021] Traditional Chinese medicine extract, accounting for 95%-99% of the total mass of the preparation, and the raw materials of the traditional Chinese medicine extract include the following components in parts by weight: 20-33 parts of speranskia tuberculata, 18-20 parts of rheum officinale, 15-25 parts of schizonepeta tenuifolia, 16-18 parts of phellodendron amurense, 16-19 parts of portulaca oleracea, 10-15 parts of sophora flavescens, 12-15 parts of sophora japonica, 14-16 parts of sanguisorba officinalis, 8-12 parts of borneol;

[0022] Chitosan hydrochloride: accounting for 1%-5% of the total mass of the preparation.

[0023] Preferably, the raw materials of the traditional Chinese medicine extract include the following components in parts by weight: 30 parts of speranskia tuberculata, 20 parts of rheum officinale, 20 parts of schizonepeta tenuifolia, 15 parts of phellodendron amurense, 15 parts of portulaca oleracea, 15 parts of sophora flavescens, 15 parts of sophora japonica, 15 parts of sanguisorba officinalis, 10 parts of borneol.

[0024] Preferably, the average molecular weight of chitosan in the chitosan hydrochloride is 40,000-60,000 D.

[0025] Preferably, the deacetylation degree of chitosan in the chitosan hydrochloride is greater than or equal to 90%.

[0026] Preferably, the chitosan hydrochloride is chitosan quaternary ammonium salt.

[0027] The third aspect of the present invention also provides a use of the above-mentioned traditional Chinese medicine composition for post-hemorrhoid operation repair, which is used for the repair of the wound surface after hemorrhoid surgery.

[0028] By implementing the above technical solutions, the present invention has the following beneficial effects:

[0029] 1. The traditional Chinese medicine composition provided by the present invention, through the compatibility of each component, is suitable for the repair of the wound surface after hemorrhoid surgery, systematically solves the problems of bleeding, pain, infection and slow healing in post-hemorrhoid operation repair, and has a rapid repair effect on the wound surface after hemorrhoid surgery.

[0030] 2. The composition of the present invention, with the aid of chitosan hydrochloride, can quickly form a film on the wound surface after spraying, and can stably adhere after forming the film, promoting the efficacy of the drug. Detailed implementation mode

[0031] The present invention will be described in detail below with reference to specific embodiments.

[0032] Example 1

[0033] This example provides a traditional Chinese medicine composition for dispelling stasis and dredging collaterals: 28 g of speranskia herb, 20 g of rhubarb, 20 g of schizonepeta, 15 g of phellodendron bark, 15 g of purslane, 15 g of sophora flavescens, 15 g of Japanese pagoda tree fruit, 15 g of sanguisorba root, and 10 g of borneol.

[0034] Example 2

[0035] This example provides a traditional Chinese medicine composition for dispelling stasis and dredging collaterals: 30 g of speranskia herb, 20 g of rhubarb, 20 g of schizonepeta, 15 g of phellodendron bark, 15 g of purslane, 15 g of sophora flavescens, 15 g of Japanese pagoda tree fruit, 15 g of sanguisorba root, and 10 g of borneol.

[0036] Example 3

[0037] This example provides a traditional Chinese medicine composition for dispelling stasis and dredging collaterals: 30 g of speranskia herb, 22 g of rhubarb, 22 g of schizonepeta, 15 g of phellodendron bark, 15 g of purslane, 15 g of sophora flavescens, 15 g of Japanese pagoda tree fruit, 15 g of sanguisorba root, and 10 g of borneol.

[0038] Example 4

[0039] This example provides a traditional Chinese medicine composition for dispelling stasis and dredging collaterals: 35 g of speranskia herb, 20 g of rhubarb, 20 g of schizonepeta, 15 g of phellodendron bark, 15 g of purslane, 15 g of sophora flavescens, 15 g of Japanese pagoda tree fruit, 15 g of sanguisorba root, and 10 g of borneol. The traditional Chinese medicine compositions corresponding to Examples 1 - 4 are extracted to prepare an extract.

