Sodium phosphate compound as well as preparation method and application thereof

Abstract

The invention provides a sodium phosphate compound. The sodium phosphate compound comprises 15-30 parts by weight of sodium dihydrogen phosphate or a monohydrate of sodium dihydrogen phosphate; 3-6 parts by weight of disodium hydrogen phosphate; 0.05 to 0.3 part by weight of licardoine hydrochloride; 0 to 0.04 part by weight of an aromatic; and 0 to 0.25 part by weight of a sweetening agent. Sodium dihydrogen phosphate or a monohydrate of sodium dihydrogen phosphate, disodium hydrogen phosphate and lidocaine hydrochloride are prepared into a compound, and the compound is administrated when being used, so that the compound has a remarkable clinical effect when being used for cleaning intestinal tracts, the satisfaction degree of medication can be improved, the enteroscopy quality can be improved, the postoperative exhaust and defecation time can be shortened, and postoperative complications can be reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and particularly relates to a sodium phosphate complex, a preparation method thereof, and an application thereof. Background Art

[0002] Sodium phosphate is a high-quality intestinal preparation drug used for cleaning the intestine before colon X-ray, intestinal endoscopy examination or surgery of patients.

[0003] Currently, the marketed preparations of sodium phosphate include powders, oral solutions and tablets. Among them, the oral solution is inconvenient to carry and contains preservatives, having potential safety hazards and being not suitable for use by elderly patients or children; when the tablets are administered orally, the dosage for cleaning the intestine once is 40 tablets and needs to be taken in several times, with a large number of tablets to be taken, bringing inconvenience to patients; the powder has no potential safety hazards and is relatively convenient to take, becoming the currently commonly used dosage form.

[0004] Chinese Patent CN102232969B discloses a sodium phosphate powder, including sodium dihydrogen phosphate, disodium hydrogen phosphate, dimethicone and silicon dioxide. This composition has a significant clinical effect when cleaning the intestine, with excellent intestinal cleanliness, good patient tolerance and little electrolyte disorder, but the satisfaction of taking the powder is poor, the postoperative exhaust and defecation times are long, and the postoperative complication indexes are not ideal. Summary of the Invention

[0005] In view of this, the present invention provides a sodium phosphate complex, a preparation method thereof, and an application thereof. The sodium phosphate complex provided by the present application has a significant clinical effect when used for cleaning the intestine, can improve the satisfaction of taking medicine, improve the quality of colonoscopy examination, and reduce the postoperative exhaust and defecation times and postoperative complications.

[0006] The present application provides a sodium phosphate complex, including:

[0007] 15 to 30 parts by weight of sodium dihydrogen phosphate or its monohydrate;

[0008] 3 to 6 parts by weight of disodium hydrogen phosphate;

[0009] 0.05 to 0.3 parts by weight of lidocaine hydrochloride;

[0010] 0 to 0.04 parts by weight of fragrance

[0011] 0 to 0.25 parts by weight of sweetener.

[0012] In some specific implementation manners, the sweetener is selected from one or more of acesulfame potassium, sucralose or sodium saccharin.

[0013] In some specific implementation manners, the fragrance is selected from lemon essence.

[0014] In some specific implementation manners, the particle sizes of the sodium dihydrogen phosphate or its monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride and the sweetener are less than 80 mesh.

[0015] In some specific implementation manners, the amount of the flavoring agent is 0.015 to 0.04 parts by weight.

[0016] In some specific implementation manners, the amount of the sweetener is 0.05 to 0.25 parts by weight.

[0017] The present application also provides a preparation method of the sodium phosphate complex as described in the above technical solution, including the following steps:

[0018] Mix the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride, optional sweetener and flavoring agent evenly to obtain the sodium phosphate complex.

[0019] In some specific implementation manners, the sodium dihydrogen phosphate raw material is sodium dihydrogen phosphate monohydrate;

[0020] Before mixing, pass the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride and the sweetener through an 80-mesh sieve.

[0021] In some specific implementation manners, the rotation speed of the mixing is 1 to 10 revolutions per minute, and the time is 10 to 60 minutes.

[0022] The present application also provides the use of the sodium phosphate complex as described in the above technical solution in the preparation of a drug for shortening the defecation time after colonoscopy and / or reducing the complications after colonoscopy.

