Sodium phosphate salt complexes, methods of making and using the same

Abstract

The application provides a sodium phosphate salt complex, which comprises 15-30 parts by weight of sodium dihydrogen phosphate or a monohydrate thereof, 3-6 parts by weight of disodium hydrogen phosphate, 0.05-0.3 parts by weight of lidocaine hydrochloride, 0-0.04 parts by weight of a fragrance and 0-0.25 parts by weight of a sweetening agent. The sodium dihydrogen phosphate or the monohydrate thereof, the disodium hydrogen phosphate and the lidocaine hydrochloride are prepared into a complex, and are administered simultaneously in use, so that the clinical effect is remarkable when the intestines are cleaned, the drug satisfaction is improved, the enteroscopy quality is improved, the postoperative exhaust defecation time is reduced and postoperative complications are reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of pharmaceutical preparations, in particular to a sodium phosphate salt compound, a preparation method thereof and application thereof. BACKGROUND

[0002] The sodium phosphate salt is a high-quality intestinal preparation drug, which is used for cleaning the intestine before X-ray and endoscopy examination or surgery.

[0003] At present, the marketed preparations of the sodium phosphate salt include a powder, an oral solution and a tablet. Among them, the oral solution is inconvenient to carry, contains a preservative, has a safety hazard, and is not suitable for the elderly or children; when the tablet is orally administered, the dosage for cleaning the intestine once is 40 tablets, and needs to be taken in several times, the number of which is too large, which brings inconvenience to the patients; the powder has no safety hazard, and is convenient to take, and becomes a commonly used dosage form at present.

[0004] Chinese patent CN102232969B discloses a sodium phosphate salt powder, which comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, dimethicone and silicon dioxide. The composition has a significant clinical effect when cleaning the intestine, has excellent intestinal cleanliness, good patient tolerance, and small water and electrolyte disorder, but the satisfaction of the powder is poor, the postoperative exhaust and defecation time is long, and the postoperative complication index is not ideal. SUMMARY

[0005] Therefore, the present application provides a sodium phosphate salt compound, a preparation method thereof and application thereof. The sodium phosphate salt compound provided by the present application has a significant clinical effect when cleaning the intestine, can improve the satisfaction of the drug, improve the quality of enteroscopy, and reduce the postoperative exhaust, defecation time and postoperative complications.

[0006] The present application provides a sodium phosphate salt compound, which comprises:

[0007] 15-30 parts by weight of sodium dihydrogen phosphate or monohydrate thereof;

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

[0009] 0.05-0.3 parts by weight of linaclotide hydrochloride;

[0010] 0-0.04 parts by weight of a fragrance

[0011] 0-0.25 parts by weight of a sweetener.

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

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

[0014] In some specific implementations, the particle size of the sodium dihydrogen phosphate or monohydrate thereof, the disodium hydrogen phosphate, the lidocaine hydrochloride, and the sweetener is less than 80 mesh.

[0015] In some specific implementations, the amount of the fragrance is 0.015-0.04 parts by weight.

[0016] In some specific implementations, the amount of the sweetener is 0.05-0.25 parts by weight.

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

[0018] The sodium dihydrogen phosphate raw material, the disodium hydrogen phosphate raw material, the lidocaine hydrochloride, the optional sweetener, and the fragrance are mixed uniformly to obtain the sodium phosphate salt complex.

[0019] In some specific implementations, the sodium dihydrogen phosphate raw material is sodium dihydrogen phosphate monohydrate.

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

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

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

[0023] The present application prepares a complex of sodium dihydrogen phosphate or monohydrate thereof, disodium hydrogen phosphate, and lidocaine hydrochloride, and the three are administered simultaneously, which has a remarkable clinical effect in cleaning the intestinal tract, can improve the satisfaction of drug use, improve the quality of enteroscopy, reduce the postoperative exhaust and defecation time, and reduce postoperative complications. Experimental results show that, compared with sodium phosphate salt powder, sodium phosphate salt powder + lidocaine hydrochloride paste administered separately 4-6 hours before surgery, and sodium phosphate salt powder + lidocaine hydrochloride paste administered separately 5-10 minutes before surgery, the present application, which prepares a complex of sodium phosphate salt and lidocaine hydrochloride and administers the three simultaneously, is superior to sodium phosphate salt powder in terms of the satisfaction of intestinal tract preparation effect and the cleanliness of the intestinal tract, and is equivalent to the sequential combination of sodium phosphate salt powder and lidocaine, without obvious improvement. However, the present application, which prepares a complex of sodium phosphate salt and lidocaine hydrochloride and administers the three simultaneously, is obviously superior to sodium phosphate salt powder and the sequential combination of sodium phosphate salt powder and lidocaine in terms of postoperative exhaust and defecation time, postoperative complications, and other indicators. DETAILED DESCRIPTION

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

[0025] The use of the terms "including," "comprising," or "having" and variations thereof, as used in this document, are intended to be open-ended and non-limiting, for example, by not excluding other, unrecited elements or steps, unless otherwise specifically stated or understood from the context.