[0040] The extraction steps are as follows:

[0041] 1. Add water with a weight 10 times that of the medicinal materials to the traditional Chinese medicine composition and soak for 2 h.

[0042] 2. Decoct for 1 h and filter.

[0043] 3. Add water with a weight 8 times that of the medicinal materials to the medicinal residues, decoct for another 1 h, and filter;

[0044] 4. Add water with a weight 8 times that of the medicinal materials to the medicinal residues, decoct for another 1 h, and filter;

[0045] 5. Combine the decoction liquids from the 3 times of decoction, and concentrate under reduced pressure to about 0.8 kg to obtain a traditional Chinese medicine concentrated liquid.

[0046] Example 5

[0047] This example provides a traditional Chinese medicine spray - forming film preparation for dispelling stasis and dredging collaterals, including: a traditional Chinese medicine composition for dispelling stasis and dredging collaterals and quaternary ammonium salt of chitosan.

[0048] In this example, first, the effects of the addition amount of quaternary ammonium salt of chitosan, the average molecular weight of chitosan, and the degree of deacetylation on the results were tested. The test table is shown in Table 1 (using the traditional Chinese medicine composition of Example 1 as the test object).

[0049] Table 1 Film - forming performance test table

[0050]

[0051] Finally, relevant preparations were prepared according to the chitosan quaternary ammonium salt addition amount of 1.2%, the average molecular weight of 40,000 - 60,000 D, and the deacetylation degree of ≥95%.

[0052] The traditional Chinese medicine spray film-forming preparation includes: 98.8% of the traditional Chinese medicine composition corresponding to Examples 1 to 4, and 1.2% of chitosan quaternary ammonium salt (the average molecular weight of chitosan is 40,000 - 60,000 D, and the deacetylation degree is ≥95%).

[0053] The preparations corresponding to the traditional Chinese medicine compositions in Examples 1 to 4 were respectively denoted as Preparation A, Preparation B, Preparation C, and Preparation D.

[0054] Antibacterial experiments (paper disk diffusion method) were carried out on the preparations A, B, C, and D of the examples. The experimental bacterial strains were selected as follows:

[0055] Escherichia coli (ATCC 25922), Staphylococcus aureus (ATCC 25923), Pseudomonas aeruginosa (ATCC 27853)

[0056] At the same time, a control was set: 0.1% chlorhexidine solution (broad-spectrum antibacterial agent) and a negative control: normal saline.

[0057] Experimental method:

[0058] 1. The bacterial solution (concentration 1×10 6 CFU / mL) was evenly spread on the MHA agar plate.

[0059] 2. Sterile filter paper disks (diameter 6 mm) were respectively soaked in the experimental group and control group solutions, and after draining, they were pasted on the agar surface.

[0060] 3. After culturing at 37°C for 24 hours, the diameter of the antibacterial zone (including the paper disk) was measured.

[0061] Each group of experiments was repeated 3 times, and the average value was taken.

[0062] Evaluation index:

[0063] Diameter of the antibacterial zone: ≥20 mm: strong antibacterial effect; 15 - 19 mm: moderate antibacterial effect; ≤14 mm: low or no antibacterial effect.

[0064] See Table 2 for the experimental results:

[0065] Table 2 Antibacterial experiment results

[0066]

[0067]

[0068] As can be seen from Table 2, the preparations A, B, C, and D of the present invention all have good antibacterial effects.

[0069] Application Example 1

[0070] Clinically, 40 volunteers who had undergone hemorrhoid surgery (patients aged 30 - 40 years) were selected. The preparations A, B, C, and D corresponding to Examples 1 - 4 were directly filled into spray bottles, and 10 patients were treated with each preparation. The preparations were sprayed into the anus and the skin around the anus of the patients who had undergone hemorrhoid surgery, twice a day.

[0071] The repair time of the hemorrhoid surgery wound surface (average value of the time of 10 patients) was statistically analyzed, and the results are shown in Table 3.