[0023] The present application prepares a complex of sodium dihydrogen phosphate or its monohydrate, disodium hydrogen phosphate and lidocaine hydrochloride, and administers the drugs simultaneously during use. It has a significant clinical effect in cleaning the intestine, can improve the medication satisfaction, improve the quality of colonoscopy, reduce the postoperative exhaust and defecation time and postoperative complications. The experimental results show that, compared with separately administering sodium phosphate powder, sodium phosphate powder + lidocaine hydrochloride mucilage 4 to 6 hours before surgery, and sodium phosphate powder + lidocaine hydrochloride mucilage 5 to 10 minutes before surgery, preparing a complex of sodium phosphate and lidocaine hydrochloride and administering them simultaneously in the present application is superior to sodium phosphate powder in terms of the satisfaction with the intestinal preparation effect and intestinal cleanliness, and is equivalent to the effect of the sequential combined use of sodium phosphate powder and lidocaine, without obvious improvement. However, preparing a complex of sodium phosphate and lidocaine hydrochloride and administering them simultaneously in the present application is significantly superior to sodium phosphate powder and the sequential combined use of sodium phosphate powder and lidocaine in terms of indexes such as postoperative exhaust and defecation time and postoperative complications. Specific Embodiments

[0024] It should be understood that the expression "one or more of..." individually includes each of the recited objects following the expression and various different combinations of two or more of the recited objects, unless otherwise understood from the context and usage. The expression "and / or" in combination with three or more recited objects should be understood to have the same meaning, unless otherwise understood from the context.

[0025] The terms "comprising", "having" or "containing", including the use of their grammatical synonyms, should generally be understood as open-ended and non-limiting, for example, not excluding other unrecited elements or steps, unless specifically stated otherwise or otherwise understood from the context.

[0026] It should be understood that the order of steps or the order of performing certain actions is not important as long as the present invention remains operable. In addition, two or more steps or actions can be performed simultaneously.

[0027] The use of any and all examples or exemplary language such as "for example" or "including" in this document is merely intended to better illustrate the present invention and does not limit the scope of the present invention unless a claim is made. No language in this specification should be construed as indicating that any unclaimed element is essential for the practice of the present invention.

[0028] In addition, the numerical ranges and parameters used to define the present invention are approximate values. The relevant numerical values in the specific embodiments have been presented as precisely as possible herein. However, any numerical value inherently and inevitably contains standard deviations resulting from individual testing methods. Therefore, unless otherwise clearly stated, it should be understood that all ranges, quantities, numerical values and percentages used in this disclosure are modified by "about". Here, "about" generally means that the actual value is within plus or minus 10%, 5%, 1% or 0.5% of a specific numerical value or range.

[0029] The present invention provides a sodium phosphate complex, comprising:

[0030] 15 to 30 parts by weight of sodium dihydrogen phosphate or its monohydrate;

[0031] 3 to 6 parts by weight of disodium hydrogen phosphate;

[0032] 0.05 to 0.3 parts by weight of lidocaine hydrochloride;

[0033] 0 to 0.04 parts by weight of flavoring agent

[0034] 0 to 0.25 parts by weight of sweetener.

[0035] Lidocaine hydrochloride is an amide local anesthetic drug. After absorption into the blood or intravenous administration, it has obvious biphasic effects of excitation and inhibition on the central nervous system, and there may be no prior excitation. When the blood drug concentration is relatively low, analgesia, drowsiness, and an increased pain threshold occur. The applicant unexpectedly found that making a complex of sodium phosphate and lidocaine hydrochloride and administering them simultaneously is significantly superior to sodium phosphate powder and the sequential combined use of sodium phosphate powder and lidocaine in terms of indicators such as postoperative exhaust and defecation time and postoperative complications.

[0036] In some specific implementation manners, the sodium phosphate complex includes 15 to 30 parts by weight of sodium dihydrogen phosphate or its monohydrate and 3 to 6 parts by weight of disodium hydrogen phosphate. Sodium dihydrogen phosphate and disodium hydrogen phosphate are the main components of sodium phosphate, and there are no special restrictions in this application. In some specific implementation manners, the amount of sodium dihydrogen phosphate is preferably 18 to 28 parts by weight, more preferably 20 to 25 parts by weight; the amount of disodium hydrogen phosphate is preferably 4 to 5 parts by weight. In some specific implementation manners, the particle size of sodium dihydrogen phosphate and disodium hydrogen phosphate is below 80 mesh.