[0026] It should be understood that the order of steps or order for performing certain actions is immaterial so long as the application remains operable. Moreover, two or more steps or actions can be conducted simultaneously.

[0027] The use of any and all examples, or exemplary language herein, for example, "such as" or "including", is intended merely to better illustrate the application and does not indicate a limitation on the scope of the application unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the application.

[0028] Further, the numerical ranges and parameters setting forth the broadest scope of the application are approximations, and are only used to convey generally understood precision. Numerical parameters are only expected to be useful as definitions in any judicial or administrative ruling, and are not to be used in a literal and / or strict sense unless expressly so defined by the parties. Unless otherwise expressly provided, all ranges, quantities, numerical values and percentages used herein are modified to be "about" modified unless otherwise expressly provided. Herein, "about" is understood to be within ±10%, ±5%, ±1% or ±0.5% of a particular value or range.

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

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

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

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

[0033] 0 to 0.04 parts by weight of a fragrance

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

[0035] Lidocaine hydrochloride is an amide local anesthetic drug, and has obvious excitatory and inhibitory biphasic effects on the central nervous system after blood absorption or intravenous administration, and can have no precursor excitement, and when the blood drug concentration is low, analgesia and drowsiness, pain threshold increase. The applicant accidentally found that after the sodium phosphate salt and lidocaine hydrochloride were made into a compound and administered at the same time, the indexes such as postoperative exhaust and defecation time, postoperative complications were obviously better than those of sodium phosphate salt powder and the sequential combination of sodium phosphate salt powder and lidocaine.

[0036] In some specific implementations, the sodium phosphate salt compound includes 15-30 parts by weight of sodium dihydrogen phosphate or its monohydrate and 3-6 parts by weight of disodium hydrogen phosphate. Sodium dihydrogen phosphate and disodium hydrogen phosphate are the main components of sodium phosphate salt, and the present application has no special limitation. In some specific implementations, the amount of sodium dihydrogen phosphate is preferably 18-28 parts by weight, and more preferably 20-25 parts by weight; the amount of disodium hydrogen phosphate is preferably 4-5 parts by weight. In some specific implementations, the particle size of sodium dihydrogen phosphate and disodium hydrogen phosphate is below 80 mesh.

[0037] The sodium phosphate salt compound also includes lidocaine hydrochloride, which, in the present application, plays a role in reducing postoperative exhaust and defecation time, postoperative complications, etc. by compounding with sodium phosphate salt. In some specific implementations, the amount of lidocaine hydrochloride is preferably 0.05-0.3 parts by weight, more preferably 0.1-0.25 parts by weight, and more preferably 0.15-0.2 parts by weight. In some specific implementations, the lidocaine hydrochloride is a powder, and the particle size thereof is preferably below 80 mesh.

[0038] In some specific implementations, the sodium phosphate salt compound optionally includes a flavoring agent or a sweetener for improving its taste and flavor. In some specific implementations, the sweetener includes but is not limited to one or more of acesulfame potassium, sucralose or sodium saccharin, and the amount of the sweetener is 0-0.25 parts by weight, preferably 0.05-0.25 parts by weight. In some specific implementations, the flavoring agent includes but is not limited to lemon flavoring, and the amount of the flavoring agent is 0-0.04 parts by weight, preferably 0.015-0.04 parts by weight.

[0039] The present application also provides a preparation method of the sodium phosphate salt compound described in the above technical solution, which includes the following steps:

[0040] The sodium dihydrogen phosphate raw material, the disodium hydrogen phosphate raw material, the lidocaine hydrochloride, the optional sweetener and the flavoring agent are uniformly mixed to obtain the sodium phosphate salt compound.

[0041] The sodium phosphate salt complex can be obtained by mixing the sodium dihydrogen phosphate raw material, the disodium hydrogen phosphate raw material, the lidocaine hydrochloride, the optional sweetener and the fragrance uniformly. In some specific embodiments, the sodium dihydrogen phosphate raw material, the disodium hydrogen phosphate raw material, the lidocaine hydrochloride, the optional sweetener and the fragrance are mixed uniformly in a hopper mixer.