[0072] Table 3

[0073] Repair time (days) of hemorrhoid surgery wound Preparation A 15 Preparation B 10 Preparation C 12 Preparation D 12

[0074] Application Example 2

[0075] Clinically, 40 volunteers who had undergone hemorrhoid surgery (patients aged 30 - 40 years) were selected. The preparations A1, B1, C1, and D1 obtained in Example 5 were filled into spray bottles. The preparations could form a film on the surface of the wound within 30 seconds after spraying into the anus and the skin around the anus of the patients who had undergone hemorrhoid surgery (10 patients were treated with each preparation), twice a day.

[0076] Meanwhile, 10 patients in the control group (patients aged 30 - 40 years) received conventional postoperative care (cleaning with normal saline + covering with vaseline gauze).

[0077] The repair time of the hemorrhoid surgery wound surface (average value of the time of 10 patients) was statistically analyzed, and the results are shown in Table 4.

[0078] Table 4

[0079] Repair time (days) of hemorrhoid surgery wound Preparation A1 7 Preparation B1 6 Preparation C1 8 Preparation D1 7 Control group 22

[0080] By comparing Table 4 with Table 3, it can be seen that the preparations A1, B1, C1, and D1 prepared in Example 5 can form a local skin protection film and have an isolating effect on the skin. The traditional Chinese medicine in them has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, and directly acts on the surface of the wound, having a better repair effect on the wound.

[0081] Next, the curative effects of the wound complications of the patients using the preparations A1, B1, C1, and D1 were statistically analyzed. The statistical items and results are as follows.

[0082] 1. Postoperative pain condition

[0083] The pain of the patients was evaluated on the 1st, 3rd, and 7th days after surgery (the same analgesia regimen was uniformly used after surgery to avoid drug interference).

[0084] The scoring method used was the visual analogue scale (VAS), where 0 points represented no symptoms and 10 points represented the most severe symptoms. The specific pain scores were as follows:

[0085] VAS = 0, painless; 1 ≤ VAS < 3, mild pain; 4 < VAS < 6, moderate pain; 7 < VAS < 10, severe pain. The pain values were recorded and statistically analyzed.

[0086] The patients were guided by trained nurses to complete the scoring independently.

[0087] Before each scoring, it was uniformly stated: "Please mark on the line from 0 to 10 according to the current pain level."

[0088] The data was independently entered by two people to ensure accuracy.

[0089] The results are shown in Table 5.

[0090] Table 5

[0091]

[0092]

[0093] Note: Compared with the control group, *P < 0.05, the difference was statistically significant.

[0094] It can be seen from Table 5 that the traditional Chinese medicine spray film-forming preparation of the present invention (especially preparation B1) can significantly shorten the duration of postoperative pain of hemorrhoids and accelerate pain relief.

[0095] 2. Anal margin edema condition after surgery

[0096] The anal margin edema condition of the patients after surgical treatment was recorded on the 1st, 3rd, and 7th days after surgery (the same dose of diosmin (venous active drug) was uniformly used after surgery to control the basic edema).

[0097] No edema of the anal margin skin was 0 points; mild elevation of the anal margin skin, 1 area of edema, diameter < 1 cm was 2 points; moderate elevation of the anal margin skin with 1 or more areas of edema, 1 cm < diameter < 2 cm was 4 points; obvious elevation of the anal margin skin, 1 or more areas of edema, diameter > 2 cm was 6 points.

[0098] The edema condition was independently evaluated by 2 anorectal surgeons who did not participate in the grouping, and the mean value was taken.

[0099] The results are shown in Table 6.

[0100] Table 6

[0101] Preparation A1 Preparation B1 Preparation C1 Preparation D1 Control group The first day after surgery 5.2±0.9* 3.0±0.5* 4.2±0.8* 3.8±06* 5.8±1.0 The third day after surgery 3.5±0.6* 1.6±0.3* 3.3±0.3* 2.8±0.5* 4.8±0.9 The seventh day after surgery 1.8±0.4* 0.3±0.1* 1.6±0.2* 1.2±0.3* 3.0±0.7

[0102] Note: Compared with the control group, *P < 0.05, the difference was statistically significant.