[0037] The sodium phosphate complex further includes lidocaine hydrochloride. In this application, the role of lidocaine hydrochloride is to be compounded with sodium phosphate to reduce the postoperative exhaust and defecation time, postoperative complications, etc. In some specific implementation manners, the amount of lidocaine hydrochloride is preferably 0.05 to 0.3 parts by weight, more preferably 0.1 to 0.25 parts by weight, and even more preferably 0.15 to 0.2 parts by weight. In some specific implementation manners, the lidocaine hydrochloride is in powder form, and its particle size is preferably below 80 mesh.

[0038] In some specific implementation manners, the sodium phosphate complex optionally includes a flavoring agent or a sweetening agent to improve its taste and flavor. In some specific implementation manners, the sweetening agent includes, but is not limited to, one or more of acesulfame potassium, sucralose, or sodium saccharin, and the amount of the sweetening agent is 0 to 0.25 parts by weight, preferably 0.05 to 0.25 parts by weight. In some specific implementation manners, the flavoring agent includes, but is not limited to, lemon essence, and the amount of the flavoring agent is 0 to 0.04 parts by weight, preferably 0.015 to 0.04 parts by weight.

[0039] The present invention also provides a preparation method of the sodium phosphate complex described in the above technical solution, including the following steps:

[0040] Mix the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride, optional sweetening agent, and flavoring agent evenly to obtain the sodium phosphate complex.

[0041] The present invention mixes sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride, optional sweetener and flavoring agent evenly to obtain a sodium phosphate salt complex. In some specific implementation manners, the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride, optional sweetener and flavoring agent are evenly mixed in a hopper mixer.

[0042] In some specific implementation manners, the sodium dihydrogen phosphate raw material is sodium dihydrogen phosphate monohydrate. Before mixing, the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride and sweetener are sieved through a 80-mesh sieve. Specifically, before mixing, the sodium dihydrogen phosphate raw material and disodium hydrogen phosphate raw material are directly sieved through an 80-mesh sieve, and lidocaine hydrochloride and sweetener are crushed and then sieved through an 80-mesh sieve.

[0043] In some specific implementation manners, the rotation speed of the mixing is 1 rpm to 10 rpm, preferably 3 rpm to 8 rpm, and the time is 10 minutes to 60 minutes, preferably 15 minutes to 45 minutes. After mixing is completed, the obtained mixture is sub-packed to obtain the sodium phosphate salt complex.

[0044] This application uses the sodium phosphate salt complex for preoperative intestinal cleaning, which can not only improve the medication satisfaction and intestinal cleanliness, but also reduce the postoperative exhaust and defecation time and the occurrence of postoperative complications, etc.

[0045] The following further illustrates the sodium phosphate salt complex and its preparation method provided by this application in conjunction with examples.

[0046] Example 1

[0047] 1. Prescription:

[0048] Sodium dihydrogen phosphate monohydrate 21.6 kg Disodium hydrogen phosphate 4.3 kg Lidocaine hydrochloride 0.10 kg Saccharin sodium 0.1 kg Lemon essence 0.015 kg Manufactured into 1000 bags

[0049] 2. Preparation process steps:

[0050] (1) Pretreatment of raw and auxiliary materials

[0051] Sieve sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate through an 80-mesh sieve and set aside;

[0052] Crush lidocaine hydrochloride and saccharin sodium and sieve through an 80-mesh sieve and set aside;

[0053] (2) Total mixing: Weigh the above-mentioned sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride and saccharin sodium that have been crushed and sieved, add them to a hopper mixer, and then weigh the prescribed amount of lemon essence and add it to the hopper mixer. Set the mixing rotation speed at 6 rpm and the mixing time at 30 minutes, and mix them evenly.

[0054] (3) Sub-packaging: The mixed materials are sub-packaged with aluminum-plastic composite film to obtain the sodium phosphate complex.

[0055] Example 2

[0056] 1. Prescription:

[0057] Sodium dihydrogen phosphate monohydrate 21.6 kg Disodium hydrogen phosphate 4.3 kg Lidocaine hydrochloride 0.15 kg Acesulfame potassium 0.15 kg Lemon essence 0.030 kg Manufactured into 1000 bags

[0058] 2. Preparation process steps:

[0059] (1) Pretreatment of raw and auxiliary materials

[0060] Sieve monohydrate sodium dihydrogen phosphate and disodium hydrogen phosphate through a 80-mesh sieve and set aside;

[0061] Crush lidocaine hydrochloride and acesulfame potassium through an 80-mesh sieve and set aside;

[0062] (2) Total mixing: Weigh the above-mentioned monohydrate sodium dihydrogen phosphate, disodium hydrogen phosphate, lidocaine hydrochloride and acesulfame potassium that have been crushed and sieved, add them to a hopper mixer, and then weigh the prescribed amount of lemon essence and add it to the hopper mixer. Set the mixing speed at 8 revolutions per minute and the mixing time at 15 minutes to mix them evenly.