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

[0043] In some specific embodiments, the rotation speed of the mixing is 1-10 revolutions per minute, preferably 3-8 revolutions per minute, and the mixing time is 10-60 minutes, preferably 15-45 minutes. After the mixing is completed, the obtained mixture is divided into portions, and the sodium phosphate salt complex is obtained.

[0044] The sodium phosphate salt complex provided by the present application is used for preoperative bowel cleaning, which can not only improve the drug satisfaction and the cleanliness of the bowel, but also reduce the postoperative exhaust defecation time and postoperative complications.

[0045] The sodium phosphate salt complex provided by the present application and the preparation method thereof are further described below in combination with examples.

[0046] Example 1

[0047] 1. Prescription:

[0048] Sodium phosphate monobasic monohydrate 21.6 kg Sodium phosphate dibasic 4.3 kg Lidocaine hydrochloride 0.10 kg Saccharin sodium 0.1 kg Lemon flavor 0.015 kg Make 1000 bags

[0049] 2. Preparation process steps:

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

[0051] The sodium dihydrogen phosphate monohydrate and the disodium hydrogen phosphate are sieved through an 80-mesh sieve and prepared for use;

[0052] The lidocaine hydrochloride and the sodium saccharin are crushed and sieved through an 80-mesh sieve and prepared for use;

[0053] (2) Total mixing: The above sieved and crushed sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride and sodium saccharin are weighed and added to a hopper mixer, and the prescription amount of lemon essence is weighed and added to the hopper mixer. The mixing rotation speed is set to 6 revolutions per minute, and the mixing time is set to 30 minutes. The mixture is uniformly mixed.

[0054] (3) Packaging: the mixed material is packaged with aluminum plastic composite film to obtain a sodium phosphate salt complex.

[0055] Example 2

[0056] 1. Prescription:

[0057] Sodium phosphate monobasic monohydrate 21.6 kg Sodium phosphate dibasic 4.3 kg Lidocaine hydrochloride 0.15 kg Acesulfame potassium 0.15 kg Lemon flavor 0.030 kg Make 1000 bags

[0058] 2. Preparation process steps:

[0059] (1) Raw material pretreatment

[0060] The sodium dihydrogen phosphate monohydrate and the disodium hydrogen phosphate are sieved through an 80-mesh sieve and prepared for use;

[0061] The lidocaine hydrochloride and the sucralose are crushed and sieved through an 80-mesh sieve and prepared for use;

[0062] (2) Total mixing: the above sieved and crushed sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride and sucralose are weighed and added to a hopper mixer, and the prescription amount of lemon essence is added to the hopper mixer, the mixing speed is set to 8 revolutions per minute, and the mixing time is 15 minutes, and the mixture is mixed uniformly.

[0063] (3) Packaging: the mixed material is packaged with aluminum plastic composite film to obtain a sodium phosphate salt complex.

[0064] Example 3

[0065] 1. Prescription:

[0066] Sodium phosphate monobasic monohydrate 21.6 kg Sodium phosphate dibasic 4.3 kg Lidocaine hydrochloride 0.20 kg Sucralose 0.05 kg Lemon flavor 0.040 kg Make 1000 bags

[0067] 2. Preparation process steps:

[0068] (1) Raw material pretreatment

[0069] The sodium dihydrogen phosphate monohydrate and the disodium hydrogen phosphate are sieved through an 80-mesh sieve and prepared for use;

[0070] The lidocaine hydrochloride and the sucralose are crushed and sieved through an 80-mesh sieve and prepared for use;

[0071] (2) Total mixing: the above sieved and crushed sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride and sucralose are weighed and added to a hopper mixer, and the prescription amount of lemon essence is added to the hopper mixer, the mixing speed is set to 10 revolutions per minute, and the mixing time is 45 minutes, and the mixture is mixed uniformly.

[0072] (3) Packaging: the mixed material is packaged with aluminum plastic composite film to obtain a sodium phosphate salt complex

[0073] Example 4

[0074] 1. Prescription:

[0075] Sodium phosphate monobasic monohydrate 21.6 kg Sodium phosphate dibasic 4.3 kg Lidocaine hydrochloride 0.18 kg Acesulfame potassium 0.25 kg Lemon flavor 0.02 kg Make 1000 bags

[0076] 2. Preparation process steps:

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

[0078] Sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate were sieved through an 80-mesh sieve and prepared for use;

[0079] Lidocaine hydrochloride and acesulfame were crushed and sieved through an 80-mesh sieve and prepared for use;

[0080] (2) Total mixing: The above sieved and crushed sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, lidocaine hydrochloride, and acesulfame were weighed and added to a hopper mixer. The prescription amount of lemon banana was also weighed and added to the hopper mixer. The mixing speed was set to 7 revolutions per minute, and the mixing time was 25 minutes. The mixture was mixed until it was uniform.