[0103] As can be seen from Table 6, the traditional Chinese medicine spray film-forming preparation of the present invention (especially preparation B1) can significantly reduce the postoperative perianal edge edema and accelerate the regression of edema.

Claims

1. A traditional Chinese medicine composition for postoperative repair of hemorrhoids, characterized in that, Comprising the following components in parts by weight: 20 - 33 parts of Speranskia tuberculata, 18 - 20 parts of Rheum officinale, 15 - 25 parts of Schizonepeta tenuifolia, 16 - 18 parts of Phellodendron amurense, 16 - 19 parts of Portulaca oleracea, 10 - 15 parts of Sophora flavescens, 12 - 15 parts of Sophora japonica, 14 - 16 parts of Sanguisorba officinalis, 8 - 12 parts of Borneol.

2. The traditional Chinese medicine composition for postoperative repair of hemorrhoids according to claim 1, wherein The traditional Chinese medicine composition comprises the following components in parts by weight: 30 parts of Speranskia tuberculata, 20 parts of Rheum officinale, 20 parts of Schizonepeta tenuifolia, 15 parts of Phellodendron amurense, 15 parts of Portulaca oleracea, 15 parts of Sophora flavescens, 15 parts of Sophora japonica, 15 parts of Sanguisorba officinalis, 10 parts of Borneol.

3. A traditional Chinese medicine spray film-forming preparation for postoperative repair of hemorrhoids, characterized in that, Comprising the following components: traditional Chinese medicine extract, accounting for 95% - 99% of the total mass of the preparation, and the raw materials of the traditional Chinese medicine extract comprise the following components in parts by weight: 20 - 33 parts of Speranskia tuberculata, 18 - 20 parts of Rheum officinale, 15 - 25 parts of Schizonepeta tenuifolia, 16 - 18 parts of Phellodendron amurense, 16 - 19 parts of Portulaca oleracea, 10 - 15 parts of Sophora flavescens, 12 - 15 parts of Sophora japonica, 14 - 16 parts of Sanguisorba officinalis, 8 - 12 parts of Borneol; Chitosan hydrochloride, accounting for 1% - 5% of the total mass of the preparation.

4. The Chinese medicine spray film-forming preparation for postoperative repair of hemorrhoids according to claim 3, characterized in that, The raw materials of the traditional Chinese medicine extract comprise the following components in parts by weight: 30 parts of Speranskia tuberculata, 20 parts of Rheum officinale, 20 parts of Schizonepeta tenuifolia, 15 parts of Phellodendron amurense, 15 parts of Portulaca oleracea, 15 parts of Sophora flavescens, 15 parts of Sophora japonica, 15 parts of Sanguisorba officinalis, 10 parts of Borneol.

5. The Chinese medicine spray film-forming preparation for postoperative repair of hemorrhoids according to claim 3, characterized in that, The average molecular weight of chitosan in the chitosan hydrochloride is 40000 - 60000 D.

6. The Chinese medicine spray film-forming preparation for postoperative repair of hemorrhoids according to claim 3, characterized in that, The deacetylation degree of chitosan in the chitosan hydrochloride is greater than or equal to 90%.

7. A traditional Chinese medicine spray film-forming preparation for postoperative repair of hemorrhoids according to claim 3, characterized in that, The chitosan hydrochloride is a chitosan quaternary ammonium salt.

8. The Chinese medicine spray film-forming preparation for postoperative repair of hemorrhoids according to claim 3, characterized in that, The traditional Chinese medicine spray film-forming preparation can form a film 30 s after spraying.

9. Use of a traditional Chinese medicine composition for postoperative repair of hemorrhoids as described in any one of claims 1-2 or a traditional Chinese medicine spray film-forming preparation for postoperative repair of hemorrhoids as described in any one of claims 3-8, characterized in that For the repair of the wound surface after hemorrhoid surgery.

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