[0063] (3) Sub-packaging: The mixed materials are sub-packaged with aluminum-plastic composite film to obtain the sodium phosphate complex.

[0064] Example 3

[0065] 1. Prescription:

[0066] Sodium dihydrogen phosphate monohydrate 21.6 kg Disodium hydrogen phosphate 4.3 kg Lidocaine hydrochloride 0.20 kg Sucralose 0.05 kg Lemon essence 0.040 kg Manufactured into 1000 bags

[0067] 2. Preparation process steps:

[0068] (1) Pretreatment of raw and auxiliary materials

[0069] Sieve monohydrate sodium dihydrogen phosphate and disodium hydrogen phosphate through an 80-mesh sieve and set aside;

[0070] Crush lidocaine hydrochloride and sucralose through an 80-mesh sieve and set aside;

[0071] (2) Total mixing: Weigh the above-mentioned monohydrate sodium dihydrogen phosphate, disodium hydrogen phosphate, lidocaine hydrochloride and sucralose that have been crushed and sieved, add them to a hopper mixer, and then weigh the prescribed amount of lemon essence and add it to the hopper mixer. Set the mixing speed at 10 revolutions per minute and the mixing time at 45 minutes to mix them evenly.

[0072] (3) Sub-packaging: The mixed materials are sub-packaged with aluminum-plastic composite film to obtain the sodium phosphate complex

[0073] Example 4

[0074] 1. Prescription:

[0075] Sodium dihydrogen phosphate monohydrate 21.6 kg Disodium hydrogen phosphate 4.3 kg Lidocaine hydrochloride 0.18 kg Acesulfame potassium 0.25 kg Lemon essence 0.02 kg Manufactured into 1000 bags

[0076] 2. Preparation process steps:

[0077] (1) Pretreatment of raw and auxiliary materials

[0078] Pass monosodium phosphate monohydrate and disodium hydrogen phosphate through an 80 - mesh sieve and set aside.

[0079] Crush lidocaine hydrochloride and acesulfame potassium through an 80 - mesh sieve and set aside.

[0080] (2) Total mixing: Weigh the above - crushed and sieved monosodium phosphate monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride and acesulfame potassium and add them to a hopper mixer. Then weigh the prescribed amount of lemon and banana and add them to the hopper mixer. Set the mixing speed at 7 revolutions per minute and the mixing time at 25 minutes to mix them evenly.

[0081] (3) Sub - packaging: Sub - package the mixed material with an aluminum - plastic composite film to obtain the sodium phosphate complex.

[0082] Test example

[0083] From November 2023 to December 2023, 120 cases received routine colonoscopy in a certain hospital in Hubei. A randomized, blinded, controlled design was adopted. The 120 patients were randomly divided into Control Group 1 (commercial sodium phosphate powder) with 30 cases, Control Group 2 (commercial sodium phosphate powder + taking lidocaine hydrochloride mucilage 4 - 6 hours before surgery) with 30 cases, Control Group 3 (commercial sodium phosphate powder + taking lidocaine hydrochloride mucilage 5 - 10 minutes before surgery) with 30 cases, and the Experimental Group (sodium phosphate complex prepared in Example 1) with 30 cases. Among them, in Control Group 1, there were 17 males and 13 females, with an average age of 57.8 years; in Control Group 2, there were 14 males and 16 females, with an average age of 55.9 years; in Control Group 3, there were 15 males and 15 females, with an average age of 58.5 years; in the Experimental Group, there were 16 males and 14 females, with an average age of 54.5 years. There were no statistically significant differences in gender, age, height, body weight, heart rate, blood pressure, and purpose of bowel preparation among the four groups (P > 0.05), and they were comparable.

[0084] Treatment method:

[0085] Control Group 1 (marketed sodium phosphate powder, Sichuan Jianneng Pharmaceutical Co., Ltd., batch number: 230401, marketed lidocaine hydrochloride mucilage, Sichuan Jianneng Pharmaceutical Co., Ltd., batch number: 230203). After diluting the sodium phosphate powder with warm water, take 1 bag at 19:00 on the night before the examination and at 7:00 on the same day (the dosage is 21.6 g of sodium dihydrogen phosphate and 4.3 g of disodium hydrogen phosphate). You can continue to drink water until clear watery stools are excreted. Take 10 g of lidocaine hydrochloride mucilage (0.2 g in terms of lidocaine hydrochloride) at 5:00 on the same day (4 - 6 hours in advance).