[0081] (3) Sub-packing: The mixed material was sub-packed with aluminum plastic composite film to obtain a sodium phosphate salt compound.

[0082] Test example

[0083] From November 2023 to December 2023, 120 cases of ordinary colonoscopy were performed in a hospital in Hubei. A random, blind, and controlled design was used. 120 patients were randomly divided into control group 1 (marketed sodium phosphate salt powder) 30 cases, control group 2 (marketed sodium phosphate salt powder + taking lidocaine hydrochloride gum before surgery 4-6 hours) 30 cases, control group 3 (marketed sodium phosphate salt powder + taking lidocaine hydrochloride gum before surgery 5-10 minutes) 30 cases, and test group (sodium phosphate salt compound prepared in Example 1) 30 cases. Among them, control group 1 had 17 males and 13 females, with an average age of 57.8 years; control group 2 had 14 males and 16 females, with an average age of 55.9 years; control group 3 had 15 males and 15 females, with an average age of 58.5 years; and the test group had 16 males and 14 females, with an average age of 54.5 years. There were no statistically significant differences in gender, age, height, body mass, heart rate, blood pressure, and intestinal preparation purposes between the four groups (P>0.05), and they were comparable.

[0084] Treatment method:

[0085] Control group 1 (marketed sodium phosphate salt powder, Sichuan Jianeng Pharmaceutical Co., Ltd., batch number: 230401, marketed hydrochloric acid lidocaine paste, Sichuan Jianeng Pharmaceutical Co., Ltd., batch number: 230203), after diluting the sodium phosphate salt powder with warm water, 1 bag (the amount of sodium phosphate salt powder is 21.6g of sodium dihydrogen phosphate and 4.3g of disodium hydrogen phosphate) was taken at 19:00 the night before the examination and 7:00 on the same day, and water could be drunk until the clear water-like stool was eliminated. At 5:00 on the same day (4-6 hours in advance), 10g of hydrochloric acid lidocaine paste (0.2g of hydrochloric acid lidocaine) was taken.

[0086] Control group 2 (marketed sodium phosphate salt powder, Sichuan Jianeng Pharmaceutical Co., Ltd., batch number: 230401, marketed hydrochloric acid lidocaine paste, Sichuan Jianeng Pharmaceutical Co., Ltd., batch number: 230203), after diluting the sodium phosphate salt powder with warm water, 1 bag (the amount of sodium phosphate salt powder is 21.6g of sodium dihydrogen phosphate and 4.3g of disodium hydrogen phosphate) was taken at 19:00 the night before the examination and 7:00 on the same day, and water could be drunk until the clear water-like stool was eliminated. At 9:50-9:55 on the same day (5-10 minutes in advance), 10g of hydrochloric acid lidocaine paste (0.2g of hydrochloric acid lidocaine) was taken.

[0087] Control group 3 (marketed sodium phosphate salt powder, Sichuan Jianeng Pharmaceutical Co., Ltd., batch number: 230401), after diluting the sodium phosphate salt powder with warm water, 1 bag (the amount of sodium phosphate salt powder is 21.6g of sodium dihydrogen phosphate and 4.3g of disodium hydrogen phosphate) was taken at 19:00 the night before the examination and 7:00 on the same day, and water could be drunk until the clear water-like stool was eliminated.

[0088] Test group (self-made product, Example 1), after diluting the sodium phosphate salt complex with warm water, 1 bag (1 bag contains 21.6g of sodium dihydrogen phosphate, 4.3g of disodium hydrogen phosphate and 0.1g of hydrochloric acid lidocaine) was taken at 19:00 the night before the examination and 7:00 on the same day, and water could be drunk until the clear water-like stool was eliminated.

[0089] Observation items:

[0090] 1. Questionnaires were distributed to investigate the satisfaction of patients, doctors and nurses with the effect of intestinal preparation, the satisfaction of patients included drug compliance, tolerance of patients during the detection process, and the satisfaction of doctors and nurses included the cooperation of patients, the smoothness of the examination process, the overall satisfaction of the examination, etc.

[0091] 2. Intestinal cleanliness effect evaluation: excellent (3): empty, collapsed without gas, no hyperemia of mucosa, complete exposure of surgical field; good (2): not full, a small amount of gas, mild hyperemia of mucosa, complete exposure of surgical field; medium (1): not full, a large amount of gas, hyperemia of mucosa, incomplete exposure of surgical field; poor (0): distended, a large amount of gas, obvious hyperemia of mucosa, not covered surgical field.

[0092] 3. Postoperative exhaust and defecation time of patients in the four groups was observed.

[0093] 4. Postoperative complications such as incision infection, abdominal infection, anastomotic fistula, etc. of patients in the four groups were observed.

[0094] The treatment results are as follows:

[0095] (1) Satisfaction degree of intestinal preparation effect

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

[0097]

[0098] As shown in Table 1, the overall satisfaction degree of the test group is 90.00% to 96.67%; the overall satisfaction degree of control group 1 and control group 2 is 76.67% to 83.33%, and the overall satisfaction degree of control group 3 is 66.67% to 73.33%. The overall satisfaction degree of the test group is much higher than that of the control groups, indicating that the compound provided by the application can effectively improve the satisfaction degree of intestinal preparation effect.

[0099] (2) Intestinal cleanliness

[0100] Table 2 Comparison of full colon cleaning quality of patients in the four groups

[0101] Group Example 0 level 1 level 2 level 3 level Test 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 shown in Table 2, the full colon cleaning quality of the test group can reach 86.7% to 93.3%; the full colon cleaning quality of control group 1 is 73.3% to 80.0%; the full colon cleaning quality of control group 2 is 73.3% to 83.3%, and the full colon cleaning quality of control group 3 is 66.7% to 76.7%. The full colon cleaning quality of the test group is much higher than that of the control groups, indicating that the compound provided by the application can effectively improve the intestinal cleanliness.

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

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

[0105] Group n Postoperative exhaust time Defecation time Test group 30 17.32 ± 3.988 abc ]] 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: a: p < 0.05 compared with control group 1; b: p < 0.05 compared with control group 2; c: p < 0.05 compared with control group 3.

[0107] As shown in Table 3, the anal exhaust and defecation time of the patients in the test group were earlier than those in control groups 1-3, and there were significant differences, indicating that the test group had obvious advantages in promoting the exhaust and defecation time of the patients after operation.

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

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

[0110]

[0111] As shown in Table 4, the incidence of postoperative complications of the patients in the test group was significantly lower than that in control groups 1-3, indicating that the test group had obvious improvement in the complications of the patients after operation compared with the control groups.

[0112] As shown in Tables 1-4, compared with sodium phosphate salt powder, sodium phosphate salt powder + hydrochloric acid lidocaine gum separated administration 4-6 hours before operation, and sodium phosphate salt powder + hydrochloric acid lidocaine gum separated administration 5-10 minutes before operation, the present application prepared the sodium phosphate salt and hydrochloric acid lidocaine into a compound for simultaneous administration, which was superior to sodium phosphate salt powder in the satisfaction of intestinal preparation effect and intestinal cleanliness, and was equivalent to the effect of sodium phosphate salt powder and lidocaine combined in sequence, without obvious improvement. However, the present application prepared the sodium phosphate salt and hydrochloric acid lidocaine into a compound for simultaneous administration was obviously superior to sodium phosphate salt powder and lidocaine combined in sequence in the postoperative exhaust and defecation time, postoperative complications and other indicators.

[0113] The above only describes the preferred embodiments of the present application, and it should be noted that for those skilled in the art, some improvements and refinements can be made without departing from the principles of the present application, and these improvements and refinements should also be considered as the protection scope of the present application.

Claims

1. A sodium phosphate complex, comprising: 20-25 parts by weight of sodium dihydrogen phosphate or its monohydrate; 4-5 parts by weight of disodium hydrogen phosphate; 0.1 to 0.25 parts by weight of lidocaine hydrochloride; 0~0.04 parts by weight of fragrance; 0 to 0.25 parts by weight of sweetener.

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

3. The sodium phosphate complex according to claim 1, characterized in that, The fragrance is selected from lemon flavoring.

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 below 80 mesh.

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

6. The sodium phosphate complex according to claim 5, characterized in that, 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: Sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride, sweetener and flavoring agent are mixed evenly to obtain sodium phosphate salt 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, the sodium dihydrogen phosphate raw material, disodium hydrogen phosphate raw material, lidocaine hydrochloride and sweetener are passed through an 80-mesh sieve.

9. The preparation method according to claim 8, characterized in that, The mixing speed is 1 rpm to 10 rpm, and the time is 10 minutes to 60 minutes.

10. The use of the sodium phosphate complex according to any one of claims 1 to 6 in the preparation of a medicament for shortening the postoperative defecation time and / or reducing postoperative complications of colonoscopy.

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