[0086] Control Group 2 (marketed sodium phosphate powder, Sichuan Jianneng Pharmaceutical Co., Ltd., batch number: 230401, marketed lidocaine hydrochloride mucilage, Sichuan Jianneng Pharmaceutical Co., Ltd., batch number: 230203). After diluting the sodium phosphate powder with warm water, take 1 bag at 19:00 on the night before the examination and at 7:00 on the same day (the dosage is 21.6 g of sodium dihydrogen phosphate and 4.3 g of disodium hydrogen phosphate). You can continue to drink water until clear watery stools are excreted. Take 10 g of lidocaine hydrochloride mucilage (0.2 g in terms of lidocaine hydrochloride) at 9:50 - 9:55 on the same day (5 - 10 minutes in advance).

[0087] Control Group 3 (marketed sodium phosphate powder, Sichuan Jianneng Pharmaceutical Co., Ltd., batch number: 230401). After diluting the sodium phosphate powder with warm water, take 1 bag at 19:00 on the night before the examination and at 7:00 on the same day (the dosage is 21.6 g of sodium dihydrogen phosphate and 4.3 g of disodium hydrogen phosphate). You can continue to drink water until clear watery stools are excreted.

[0088] Experimental Group (self - made product, Example 1). After diluting the sodium phosphate complex with warm water, take 1 bag each at 19:00 on the night before the examination and at 7:00 on the same day (the dosage of 1 bag is 21.6 g of sodium dihydrogen phosphate, 4.3 g of disodium hydrogen phosphate, and 0.1 g of lidocaine hydrochloride). You can continue to drink water until clear watery stools are excreted.

[0089] Observation Items:

[0090] 1. Distribute questionnaires to investigate the satisfaction of patients, doctors, and nurses with the effect of bowel preparation. The satisfaction of patients includes indicators such as medication compliance and the tolerance of patients during the detection process. The satisfaction of doctors and nurses includes indicators such as the cooperation degree of patients, the smoothness of the examination process, and the overall satisfaction of the examination.

[0091] 2. Evaluation of intestinal cleanliness effect: Excellent (Grade 3): The intestinal tract is empty, collapsed, without gas accumulation, the mucosa is not congested, and the surgical field is completely exposed; Good (Grade 2): The intestinal tract is not full, with a small amount of gas, the mucosa is slightly congested, and the surgical field is completely exposed; Moderate (Grade 1): The intestinal tract is not full, with a large amount of gas, the mucosa is congested, and the surgical field is not completely exposed; Poor (Grade 0): The intestinal tract is inflated, with a large amount of gas accumulation, the mucosa is significantly congested, and the surgical field is not covered.

[0092] 3. Observe the postoperative exhaust and defecation times of the four groups of patients.

[0093] 4. Observe the occurrence of postoperative complications such as incision infection, abdominal cavity infection, anastomotic fistula, etc. in the four groups of patients.

[0094] The treatment results are as follows:

[0095] (1) Satisfaction with the effect of intestinal preparation

[0096] Table 1 Comparison of satisfaction with the effect of intestinal preparation among patients, doctors, and nurses (%)

[0097]

[0098] As can be seen from Table 1, the overall satisfaction of the experimental group was 90.00% - 96.67%; the overall satisfaction of Control Group 1 and Control Group 2 was 76.67% - 83.33%, and the overall satisfaction of Control Group 3 was 66.67% - 73.33%. The overall satisfaction of the experimental group was much higher than that of the control groups, indicating that the complex provided by this application can effectively improve the satisfaction with the effect of intestinal preparation.

[0099] (2) Intestinal cleanliness

[0100] Table 2 Comparison of the total colon cleaning quality among the four groups of patients

[0101] Group Number of cases Grade 0 Grade 1 Grade 2 Grade 3 Experimental group 30 1(3.3％) 1(3.3％) 2(6.7％) 26(86.7％) Control group 1 30 2(6.67％) 4(13.3％) 2(6.7％) 22(73.3％) Control group 2 30 2(6.7％) 3(10.0％) 3(10.0％) 22(73.3％) Control group 3 30 3(10.0％) 4(13.3％) 3(10.0％) 20(66.7％)

[0102] As can be seen from Table 2, the total colon cleaning quality of the experimental group reached 86.7% - 93.3%; the total colon cleaning quality of Control Group 1 was 73.3% - 80.0%; the total colon cleaning quality of Control Group 2 was 73.3% - 83.3%, and the total colon cleaning quality of Control Group 3 was 66.7% - 76.7%. The total colon cleaning quality of the experimental group was much higher than that of the control groups, indicating that the complex provided by this application can effectively improve intestinal cleanliness.

[0103] (3) Comparison of postoperative exhaust and defecation times between the two groups of patients

[0104] Table 3 Comparison of postoperative exhaust and defecation times among the four groups of patients (h, )

[0105] Group n Postoperative exhaust time Defecation time Experimental group 30 <![CDATA[17.32±3.988 abc > <![CDATA[51.15±10.952 abc > Control group 1 30 21.25±5.032 57.02±15.135 Control group 2 30 21.85±4.016 59.15±13.467 Control group 3 30 22.32±4.527 58.15±16.286

[0106] Note: When compared with control group 1, a: p < 0.05; when compared with control group 2, b: p < 0.05; when compared with control group 3, c: p < 0.05;

[0107] As can be seen from Table 3, the postoperative anal exhaust and defecation times of the patients in the experimental group were earlier than those in control groups 1 - 3, and all showed significant differences, indicating that the experimental group had obvious advantages in promoting postoperative exhaust and defecation times.

[0108] (4) Postoperative complications of the two groups

[0109] Table 4 Comparison of postoperative complications between the two groups of patients

[0110]

[0111] As can be seen from Table 4, the incidences of postoperative complications of the patients in the experimental group were significantly lower than those in control groups 1 - 3, indicating that the experimental group had obvious improvements in postoperative complications compared with the control groups.

[0112] As can be seen from Tables 1 - 4, compared with sodium phosphate powder, sodium phosphate powder + lidocaine hydrochloride mucilage administered separately 4 - 6 hours before surgery, and sodium phosphate powder + lidocaine hydrochloride mucilage administered separately 5 - 10 minutes before surgery, in this application, sodium phosphate and lidocaine hydrochloride are prepared into a complex and administered simultaneously, which is superior to sodium phosphate powder in terms of satisfaction with intestinal preparation effect and intestinal cleanliness, and is equivalent to the effect of sequential combined use of sodium phosphate powder and lidocaine, without obvious improvement. However, in this application, preparing sodium phosphate and lidocaine hydrochloride into a complex and administering them simultaneously is significantly superior to sodium phosphate powder and the sequential combined use of sodium phosphate powder and lidocaine in terms of postoperative exhaust and defecation times, postoperative complications and other indicators.

[0113] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A sodium phosphate complex, comprising: 15 to 30 parts by weight of sodium dihydrogen phosphate or its monohydrate; 3 to 6 parts by weight of disodium hydrogen phosphate; 0.05 to 0.3 parts by weight of lidocaine hydrochloride; 0 to 0.04 parts by weight of flavoring agent 0 to 0.25 parts by weight of sweetener.

2. The sodium phosphate complex according to claim 1, wherein The sweetener is selected from one or more of acesulfame potassium, sucralose or sodium saccharin.

3. The sodium phosphate complex according to claim 1, wherein The flavoring agent is selected from lemon essence.

4. The sodium phosphate complex according to any one of claims 1 to 3, characterized in that, The particle size of the sodium dihydrogen phosphate or its monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride and sweetener is less than 80 mesh.

5. The sodium phosphate complex according to claim 4, characterized in that, The amount of the flavoring agent is 0.015 to 0.04 parts by weight.

6. The sodium phosphate complex according to claim 5, wherein, The amount of the sweetener is 0.05 to 0.25 parts by weight.

7. A method for preparing the sodium phosphate complex according to any one of claims 1 to 6, comprising the following steps: Mixing the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride, optional sweetener and flavoring agent evenly to obtain the sodium phosphate complex.

8. The preparation method according to claim 7, characterized in that, The sodium dihydrogen phosphate raw material is sodium dihydrogen phosphate monohydrate; Before mixing, passing the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride and sweetener through an 80-mesh sieve.

9. The preparation method according to claim 8, characterized in that, The rotation speed of the mixing is 1 to 10 revolutions per minute, and the time is 10 to 60 minutes.

10. Use of the sodium phosphate complex according to any one of claims 1 to 6 in the preparation of a drug for shortening the defecation time after colonoscopy and / or reducing the complications after colonoscopy.

Images